Hearing LossNCT06955494
ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life
A study testing Empowerment Network for Auditory-Cognitive Training (ENACT) Program in people with Hearing Loss and Cognitive Impairment, Mild, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Although previous studies indicated that tackling hearing loss may have a secondary benefit in improving cognitive function and delaying the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hearing Loss, Cognitive Impairment, Mild
- What is being tested?
- Empowerment Network for Auditory-Cognitive Training (ENACT) Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild cognitive impairment accordingly to the Petersen's criteria
- With at least one-side hearing impairment as defined by a score of 2- or 3- digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test)
- Has a smartphone to access the online training materials
- Not received formal cognitive and auditory training in the past 6 months.
- Available of primary caregiver in the family
- give consent to participate
Who cannot join
- moderate and severe cognitive impairment
- Other sensory impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Doris Yu Sau Fung, PhD, +852 3917 6319, dyu1@hku.hk
About this study
Official title: The Effect of the "Empowerment Network for Auditory-Cognitive Training (ENACT) Program" on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life of Persons Living With Mild Cognitive Impairment
Although previous studies indicated that tackling hearing loss may have a secondary benefit in improving cognitive function and delaying the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training into cognitive training, as both of them are activity-based and focus on increasing the attention and working memory of an individual to engage in the auditory communication process. Moreover, auditory instruction is one of the core mediums in delivering cognitive training activities. It is highly possible to integrate the auditory training curricular to the corresponding administration process. To tackle the enhanced support need of individuals with dual functional impairment to engage in an integrated training protocol, strategies including a goal-oriented approach and peer support can be integrated to optimize the empowerment network. Including family members in the training is also important, as the auditory-communication process in everyday life would take place in the social interactional context.
This is a pilot mixed-method pilot study comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community centers. The inclusion criteria include mild cognitive impairment according to Petersen's criteria; with at least one-side hearing impairment as defined by a score of 2- or 3-digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test); has a smartphone to access the online training materials; not received formal cognitive and auditory training in the past 6 months. After the baseline outcome evaluation, they will be randomized to receive the 12-week ENACT program or the usual care control. The nurse-led ENACT program comprises three phases, including i) the goal-oriented health counselling phase, ii) the peer-assisted group-based auditory-cognitive training phase, and iii) the family-engaged active-communication training phase. The outcome evaluation on hearing function, perceived benefit of auditory training, cognitive function, and HRQoL will be assessed at baseline, in the 12th and 18th weeks. Qualitative interviews will be conducted
Read the detailed description
Research evidence on tackling the dual cognitive and hearing impairment is very limited. Although previous studies indicated that tackling hearing loss may have a secondary benefit on improving cognitive function and delay the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. In fact, cognitive training is a standard evidence-based care to managing MCI. It is timely to explore how the management of hearing loss can be integrated to cognitive training to tackle the dual impairment. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training to cognitive training, as both of them are activity-based and focusing on increasing the attention and working memory of an individual to engage in the auditory-communication process. Moreover, auditory instruction is one of the core mediums in delivering cognitive training activities. It is highly possible to integrate the auditory training curricular to the corresponding administration process. To tackle the enhanced support need of individuals with dual functional impairment to engage in an integrated training protocol, strategies including goal-oriented approach and peer support can be integrated to optimize the empowerment network. Including family members in the training is also important, as the auditory-communication process in everyday life would take place in the social interactional context.
The target population is the persons living with mild cognitive impairment (PLwMCI) who have hearing impairment. MCI is defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment (education adjusted), the presence of subjective memory complaint and preserved daily activity function. [30] Hearing impairment is identified by the integrated Digit-In-Noise (DIN) test developed by the Co-I (L Wong) with the results of 2- or 3-digit results greater than the norm value to indicate hearing loss. Other inclusion criteria include: i) available of primary caregiver in the family, ii) have smart phone to receive online training materials, iii) not receive formal cognitive or auditory training in the past 6 months, iv) no other sensory impairment, and v) consent to participate.
The 12-week Empowerment Network on Auditory-Cognitive Training (ENACT) Program aims to offer combined auditory and cognitive training to the PLwMCI with hearing loss. A person-centered approach is used to not only engage the PLwMCI in combined auditory-cognitive training, but also to empower them and their significant others to maintain better communication, social interaction and social engagement in everyday life. Empowerment network refers to the use of collaborative and partnership approach between the nurse, family member and peer health coach to optimize and sustain the training effects of ENACT program. The ENACT Program comprises of three phases as follows:
Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment, particularly on how it affects their daily living, social engagement, coping and adaptation. Education on how such functional decline set up a vicious cycle of further impairment will be given to motivate self-directed goal setting. An agreeable action plan with consideration of the clients' preference and resource will be developed. On the followed week, the nurse will conduct a telephone visit to follow up the action plan implementation and give additional support if needed.
Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. The content for the six sessions is developed according to the hierarchy of auditory skills proposed by Erher which comprises four level of increasing difficulty including sound awareness, sound discrimination, sound identification and sound comprehension. Activities proposed by the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) on working memory training, attention bias motivation, and cognitive interpretive training are integrated in planning the auditory training activities to achieve the dual benefit.[33] To better secure the participants' confidence and motivation in learning, the training will be commenced with low difficulty level with lower level auditory training, and progressively to incorporate more cognitive training activities and higher level auditory training. A total of 2-3 trained peer health coach will join the group session to facilitate the practice. Home exercise in format of audio-scripts and online response grid are developed, so that the health coach can better engage the participants via their preferred social platform such as WhatsApp's or WeChat for two times before the next group session. Each qualified health coach has received 12- hour training which covers effective communication with persons with auditory-cognitive impairment, instructions to administer auditory and cognitive training activities, and motivational strategies for older adults.
Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. The content is developed according to Active Communication Education (ACE Program) which developed for adults with hearing loss. This phase will comprise 2 bi-weekly training sessions for the PLwMCI and 2 online training sessions with the involvement of the primary family caregivers. The online session is needed as effective communication take places in interactional and interpersonal context. The importance and strategies for the family to engage the PLwMCI in everyday decision-making and activity will also be highlighted.
In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.
This is a pilot mixed method study, comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community center. The inclusion criteria include mild cognitive impairment accordingly to the Petersen's criteria; with at least one-side hearing impairment as defined by a score of 2- or 3- digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test); has a smartphone to access the online training materials; not received formal cognitive and auditory training in the past 6 months. After the baseline outcome evaluation, they will be randomized to receive the 12-week ENACT program or the usual care control. The nurse-led ENACT program comprises three phases including i) goal-oriented health counseling phase, ii) the peer-assisted group-based auditory-cognitive training phase, and iii) the family engaged active-communication training phase. The outcome evaluation on hearing function, perceived benefit of auditory training, the cognitive function and HRQoL will be assessed at baseline, 12th and 18th week. Qualitative interview with the PLwMCI, their family members and the peer health coach will be conducted to solicit their experience in the process.
The nurse will assess the baseline outcomes of the participants with the following validated measures before randomization. Another RA who has no information about the group assignment will conduct the post-test measure at the 12th and 18th week after the commencement of the intervention.
- A battery of cognitive assessment will be used to evaluate various domains of cognition of the PLwMCI, including the Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) for global cognition, the digit span-forward and backward test for attention and working memory, and Trail-Making Test Part A and B for complex attention, executive function and task switching. Multiple assessments are essential for detecting subtle cognitive changes.
- The Glasgow Hearing Aid Benefit Profile will assess the self-perceived benefit of auditory training.
- The Revised Hearing Handicap Inventory for the Elderly [37] to assess the perceived hearing loss.
- The Short-From 12 Survey to measure the overall HRQoL as well as the physical and mental health.
Upon the completion of the ENACT Program, interviews will be conducted to the participants and their family caregivers in a dyadic format. Focus group interview will be conducted to health coach. The interviews will be audiotaped with the consent of the participants. Interview guides with open-ended questions are used to guide the interviews.
Data will be analyzed on an intention-to-treat basis. Skewed variables will be transformed before subjected to analyses. Baseline characteristics between the two arms of participants will be compared using t test, chi-square test or Fisher's exact test, as appropriate. Generalized Estimating Equation will be used to compare the differential changes on the health outcomes of the PLwMCI and family caregivers across the baseline, 12th week (T2) and 18th Week (T3) between the two study arms, with adjustment for a set of priori control variables including age, sex, educational level and other comorbidity burden. The findings will provide important insights on the feasibility, clients' perception and preliminary effect of an innovative care approach to tackle dual functional loss in PLwMCI with hearing loss.
- Conditions
- Hearing Loss, Cognitive Impairment, Mild
- Being tested
- Empowerment Network for Auditory-Cognitive Training (ENACT) Program, Usual Care
- Keywords
- cognitive impairment, hearing loss
- Medical subject headings
- Hearing Loss, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment Network for Auditory-Cognitive Training (ENACT) ProgramOther
The ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.
Usual CareOther
Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection.
| Study group | Role | What they receive |
|---|---|---|
| ENACT program | Experimental | The ENACT Program is an overall 12-week training and comprises of three phases as follows:
1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment.
2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers.
3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss.
In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly. Receives: Other: Empowerment Network for Auditory-Cognitive Training (ENACT) Program |
| Usual care | Placebo comparator | Usual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Measured: Baseline (T0)
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Measured: 12th week (T1) after baseline
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Measured: 18th week (T2) after baseline
The digit span-forward and backward test
Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
Measured: Baseline (T0)
The digit span-forward and backward test
Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
Measured: 12th week (T1) after baseline
The digit span-forward and backward test
Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
Measured: 18th week (T2) after baseline
Trail-Making Test Part A and B
Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function
Measured: Baseline (T0)
Trail-Making Test Part A and B
Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function
Measured: 12th week (T1) after baseline
Trail-Making Test Part A and B
Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function
Measured: 18th week (T2) after baseline
Secondary outcomes (9)
Glasgow Hearing Aid Benefit Profile
Assess the self-perceived benefit of auditory training
Measured: Baseline (T0)
Glasgow Hearing Aid Benefit Profile
Assess the self-perceived benefit of auditory training
Measured: 12th week (T1) after baseline
Glasgow Hearing Aid Benefit Profile
Assess the self-perceived benefit of auditory training
Measured: 18th week (T2) after baseline
Revised Hearing Handicap Inventory for the Elderly
Assess the perceived hearing loss, higher score means greater handicapping effect of a hearing impairment
Measured: Baseline (T0)
Revised Hearing Handicap Inventory for the Elderly
Assess the perceived hearing loss, higher score means greater handicapping effect of a hearing impairment
Measured: 12th week (T1) after baseline
Revised Hearing Handicap Inventory for the Elderly
Assess the perceived hearing loss, higher score means greater handicapping effect of a hearing impairment
Measured: 18th week (T2) after baseline
12-Item Short-Form Health Survey
Measure the overall Health-Related Quality of Life as well as the physical and mental health, scale from 0-100, higher score indicates better quality of life
Measured: Baseline (T0)
12-Item Short-Form Health Survey
Measure the overall Health-Related Quality of Life as well as the physical and mental health, scale from 0-100, higher score indicates better quality of life
Measured: 12th week (T1) after baseline
12-Item Short-Form Health Survey
Measure the overall Health-Related Quality of Life as well as the physical and mental health, scale from 0-100, higher score indicates better quality of life
Measured: 18th week (T2) after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start4 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- SAU FUNG DORIS YU, PhD, Principal investigator, HKU School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955494
- Sponsor's protocol ID
- ENACT-Pilot
- Status last verified
- Nov 2025
- First submitted
- 18 Mar 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available.
Publications
Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.
PubMed 15324362Laplante-Levesque A, Hickson L, Worrall L. Rehabilitation of older adults with hearing impairment: a critical review. J Aging Health. 2010 Mar;22(2):143-53. doi: 10.1177/0898264309352731. Epub 2010 Jan 7.
PubMed 20056812Hallberg LR, Hallberg U, Kramer SE. Self-reported hearing difficulties, communication strategies and psychological general well-being (quality of life) in patients with acquired hearing impairment. Disabil Rehabil. 2008;30(3):203-12. doi: 10.1080/09638280701228073.
PubMed 17852289Sprinzl GM, Riechelmann H. Current trends in treating hearing loss in elderly people: a review of the technology and treatment options - a mini-review. Gerontology. 2010;56(3):351-8. doi: 10.1159/000275062. Epub 2010 Jan 12.
PubMed 20090297Jorgensen LE, Messersmith JJ. Impact of Aging and Cognition on Hearing Assistive Technology Use. Semin Hear. 2015 Aug;36(3):162-74. doi: 10.1055/s-0035-1555119.
PubMed 27516716Gallagher NE, Woodside JV. Factors Affecting Hearing Aid Adoption and Use: A Qualitative Study. J Am Acad Audiol. 2018 Apr;29(4):300-312. doi: 10.3766/jaaa.16148.
PubMed 29664724Zheng H, Wong LLN, Hickson L. Barriers to hearing aid adoption among older adults in mainland China. Int J Audiol. 2023 Sep;62(9):814-825. doi: 10.1080/14992027.2022.2105263. Epub 2022 Aug 23.
PubMed 35997572Bucholc M, Bauermeister S, Kaur D, McClean PL, Todd S. The impact of hearing impairment and hearing aid use on progression to mild cognitive impairment in cognitively healthy adults: An observational cohort study. Alzheimers Dement (N Y). 2022 Feb 22;8(1):e12248. doi: 10.1002/trc2.12248. eCollection 2022.
PubMed 35229022Dawes P, Wolski L, Himmelsbach I, Regan J, Leroi I. Interventions for hearing and vision impairment to improve outcomes for people with dementia: a scoping review. Int Psychogeriatr. 2019 Feb;31(2):203-221. doi: 10.1017/S1041610218000728. Epub 2018 Sep 24.
PubMed 30244688Chen L, Zhou R. Does self-reported hearing difficulty decrease older adults' cognitive and physical functioning? The mediating role of social isolation. Maturitas. 2020 Nov;141:53-58. doi: 10.1016/j.maturitas.2020.06.011. Epub 2020 Jun 20.
PubMed 33036703Mitchell AJ, Shiri-Feshki M. Rate of progression of mild cognitive impairment to dementia--meta-analysis of 41 robust inception cohort studies. Acta Psychiatr Scand. 2009 Apr;119(4):252-65. doi: 10.1111/j.1600-0447.2008.01326.x. Epub 2008 Feb 18.
PubMed 19236314Lawrence BJ, Jayakody DMP, Bennett RJ, Eikelboom RH, Gasson N, Friedland PL. Hearing Loss and Depression in Older Adults: A Systematic Review and Meta-analysis. Gerontologist. 2020 Apr 2;60(3):e137-e154. doi: 10.1093/geront/gnz009.
PubMed 30835787Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.
PubMed 14570962Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
PubMed 22169081
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the "Empowerment Network for Auditory-Cognitive Training (ENACT) Program" on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life of Persons Living With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06955494
- Acronym / sponsor ID
- ENACT-Pilot
- Conditions
- Hearing Loss, Cognitive Impairment, Mild
- Keywords
- cognitive impairment, hearing loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although previous studies indicated that tackling hearing loss may have a secondary benefit in improving cognitive function and delaying the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training into cognitive training, as both of them are activity-based and focus on increasing the attention and working memory of an individual to engage in the auditory communication process. Moreover, auditory instruction is one of the core mediums in delivering cognitive training activities. It is highly possible to integrate the auditory training curricular to the corresponding administration process. To tackle the enhanced support need of individuals with dual functional impairment to engage in an integrated training protocol, strategies including a goal-oriented approach and peer support can be integrated to optimize the empowerment network. Including family members in the training is also important, as the auditory-communication process in everyday life would take place in the social interactional context.
This is a pilot mixed-method pilot study comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community centers. The inclusion criteria include mild cognitive impairment according to Petersen's criteria; with at least one-side hearing impairment as defined by a score of 2- or 3-digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test); has a smartphone to access the online training materials; not received formal cognitive and auditory training in the past 6 months. After the baseline outcome evaluation, they will be randomized to receive the 12-week ENACT program or the usual care control. The nurse-led ENACT program comprises three phases, including i) the goal-oriented health counselling phase, ii) the peer-assisted group-based auditory-cognitive training phase, and iii) the family-engaged active-communication training phase. The outcome evaluation on hearing function, perceived benefit of auditory training, cognitive function, and HRQoL will be assessed at baseline, in the 12th and 18th weeks. Qualitative interviews will be conducted
Detailed description
Research evidence on tackling the dual cognitive and hearing impairment is very limited. Although previous studies indicated that tackling hearing loss may have a secondary benefit on improving cognitive function and delay the onset of dementia, a more integrated care approach to optimize both hearing and cognitive function may be needed for individuals who already developed cognitive decline. In fact, cognitive training is a standard evidence-based care to managing MCI. It is timely to explore how the management of hearing loss can be integrated to cognitive training to tackle the dual impairment. To address the dual care needs for PwMCI and hearing impairment, it may be possible to integrate auditory training to cognitive training, as both of them are activity-based and focusing on increasing the attention and working memory of an individual to engage in the auditory-communication process. Moreover, auditory instruction is one of the core mediums in delivering cognitive training activities. It is highly possible to integrate the auditory training curricular to the corresponding administration process. To tackle the enhanced support need of individuals with dual functional impairment to engage in an integrated training protocol, strategies including goal-oriented approach and peer support can be integrated to optimize the empowerment network. Including family members in the training is also important, as the auditory-communication process in everyday life would take place in the social interactional context.
The target population is the persons living with mild cognitive impairment (PLwMCI) who have hearing impairment. MCI is defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment (education adjusted), the presence of subjective memory complaint and preserved daily activity function. [30] Hearing impairment is identified by the integrated Digit-In-Noise (DIN) test developed by the Co-I (L Wong) with the results of 2- or 3-digit results greater than the norm value to indicate hearing loss. Other inclusion criteria include: i) available of primary caregiver in the family, ii) have smart phone to receive online training materials, iii) not receive formal cognitive or auditory training in the past 6 months, iv) no other sensory impairment, and v) consent to participate.
The 12-week Empowerment Network on Auditory-Cognitive Training (ENACT) Program aims to offer combined auditory and cognitive training to the PLwMCI with hearing loss. A person-centered approach is used to not only engage the PLwMCI in combined auditory-cognitive training, but also to empower them and their significant others to maintain better communication, social interaction and social engagement in everyday life. Empowerment network refers to the use of collaborative and partnership approach between the nurse, family member and peer health coach to optimize and sustain the training effects of ENACT program. The ENACT Program comprises of three phases as follows:
Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment, particularly on how it affects their daily living, social engagement, coping and adaptation. Education on how such functional decline set up a vicious cycle of further impairment will be given to motivate self-directed goal setting. An agreeable action plan with consideration of the clients' preference and resource will be developed. On the followed week, the nurse will conduct a telephone visit to follow up the action plan implementation and give additional support if needed.
Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. The content for the six sessions is developed according to the hierarchy of auditory skills proposed by Erher which comprises four level of increasing difficulty including sound awareness, sound discrimination, sound identification and sound comprehension. Activities proposed by the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) on working memory training, attention bias motivation, and cognitive interpretive training are integrated in planning the auditory training activities to achieve the dual benefit.[33] To better secure the participants' confidence and motivation in learning, the training will be commenced with low difficulty level with lower level auditory training, and progressively to incorporate more cognitive training activities and higher level auditory training. A total of 2-3 trained peer health coach will join the group session to facilitate the practice. Home exercise in format of audio-scripts and online response grid are developed, so that the health coach can better engage the participants via their preferred social platform such as WhatsApp's or WeChat for two times before the next group session. Each qualified health coach has received 12- hour training which covers effective communication with persons with auditory-cognitive impairment, instructions to administer auditory and cognitive training activities, and motivational strategies for older adults.
Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. The content is developed according to Active Communication Education (ACE Program) which developed for adults with hearing loss. This phase will comprise 2 bi-weekly training sessions for the PLwMCI and 2 online training sessions with the involvement of the primary family caregivers. The online session is needed as effective communication take places in interactional and interpersonal context. The importance and strategies for the family to engage the PLwMCI in everyday decision-making and activity will also be highlighted.
In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.
This is a pilot mixed method study, comprising a randomized controlled trial and a post-trail qualitative interview. A total of 62 participants will be recruited from two community center. The inclusion criteria include mild cognitive impairment accordingly to the Petersen's criteria; with at least one-side hearing impairment as defined by a score of 2- or 3- digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test); has a smartphone to access the online training materials; not received formal cognitive and auditory training in the past 6 months. After the baseline outcome evaluation, they will be randomized to receive the 12-week ENACT program or the usual care control. The nurse-led ENACT program comprises three phases including i) goal-oriented health counseling phase, ii) the peer-assisted group-based auditory-cognitive training phase, and iii) the family engaged active-communication training phase. The outcome evaluation on hearing function, perceived benefit of auditory training, the cognitive function and HRQoL will be assessed at baseline, 12th and 18th week. Qualitative interview with the PLwMCI, their family members and the peer health coach will be conducted to solicit their experience in the process.
The nurse will assess the baseline outcomes of the participants with the following validated measures before randomization. Another RA who has no information about the group assignment will conduct the post-test measure at the 12th and 18th week after the commencement of the intervention.
- A battery of cognitive assessment will be used to evaluate various domains of cognition of the PLwMCI, including the Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) for global cognition, the digit span-forward and backward test for attention and working memory, and Trail-Making Test Part A and B for complex attention, executive function and task switching. Multiple assessments are essential for detecting subtle cognitive changes.
- The Glasgow Hearing Aid Benefit Profile will assess the self-perceived benefit of auditory training.
- The Revised Hearing Handicap Inventory for the Elderly [37] to assess the perceived hearing loss.
- The Short-From 12 Survey to measure the overall HRQoL as well as the physical and mental health.
Upon the completion of the ENACT Program, interviews will be conducted to the participants and their family caregivers in a dyadic format. Focus group interview will be conducted to health coach. The interviews will be audiotaped with the consent of the participants. Interview guides with open-ended questions are used to guide the interviews.
Data will be analyzed on an intention-to-treat basis. Skewed variables will be transformed before subjected to analyses. Baseline characteristics between the two arms of participants will be compared using t test, chi-square test or Fisher's exact test, as appropriate. Generalized Estimating Equation will be used to compare the differential changes on the health outcomes of the PLwMCI and family caregivers across the baseline, 12th week (T2) and 18th Week (T3) between the two study arms, with adjustment for a set of priori control variables including age, sex, educational level and other comorbidity burden. The findings will provide important insights on the feasibility, clients' perception and preliminary effect of an innovative care approach to tackle dual functional loss in PLwMCI with hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly.
| Arm | Type | Receives |
|---|---|---|
| ENACT program | Experimental | Other: Empowerment Network for Auditory-Cognitive Training (ENACT) ProgramThe ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly. |
| Usual care | Placebo comparator | Other: Usual CareUsual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild cognitive impairment accordingly to the Petersen's criteria
- With at least one-side hearing impairment as defined by a score of 2- or 3- digit test greater than the norm value on the integrated Digit-in-Noise (iDIN test)
- Has a smartphone to access the online training materials
- Not received formal cognitive and auditory training in the past 6 months.
- Available of primary caregiver in the family
Key exclusion criteria (2 listed)
- moderate and severe cognitive impairment
- Other sensory impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment Network for Auditory-Cognitive Training (ENACT) ProgramThe ENACT Program is an overall 12-week training and comprises of three phases as follows: 1. Goal-oriented health counseling phase (1st - 2nd week) - A nurse consultation will be conducted in the center with the aim to identify the participants' experience of living with the hearing and cognitive impairment. 2. Peer-assisted group-based auditory-cognitive training phase (3rd-8th week) - This phase is led and conducted by the nurse with the focus to provide combined group-based auditory and cognitive training (group size = 6) with support from the trained peers. 3. Family engaged active-communication training phase (9th - 12th week) - This phase is to empower the PLwMCI and their primary caregivers on active communication strategies in the presence of hearing loss. In the 2nd and 3rd phase, the nurse will continue to monitor the goal attainment of the PLwMCI and make additional health counseling and goal adjustment accordingly. | Other | ENACT program |
| Usual CareUsual care will be provided to the control group which mainly covers the social activities offered by the affiliated center. The participants are requested not to join any activities relating to cognitive training or auditory training before the post-test data collection. | Other | Usual care |
Primary outcome
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
Time frame: Baseline (T0)
Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
Time frame: 12th week (T1) after baseline
Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog)
Time frame: 18th week (T2) after baseline
Evaluate the cognitive domain function of the patient with dementia (PwD), scale from 0-70, with higher score indicating poor cognitive function.
The digit span-forward and backward test
Time frame: Baseline (T0)
Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
The digit span-forward and backward test
Time frame: 12th week (T1) after baseline
Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
The digit span-forward and backward test
Time frame: 18th week (T2) after baseline
Evaluate the attention and working memory of the patient with dementia, scales from 10 to 56, with higher score indicating better attention and working memory function
Trail-Making Test Part A and B
Time frame: Baseline (T0)
Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function
Trail-Making Test Part A and B
Time frame: 12th week (T1) after baseline
Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function
Trail-Making Test Part A and B
Time frame: 18th week (T2) after baseline
Evaluate the complex attention, executive function and task switching, with shorter time required to complete the task indicating better complex attention, executive function and task switching function
9 secondary outcomes
Glasgow Hearing Aid Benefit Profile
Time frame: Baseline (T0)
Glasgow Hearing Aid Benefit Profile
Time frame: 12th week (T1) after baseline
Glasgow Hearing Aid Benefit Profile
Time frame: 18th week (T2) after baseline
Revised Hearing Handicap Inventory for the Elderly
Time frame: Baseline (T0)
Revised Hearing Handicap Inventory for the Elderly
Time frame: 12th week (T1) after baseline
Revised Hearing Handicap Inventory for the Elderly
Time frame: 18th week (T2) after baseline
12-Item Short-Form Health Survey
Time frame: Baseline (T0)
12-Item Short-Form Health Survey
Time frame: 12th week (T1) after baseline
12-Item Short-Form Health Survey
Time frame: 18th week (T2) after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 15324362Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.
- Background: PubMed 20056812Laplante-Levesque A, Hickson L, Worrall L. Rehabilitation of older adults with hearing impairment: a critical review. J Aging Health. 2010 Mar;22(2):143-53. doi: 10.1177/0898264309352731. Epub 2010 Jan 7.
- Background: PubMed 17852289Hallberg LR, Hallberg U, Kramer SE. Self-reported hearing difficulties, communication strategies and psychological general well-being (quality of life) in patients with acquired hearing impairment. Disabil Rehabil. 2008;30(3):203-12. doi: 10.1080/09638280701228073.
- Background: PubMed 20090297Sprinzl GM, Riechelmann H. Current trends in treating hearing loss in elderly people: a review of the technology and treatment options - a mini-review. Gerontology. 2010;56(3):351-8. doi: 10.1159/000275062. Epub 2010 Jan 12.
- Background: PubMed 27516716Jorgensen LE, Messersmith JJ. Impact of Aging and Cognition on Hearing Assistive Technology Use. Semin Hear. 2015 Aug;36(3):162-74. doi: 10.1055/s-0035-1555119.
- Background: PubMed 29664724Gallagher NE, Woodside JV. Factors Affecting Hearing Aid Adoption and Use: A Qualitative Study. J Am Acad Audiol. 2018 Apr;29(4):300-312. doi: 10.3766/jaaa.16148.
- Background: PubMed 35997572Zheng H, Wong LLN, Hickson L. Barriers to hearing aid adoption among older adults in mainland China. Int J Audiol. 2023 Sep;62(9):814-825. doi: 10.1080/14992027.2022.2105263. Epub 2022 Aug 23.
- Background: PubMed 35229022Bucholc M, Bauermeister S, Kaur D, McClean PL, Todd S. The impact of hearing impairment and hearing aid use on progression to mild cognitive impairment in cognitively healthy adults: An observational cohort study. Alzheimers Dement (N Y). 2022 Feb 22;8(1):e12248. doi: 10.1002/trc2.12248. eCollection 2022.
- Background: PubMed 30244688Dawes P, Wolski L, Himmelsbach I, Regan J, Leroi I. Interventions for hearing and vision impairment to improve outcomes for people with dementia: a scoping review. Int Psychogeriatr. 2019 Feb;31(2):203-221. doi: 10.1017/S1041610218000728. Epub 2018 Sep 24.
- Background: PubMed 33036703Chen L, Zhou R. Does self-reported hearing difficulty decrease older adults' cognitive and physical functioning? The mediating role of social isolation. Maturitas. 2020 Nov;141:53-58. doi: 10.1016/j.maturitas.2020.06.011. Epub 2020 Jun 20.
- Background: PubMed 19236314Mitchell AJ, Shiri-Feshki M. Rate of progression of mild cognitive impairment to dementia--meta-analysis of 41 robust inception cohort studies. Acta Psychiatr Scand. 2009 Apr;119(4):252-65. doi: 10.1111/j.1600-0447.2008.01326.x. Epub 2008 Feb 18.
- Background: PubMed 30835787Lawrence BJ, Jayakody DMP, Bennett RJ, Eikelboom RH, Gasson N, Friedland PL. Hearing Loss and Depression in Older Adults: A Systematic Review and Meta-analysis. Gerontologist. 2020 Apr 2;60(3):e137-e154. doi: 10.1093/geront/gnz009.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SAU FUNG DORIS YU, PhD principal investigator
HKU School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Network for Auditory-Cognitive Training (ENACT) Program in people with Hearing Loss and Cognitive Impairment, Mild, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SAU FUNG DORIS YU, PhD (852-39176319, dyu1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale -Cognitive Subscale (ADAS-Cog) (time frame: Baseline (T0)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955494, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.