Written InformationNCT03742609
A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit
A study testing ii) the reminder, ii) written behavioural plan and iv) all materials in people with Written Information and Written Info and Hearing Aid Reminder, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Written Information, Written Info and Hearing Aid Reminder, Written Info and Planning on Hearing Aid Use
- What is being tested?
- ii) the reminder, ii) written behavioural plan and iv) all materials
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years old or above
- Have never used a hearing aid before
- Have good understanding of English
- have sufficient mental capacity to provide informal consent based on audiologist's opinion
Who cannot join
- Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
- presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.
The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.
Read the detailed description
The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.
- Conditions
- Written Information, Written Info and Hearing Aid Reminder, Written Info and Planning on Hearing Aid Use, All Materials
- Being tested
- ii) the reminder, ii) written behavioural plan, iv) all materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ii) the reminderOther
Participants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s)
ii) written behavioural planOther
Participants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s).
iv) all materialsOther
- provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.
| Study group | Role | What they receive |
|---|---|---|
| Information only | No intervention | provision of written information regarding consequences of using a hearing aid and not using a hearing. For example using a hearing aid will improve ability to hear others. |
| Physical reminder only | Active comparator | provision of written information regarding consequences of using a hearing aid and not using a hearing and physical reminder to use a hearing aid. For example, a hearing aid box as a physical reminder to use the hearing aids. Receives: Other: ii) the reminder |
| Behaviour Plan only | Active comparator | provision of written information regarding consequences of using a hearing aid and not using a hearing and creation of behaviour plan to use a hearing aid. For example, when and where to use the hearing aids. Receives: Other: ii) written behavioural plan |
| Info, Reminder and Plan | Experimental | provision of written information regarding consequences of using a hearing aid and not using a hearing, physical reminder and creation of behaviour plan to use a hearing aid Receives: Other: iv) all materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing aid use
Self-reported hearing aid use
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start29 Jan 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Written InformationStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Afzarini Hasnita Binti Ismail, University of Manchester
- Investigators
- Piers Dawes, Dr, Principal investigator, Manchester Centre for Audiology and Deafness,University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742609
- Sponsor's protocol ID
- 234737
- Status last verified
- Jul 2019
- First submitted
- 13 Nov 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ismail AH, Armitage CJ, Munro KJ, Marsden A, Dawes PD. Evaluation of the I-PLAN Intervention to Promote Hearing Aid Use in New Adult Users: a Randomized Controlled Trial. Ear Hear. 2022 Jul-Aug 01;43(4):1103-1113. doi: 10.1097/AUD.0000000000001195. Epub 2022 Jan 6.
PubMed 34999593
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.
- ClinicalTrials.gov ID
- NCT03742609
- Acronym / sponsor ID
- 234737
- Conditions
- Written Information, Written Info and Hearing Aid Reminder, Written Info and Planning on Hearing Aid Use, All Materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 15 Nov 2018 (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.
The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.
Detailed description
The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Information only | No intervention | –provision of written information regarding consequences of using a hearing aid and not using a hearing. For example using a hearing aid will improve ability to hear others. |
| Physical reminder only | Active comparator | Other: ii) the reminderprovision of written information regarding consequences of using a hearing aid and not using a hearing and physical reminder to use a hearing aid. For example, a hearing aid box as a physical reminder to use the hearing aids. |
| Behaviour Plan only | Active comparator | Other: ii) written behavioural planprovision of written information regarding consequences of using a hearing aid and not using a hearing and creation of behaviour plan to use a hearing aid. For example, when and where to use the hearing aids. |
| Info, Reminder and Plan | Experimental | Other: iv) all materialsprovision of written information regarding consequences of using a hearing aid and not using a hearing, physical reminder and creation of behaviour plan to use a hearing aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years old or above
- Have never used a hearing aid before
- Have good understanding of English
- have sufficient mental capacity to provide informal consent based on audiologist's opinion
Key exclusion criteria (2 listed)
- Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
- presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)
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 |
|---|---|---|
| ii) the reminderParticipants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s) | Other | Physical reminder only |
| ii) written behavioural planParticipants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s). | Other | Behaviour Plan only |
| iv) all materialsi) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use. | Other | Info, Reminder and Plan |
Primary outcome
Hearing aid use
Time frame: 6-weeks
Self-reported hearing aid use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 34999593Ismail AH, Armitage CJ, Munro KJ, Marsden A, Dawes PD. Evaluation of the I-PLAN Intervention to Promote Hearing Aid Use in New Adult Users: a Randomized Controlled Trial. Ear Hear. 2022 Jul-Aug 01;43(4):1103-1113. doi: 10.1097/AUD.0000000000001195. Epub 2022 Jan 6.
Related trials for Written Information
Recruiting
AI-Assisted Written Information in Chronic Anal Fissure
Chronic Anal Fissure
Recruiting
AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease
Symptomatic Hemorrhoidal Disease, Hemorrhoids Grade I and II
Recruiting
Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
Chronic Low Back Pain (Non-specific, Uncomplicated)
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. This study is not recruiting at the moment.
Piers Dawes, Dr principal investigator
Manchester Centre for Audiology and Deafness,University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ii) the reminder, ii) written behavioural plan and iv) all materials in people with Written Information and Written Info and Hearing Aid Reminder, run by University of Manchester at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 30 Jul 2019. 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 United Kingdom. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing aid use (time frame: 6-weeks). 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 NCT03742609, which also lists 1 linked publication.
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 30 Jul 2019.