Hearing LossACHIEVE-PNCT02412254
Aging, Cognition, and Hearing Evaluation in Elders Study
A study testing Best practices hearing rehabilitative treatment and Successful aging intervention in people with Hearing Loss, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on… Read more about this study
- Who is it for?
- Ages 70 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Best practices hearing rehabilitative treatment and Successful aging intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 8 Mar 2021
- 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 70 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 70-84 years.
- Community-dwelling.
- Fluent English-speaker.
- Residency. Participants must plan to reside in the local area for the study duration (6 months).
- Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and <70 dB.
- Word Recognition in Quiet score >60% bilaterally.
- Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more
- Willingness to participate. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to follow the study protocol for the duration of the trial.
Who cannot join
- Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study:
- Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
- Self-reported hearing aid use in the past year (>5 hours/week).
- Vision impairment (worse than 20/40 on MN Near Vision Card).
- Medical contraindication to use of hearing aids (e.g., draining ear).
- Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears.
- Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis
- No participants are excluded based on race or sex
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Comstock Center for Public Health Research
Hagerstown, Maryland, 21740
About this study
Official title: Aging, Cognition, and Hearing Evaluation in Elders Pilot Study
The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.
- Conditions
- Hearing Loss
- Being tested
- Best practices hearing rehabilitative treatment, Successful aging intervention
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practices hearing rehabilitative treatmentOther
Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.
Successful aging interventionOther
One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant
| Study group | Role | What they receive |
|---|---|---|
| Hearing intervention | Active comparator | Best practices hearing rehabilitative treatment Receives: Other: Best practices hearing rehabilitative treatment |
| Successful aging intervention | Placebo comparator | Successful aging intervention Receives: Other: Successful aging intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Inventory for the Elderly (HHIE)
Measured: 6 month follow-up
Secondary outcomes (1)
Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
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 Hearing LossStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Frank Lin, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412254
- Sponsor's protocol ID
- IRB00067383
- Other IDs
- R34AG046548
- Acronym
- ACHIEVE-P
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2015
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep.
PubMed 29067347
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging, Cognition, and Hearing Evaluation in Elders Pilot Study
- ClinicalTrials.gov ID
- NCT02412254
- Acronym / sponsor ID
- ACHIEVE-P / IRB00067383
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2015
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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 investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing intervention | Active comparator | Other: Best practices hearing rehabilitative treatmentBest practices hearing rehabilitative treatment |
| Successful aging intervention | Placebo comparator | Other: Successful aging interventionSuccessful aging intervention |
Who may qualify
- Ages
- 70 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 70-84 years.
- Community-dwelling.
- Fluent English-speaker.
- Residency. Participants must plan to reside in the local area for the study duration (6 months).
- Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and <70 dB.
Key exclusion criteria (8 listed)
- Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study:
- Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
- Self-reported hearing aid use in the past year (>5 hours/week).
- Vision impairment (worse than 20/40 on MN Near Vision Card).
- Medical contraindication to use of hearing aids (e.g., draining ear).
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 |
|---|---|---|
| Best practices hearing rehabilitative treatmentIntervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training. | Other | Hearing intervention |
| Successful aging interventionOne-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant | Other | Successful aging intervention |
Primary outcome
Hearing Handicap Inventory for the Elderly (HHIE)
Time frame: 6 month follow-up
1 secondary outcome
Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests
Time frame: 6 months
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 8 Apr 2021.
- Derived from this study: PubMed 29067347Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep.
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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. This study is not recruiting at the moment.
Frank Lin principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best practices hearing rehabilitative treatment and Successful aging intervention in people with Hearing Loss, run by Johns Hopkins University at 1 site in United States.
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 8 inclusion and 8 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 8 Apr 2021. 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 States. 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?
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 Handicap Inventory for the Elderly (HHIE) (time frame: 6 month follow-up). 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 NCT02412254, 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 8 Apr 2021.