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Age-related Hearing LossNCT04659967

Hearing Loss and Communication Needs in a Group Care Setting for Older Adults

A study testing Virtual Training in people with Age-related Hearing Loss, run by University of Massachusetts, Amherst at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to develop and test a multicomponent hearing care intervention for the PACE staff members in order to learn more about communication and engagement. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Age-related Hearing Loss
What is being tested?
Virtual Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
2 Dec 2020to 30 Jun 2023
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

  • PACE staff who work in the Day Health Center and are available to attend the training on-site at PACE are eligible for inclusion. All staff are invited to join the training (via Zoom, if necessary), but to complete the research activities, they have to complete the training in-person due to the hands-on component of learning to use the hearing device.

Who cannot join

  • Staff members who cannot attend the (virtual) in-person training.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • PACE Upham's Elder Service Plan

    Boston, Massachusetts, 02125

  • PACE Organization of Rhode Island

    Providence, Rhode Island, 02905

  • Mercy LIFE PACE

    West Springfield, Massachusetts, 01089

Other trials in United States

About this study

The purpose of this study is to develop and test a multicomponent hearing care intervention for the PACE staff members in order to learn more about communication and engagement.

Read the detailed description

The long-term objective of this proposal is to increase the accessibility and affordability of hearing loss treatment for older adults with hearing loss, with a particular interest in adults that have mild cognitive impairment (MCI) or dementia. Age-related hearing loss (ARHL) in persons with MCI or dementia may exacerbate dementia-related symptoms such as depression, apathy, agitation/aggression. Moreover, engagement and activity participation are recognized as critical aspects of dementia care management, but those individuals who also experience ARHL are at a disadvantage. A pilot testing of behavioral communication intervention will be completed at multiple Program for All-inclusive Care for the Elderly (PACE) sites in New England. A multicomponent hearing care intervention will be tested that includes staff training and non-custom personal amplification use with older adults in a group care setting. This feasibility study will lead to the refinement of the intervention protocols to be used in a future grant application that will test the real-world efficacy of the intervention.

Being tested
Virtual Training
Medical subject headings
Presbycusis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual TrainingBehavioural

    Participants will receive a virtual training that is tailored to age-related hearing loss, use of non-custom personal amplification devices, and communication strategies.

Study groups in NCT04659967
Study groupRoleWhat they receive
Pre/Post Training (Within subject)ExperimentalParticipants will complete a baseline questionnaire followed by immediate virtual training, and complete a post-training questionnaire. Participants will also be asked to complete a questionnaire 1-month, 3-months, and 6-months post-training.
Receives: Behavioral: Virtual Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline on a Hearing communication Knowledge Assessment at 1 Month.

    Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.

    Measured: 1 month follow-up

  2. Change From Baseline on a Hearing communication Knowledge Assessment at 3 Months.

    Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.

    Measured: 3 month follow-up

  3. Change From Baseline on a Hearing communication Knowledge Assessment at 6 Months.

    Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.

    Measured: 6 month follow-up

Secondary outcomes (1)

  1. Qualitative Interviews

    We will purposefully sample staff members whose quantitative results indicate that they were either successful or unsuccessful in learning and using new communication behaviors.

    Measured: 6-12 months post training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start2 Dec 2020
  3. Primary completion22 Nov 2021
  4. Study completion30 Jun 2023 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Staff will be invited to participate in an experiential virtual sensitivity training. A pre/post quasi-experimental design will be undertaken. Staff will be asked to complete a pre-training questionnaire as well as follow-up questionnaires immediately after the training and one month, three months, and six months post training to measure knowledge gained and to probe for behavior change related to the communication strategies taught during the training. Some participants who complete questionnaires will be contacted and invited to participate in a research interview about their communication experiences at PACE. The training session will last for up to 1 hour. All questionnaires are expected to take approximately 15 minutes each. Interviews will take 1-hour.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659967
Sponsor's protocol ID
680
Other IDs
1K23DC016855
Status last verified
May 2022
First submitted
2 Dec 2020
Last updated
6 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15.

    PubMed 22791988

  • Chen DS, Betz J, Yaffe K, Ayonayon HN, Kritchevsky S, Martin KR, Harris TB, Purchase-Helzner E, Satterfield S, Xue QL, Pratt S, Simonsick EM, Lin FR; Health ABC study. Association of hearing impairment with declines in physical functioning and the risk of disability in older adults. J Gerontol A Biol Sci Med Sci. 2015 May;70(5):654-61. doi: 10.1093/gerona/glu207. Epub 2014 Dec 3.

    PubMed 25477427

  • Cohen-Mansfield J, Taylor JW. Hearing aid use in nursing homes. Part 1: Prevalence rates of hearing impairment and hearing aid use. J Am Med Dir Assoc. 2004 Sep-Oct;5(5):283-8.

    PubMed 15357885

  • Genther DJ, Betz J, Pratt S, Kritchevsky SB, Martin KR, Harris TB, Helzner E, Satterfield S, Xue QL, Yaffe K, Simonsick EM, Lin FR; Health ABC Study. Association of hearing impairment and mortality in older adults. J Gerontol A Biol Sci Med Sci. 2015 Jan;70(1):85-90. doi: 10.1093/gerona/glu094. Epub 2014 Jul 14.

    PubMed 25024235

  • Genther DJ, Betz J, Pratt S, Martin KR, Harris TB, Satterfield S, Bauer DC, Newman AB, Simonsick EM, Lin FR; Health, Aging and Body Composition Study. Association Between Hearing Impairment and Risk of Hospitalization in Older Adults. J Am Geriatr Soc. 2015 Jun;63(6):1146-52. doi: 10.1111/jgs.13456. Epub 2015 Jun 11.

    PubMed 26096388

  • Haque, R., Abdelrehman, N., & Alavi, Z. (2012). "There's a monster under my bed": Hearing aids and dementia in long-term care settings. Annals of Long-Term Care, 20(8), 28-33.

  • Hopper, T., & Hinton, P. (2012). Hearing loss among individuals with dementia: Barriers and facilitators to care. Canadian Journal of Speech-Language Pathology & Audiology, 36(4), 302-313.

  • Hopper TL. "They're just going to get worse anyway": perspectives on rehabilitation for nursing home residents with dementia. J Commun Disord. 2003 Sep-Oct;36(5):345-59. doi: 10.1016/s0021-9924(03)00050-9.

    PubMed 12927943

  • Lin FR, Albert M. Hearing loss and dementia - who is listening? Aging Ment Health. 2014;18(6):671-3. doi: 10.1080/13607863.2014.915924. No abstract available.

    PubMed 24875093

  • Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB, Ferrucci L. Hearing loss and incident dementia. Arch Neurol. 2011 Feb;68(2):214-20. doi: 10.1001/archneurol.2010.362.

    PubMed 21320988

  • Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.

    PubMed 23337978

  • Mamo SK, Nirmalasari O, Nieman CL, McNabney MK, Simpson A, Oh ES, Lin FR. Hearing Care Intervention for Persons with Dementia: A Pilot Study. Am J Geriatr Psychiatry. 2017 Jan;25(1):91-101. doi: 10.1016/j.jagp.2016.08.019. Epub 2016 Sep 22.

    PubMed 27890543

  • Mick P, Kawachi I, Lin FR. The association between hearing loss and social isolation in older adults. Otolaryngol Head Neck Surg. 2014 Mar;150(3):378-84. doi: 10.1177/0194599813518021. Epub 2014 Jan 2.

    PubMed 24384545

  • Lin FR, Hazzard WR, Blazer DG. Priorities for Improving Hearing Health Care for Adults: A Report From the National Academies of Sciences, Engineering, and Medicine. JAMA. 2016 Aug 23-30;316(8):819-20. doi: 10.1001/jama.2016.7916. No abstract available.

    PubMed 27254725

  • Nieman CL, Marrone N, Mamo SK, Betz J, Choi JS, Contrera KJ, Thorpe RJ Jr, Gitlin LN, Tanner EK, Han HR, Szanton SL, Lin FR. The Baltimore HEARS Pilot Study: An Affordable, Accessible, Community-Delivered Hearing Care Intervention. Gerontologist. 2017 Nov 10;57(6):1173-1186. doi: 10.1093/geront/gnw153.

    PubMed 27927734

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Training in people with Age-related Hearing Loss, run by University of Massachusetts, Amherst at 3 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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?

Results are not available in the source record.

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?

Change From Baseline on a Hearing communication Knowledge Assessment at 1 Month. (time frame: 1 month follow-up). The study lists 3 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 NCT04659967, which also lists 15 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 6 May 2022.

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