CClinicalTrials.gg
Status unknownNCT04659967Updated May 6, 2022

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

An interventional study of Virtual Training in Age-related Hearing Loss, sponsored by University of Massachusetts, Amherst. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-06.

Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Age-related Hearing Loss
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Staff members who cannot attend the (virtual) in-person training.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Pre/Post Training (Within subject)

    Participants 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.

    Behavioral: Virtual Training

Interventions

  • BehavioralVirtual Training

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

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What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 6 month follow-up

Secondary outcomes

  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.

    Time frame: 6-12 months post training

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Study locations

3 sites
  • PACE Upham's Elder Service Plan
    Boston, Massachusetts 02125, United States
  • Mercy LIFE PACE
    West Springfield, Massachusetts 01089, United States
  • PACE Organization of Rhode Island
    Providence, Rhode Island 02905, United States
07

References and documents

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 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT04659967
Lead sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Sara Mamo (Assistant Professor, University of Massachusetts, Amherst) — Principal investigator
First posted
Dec 9, 2020
Start date
Dec 2, 2020
Primary completion
Nov 22, 2021
Completion
Jun 30, 2023 (estimated)
Last update
May 6, 2022

Study contacts

Sara K Mamo, AuD, PhD
principal investigator · University of Massachusetts, Amherst

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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