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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04659967
Other study ID # 680
Secondary ID 1K23DC016855
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2, 2020
Est. completion date June 30, 2023

Study information

Verified date May 2022
Source University of Massachusetts, Amherst
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date June 30, 2023
Est. primary completion date November 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: - Staff members who cannot attend the (virtual) in-person training.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual 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.

Locations

Country Name City State
United States PACE Upham's Elder Service Plan Boston Massachusetts
United States PACE Organization of Rhode Island Providence Rhode Island
United States Mercy LIFE PACE West Springfield Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Amherst National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month follow-up
Primary 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. 3 month follow-up
Primary 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. 6 month follow-up
Secondary 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. 6-12 months post training
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