Hearing Loss and Communication Needs in a Group Care Setting for Older Adults
Primary Purpose
Age-related Hearing Loss
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Training
Sponsored by
About this trial
This is an interventional other trial for Age-related Hearing Loss
Eligibility Criteria
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.
Sites / Locations
- PACE Upham's Elder Service Plan
- Mercy LIFE PACE
- PACE Organization of Rhode Island
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre/Post Training (Within subject)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04659967
First Posted
December 2, 2020
Last Updated
May 5, 2022
Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT04659967
Brief Title
Hearing Loss and Communication Needs in a Group Care Setting for Older Adults
Official Title
Hearing Loss and Communication Needs in a Group Care Setting for Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
November 22, 2021 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre/Post Training (Within subject)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Training
Intervention Description
Participants will receive a virtual training that is tailored to age-related hearing loss, use of non-custom personal amplification devices, and communication strategies.
Primary Outcome Measure Information:
Title
Change From Baseline on a Hearing communication Knowledge Assessment at 1 Month.
Description
Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.
Time Frame
1 month follow-up
Title
Change From Baseline on a Hearing communication Knowledge Assessment at 3 Months.
Description
Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.
Time Frame
3 month follow-up
Title
Change From Baseline on a Hearing communication Knowledge Assessment at 6 Months.
Description
Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Qualitative Interviews
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara K Mamo, AuD, PhD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
PACE Upham's Elder Service Plan
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States
Facility Name
Mercy LIFE PACE
City
West Springfield
State/Province
Massachusetts
ZIP/Postal Code
01089
Country
United States
Facility Name
PACE Organization of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22791988
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
15357885
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.
Results Reference
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PubMed Identifier
25024235
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.
Results Reference
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PubMed Identifier
26096388
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.
Results Reference
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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.
Results Reference
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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.
Results Reference
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PubMed Identifier
12927943
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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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.
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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.
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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.
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Citation
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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.
Results Reference
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Hearing Loss and Communication Needs in a Group Care Setting for Older Adults
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