NCT04659967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

December 2, 2020

Last Update Submit

May 5, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Qualitative Interviews

    6-12 months post training

Study Arms (1)

Pre/Post Training (Within subject)

EXPERIMENTAL

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

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

Pre/Post Training (Within subject)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PACE Upham's Elder Service Plan

Boston, Massachusetts, 02125, United States

Location

Mercy LIFE PACE

West Springfield, Massachusetts, 01089, United States

Location

PACE Organization of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (15)

  • 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.

    PMID: 22791988BACKGROUND
  • 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.

    PMID: 25477427BACKGROUND
  • 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.

    PMID: 15357885BACKGROUND
  • 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.

    PMID: 25024235BACKGROUND
  • 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.

    PMID: 26096388BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12927943BACKGROUND
  • 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.

    PMID: 24875093BACKGROUND
  • 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.

    PMID: 21320988BACKGROUND
  • 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.

    PMID: 23337978BACKGROUND
  • 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.

    PMID: 27890543BACKGROUND
  • 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.

    PMID: 24384545BACKGROUND
  • 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.

    PMID: 27254725BACKGROUND
  • 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.

    PMID: 27927734BACKGROUND

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sara K Mamo, AuD, PhD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

December 2, 2020

Primary Completion

November 22, 2021

Study Completion

June 30, 2023

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations