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

May 5, 2022 updated by: Sara Mamo, University of Massachusetts, Amherst
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline on a Hearing communication Knowledge Assessment at 1 Month.
Time Frame: 1 month follow-up
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.
Time Frame: 3 month follow-up
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.
Time Frame: 6 month follow-up
Participants will complete a questionnaire to monitor retention of communication strategies and behaviors.
6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Interviews
Time Frame: 6-12 months post training
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Amherst

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Sara K Mamo, AuD, PhD, University of Massachusetts, Amherst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

November 22, 2021

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 680
  • 1K23DC016855 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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