Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)

October 3, 2019 updated by: University of Arizona

Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border

The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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
    • Arizona
      • Nogales, Arizona, United States, 85621-1063
        • Mariposa Community Health Center

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum age: 50 years
  • Audiometrically-confirmed hearing loss
  • Availability of a communication partner to attend the program with the participant
  • Be Spanish speaking and able to sign written informed consent

Exclusion Criteria:

  • Cognitive impairment

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist
Experimental: Immediate communication education and support group
Behavioral: community health worker-audiologist communication education and support group
A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention
Time Frame: 8 weeks
Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
Time Frame: 8 weeks
Questionnaire includes 7 possible actions for managing hearing health or accessing hearing health care services (discussed with family, discussed with doctor, discussed with specialist, had a hearing test, used an assistive device, used a hearing aid, used hearing protection).
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean value for hearing-specific health-related quality of life at eight weeks post baseline as measured by a series of study-specific questions, some of which are adapted from the Self Assessment of Communication
Time Frame: 8 weeks
Participants rate the impact of hearing loss on various aspects of their lives, such as their emotional state and enjoyment of life.
8 weeks
Communication function with partner: Mean frequency and severity of communication-related challenges as measured by a series of study-specific questions at eight weeks post baseline
Time Frame: 8 weeks
Frequency and difficulty of communication-related challenges resulting from hearing loss.
8 weeks
Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions
Time Frame: 8 weeks
Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.
8 weeks

Collaborators and Investigators

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

Sponsor

University of Arizona

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Nicole Marrone, PhD, University of Arizona

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)

August 19, 2015

Primary Completion (Actual)

January 23, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UArizona1
  • R33DC013681 (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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