Back to resultsRandomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)
Primary Purpose
Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
community health worker-audiologist communication education and support group
Sponsored by
About this trial
This is an interventional supportive care trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- Mariposa Community Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate communication education and support group
Waitlist
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
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).
Full Information
NCT ID
NCT03255161
First Posted
August 14, 2017
Last Updated
October 3, 2019
Sponsor
University of Arizona
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03255161
Brief Title
Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)
Official Title
Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2015 (Actual)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
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 test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate communication education and support group
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
community health worker-audiologist communication education and support group
Intervention Description
A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
Description
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).
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
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
Description
Participants rate the impact of hearing loss on various aspects of their lives, such as their emotional state and enjoyment of life.
Time Frame
8 weeks
Title
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
Description
Frequency and difficulty of communication-related challenges resulting from hearing loss.
Time Frame
8 weeks
Title
Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions
Description
Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Marrone, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mariposa Community Health Center
City
Nogales
State/Province
Arizona
ZIP/Postal Code
85621-1063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35724253
Citation
Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
Results Reference
derived
Learn more about this trial
Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)
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