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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03255161
• Other study ID #: UArizona1
• Secondary ID: R33DC013681
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 19, 2015
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2018
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Mariposa Community Health Center	Nogales	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Participants rate the impact of hearing loss on various aspects of their lives, such as their emotional state and enjoyment of life.	8 weeks
Other	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	Frequency and difficulty of communication-related challenges resulting from hearing loss.	8 weeks
Other	Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions	Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.	8 weeks
Primary	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.	8 weeks
Secondary	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).	8 weeks