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

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ClinicalTrials.gov Identifier: NCT03255161
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: community health worker-audiologist communication education and support group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border
Actual Study Start Date : August 19, 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

No Intervention: Waitlist



Primary Outcome Measures :
  1. Amount of use of communication strategies [ Time Frame: 8 weeks ]
    International Outcomes Inventory Alternative Interventions Scale


Secondary Outcome Measures :
  1. Access to hearing health care services [ Time Frame: 8 weeks ]
    How many actions did participants take to improve their hearing health and communication following the hearing screening associated with eligibility for the project. Questionnaire lists 6 possible actions.


Other Outcome Measures:
  1. Quality of life [ Time Frame: 8 weeks ]
    International Outcomes Inventory Alternative Interventions Scale

  2. Communication function with partner [ Time Frame: 8 weeks ]
    Frequency of self-reported communication breakdowns over the last month

  3. Self-efficacy to manage communication [ Time Frame: 8 weeks ]
    Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Minimum age: 50 years
  • Self-reported hearing loss
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255161


Contacts
Contact: Rosie Piper 520-281-1550 RPiper@mariposachc.net
Contact: Aileen Wong, AuD 520-626-9160 annw16@email.arizona.edu

Locations
United States, Arizona
Mariposa Community Health Center Recruiting
Nogales, Arizona, United States, 85621-1063
Contact: Rosie Piper    520-281-1550    RPiper@mariposachc.net   
Contact: Cecilia Navarro    520-375-6050    CxNavarro@mariposachc.net   
Sponsors and Collaborators
University of Arizona
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Nicole Marrone, PhD University of Arizona

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03255161     History of Changes
Other Study ID Numbers: UArizona1
R33DC013681 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms