ClinicalTrials.gg
Status unknownNCT03255161Updated Oct 7, 2019

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

An interventional study of community health worker-audiologist communication education and support group in Hearing Loss, sponsored by University of Arizona. Status unknown at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-07.

Sponsored by University of Arizona · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2015, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hearing Loss

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03

In context

Hearing Loss

1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 778 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Immediate communication education and support group

    Behavioral: community health worker-audiologist communication education and support group

  • No intervention
    Waitlist

Interventions

  • Behavioralcommunity 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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).

    Time frame: 8 weeks

Other outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Mariposa Community Health Center
    Nogales, Arizona 85621-1063, United States
08

References and documents

Publications

  • 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. PubMed 35724253 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03255161
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Aug 19, 2015
Primary completion
Jan 23, 2019
Completion
Jun 1, 2020 (estimated)
Last update
Oct 7, 2019

Study contacts

Nicole Marrone, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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