NCT03255161

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2018

Enrollment Period

3.4 years

First QC Date

August 14, 2017

Last Update Submit

October 3, 2019

Conditions

Hearing Loss

Outcome Measures

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.

    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

    8 weeks

Other Outcomes (3)

  • 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

    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

    8 weeks

  • Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions

    8 weeks

Study Arms (2)

Immediate communication education and support group

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

Waitlist

NO INTERVENTION

Interventions

community health worker-audiologist communication education and support groupBEHAVIORAL

A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.

Immediate communication education and support group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariposa Community Health Center

Nogales, Arizona, 85621-1063, United States

Location

Related Publications (1)

  • 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.

    PMID: 35724253DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Nicole Marrone, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 21, 2017

Study Start

August 19, 2015

Primary Completion

January 23, 2019

Study Completion

June 1, 2020

Last Updated

October 7, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)