- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05438225
Text Message Reminders for Hearing Healthcare
October 25, 2023 updated by: Uchechukwu Megwalu, Stanford University
Automated Text Message Reminders to Promote Hearing Healthcare Access - Pilot Study
Many individuals with hearing loss do not receive adequate hearing healthcare.
Given their close and long-term relationships with patients, primary care providers (PCPs) could play a vital role in improving access to hearing healthcare.
Unfortunately, hearing loss is often underdiagnosed in primary care settings, because hearing screening is not a routine part of primary care visits, and the responsibility often falls on the patient or family to recognize and address the issue.
The investigators propose to pilot test the use of text message reminders to encourage elderly patients to discuss hearing assessment with there PCPs.
The study objectives are to: 1) design an automated text-messaging reminder system; 2) assess the feasibility of deploying the intervention in a clinical trial setting; and 3) evaluate whether the intervention increases willingness to seek hearing healthcare.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- English-speaking adult patients aged 65 and older
- Have not audiometric testing within the past 5 years
- Has had at least one prior visit encounter with a Stanford primary care provider the past 1 year
- Has a cell phone with a valid phone number
Exclusion Criteria:
- History of childhood hearing loss
- Hearing aid users
- Limited English proficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Automated Text Message Reminder
Participants will receive automated reminder text instructing them to discuss hearing issues with their PCPs, and to request a referral to audiology or otolaryngology if they have hearing loss.
|
Participants in the intervention group will receive monthly automated reminder text instructing them to discuss hearing issues with their PCPs, and to request a referral to audiology or otolaryngology if they have hearing loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Likelihood of patient-physician discussion of hearing loss or hearing assessment
Time Frame: 3 months after enrollment
|
Participant-reported rating of the likelihood of discussing hearing assessment with their PCP in the next 6 months.
Likelihood will be assessed on an 11-point visual analogue scale (VAS).
Score range: 0 to 10 (0 = not likely, 10 = very likely).
Participants who have already discussed hearing assessment with their PCP will be assigned a score of 10.
|
3 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Likelihood of obtaining audiogram
Time Frame: 3 months after enrollment
|
Participant-reported rating of the likelihood of obtaining an audiogram in the next 6 months.
Likelihood will be assessed on an 11-point visual analogue scale (VAS).
Score range: 0 to 10 (0 = not likely, 10 = very likely).
Participants who have already undergone audiometric testing will be assigned a score of 10.
|
3 months after enrollment
|
|
Likelihood of obtaining hearing aids
Time Frame: 3 months after enrollment
|
Participant-reported rating of the likelihood of obtaining hearing aids if an audiogram showed significant hearing loss.
Likelihood will be assessed on an 11-point visual analogue scale (VAS).
Score range: 0 to 10 (0 = not likely, 10 = very likely).
Participants who have already obtained hearing aids will be assigned a score of 10.
|
3 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2022
Primary Completion (Actual)
October 25, 2023
Study Completion (Actual)
October 25, 2023
Study Registration Dates
First Submitted
June 24, 2022
First Submitted That Met QC Criteria
June 24, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-66347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.