Text Message Reminders for Hearing Healthcare
Primary Purpose
Hearing Loss
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated text message reminder
Sponsored by
About this trial
This is an interventional health services research trial for Hearing Loss focused on measuring hearing loss; elderly; primary care; text message
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Automated Text Message Reminder
Control Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Likelihood of patient-physician discussion of hearing loss or hearing assessment
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.
Secondary Outcome Measures
Likelihood of obtaining audiogram
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.
Likelihood of obtaining hearing aids
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05438225
Brief Title
Text Message Reminders for Hearing Healthcare
Official Title
Automated Text Message Reminders to Promote Hearing Healthcare Access - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
hearing loss; elderly; primary care; text message
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automated Text Message Reminder
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Automated text message reminder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Likelihood of patient-physician discussion of hearing loss or hearing assessment
Description
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.
Time Frame
3 months after enrollment
Secondary Outcome Measure Information:
Title
Likelihood of obtaining audiogram
Description
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.
Time Frame
3 months after enrollment
Title
Likelihood of obtaining hearing aids
Description
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.
Time Frame
3 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Text Message Reminders for Hearing Healthcare
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