NCT05438225

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

June 24, 2022

Last Update Submit

October 25, 2023

Conditions

Keywords

hearing loss; elderly; primary care; text message

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after enrollment

Secondary Outcomes (2)

  • Likelihood of obtaining audiogram

    3 months after enrollment

  • Likelihood of obtaining hearing aids

    3 months after enrollment

Study Arms (2)

Automated Text Message Reminder

EXPERIMENTAL

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.

Behavioral: Automated text message reminder

Control Group

NO INTERVENTION

Interventions

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.

Automated Text Message Reminder

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of childhood hearing loss
  • Hearing aid users
  • Limited English proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Otolaryngology - Head & Neck Surgery

Study Record Dates

First Submitted

June 24, 2022

First Posted

June 29, 2022

Study Start

October 17, 2022

Primary Completion

October 25, 2023

Study Completion

October 25, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations