Hearing LossNCT05438225
Text Message Reminders for Hearing Healthcare
A study testing Automated text message reminder in people with Hearing Loss, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Automated text message reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- History of childhood hearing loss
- Hearing aid users
- Limited English proficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hearing Loss
- Being tested
- Automated text message reminder
- Keywords
- hearing loss; elderly; primary care; text message
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated text message reminderBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Automated text message reminder |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after enrollment
Secondary outcomes (2)
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.
Measured: 3 months after enrollment
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.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start17 Oct 2022
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uchechukwu Megwalu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438225
- Sponsor's protocol ID
- IRB-66347
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Text Message Reminders to Promote Hearing Healthcare Access - Pilot Study
- ClinicalTrials.gov ID
- NCT05438225
- Acronym / sponsor ID
- IRB-66347
- Conditions
- Hearing Loss
- Keywords
- hearing loss; elderly; primary care; text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Text Message Reminder | Experimental | Behavioral: Automated text message reminderParticipants 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. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of childhood hearing loss
- Hearing aid users
- Limited English proficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated text message reminderParticipants 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. | Behavioural | Automated Text Message Reminder |
Primary outcome
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.
2 secondary outcomes
Likelihood of obtaining audiogram
Time frame: 3 months after enrollment
Likelihood of obtaining hearing aids
Time frame: 3 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated text message reminder in people with Hearing Loss, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likelihood of patient-physician discussion of hearing loss or hearing assessment (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.