Gastroesophageal RefluxNCT05900687
Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
A study testing Use of mHealth Question Prompt List app in people with Gastroesophageal Reflux and Patient Activation, run by Stanford University at 1 site in United States.
Trial summary
More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastroesophageal Reflux, Patient Activation
- What is being tested?
- Use of mHealth Question Prompt List app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of GERD
- GerdQ score of >=8
- documented PPI use for GERD
- internet access at home or computer/mobile device
- ability to provide written or e-consent.
Who cannot join
- Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
- non-English speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.
- Conditions
- Gastroesophageal Reflux, Patient Activation
- Being tested
- Use of mHealth Question Prompt List app
- Medical subject headings
- Gastroesophageal Reflux, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of mHealth Question Prompt List appBehavioural
Also called Esophagus-Qs
mHealth Question Prompt List app that facilitates in asking questions with a physician during a consultation specific to GERD
| Study group | Role | What they receive |
|---|---|---|
| Focus Group (Aim 1) | No intervention | Participants give feedback about day-to-day challenges with GERD. |
| Focus Group (Aim 2) | No intervention | Participants give feedback about mobile health app prototype |
| mHealth app (Aim 3) | Experimental | Participants will be exposed to an app-based question prompt list with gamification features to promote medication adherence as part of their communication with their health provider. Receives: Behavioral: Use of mHealth Question Prompt List app |
| Standard of care (Aim 3) | No intervention | Participants will be exposed to standard of care communication with their health provider (no mHealth app). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure Scale Score
Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.
Measured: month 3
Patient Activation Measure Scale Score
Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.
Measured: month 6
Secondary outcomes (3)
Pill Count
measures medication adherence
Measured: months 3 and 6
12-item Short Form Survey
patient survey that measures health related quality of life
Measured: months 3 and 6
Gerd-Q
patient survey that measures symptom severity of GERD
Measured: months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afrin Kamal, Stanford University
- Investigators
- Afrin N Kamal, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900687
- Sponsor's protocol ID
- 62297
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 12 Jun 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05900687
- Acronym / sponsor ID
- 62297
- Conditions
- Gastroesophageal Reflux, Patient Activation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Jun 2023 (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.
More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Focus Group (Aim 1) | No intervention | –Participants give feedback about day-to-day challenges with GERD. |
| Focus Group (Aim 2) | No intervention | –Participants give feedback about mobile health app prototype |
| mHealth app (Aim 3) | Experimental | Behavioral: Use of mHealth Question Prompt List appParticipants will be exposed to an app-based question prompt list with gamification features to promote medication adherence as part of their communication with their health provider. |
| Standard of care (Aim 3) | No intervention | –Participants will be exposed to standard of care communication with their health provider (no mHealth app). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical diagnosis of GERD
- GerdQ score of >=8
- documented PPI use for GERD
- internet access at home or computer/mobile device
- ability to provide written or e-consent.
Key exclusion criteria (2 listed)
- Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
- non-English speaking patients
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 |
|---|---|---|
| Use of mHealth Question Prompt List appAlso: Esophagus-QsmHealth Question Prompt List app that facilitates in asking questions with a physician during a consultation specific to GERD | Behavioural | mHealth app (Aim 3) |
Primary outcome
Patient Activation Measure Scale Score
Time frame: month 3
Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.
Patient Activation Measure Scale Score
Time frame: month 6
Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.
3 secondary outcomes
Pill Count
Time frame: months 3 and 6
12-item Short Form Survey
Time frame: months 3 and 6
Gerd-Q
Time frame: months 3 and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Afrin N Kamal, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of mHealth Question Prompt List app in people with Gastroesophageal Reflux and Patient Activation, 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Activation Measure Scale Score (time frame: month 3). The study lists 2 primary outcomes in all. 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 12 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.