Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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.

Official Title
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Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux, Patient Activation

Intervention / Treatment
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* Behavioral: Use of mHealth Question Prompt List app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry) non-English speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Focus Group (Aim 1)<br>Participants give feedback about day-to-day challenges with GERD. | |
| No Intervention: Focus Group (Aim 2)<br>Participants give feedback about mobile health app prototype | |
| Experimental: mHealth app (Aim 3)<br>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. | Behavioral: Use of mHealth Question Prompt List app<br>* mHealth Question Prompt List app that facilitates in asking questions with a physician during a consultation specific to GERD<br>* Other names: Esophagus-Qs;|
| No Intervention: Standard of care (Aim 3)<br>Participants will be exposed to standard of care communication with their health provider (no mHealth app). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure Scale Score | Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health. | 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. | month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pill Count | measures medication adherence | months 3 and 6 | 
| 12-item Short Form Survey | patient survey that measures health related quality of life | months 3 and 6 | 
| Gerd-Q | patient survey that measures symptom severity of GERD | months 3 and 6 |