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

Not Applicable

Not yet recruiting

• Conditions: Patient Activation; Gastroesophageal Reflux
• Interventions: Behavioral: Use of mHealth Question Prompt List app

• Registration Number: NCT05900687
• Lead Sponsor: Stanford University

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Study Start: 2023-07-01
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth app (Aim 3)	Use of mHealth Question Prompt List app	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.

Primary Outcome Measures

Name	Time	Method
Patient Activation Measure Scale Score	month 6	Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States