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

Stanford University

Status: Not yet enrolling

Conditions: Patient Activation; Gastroesophageal Reflux

Treatments: Behavioral: Use of mHealth Question Prompt List app

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05900687

62297

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Focus Group (Aim 1)

No Intervention group

Description:

Participants give feedback about day-to-day challenges with GERD.

Focus Group (Aim 2)

No Intervention group

Description:

Participants give feedback about mobile health app prototype

mHealth app (Aim 3)

Experimental group

Description:

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.

Treatment:

Behavioral: Use of mHealth Question Prompt List app

Standard of care (Aim 3)

No Intervention group

Description:

Participants will be exposed to standard of care communication with their health provider (no mHealth app).