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

May 31, 2023 updated by: Afrin Kamal, Stanford University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
month 3
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.
month 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Afrin N Kamal, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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