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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05900687

Collaborator

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

150

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Patient Activation	Behavioral: Use of mHealth Question Prompt List app	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

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

Investigators

Principal Investigator: Afrin N Kamal, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Afrin Kamal, Clinical Assistant Professor of Medicine, Stanford University

ClinicalTrials.gov Identifier:

NCT05900687

Other Study ID Numbers:

62297

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esophagitis, Peptic

Study Results

No Results Posted as of Jun 12, 2023