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Behavioral Intervention

mHealth App for Acid Reflux

N/A
Waitlist Available
Led By Afrin N Kamal, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3 and 6
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to develop an app to help GERD patients better manage their symptoms by asking questions about their condition. The app will be tested to measure its effectiveness.

Who is the study for?
This trial is for individuals with a clinical diagnosis of GERD, experiencing chronic symptoms despite using proton pump inhibitors (PPIs). Participants must have a GerdQ score of 8 or higher, access to the internet and a mobile device or computer, and be able to give consent.
What is being tested?
The study is testing an mHealth app designed to help GERD patients communicate better with their doctors. It involves developing the app based on patient feedback and measuring if it increases patient activation compared to usual care without the app.
What are the potential side effects?
Since this intervention involves using an mHealth application, there are no direct medical side effects. However, participants may experience frustration or difficulty in using technology.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3 and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Activation Measure Scale Score
Secondary study objectives
12-item Short Form Survey
Gerd-Q
Pill Count

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: mHealth app (Aim 3)Experimental Treatment1 Intervention
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.
Group II: Focus Group (Aim 1)Active Control1 Intervention
Participants give feedback about day-to-day challenges with GERD.
Group III: Focus Group (Aim 2)Active Control1 Intervention
Participants give feedback about mobile health app prototype
Group IV: Standard of care (Aim 3)Active Control1 Intervention
Participants will be exposed to standard of care communication with their health provider (no mHealth app).

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,668 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,682 Total Patients Enrolled
Afrin N Kamal, MDPrincipal InvestigatorStanford University

Media Library

mHealth Question Prompt List app (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05900687 — N/A
Gastroesophageal Reflux Disease Research Study Groups: Focus Group (Aim 1), Focus Group (Aim 2), mHealth app (Aim 3), Standard of care (Aim 3)
Gastroesophageal Reflux Disease Clinical Trial 2023: mHealth Question Prompt List app Highlights & Side Effects. Trial Name: NCT05900687 — N/A
mHealth Question Prompt List app (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900687 — N/A
~96 spots leftby Jun 2027
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