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

NCT ID: NCT05900687

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2028-06-01

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux Patient Activation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Focus Group (Aim 1)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Focus Group (Aim 2)

Participants give feedback about mobile health app prototype

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Use of mHealth Question Prompt List app

Intervention Type BEHAVIORAL

mHealth Question Prompt List app that facilitates in asking questions with a physician during a consultation specific to GERD

Standard of care (Aim 3)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Esophagus-Qs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Afrin Kamal

Clinical Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Afrin N Kamal, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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62297

Identifier Type: -

Identifier Source: org_study_id

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