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

Primary Purpose

Gastroesophageal Reflux, Patient Activation

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Use of mHealth Question Prompt List app

About this trial

This is an interventional health services research trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Focus Group (Aim 1)

Focus Group (Aim 2)

mHealth app (Aim 3)

Standard of care (Aim 3)

Arm Description

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

Participants give feedback about mobile health app prototype

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.

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

Outcomes

Primary Outcome Measures

Patient Activation Measure Scale Score

Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

Patient Activation Measure Scale Score

Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

Secondary Outcome Measures

Pill Count

measures medication adherence

12-item Short Form Survey

patient survey that measures health related quality of life

Gerd-Q

patient survey that measures symptom severity of GERD

Full Information

NCT ID

NCT05900687

First Posted

May 31, 2023

Last Updated

May 31, 2023

Sponsor

Stanford University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05900687

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

June 1, 2027 (Anticipated)

Study Completion Date

June 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux, Patient Activation

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Focus Group (Aim 1)

Arm Type

No Intervention

Arm Description

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

Arm Title

Focus Group (Aim 2)

Arm Type

No Intervention

Arm Description

Participants give feedback about mobile health app prototype

Arm Title

mHealth app (Aim 3)

Arm Type

Experimental

Arm 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.

Arm Title

Standard of care (Aim 3)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Use of mHealth Question Prompt List app

Other Intervention Name(s)

Esophagus-Qs

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient Activation Measure Scale Score

Description

Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

Time Frame

month 3

Title

Patient Activation Measure Scale Score

Description

Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.

Time Frame

month 6

Secondary Outcome Measure Information:

Title

Pill Count

Description

measures medication adherence

Time Frame

months 3 and 6

Title

12-item Short Form Survey

Description

patient survey that measures health related quality of life

Time Frame

months 3 and 6

Title

Gerd-Q

Description

patient survey that measures symptom severity of GERD

Time Frame

months 3 and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Afrin N Kamal, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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