NCT05900687

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jul 2023Jun 2028

First Submitted

Initial submission to the registry

May 31, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

June 12, 2023

Status Verified

May 1, 2023

Enrollment Period

3.9 years

First QC Date

May 31, 2023

Last Update Submit

May 31, 2023

Conditions

Gastroesophageal RefluxPatient Activation

Outcome Measures

Primary Outcomes (2)

  • Patient Activation Measure Scale Score

    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

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

    month 6

Secondary Outcomes (3)

  • Pill Count

    months 3 and 6

  • 12-item Short Form Survey

    months 3 and 6

  • Gerd-Q

    months 3 and 6

Study Arms (4)

Focus Group (Aim 1)

NO INTERVENTION

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

Focus Group (Aim 2)

NO INTERVENTION

Participants give feedback about mobile health app prototype

mHealth app (Aim 3)

EXPERIMENTAL

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

Standard of care (Aim 3)

NO INTERVENTION

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

Interventions

Use of mHealth Question Prompt List appBEHAVIORAL

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

Also known as: Esophagus-Qs
mHealth app (Aim 3)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
  • non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxPatient Participation

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Afrin N Kamal, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Medicine

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 12, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

June 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)