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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05900687

Enrollment

150

Registered

2023-06-12

Start date

2023-07-01

Completion date

2028-06-01

Last updated

2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Patient Activation

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.

Interventions

BEHAVIORALUse 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026