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NCT Number: NCT05900687

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

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.

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Key information

Conditions

Gastroesophageal Reflux Behavior Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Health Behavior Patient Acceptance of Health Care Patient Activation Patient Participation Treatment Adherence and Compliance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of mHealth Question Prompt List app

Behavioral

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

Other names: Esophagus-Qs

Primary outcomes

  1. Patient Activation Measure Scale Score

    Time frame: month 3

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

  2. Patient Activation Measure Scale Score

    Time frame: month 6

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

Secondary outcomes

  1. Pill Count

    Time frame: months 3 and 6

    measures medication adherence

  2. 12-item Short Form Survey

    Time frame: months 3 and 6

    patient survey that measures health related quality of life

  3. Gerd-Q

    Time frame: months 3 and 6

    patient survey that measures symptom severity of GERD

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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