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

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ClinicalTrials.gov Identifier: NCT05900687
Recruitment Status : Not yet recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Afrin Kamal, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Patient Activation Behavioral: Use of mHealth Question Prompt List app Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : June 1, 2027
Estimated Study Completion Date : June 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Focus Group (Aim 1)
Participants give feedback about day-to-day challenges with GERD.
No Intervention: Focus Group (Aim 2)
Participants give feedback about mobile health app prototype
Experimental: 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.
 Behavioral: 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
Other Name: Esophagus-Qs
No Intervention: Standard of care (Aim 3)
Participants will be exposed to standard of care communication with their health provider (no mHealth app).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05900687


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Afrin N Kamal, MD Stanford University
More Information
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Responsible Party: Afrin Kamal, Clinical Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT05900687    
Other Study ID Numbers: 62297
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: June 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases