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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05900687
• Other study ID #: 62297
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 1, 2028

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Patient Activation

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pill Count	measures medication adherence	months 3 and 6
Secondary	12-item Short Form Survey	patient survey that measures health related quality of life	months 3 and 6
Secondary	Gerd-Q	patient survey that measures symptom severity of GERD	months 3 and 6