Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
clinical diagnosis of GERD
GerdQ score of >=8
documented PPI use for GERD
internet access at home or computer/mobile device
Disqualifiers
Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
non-English speaking patients
Trial design
Design model
Parallel
Treatments tested in this trial
Use of mHealth Question Prompt List app
BehavioralmHealth Question Prompt List app that facilitates in asking questions with a physician during a consultation specific to GERD
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: Focus Group (Aim 1)No intervention 0 interventions
Group B: Focus Group (Aim 2)No intervention 0 interventions
Group C: mHealth app (Aim 3)Experimental treatment 1 intervention
Group D: Standard of care (Aim 3)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient Activation Measure Scale Score
Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.
Time frame
month 32
Patient Activation Measure Scale Score
Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.
Time frame
month 6Secondary outcomes
1
Pill Count
measures medication adherence
Time frame
months 3 and 62
12-item Short Form Survey
patient survey that measures health related quality of life
Time frame
months 3 and 63
Gerd-Q
patient survey that measures symptom severity of GERD
Time frame
months 3 and 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
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