Decision Aid for Gastroesophageal Reflux Disease Management

• Conditions: Gastroesophageal Reflux Disease; Esophageal Cancer; Barrett's Esophagus
• Interventions: Other: Decision Aid

• Registration Number: NCT01641887
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on \~100 patients who have GERD to assess effectiveness.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04
• Study Start: 2014-01
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with GERD,
• Age at least 18,
• Able to give consent

Exclusion Criteria

• Unable to perform decision aid on a computer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GERD patients	Decision Aid	Patients who have GERD will be recruited for this study.

Primary Outcome Measures

Name	Time	Method
Participant acceptability	Patients will be surveyed on the day of the decision aid (1 day).	Patients will be surveyed after using the intervention to determine if they felt it was useful and whether they would recommend it to others.
Participant Satisfaction	Patients will be surveyed on the day of the decision aid (1 day).	The Patient Satisfaction with Decision Scale will be adapted for this study. This is a six-item scale has been shown to be reliable and valid.

Secondary Outcome Measures

Name	Time	Method
Patient decisions	Patients will be surveyed on the day of the decision aid (1 day).	Patient intervention choice will be solicited both before and after the decision aid.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States