Decision Aid for Gastroesophageal Reflux Disease Management

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01641887
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease; Esophageal Cancer; Barrett's Esophagus	Other: Decision Aid

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
GERD patients Patients who have GERD will be recruited for this study.	Other: Decision Aid; Patients will use a decision aid administered on a computer.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with GERD,

• Age at least 18,

• Able to give consent

Exclusion Criteria:

• Unable to perform decision aid on a computer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chin Hur, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01641887
• Other Study ID Numbers: 2012-MGH-Hur-GERD
• First Posted: Jul 17, 2012
• Last Update Posted: Apr 4, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Chin Hur, Principal Investigator, Massachusetts General Hospital: GERD; Heartburn; Decision Aid
• Additional relevant MeSH terms: Barrett Esophagus; Gastroesophageal Reflux; Esophagitis, Peptic

Study Results

No Results Posted as of Apr 4, 2013