Decision Aid for Gastroesophageal Reflux Disease Management

Esophageal Cancer Clinical Trial

Official title:

Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01641887
• Other study ID #: 2012-MGH-Hur-GERD
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2012
• Last updated: April 1, 2013
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2013
• Source: Massachusetts General Hospital
• Contact: Chin Hur, MD, MPH
• Phone: 617.724.4445
• Email: chur[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• Decision Aid
Patients will use a decision aid administered on a computer.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant acceptability	Patients will be surveyed after using the intervention to determine if they felt it was useful and whether they would recommend it to others.	Patients will be surveyed on the day of the decision aid (1 day).	No
Primary	Participant Satisfaction	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.	Patients will be surveyed on the day of the decision aid (1 day).	No
Secondary	Patient decisions	Patient intervention choice will be solicited both before and after the decision aid.	Patients will be surveyed on the day of the decision aid (1 day).	No