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Decision Aid for Gastroesophageal Reflux Disease Management

This study is not yet open for participant recruitment.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01641887
First received: July 11, 2012
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Gastroesophageal Reflux Disease
Esophageal Cancer
Barrett's Esophagus
 Other: Decision Aid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Participant acceptability [ Time Frame: Patients will be surveyed on the day of the decision aid (1 day). ] [ Designated as safety issue: No ]
    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 [ Time Frame: Patients will be surveyed on the day of the decision aid (1 day). ] [ Designated as safety issue: No ]
    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:
  • Patient decisions [ Time Frame: Patients will be surveyed on the day of the decision aid (1 day). ] [ Designated as safety issue: No ]
    Patient intervention choice will be solicited both before and after the decision aid.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have GERD who have not yet had endoscopy.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641887

Contacts
Contact: Chin Hur, MD, MPH 617.724.4445 chur@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Chin Hur     617-724-4445     chur@partners.org    
Principal Investigator: Chin Hur, MD, MPH            
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Chin Hur, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01641887     History of Changes
Other Study ID Numbers: 2012-MGH-Hur-GERD
Study First Received: July 11, 2012
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
GERD
Heartburn
Decision Aid

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Diseases
Esophageal Neoplasms
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Gastrointestinal Diseases
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on May 23, 2013