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Decision Aid for Gastroesophageal Reflux Disease Management

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Chin Hur, Massachusetts General Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641887
First Posted: July 17, 2012
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital
  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:


Further study details as provided by Chin Hur, Massachusetts General Hospital:

Primary Outcome Measures:
  • Participant acceptability [ Time Frame: 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 [ Time Frame: 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:
  • Patient decisions [ Time Frame: 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chin Hur, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01641887     History of Changes
Other Study ID Numbers: 2012-MGH-Hur-GERD
First Submitted: July 11, 2012
First Posted: July 17, 2012
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Chin Hur, Massachusetts General Hospital:
GERD
Heartburn
Decision Aid

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