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Decision Aid for Gastroesophageal Reflux Disease Management

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.
ClinicalTrials.gov Identifier: NCT01641887
Recruitment Status : Unknown
Verified April 2013 by Chin Hur, Massachusetts General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2012
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital

Tracking Information
First Submitted Date July 11, 2012
First Posted Date July 17, 2012
Last Update Posted Date April 4, 2013
Study Start Date January 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2012)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01641887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 16, 2012)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Decision Aid for Gastroesophageal Reflux Disease Management
Official Title Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have GERD who have not yet had endoscopy.
Condition
  • Gastroesophageal Reflux Disease
  • Esophageal Cancer
  • Barrett's Esophagus
Intervention Other: Decision Aid
Patients will use a decision aid administered on a computer.
Study Groups/Cohorts GERD patients
Patients who have GERD will be recruited for this study.
Intervention: Other: Decision Aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 1, 2013)
100
Original Estimated Enrollment
 (submitted: July 16, 2012)
50
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to perform decision aid on a computer
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01641887
Other Study ID Numbers 2012-MGH-Hur-GERD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chin Hur, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Massachusetts General Hospital
Verification Date April 2013