- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641887
Decision Aid for Gastroesophageal Reflux Disease Management
April 1, 2013 updated by: Chin Hur, Massachusetts General Hospital
Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have GERD who have not yet had endoscopy.
Description
Inclusion Criteria:
- Patients with GERD,
- Age at least 18,
- Able to give consent
Exclusion Criteria:
- Unable to perform decision aid on a computer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
GERD patients
Patients who have GERD will be recruited for this study.
|
Patients will use a decision aid administered on a computer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Patients will be surveyed on the day of the decision aid (1 day).
|
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.
|
Patients will be surveyed on the day of the decision aid (1 day).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Patients will be surveyed on the day of the decision aid (1 day).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
July 11, 2012
First Submitted That Met QC Criteria
July 16, 2012
First Posted (Estimate)
July 17, 2012
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 1, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Precancerous Conditions
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Barrett Esophagus
Other Study ID Numbers
- 2012-MGH-Hur-GERD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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