Decision Aid for Gastroesophageal Reflux Disease Management

NCT01641887 | Unknown

• 1 other identifier: 2012-MGH-Hur-GERD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease; Esophageal Cancer; Barrett's Esophagus

Keywords

GERD; Heartburn; Decision Aid

Outcome Measures

Primary Outcomes (2)

• 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).

• 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).

Secondary Outcomes (1)

• Patient decisions

  Patients will be surveyed on the day of the decision aid (1 day).

Study Arms (1)

GERD patients

Patients who have GERD will be recruited for this study.

Other: Decision Aid

Interventions

Decision Aid OTHER

Patients will use a decision aid administered on a computer.

GERD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have GERD who have not yet had endoscopy.

You may qualify if:

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

You may not qualify if:

• Unable to perform decision aid on a computer

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophageal Neoplasms; Barrett Esophagus; Heartburn

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

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; Precancerous Conditions; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Chin Hur, MD, MPH

CONTACT

617.724.4445; chur@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 17, 2012
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)