Gastroesophageal Reflux DiseaseNCT01641887
Decision Aid for Gastroesophageal Reflux Disease Management
An observational study of Gastroesophageal Reflux Disease and Esophageal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Esophageal Cancer, Barrett's Esophagus
- What is being tested?
- Decision Aid
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have GERD who have not yet had endoscopy.
Who may be able to join
- Patients with GERD,
- Age at least 18,
- Able to give consent
Who cannot join
- Unable to perform decision aid on a computer
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Chin Hur, 617-724-4445, chur@partners.org
Chin Hur, MD, MPH
About this study
Official title: 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.
- Being tested
- Decision Aid
- Keywords
- GERD, Heartburn, Decision Aid
- Medical subject headings
- Gastroesophageal Reflux, Esophageal Neoplasms, Barrett Esophagus, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Patients will use a decision aid administered on a computer.
| Study group | Role | What they receive |
|---|---|---|
| GERD patients | Patients who have GERD will be recruited for this study. Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Patients will be surveyed on the day of the decision aid (1 day).
Secondary outcomes (1)
Patient decisions
Patient intervention choice will be solicited both before and after the decision aid.
Measured: Patients will be surveyed on the day of the decision aid (1 day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Hur, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641887
- Sponsor's protocol ID
- 2012-MGH-Hur-GERD
- Status last verified
- Apr 2013
- First submitted
- 11 Jul 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01641887
- Acronym / sponsor ID
- 2012-MGH-Hur-GERD
- Keywords
- GERD, Heartburn, Decision Aid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GERD patients | – | Other: Decision AidPatients who have GERD will be recruited for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have GERD who have not yet had endoscopy.
Key inclusion criteria (3 listed)
- Patients with GERD,
- Age at least 18,
- Able to give consent
Key exclusion criteria (1 listed)
- Unable to perform decision aid on a computer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidPatients will use a decision aid administered on a computer. | Other | GERD patients |
Primary outcome
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.
1 secondary outcome
Patient decisions
Time frame: Patients will be surveyed on the day of the decision aid (1 day).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Esophageal Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin Hur, MD, MPH (617.724.4445, chur@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant acceptability (time frame: Patients will be surveyed on the day of the decision aid (1 day).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.