Impact of Decision Aids on Bariatric Surgery Choice
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shared decision making with decision aids
Sponsored by
About this trial
This is an interventional health services research trial for Obesity, Morbid
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
- Body mass index (BMI) ≧ 37 kg / m2
Exclusion Criteria:
- Endocrine system abnormalities in patients
- Drug abuse or mental illness
- Major organ dysfunction and can accept surgery
- Patients cannot understand Chinese
- Age less than 20 years old or more than 70 years old
Sites / Locations
- Taipei Medical University-Shuang Ho Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DAs group
Control group
Arm Description
Shared decision making using decision aids
Standard oral explanation guided with booklets
Outcomes
Primary Outcome Measures
Decisional conflict
Total scores of decisional conflict scale
Secondary Outcome Measures
Decision regret
Total scores of decision regret
Full Information
NCT ID
NCT03578211
First Posted
June 25, 2018
Last Updated
May 3, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03578211
Brief Title
Impact of Decision Aids on Bariatric Surgery Choice
Official Title
Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 16, 2020 (Actual)
Study Completion Date
July 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAs group
Arm Type
Experimental
Arm Description
Shared decision making using decision aids
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard oral explanation guided with booklets
Intervention Type
Behavioral
Intervention Name(s)
Shared decision making with decision aids
Intervention Description
For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.
Primary Outcome Measure Information:
Title
Decisional conflict
Description
Total scores of decisional conflict scale
Time Frame
One week after intervention
Secondary Outcome Measure Information:
Title
Decision regret
Description
Total scores of decision regret
Time Frame
3 month after bariatric surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
Body mass index (BMI) ≧ 37 kg / m2
Exclusion Criteria:
Endocrine system abnormalities in patients
Drug abuse or mental illness
Major organ dysfunction and can accept surgery
Patients cannot understand Chinese
Age less than 20 years old or more than 70 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Hao Su, MD
Organizational Affiliation
Metabolic and Weight Management Center, Shuang-Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital
City
New Taipei City
State/Province
Zhonghe District
ZIP/Postal Code
23561
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Impact of Decision Aids on Bariatric Surgery Choice
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