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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
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity, Morbid

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
  2. Body mass index (BMI) ≧ 37 kg / m2

Exclusion Criteria:

  1. Endocrine system abnormalities in patients
  2. Drug abuse or mental illness
  3. Major organ dysfunction and can accept surgery
  4. Patients cannot understand Chinese
  5. 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

First Posted
June 25, 2018
Last Updated
May 3, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
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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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