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How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan

Primary Purpose

Shared Decision Making, OSA - Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Decision aid
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 Shared Decision Making

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese

Exclusion Criteria:

  • Exclude dementia, mental illness, language difficulties

Sites / Locations

  • Taipei Medical University Shuang Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Controlled group

Decision aid group

Arm Description

Standard oral explanation with booklet

Shared decision making using decision aid

Outcomes

Primary Outcome Measures

Decision conflict
We'd like to measure the score of SURE test, which published by Légaré at 2008, as a decisional conflict scale. SURE includes 4 questions representing "sure of myself, understand information, risk-benefit ratio, encouragement". Each question consisted of a typical five-level Likert item (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).

Secondary Outcome Measures

Health literacy
Self-evaluation score of health literacy. We measure health literacy via one question of SURE test (Sure of myself - Do you feel SURE about the best choice for you?). This question also consisted of a typical five-level Likert item (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).

Full Information

First Posted
June 28, 2019
Last Updated
October 19, 2020
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04076332
Brief Title
How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
Official Title
How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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

5. Study Description

Brief Summary
Shared decision-making helps patients to establish a treatment plan with clinicians together. Our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea.
Detailed Description
Shared decision-making helps patients to establish a treatment plan with clinicians together. Our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea. Inclusion criteria: include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese. Exclusion criteria: dementia, mental illness, language difficulties.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shared Decision Making, OSA - Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Controlled group
Arm Type
No Intervention
Arm Description
Standard oral explanation with booklet
Arm Title
Decision aid group
Arm Type
Experimental
Arm Description
Shared decision making using decision aid
Intervention Type
Other
Intervention Name(s)
Decision aid
Intervention Description
Decision aid is a tool that helps patients become involved in decision making on choosing treatment plans. Decision aid provides information about the options and outcomes, and by clarifying personal values.
Primary Outcome Measure Information:
Title
Decision conflict
Description
We'd like to measure the score of SURE test, which published by Légaré at 2008, as a decisional conflict scale. SURE includes 4 questions representing "sure of myself, understand information, risk-benefit ratio, encouragement". Each question consisted of a typical five-level Likert item (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).
Time Frame
Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Secondary Outcome Measure Information:
Title
Health literacy
Description
Self-evaluation score of health literacy. We measure health literacy via one question of SURE test (Sure of myself - Do you feel SURE about the best choice for you?). This question also consisted of a typical five-level Likert item (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).
Time Frame
Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese Exclusion Criteria: Exclude dementia, mental illness, language difficulties
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dean Wu, MD, PhD
Phone
886-2-2249-0088
Ext
8112
Email
tingyu02139@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Wu, MD, PhD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean Wu, MD, PhD
Phone
886-2-2249-0088
Ext
8112
Email
tingyu02139@gmail.com
First Name & Middle Initial & Last Name & Degree
Dean Wu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28162150
Citation
Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.
Results Reference
result
PubMed Identifier
19960649
Citation
Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
Results Reference
result
Links:
URL
https://aasm.org/clinical-resources/practice-standards/practice-guidelines/
Description
American Academy of Sleep Medicine Practice Guidelines
URL
https://www.uptodate.com/contents/obstructive-sleep-apnea-and-cardiovascular-disease-in-adults
Description
UpToDate: Obstructive sleep apnea and cardiovascular disease in adults
URL
https://www.uptodate.com/contents/sleep-related-breathing-disorders-and-stroke
Description
UpToDate: Sleep-related breathing disorders and stroke

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How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan

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