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NCT04076332 Clinical Trial

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

Shared Decision Making Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04076332
Other study ID # N201904088
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 10, 2019
Est. completion date August 1, 2021

Study information
Verified date September 2020
Source Taipei Medical University Shuang Ho Hospital
Contact Dean Wu, MD, PhD
Phone 886-2-2249-0088
Email tingyu02139@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date August 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Decision aid
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.

Locations
Country Name City State
Taiwan Taipei Medical University Shuang Ho Hospital New Taipei City

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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, manage — View 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 Ma — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Secondary 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). Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
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