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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Apnea
• OSA - Obstructive Sleep Apnea
• Shared Decision Making
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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

External Links

•   American Academy of Sleep Medicine Practice Guidelines
•   UpToDate: Obstructive sleep apnea and cardiovascular disease in adults
•   UpToDate: Overview of obstructive sleep apnea in adults
•   UpToDate: Sleep-related breathing disorders and stroke