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

Not Applicable

• Conditions: OSA - Obstructive Sleep Apnea; Shared Decision Making
• Interventions: Other: Decision aid

• Registration Number: NCT04076332
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2019-12-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20
• Primary Completion: 2021-05-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aid group	Decision aid	Shared decision making using decision aid

Primary Outcome Measures

Name	Time	Method
Decision conflict	Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department	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

Name	Time	Method
Health literacy	Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department	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).

Trial Locations

Locations (1)

Taipei Medical University Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan