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

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04076332
Collaborator
(none)
90
1
2
19.7
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Decision aid
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
Actual Study Start Date :
Dec 10, 2019
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Controlled group

Standard oral explanation with booklet

Experimental: Decision aid group

Shared decision making using decision aid

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Shuang Ho Hospital New Taipei City Taiwan 235

Sponsors and Collaborators

  • Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Chair: Dean Wu, MD, PhD, Taipei Medical University Shuang Ho Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier:
NCT04076332
Other Study ID Numbers:
  • N201904088
First Posted:
Sep 3, 2019
Last Update Posted:
Oct 20, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2020