NCT04076332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

June 28, 2019

Last Update Submit

October 19, 2020

Conditions

Shared Decision MakingOSA - Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Health literacy

    Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department

Study Arms (2)

Controlled group

NO INTERVENTION

Standard oral explanation with booklet

Decision aid group

EXPERIMENTAL

Shared decision making using decision aid

Other: Decision aid

Interventions

Decision aidOTHER

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.

Decision aid group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Exclude dementia, mental illness, language difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28162150RESULT

  • 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.

    PMID: 19960649RESULT

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Dean Wu, MD, PhD

    Taipei Medical University Shuang Ho Hospital

    STUDY CHAIR

Central Study Contacts

Dean Wu, MD, PhD

CONTACT

886-2-2249-0088tingyu02139@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

September 3, 2019

Study Start

December 10, 2019

Primary Completion

May 1, 2021

Study Completion

August 1, 2021

Last Updated

October 20, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)