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

NCT ID: NCT04076332

Last Updated: 2020-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Shared Decision Making OSA - Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Controlled group

Standard oral explanation with booklet

Group Type NO_INTERVENTION

No interventions assigned to this group

Decision aid group

Shared decision making using decision aid

Group Type EXPERIMENTAL

Decision aid

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Wu, MD, PhD

Role: STUDY_CHAIR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Dean Wu, MD, PhD

Role: CONTACT

886-2-2249-0088 ext. 8112

Facility Contacts

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Dean Wu, MD, PhD

Role: primary

886-2-2249-0088 ext. 8112

References

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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.

Reference Type RESULT
PMID: 28162150 (View on PubMed)

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.

Reference Type RESULT
PMID: 19960649 (View on PubMed)

Related Links

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https://aasm.org/clinical-resources/practice-standards/practice-guidelines/

American Academy of Sleep Medicine Practice Guidelines

https://www.uptodate.com/contents/obstructive-sleep-apnea-and-cardiovascular-disease-in-adults

UpToDate: Obstructive sleep apnea and cardiovascular disease in adults

https://www.uptodate.com/contents/sleep-related-breathing-disorders-and-stroke

UpToDate: Sleep-related breathing disorders and stroke

Other Identifiers

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N201904088

Identifier Type: -

Identifier Source: org_study_id

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