Shared Decision MakingNCT04076332
How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
A study testing Decision aid in people with Shared Decision Making and OSA - Obstructive Sleep Apnea, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Shared Decision Making, OSA - Obstructive Sleep Apnea
- What is being tested?
- Decision aid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclude dementia, mental illness, language difficulties
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
Dean Wu, MD, PhD, 886-2-2249-0088 ext. 8112, tingyu02139@gmail.com
Dean Wu, MD, PhD
About this study
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.
Read the 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.
- Being tested
- Decision aid
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Controlled group | No intervention | Standard oral explanation with booklet |
| Decision aid group | Experimental | Shared decision making using decision aid Receives: Other: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Secondary outcomes (1)
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).
Measured: Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start10 Dec 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shared Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Wu, MD, PhD, Study chair, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076332
- Sponsor's protocol ID
- N201904088
- Status last verified
- Sep 2020
- First submitted
- 28 Jun 2019
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28162150Epstein 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.
PubMed 19960649
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
- ClinicalTrials.gov ID
- NCT04076332
- Acronym / sponsor ID
- N201904088
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled group | No intervention | –Standard oral explanation with booklet |
| Decision aid group | Experimental | Other: Decision aidShared decision making using decision aid |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Exclude dementia, mental illness, language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidDecision 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. | Other | Decision aid group |
Primary outcome
Decision conflict
Time frame: 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).
1 secondary outcome
Health literacy
Time frame: Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Results publication: PubMed 28162150Kapur 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.
- Results publication: PubMed 19960649Epstein 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.
- American Academy of Sleep Medicine Practice GuidelinesLink provided by the sponsor.
- UpToDate: Obstructive sleep apnea and cardiovascular disease in adultsLink provided by the sponsor.
- UpToDate: Sleep-related breathing disorders and strokeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Wu, MD, PhD study chair
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Shared Decision Making and OSA - Obstructive Sleep Apnea, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean Wu, MD, PhD (886-2-2249-0088 ext. 8112, tingyu02139@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision conflict (time frame: Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076332, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.