Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT04076332
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2019-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decision conflict', 'timeFrame': 'Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Health literacy', 'timeFrame': 'Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shared Decision Making', 'OSA - Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '28162150', 'type': 'RESULT', 'citation': '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': '19960649', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://aasm.org/clinical-resources/practice-standards/practice-guidelines/', 'label': 'American Academy of Sleep Medicine Practice Guidelines'}, {'url': 'https://www.uptodate.com/contents/obstructive-sleep-apnea-and-cardiovascular-disease-in-adults', 'label': 'UpToDate: Obstructive sleep apnea and cardiovascular disease in adults'}, {'url': 'https://www.uptodate.com/contents/sleep-related-breathing-disorders-and-stroke', 'label': 'UpToDate: Sleep-related breathing disorders and stroke'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nInclusion 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.\n\nExclusion criteria: dementia, mental illness, language difficulties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Exclude dementia, mental illness, language difficulties'}, 'identificationModule': {'nctId': 'NCT04076332', 'briefTitle': 'How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan', 'orgStudyIdInfo': {'id': 'N201904088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controlled group', 'description': 'Standard oral explanation with booklet'}, {'type': 'EXPERIMENTAL', 'label': 'Decision aid group', 'description': 'Shared decision making using decision aid', 'interventionNames': ['Other: Decision aid']}], 'interventions': [{'name': 'Decision aid', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Decision aid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '235', 'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Dean Wu, MD, PhD', 'role': 'CONTACT', 'email': 'tingyu02139@gmail.com', 'phone': '886-2-2249-0088', 'phoneExt': '8112'}, {'name': 'Dean Wu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taipei Medical University Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Dean Wu, MD, PhD', 'role': 'CONTACT', 'email': 'tingyu02139@gmail.com', 'phone': '886-2-2249-0088', 'phoneExt': '8112'}], 'overallOfficials': [{'name': 'Dean Wu, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}