Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
Study NCT ID:
NCT04563169
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2020-09-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video Consultation in CPAP for Patients With Obstructive Sleep Apnea
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-12', 'size': 648631, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-22T09:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sex', 'timeFrame': 'Baseline', 'description': 'Female/male'}, {'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Age (years)'}, {'measure': 'Education', 'timeFrame': 'Baseline', 'description': 'Education'}, {'measure': 'Living together with a partner', 'timeFrame': 'Baseline', 'description': 'Living together wit a partner (yes/no).'}, {'measure': 'Internet use', 'timeFrame': 'Baseline', 'description': 'Internet use (duration) varying from less than six months until more than 3 years.'}], 'primaryOutcomes': [{'measure': 'CPAP use', 'timeFrame': 'Week 1 through week 4', 'description': 'Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.'}, {'measure': 'CPAP use', 'timeFrame': 'Week 4 through week 12', 'description': 'Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.'}], 'secondaryOutcomes': [{'measure': 'CPAP adherence', 'timeFrame': 'Week 1 through week 4', 'description': 'CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.'}, {'measure': 'CPAP adherence', 'timeFrame': 'Week 4 through week 24', 'description': 'CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.'}, {'measure': 'Self-efficacy', 'timeFrame': 'Baseline', 'description': 'Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated with a 4 point scale, varying from 1 (not at all true) to 4 (very true).'}, {'measure': 'Self-efficacy', 'timeFrame': 'Week 4', 'description': 'Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (not at all true) to 4 (very true).'}, {'measure': 'Outcome expectancies', 'timeFrame': 'Baseline', 'description': 'Assessed with Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (not at all true) to 4 (very true).'}, {'measure': 'Outcome expectancies', 'timeFrame': 'Week 4', 'description': 'Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (not at all true) to 4 (very true).'}, {'measure': 'Risk perception', 'timeFrame': 'Baseline', 'description': 'Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (very low) to 4 (very high).'}, {'measure': 'Risk perception', 'timeFrame': 'Week 4', 'description': 'Assessed with Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (very low) to 4 (very high).'}, {'measure': 'Expectations with video consultation', 'timeFrame': 'Baseline', 'description': 'Questions based on constructs of the Unified Theory of Acceptance and Use of Technology. Items were rated on a 7 point scale, varying from 1 (totally disagree) to 7 (totally agree).'}, {'measure': 'Experiences video consultation', 'timeFrame': 'Week 4', 'description': 'Questions based on constructs of the Unified Theory of Acceptance and Use of Technology (intervention group only). Items were rated on a 7 point scale, varying from 1 (totally disagree) to 7 (totally agree).'}, {'measure': 'Satisfaction patients', 'timeFrame': 'Week 4', 'description': 'Questionnaires were used to assess satisfaction about consultations, number of consultations, received information, satisfaction with video consultation (intervention group only) and suggestions for improvement of the use of video consultation (open ended question). Items were rated on a 5 point scale, varying from 1 (totally disagree) to 5 (totally agree). Overall satisfaction was rated on a scale varying from 1 (not satisfied) to 10 (very satisfied).'}, {'measure': 'Satisfaction patients', 'timeFrame': 'After intervention completion, up to 8 months (after start).', 'description': 'Satisfaction with video consultation, benefits (eg, time and efficiency) and integration in work process. Items were rated on a 5 point scale, varying from 1 (totally disagree) to 5 (totally agree). Overall satisfaction was rated on a scale varying from 1 (not satisfied) to 10 (very satisfied). Suggestions for improvement were assessed using an open question'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video consultation', 'E-Health', 'CPAP', 'Randomized Controlled Trial'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '33973866', 'type': 'DERIVED', 'citation': 'Kooij L, Vos PJ, Dijkstra A, Roovers EA, van Harten WH. Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial. JMIR Form Res. 2021 May 11;5(5):e20779. doi: 10.2196/20779.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the effects of video consultation versus face-to-face consultation for patients with obstructive sleep apnea on patients' CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients' and nurses' satisfaction.", 'detailedDescription': "The objective of this study is to evaluate the effects of video consultation versus face-to-face consultation for patients with obstructive sleep apnea on patients' CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients' and nurses' satisfaction.\n\nThis study is a non-blinded randomized controlled trial with an intervention group (video consultations) and a usual care group (face-to-face consultations), with assessements after 1, 2, 3, 4, 12 and 24 weeks.\n\nPatients were recruited from a large teaching hospital (Rijnstate, hospital), and included from January 2, 2019 until June 26, 2019.In total, 140 patients were randomized, (1:1 allocation)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Diagnosed with obstructive sleep apnea\n* AHI \\> 15\n* Requiring CPAP treatment\n* No history of CPAP treatment\n* Having access to a tablet or smartphone\n* Proficiency of the Dutch language\n\nExclusion Criteria:\n\n* Psychiatric or cognitive disorder'}, 'identificationModule': {'nctId': 'NCT04563169', 'briefTitle': 'Video Consultation in CPAP for Patients With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Video Consultation as an Adequate Alternative to Face-to-face Consultations in CPAP Use for Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2018-1165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video consultation', 'description': 'Patients in the video consultation group will receive video consultations.', 'interventionNames': ['Other: Video consultation']}, {'type': 'NO_INTERVENTION', 'label': 'Face-to-Face consultation', 'description': 'Patients in the usual care group will receive face-to-face consultations.'}], 'interventions': [{'name': 'Video consultation', 'type': 'OTHER', 'description': 'The first video consultation with a nurse was planned one week after start with CPAP. Three focus points were discussed during the consultations: 1) adherence (\\>6 hours per night); 2) rest AHI \\< 5 (or \\<10 if age \\>70), and 3) (improvements in) complaints. If these objectives were achieved after one week, a new consultation was planned three weeks later (four weeks after start). As long as these objectives were not achieved, video consultations were planned weekly (until after four weeks).', 'armGroupLabels': ['Video consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'overallOfficials': [{'name': 'Wim van Harten', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}