Video Consultation in CPAP for Patients With Obstructive Sleep Apnea
NCT ID: NCT04563169
Last Updated: 2020-09-24
Study Results
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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COMPLETED
NA
140 participants
INTERVENTIONAL
2019-01-02
2019-12-09
Brief Summary
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Detailed Description
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This 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.
Patients 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Video consultation
Patients in the video consultation group will receive video consultations.
Video consultation
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).
Face-to-Face consultation
Patients in the usual care group will receive face-to-face consultations.
No interventions assigned to this group
Interventions
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Video consultation
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).
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with obstructive sleep apnea
* AHI \> 15
* Requiring CPAP treatment
* No history of CPAP treatment
* Having access to a tablet or smartphone
* Proficiency of the Dutch language
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rijnstate Hospital
OTHER
Responsible Party
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Principal Investigators
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Wim van Harten
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Locations
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Rijnstate
Arnhem, , Netherlands
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-1165
Identifier Type: -
Identifier Source: org_study_id
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