Clinical trial NCT04563169: Video Consultation in CPAP for Patients With Obstructive Sleep Apnea
Official title: Video Consultation as an Adequate Alternative to Face-to-face Consultations in CPAP Use for Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Video consultation
E-Health
CPAP
Randomized Controlled Trial
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

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).

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* 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:

* Psychiatric or cognitive disorder

Primary outcomes:
measure: CPAP use
timeFrame: Week 1 through week 4
measure: CPAP use
timeFrame: Week 4 through week 12
Secondary outcomes:
measure: CPAP adherence
timeFrame: Week 1 through week 4
measure: CPAP adherence
timeFrame: Week 4 through week 24
measure: Self-efficacy
timeFrame: Baseline
measure: Self-efficacy
timeFrame: Week 4
measure: Outcome expectancies
timeFrame: Baseline
measure: Outcome expectancies
timeFrame: Week 4
measure: Risk perception
timeFrame: Baseline
measure: Risk perception
timeFrame: Week 4
measure: Expectations with video consultation
timeFrame: Baseline
measure: Experiences video consultation
timeFrame: Week 4
measure: Satisfaction patients
timeFrame: Week 4
measure: Satisfaction patients
timeFrame: After intervention completion, up to 8 months (after start).
Other outcomes:
measure: Sex
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: Living together with a partner
timeFrame: Baseline
measure: Internet use
timeFrame: Baseline
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
Study officials:
affiliation: Rijnstate Hospital
name: Wim van Harten
role: PRINCIPAL_INVESTIGATOR
References:
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.