Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Video consultation

• Registration Number: NCT04563169
• Lead Sponsor: Rijnstate Hospital

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).

Study Timeline

• Study Start: 2019-01-02
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video consultation	Video consultation	Patients in the video consultation group will receive video consultations.

Primary Outcome Measures

Name	Time	Method
CPAP use	Week 4 through week 12	Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.

Secondary Outcome Measures

Name	Time	Method
Outcome expectancies	Week 4	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).
Risk perception	Week 4	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).
CPAP adherence	Week 4 through week 24	CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
Self-efficacy	Week 4	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).
Satisfaction patients	After intervention completion, up to 8 months (after start).	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
Expectations with video consultation	Baseline	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).
Experiences video consultation	Week 4	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).

Trial Locations

Locations (1)

Rijnstate; 🇳🇱 Arnhem, Netherlands