Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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).

Official Title
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Video Consultation as an Adequate Alternative to Face-to-face Consultations in CPAP Use for Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Video consultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video consultation<br>Patients in the video consultation group will receive video consultations. | Other: Video consultation<br>* 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).<br>|
| No Intervention: Face-to-Face consultation<br>Patients in the usual care group will receive face-to-face consultations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP use | Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere. | Week 1 through week 4 | 
| CPAP use | Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere. | Week 4 through week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP adherence | CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere. | Week 1 through week 4 | 
| CPAP adherence | CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere. | Week 4 through week 24 | 
| Self-efficacy | 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). | Baseline | 
| Self-efficacy | 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). | Week 4 | 
| Outcome expectancies | 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). | Baseline | 
| Outcome expectancies | 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). | Week 4 | 
| Risk perception | Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (very low) to 4 (very high). | Baseline | 
| Risk perception | 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). | Week 4 | 
| Expectations with video consultation | 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). | Baseline | 
| Experiences video consultation | 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). | Week 4 | 
| Satisfaction patients | 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). | Week 4 | 
| Satisfaction patients | 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 | After intervention completion, up to 8 months (after start). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Video consultation, E-Health, Randomized Controlled Trial