Video Consultation in CPAP for Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Video consultation
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring Video consultation, E-Health, CPAP, Randomized Controlled Trial
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
Sites / Locations
- Rijnstate
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video consultation
Face-to-Face consultation
Arm Description
Patients in the video consultation group will receive video consultations.
Patients in the usual care group will receive face-to-face consultations.
Outcomes
Primary Outcome Measures
CPAP use
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
CPAP use
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
Secondary Outcome Measures
CPAP adherence
CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
CPAP adherence
CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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
Full Information
NCT ID
NCT04563169
First Posted
September 16, 2020
Last Updated
September 23, 2020
Sponsor
Rijnstate Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04563169
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Video consultation, E-Health, CPAP, Randomized Controlled Trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video consultation
Arm Type
Experimental
Arm Description
Patients in the video consultation group will receive video consultations.
Arm Title
Face-to-Face consultation
Arm Type
No Intervention
Arm Description
Patients in the usual care group will receive face-to-face consultations.
Intervention Type
Other
Intervention Name(s)
Video consultation
Intervention 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).
Primary Outcome Measure Information:
Title
CPAP use
Description
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
Time Frame
Week 1 through week 4
Title
CPAP use
Description
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
Time Frame
Week 4 through week 12
Secondary Outcome Measure Information:
Title
CPAP adherence
Description
CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
Time Frame
Week 1 through week 4
Title
CPAP adherence
Description
CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
Time Frame
Week 4 through week 24
Title
Self-efficacy
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).
Time Frame
Baseline
Title
Self-efficacy
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).
Time Frame
Week 4
Title
Outcome expectancies
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).
Time Frame
Baseline
Title
Outcome expectancies
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).
Time Frame
Week 4
Title
Risk perception
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).
Time Frame
Baseline
Title
Risk perception
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).
Time Frame
Week 4
Title
Expectations with video consultation
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).
Time Frame
Baseline
Title
Experiences video consultation
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).
Time Frame
Week 4
Title
Satisfaction patients
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).
Time Frame
Week 4
Title
Satisfaction patients
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
Time Frame
After intervention completion, up to 8 months (after start).
Other Pre-specified Outcome Measures:
Title
Sex
Description
Female/male
Time Frame
Baseline
Title
Age
Description
Age (years)
Time Frame
Baseline
Title
Education
Description
Education
Time Frame
Baseline
Title
Living together with a partner
Description
Living together wit a partner (yes/no).
Time Frame
Baseline
Title
Internet use
Description
Internet use (duration) varying from less than six months until more than 3 years.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim van Harten
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate
City
Arnhem
ZIP/Postal Code
6815AD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
33973866
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.
Results Reference
derived
Learn more about this trial
Video Consultation in CPAP for Patients With Obstructive Sleep Apnea
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