Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563169
• Other study ID #: 2018-1165
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: September 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Netherlands	Rijnstate	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex	Female/male	Baseline
Other	Age	Age (years)	Baseline
Other	Education	Education	Baseline
Other	Living together with a partner	Living together wit a partner (yes/no).	Baseline
Other	Internet use	Internet use (duration) varying from less than six months until more than 3 years.	Baseline
Primary	CPAP use	Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.	Week 1 through week 4
Primary	CPAP use	Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.	Week 4 through week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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).