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Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563169
Recruitment Status : Completed
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Video consultation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : December 9, 2019
Actual Study Completion Date : December 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Video consultation
Patients in the video consultation group will receive video consultations.
 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).
No Intervention: Face-to-Face consultation
Patients in the usual care group will receive face-to-face consultations.


Outcome Measures
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Primary Outcome Measures :
  1. CPAP use [ Time Frame: Week 1 through week 4 ]
    Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.

  2. CPAP use [ Time Frame: Week 4 through week 12 ]
    Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.


Secondary Outcome Measures :
  1. CPAP adherence [ Time Frame: Week 1 through week 4 ]
    CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.

  2. CPAP adherence [ Time Frame: 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.

  3. Self-efficacy [ Time Frame: Baseline ]
    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).

  4. Self-efficacy [ Time Frame: 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).

  5. Outcome expectancies [ Time Frame: Baseline ]
    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).

  6. Outcome expectancies [ Time Frame: 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).

  7. Risk perception [ Time Frame: Baseline ]
    Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (very low) to 4 (very high).

  8. Risk perception [ Time Frame: 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).

  9. Expectations with video consultation [ Time Frame: 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).

  10. Experiences video consultation [ Time Frame: 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).

  11. Satisfaction patients [ Time Frame: Week 4 ]
    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).

  12. Satisfaction patients [ Time Frame: 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


Other Outcome Measures:
  1. Sex [ Time Frame: Baseline ]
    Female/male

  2. Age [ Time Frame: Baseline ]
    Age (years)

  3. Education [ Time Frame: Baseline ]
    Education

  4. Living together with a partner [ Time Frame: Baseline ]
    Living together wit a partner (yes/no).

  5. Internet use [ Time Frame: Baseline ]
    Internet use (duration) varying from less than six months until more than 3 years.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563169


Locations
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Netherlands
Rijnstate
Arnhem, Netherlands, 6815AD
Sponsors and Collaborators
Rijnstate Hospital
Investigators
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Principal Investigator: Wim van Harten Rijnstate Hospital
  Study Documents (Full-Text)

Documents provided by Rijnstate Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] November 12, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT04563169    
Other Study ID Numbers: 2018-1165
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rijnstate Hospital:
Video consultation
E-Health
CPAP
Randomized Controlled Trial
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases