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Completed

NCT Number: NCT04563169

Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate

Arnhem, 6815AD, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video consultation

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2020
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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