NCT04563169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 16, 2020

Last Update Submit

September 23, 2020

Conditions

Obstructive Sleep Apnea

Keywords

Video consultationE-HealthCPAPRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • CPAP adherence

    Week 1 through week 4

  • CPAP adherence

    Week 4 through week 24

  • Self-efficacy

    Baseline

  • Self-efficacy

    Week 4

  • Outcome expectancies

    Baseline

  • +7 more secondary outcomes

Other Outcomes (5)

  • Sex

    Baseline

  • Age

    Baseline

  • Education

    Baseline

  • +2 more other outcomes

Study Arms (2)

Video consultation

EXPERIMENTAL

Patients in the video consultation group will receive video consultations.

Other: Video consultation

Face-to-Face consultation

NO INTERVENTION

Patients in the usual care group will receive face-to-face consultations.

Interventions

Video consultationOTHER

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).

Video consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric or cognitive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate

Arnhem, 6815AD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33973866DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Wim van Harten

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 24, 2020

Study Start

January 2, 2019

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations

NL(1)