NCT04249518

Brief Summary

Confirming or denying it in the future is an opportunity for certain patient groups to have the option of video delivery. So that in calm circumstances and possibly. several times can review the video and equipment in the home and hopefully achieve the same or better compliance with the ongoing treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

January 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

March 25, 2020

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

January 17, 2020

Last Update Submit

March 24, 2020

Conditions

Patient EmpowermentPatient EngagementPatient Compliance

Outcome Measures

Primary Outcomes (1)

  • compliance in percentage

    Compliance at one month follow up. Minimum 0 % maximum 100 % compliance.

    one month.

Secondary Outcomes (3)

  • Depression

    one month.

  • Influencer

    one month.

  • Insomnia

    One month .

Study Arms (2)

nurse instruction of CPAP

NO INTERVENTION

Normal extradition. 45 minutes face to face with a nurse.

Video extradition

EXPERIMENTAL

Access to 7 min video - explaining how to start CPAP and how to adjust the mask.

Behavioral: Videoeducation

Interventions

VideoeducationBEHAVIORAL

No drugs used. The only difference in the to arms is the way the extradition is.

Video extradition

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • candidate to CPAP
  • over age of 18

You may not qualify if:

  • Language issues
  • sight or hearing handicap
  • kognitive issues
  • if drivers license is confiscated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient ParticipationPatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jesper Bille, MD

    University Aarhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Bille, MD

CONTACT

0045+61651750doctor.bille@gmail.com

Milos Fuglsang, MD

CONTACT

0045+24463040milosfuglsang@hotmail.com

Study Design

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

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 31, 2020

Study Start

May 15, 2020

Primary Completion

February 15, 2022

Study Completion

February 15, 2023

Last Updated

March 25, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share