NCT03151317

Brief Summary

The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

October 11, 2018

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

May 11, 2017

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment adherence

    Treatment adherence will be quantified as the average number of hours of device usage per night

    a period of 28 days (retrospective study)

Study Arms (2)

With therapeutic education

Patients assigned to this group will have participated in a therapeutic education program.

Without therapeutic education (control)

Patients assigned to this (control) group have not had any kind of therapeutic education.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is composed of patients that have been equipped by the Association for Home Assistance and Rehabilitation (APARD) with either a continuous positive airway pressure (CPAP) device or a non-invasive ventilation (NIV) device.

You may qualify if:

  • Patients that have been equipped by the Association for Home Assistance and Rehabilitation (APARD) with either a continuous positive airway pressure (CPAP) device or a non-invasive ventilation (NIV) device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Apard Database

Montpellier, France

Location

Related Links

Study Officials

  • Nicolas Molinari, PhD

    University Hospitals of Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 12, 2017

Study Start

May 12, 2017

Primary Completion

July 30, 2017

Study Completion

July 30, 2017

Last Updated

October 11, 2018

Record last verified: 2017-05

Locations