Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV (APARDetp)

October 10, 2018 updated by: University Hospital, Montpellier

Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home Continuous Positive Airway Pressure or At-home Non-invasive Ventilation

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The proposed study calendar refers to the beginning and completion of work on the APARD database.

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Apard Database

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: a period of 28 days (retrospective study)
Treatment adherence will be quantified as the average number of hours of device usage per night
a period of 28 days (retrospective study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Association pour l'Assistance et la Réhabilitation à Domicile (APARD)

Investigators

  • Study Director: Nicolas Molinari, PhD, University Hospitals of Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2017

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • RECHMPL17_0077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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