Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals

NCT ID: NCT03226795

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2025-10-18

Brief Summary

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Background Cystic fibrosis is a life-threatening genetic disorder responsible for pulmonary failure and multi-systemic complications involving specific and large medical care burden. To date, no program has shown its effectiveness in improving therapeutic adherence. A new approach to develop a co-constructed program involving patients and professionals may contribute to improve therapeutic adherence.

Objectives The aim of the MUCOBS-Trial project is to create a program to increase therapeutic adherence and to evaluate its efficacy in adult patients with cystic fibrosis in 3 CF centers in France.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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interventional arm

Group Type EXPERIMENTAL

" Information-Motivation-Behavioral skills " intervention.

Intervention Type OTHER

* "information" -\> Reminders of medication: mobile application
* "Motivation" -\> Coaching by patients: intervention or coaching by an expert patient, animation of a social network of patients
* "Behavioral skills" -\> Accompaniment by professionals: therapeutic education, assessment of membership during medical visits, prioritization of treatments

Interventions

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" Information-Motivation-Behavioral skills " intervention.

* "information" -\> Reminders of medication: mobile application
* "Motivation" -\> Coaching by patients: intervention or coaching by an expert patient, animation of a social network of patients
* "Behavioral skills" -\> Accompaniment by professionals: therapeutic education, assessment of membership during medical visits, prioritization of treatments

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with Cystic Fibrosis
* Aged 18 or more
* Speaking / understanding French
* Followed in one of the participating centers (CRCM of the Auvergne-Rhône-Alpes region)
* Resident in Auvergne-Rhône-Alpes
* Affiliated to the general health insurance scheme

Exclusion Criteria

* Transplanted Patients
* Patients who participated in the working group for the co-construction of the intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CRCM mixte, Hôpital Estaing

Clermont-Ferrand, , France

Site Status RECRUITING

CRCM Adulte CHU Grenoble Alpes

La Tronche, , France

Site Status RECRUITING

Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Quitterie REYNAUD

Role: CONTACT

4 78 86 13 56 ext. +33

Marie Viprey

Role: CONTACT

4 72 11 51 62 ext. +33

Facility Contacts

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Sylvie MONTCOUQUIOL, MD

Role: primary

Rebecca HAMIDFAR, MD

Role: primary

Quitterie REYNAUD, Dr

Role: primary

Marie VIPREY

Role: backup

Other Identifiers

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69HCL17_0279

Identifier Type: -

Identifier Source: org_study_id

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