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

Cystic Fibrosis Clinical Trial

Official title:

Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226795
• Other study ID #: 69HCL17_0279
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: October 18, 2025

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: Quitterie REYNAUD
• Phone: 4 78 86 13 56
• Email: Quitterie.reynaud[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 18, 2025
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• " 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

Locations

Country	Name	City	State
France	CRCM mixte, Hôpital Estaing	Clermont-Ferrand
France	CRCM Adulte CHU Grenoble Alpes	La Tronche
France	Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence (coverage rate)	Continuous multiple-interval measures of medication availability (CMA), including: Medications for obstructive airway syndromes; Aerosolized bronchial fluidifier; Inhaled antibiotics; Vitamins; Hepatic and biliary therapeutics; Pancreatic enzyme replacement therapy; Medicinal products for acid disorders; Diabetes medications these measurements (coverage rate for each therapeutic class) will be aggregated to evaluate the medication adherence.	18 months.
Secondary	Adherence to medications for obstructive airway syndromes	Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes	18 months.
Secondary	Adherence to physiotherapy	Ratio between the number of acts refunded by the Health Insurance and the theoretical number of acts necessary for compliance with the prescription.	18 months
Secondary	Adherence score evaluated by self-administered questionnaire	Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire	6 and 18 months
Secondary	Cystic Fibrosis Knowledge Scale	Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale	6 and 18 months
Secondary	Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)	Measured by Cystic fibrosis Questionnaire (CFQ-R) specific to cystic fibrosis and validated in French	6 and 18 months
Secondary	Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1)	Forced expiratory volume in 1 s as a percentage of predicted (%FEV1) and body mass index (BMI) will be collected during the patient's usual follow-up, on the observational and interventional phases	18 months
Secondary	Clinical evolution : body mass index (BMI)	Body mass index (BMI) will be collected during the patient's usual follow-up, on the observational and interventional phases	18 months