An interventional study of " Information-Motivation-Behavioral skills " intervention. in Cystic Fibrosis, sponsored by Hospices Civils de Lyon. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Health services research
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 450 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: 18 months.
Adherence to medications for obstructive airway syndromes
Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes
Time frame: 18 months.
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.
Time frame: 18 months
Adherence score evaluated by self-administered questionnaire
Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire
Time frame: 6 and 18 months
Cystic Fibrosis Knowledge Scale
Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale
Time frame: 6 and 18 months
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
Time frame: 6 and 18 months
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
Time frame: 18 months
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
Time frame: 18 months
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