Cystic Fibrosis
Conditions
Keywords
Cystic fibrosis, Therapeutic adherence, Co-constructed intervention, Patient involvement
Brief 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.
Interventions
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
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence (coverage rate) | 18 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to physiotherapy | 18 months | Ratio between the number of acts refunded by the Health Insurance and the theoretical number of acts necessary for compliance with the prescription. |
| Adherence score evaluated by self-administered questionnaire | 6 and 18 months | Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire |
| Cystic Fibrosis Knowledge Scale | 6 and 18 months | Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale |
| Adherence to medications for obstructive airway syndromes | 18 months. | Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes |
| Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1) | 18 months | 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 |
| Clinical evolution : body mass index (BMI) | 18 months | Body mass index (BMI) will be collected during the patient's usual follow-up, on the observational and interventional phases |
| Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R) | 6 and 18 months | Measured by Cystic fibrosis Questionnaire (CFQ-R) specific to cystic fibrosis and validated in French |
Countries
France
Contacts
Primary ContactQuitterie REYNAUD
Backup ContactMarie Viprey
Outcome results
None listed