Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
- Conditions
- Cystic Fibrosis
- Interventions
- Other: " Information-Motivation-Behavioral skills " intervention.
- Registration Number
- NCT03226795
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Patients with Cystic Fibrosis
- Aged 18 or more
- Speaking / understanding French
- Followed in one of the participating centers (CRCM of the Auvergne-Rh么ne-Alpes region)
- Resident in Auvergne-Rh么ne-Alpes
- Affiliated to the general health insurance scheme
- Transplanted Patients
- Patients who participated in the working group for the co-construction of the intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description interventional arm " Information-Motivation-Behavioral skills " intervention. -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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.
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
Trial Locations
- Locations (3)
CRCM mixte, H么pital Estaing
馃嚝馃嚪Clermont-Ferrand, France
CRCM Adulte CHU Grenoble Alpes
馃嚝馃嚪La Tronche, France
Centre de Ressources et de Comp茅tences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud
馃嚝馃嚪Pierre-B茅nite, France