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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| " Information-Motivation-Behavioral skills " intervention. | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence (coverage rate) | Continuous multiple-interval measures of medication availability (CMA), including:
| 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to medications for obstructive airway syndromes | Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes | 18 months. |
| Adherence to physiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quitterie REYNAUD | Contact | 4 78 86 13 56 | +33 | Quitterie.reynaud@chu-lyon.fr |
| Marie Viprey | Contact | 4 72 11 51 62 | +33 | marie.viprey@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRCM mixte, Hôpital Estaing | Recruiting | Clermont-Ferrand | 63100 | France |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D000074822 | Treatment Adherence and Compliance |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
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 |
| Adherence score evaluated by self-administered questionnaire | Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire | 6 and 18 months |
| Cystic Fibrosis Knowledge Scale | Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale | 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 | 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 | 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 | 18 months |
| CRCM Adulte CHU Grenoble Alpes | Recruiting | La Tronche | 38700 | France |
|
| Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |