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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other:  Information-Motivation-Behavioral skills  intervention.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional arm<br> | Other:  Information-Motivation-Behavioral skills  intervention.<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic fibrosis, Therapeutic adherence, Co-constructed intervention, Patient involvement