Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
Primary Purpose
Cystic Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
" Information-Motivation-Behavioral skills " intervention.
Sponsored by
About this trial
This is an interventional health services research trial for Cystic Fibrosis focused on measuring Cystic fibrosis, Therapeutic adherence, Co-constructed intervention, Patient involvement
Eligibility Criteria
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
Sites / Locations
- CRCM mixte, Hôpital EstaingRecruiting
- CRCM Adulte CHU Grenoble AlpesRecruiting
- Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon SudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventional arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adherence to medications for obstructive airway syndromes
Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes
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.
Adherence score evaluated by self-administered questionnaire
Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire
Cystic Fibrosis Knowledge Scale
Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03226795
Brief Title
Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
Official Title
Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Anticipated)
Study Completion Date
October 18, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis, Therapeutic adherence, Co-constructed intervention, Patient involvement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
" Information-Motivation-Behavioral skills " intervention.
Intervention Description
"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
Primary Outcome Measure Information:
Title
Medication Adherence (coverage rate)
Description
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.
Secondary Outcome Measure Information:
Title
Adherence to medications for obstructive airway syndromes
Description
Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes
Time Frame
18 months.
Title
Adherence to physiotherapy
Description
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
Title
Adherence score evaluated by self-administered questionnaire
Description
Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire
Time Frame
6 and 18 months
Title
Cystic Fibrosis Knowledge Scale
Description
Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale
Time Frame
6 and 18 months
Title
Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)
Description
Measured by Cystic fibrosis Questionnaire (CFQ-R) specific to cystic fibrosis and validated in French
Time Frame
6 and 18 months
Title
Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1)
Description
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
Title
Clinical evolution : body mass index (BMI)
Description
Body mass index (BMI) will be collected during the patient's usual follow-up, on the observational and interventional phases
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quitterie REYNAUD
Phone
4 78 86 13 56
Ext
+33
Email
Quitterie.reynaud@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Viprey
Phone
4 72 11 51 62
Ext
+33
Email
marie.viprey@chu-lyon.fr
Facility Information:
Facility Name
CRCM mixte, Hôpital Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie MONTCOUQUIOL, MD
First Name & Middle Initial & Last Name & Degree
Sylvie MONTCOUQUIOL, MD
Facility Name
CRCM Adulte CHU Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca HAMIDFAR, MD
First Name & Middle Initial & Last Name & Degree
Rebecca HAMIDFAR, MD
Facility Name
Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quitterie REYNAUD, Dr
Email
quitterie.reynaud@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marie VIPREY
Email
marie.viprey@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
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