Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-13 @ 6:22 AM
Study NCT ID:
NCT03226795
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-10-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence (coverage rate)', 'timeFrame': '18 months.', 'description': 'Continuous multiple-interval measures of medication availability (CMA), including:\n\n* Medications for obstructive airway syndromes\n* Aerosolized bronchial fluidifier\n* Inhaled antibiotics\n* Vitamins\n* Hepatic and biliary therapeutics\n* Pancreatic enzyme replacement therapy\n* Medicinal products for acid disorders\n* Diabetes medications these measurements (coverage rate for each therapeutic class) will be aggregated to evaluate the medication adherence.'}], 'secondaryOutcomes': [{'measure': 'Adherence to medications for obstructive airway syndromes', 'timeFrame': '18 months.', 'description': 'Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes'}, {'measure': 'Adherence to physiotherapy', 'timeFrame': '18 months', 'description': 'Ratio between the number of acts refunded by the Health Insurance and the theoretical number of acts necessary for compliance with the prescription.'}, {'measure': 'Adherence score evaluated by self-administered questionnaire', 'timeFrame': '6 and 18 months', 'description': 'Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire'}, {'measure': 'Cystic Fibrosis Knowledge Scale', 'timeFrame': '6 and 18 months', 'description': 'Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale'}, {'measure': 'Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)', 'timeFrame': '6 and 18 months', 'description': 'Measured by Cystic fibrosis Questionnaire (CFQ-R) specific to cystic fibrosis and validated in French'}, {'measure': 'Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1)', 'timeFrame': '18 months', '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"}, {'measure': 'Clinical evolution : body mass index (BMI)', 'timeFrame': '18 months', 'description': "Body mass index (BMI) will be collected during the patient's usual follow-up, on the observational and interventional phases"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic fibrosis', 'Therapeutic adherence', 'Co-constructed intervention', 'Patient involvement'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.\n\nObjectives 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Cystic Fibrosis\n* Aged 18 or more\n* Speaking / understanding French\n* Followed in one of the participating centers (CRCM of the Auvergne-Rhône-Alpes region)\n* Resident in Auvergne-Rhône-Alpes\n* Affiliated to the general health insurance scheme\n\nExclusion Criteria:\n\n* Transplanted Patients\n* Patients who participated in the working group for the co-construction of the intervention'}, 'identificationModule': {'nctId': 'NCT03226795', 'briefTitle': 'Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.', 'orgStudyIdInfo': {'id': '69HCL17_0279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interventional arm', 'interventionNames': ['Other: " Information-Motivation-Behavioral skills " intervention.']}], 'interventions': [{'name': '" Information-Motivation-Behavioral skills " intervention.', 'type': 'OTHER', 'description': '* "information" -\\> Reminders of medication: mobile application\n* "Motivation" -\\> Coaching by patients: intervention or coaching by an expert patient, animation of a social network of patients\n* "Behavioral skills" -\\> Accompaniment by professionals: therapeutic education, assessment of membership during medical visits, prioritization of treatments', 'armGroupLabels': ['interventional arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie MONTCOUQUIOL, MD', 'role': 'CONTACT'}, {'name': 'Sylvie MONTCOUQUIOL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CRCM mixte, Hôpital Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rebecca HAMIDFAR, MD', 'role': 'CONTACT'}, {'name': 'Rebecca HAMIDFAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CRCM Adulte CHU Grenoble Alpes', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quitterie REYNAUD, Dr', 'role': 'CONTACT', 'email': 'quitterie.reynaud@chu-lyon.fr'}, {'name': 'Marie VIPREY', 'role': 'CONTACT', 'email': 'marie.viprey@chu-lyon.fr'}], 'facility': 'Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Quitterie REYNAUD', 'role': 'CONTACT', 'email': 'Quitterie.reynaud@chu-lyon.fr', 'phone': '4 78 86 13 56', 'phoneExt': '+33'}, {'name': 'Marie Viprey', 'role': 'CONTACT', 'email': 'marie.viprey@chu-lyon.fr', 'phone': '4 72 11 51 62', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}