- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03226795
Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Quitterie REYNAUD
- Telefonnummer: +33 4 78 86 13 56
- E-post: Quitterie.reynaud@chu-lyon.fr
Studer Kontakt Backup
- Navn: Marie Viprey
- Telefonnummer: +33 4 72 11 51 62
- E-post: marie.viprey@chu-lyon.fr
Studiesteder
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Clermont-Ferrand, Frankrike, 63100
- Rekruttering
- CRCM mixte, Hôpital Estaing
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Ta kontakt med:
- Sylvie MONTCOUQUIOL, MD
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Hovedetterforsker:
- Sylvie MONTCOUQUIOL, MD
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La Tronche, Frankrike, 38700
- Rekruttering
- CRCM Adulte CHU Grenoble Alpes
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Ta kontakt med:
- Rebecca HAMIDFAR, MD
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Hovedetterforsker:
- Rebecca Hamidfar, MD
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Pierre-Bénite, Frankrike, 69310
- Rekruttering
- Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud
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Ta kontakt med:
- Quitterie REYNAUD, Dr
- E-post: quitterie.reynaud@chu-lyon.fr
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Ta kontakt med:
- Marie VIPREY
- E-post: marie.viprey@chu-lyon.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: interventional arm
|
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Medication Adherence (coverage rate)
Tidsramme: 18 months.
|
Continuous multiple-interval measures of medication availability (CMA), including:
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18 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Adherence to medications for obstructive airway syndromes
Tidsramme: 18 months.
|
Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes
|
18 months.
|
Adherence to physiotherapy
Tidsramme: 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.
|
18 months
|
Adherence score evaluated by self-administered questionnaire
Tidsramme: 6 and 18 months
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Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire
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6 and 18 months
|
Cystic Fibrosis Knowledge Scale
Tidsramme: 6 and 18 months
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Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale
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6 and 18 months
|
Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)
Tidsramme: 6 and 18 months
|
Measured by Cystic fibrosis Questionnaire (CFQ-R) specific to cystic fibrosis and validated in French
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6 and 18 months
|
Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1)
Tidsramme: 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
|
18 months
|
Clinical evolution : body mass index (BMI)
Tidsramme: 18 months
|
Body mass index (BMI) will be collected during the patient's usual follow-up, on the observational and interventional phases
|
18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 69HCL17_0279
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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