NCT03226795

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2025

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

July 17, 2017

Last Update Submit

March 9, 2022

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisTherapeutic adherenceCo-constructed interventionPatient involvement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Adherence to medications for obstructive airway syndromes

    18 months.

  • Adherence to physiotherapy

    18 months

  • Adherence score evaluated by self-administered questionnaire

    6 and 18 months

  • Cystic Fibrosis Knowledge Scale

    6 and 18 months

  • Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)

    6 and 18 months

  • +2 more secondary outcomes

Study Arms (1)

interventional arm

EXPERIMENTAL
Other: " Information-Motivation-Behavioral skills " intervention.

Interventions

" Information-Motivation-Behavioral skills " intervention.OTHER

* "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

interventional arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Transplanted Patients
  • Patients who participated in the working group for the co-construction of the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CRCM mixte, Hôpital Estaing

Clermont-Ferrand, 63100, France

RECRUITING

CRCM Adulte CHU Grenoble Alpes

La Tronche, 38700, France

RECRUITING

Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Cystic FibrosisTreatment Adherence and CompliancePatient Participation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesHealth BehaviorBehaviorPatient Acceptance of Health Care

Central Study Contacts

Quitterie REYNAUD

CONTACT

4 78 86 13 56Quitterie.reynaud@chu-lyon.fr

Marie Viprey

CONTACT

4 72 11 51 62marie.viprey@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 24, 2017

Study Start

January 18, 2021

Primary Completion

April 18, 2023

Study Completion

October 18, 2025

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

FR(3)