Cystic FibrosisNCT03226795
Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals
A study testing " Information-Motivation-Behavioral skills " intervention. in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- " Information-Motivation-Behavioral skills " intervention.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Jan 2021to 18 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Transplanted Patients
- Patients who participated in the working group for the co-construction of the intervention
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CRCM mixte, Hôpital Estaing
Clermont-Ferrand, 63100
Sylvie MONTCOUQUIOL, MD
Sylvie MONTCOUQUIOL, MD
- Recruiting
CRCM Adulte CHU Grenoble Alpes
La Tronche, 38700
Rebecca HAMIDFAR, MD
Rebecca HAMIDFAR, MD
- Recruiting
Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Quitterie REYNAUD, Dr, quitterie.reynaud@chu-lyon.fr
Marie VIPREY, marie.viprey@chu-lyon.fr
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- " Information-Motivation-Behavioral skills " intervention.
- Keywords
- Cystic fibrosis, Therapeutic adherence, Co-constructed intervention, Patient involvement
- Medical subject headings
- Cystic Fibrosis, Treatment Adherence and Compliance, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
" 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
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | Not described Receives: Other: " Information-Motivation-Behavioral skills " intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months.
Secondary outcomes (7)
Adherence to medications for obstructive airway syndromes
Continuous multiple-interval measures of medication availability (CMA) for Medications for obstructive airway syndromes
Measured: 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.
Measured: 18 months
Adherence score evaluated by self-administered questionnaire
Measured from a self-administered questionnaire, adapted from the Cystic Fibrosis Compliance questionnaire
Measured: 6 and 18 months
Cystic Fibrosis Knowledge Scale
Measured from a self-knowledge questionnaire adapted from the Cystic Fibrosis Knowledge Scale
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start18 Jan 2021
- Primary completion18 Apr 2023 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226795
- Sponsor's protocol ID
- 69HCL17_0279
- Status last verified
- Mar 2022
- First submitted
- 17 Jul 2017
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.
- ClinicalTrials.gov ID
- NCT03226795
- Acronym / sponsor ID
- 69HCL17_0279
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Therapeutic adherence, Co-constructed intervention, Patient involvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 Apr 2023 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Other: " Information-Motivation-Behavioral skills " intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Transplanted Patients
- Patients who participated in the working group for the co-construction of the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| " Information-Motivation-Behavioral skills " intervention.* "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 | Other | interventional arm |
Primary outcome
Medication Adherence (coverage rate)
Time frame: 18 months.
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.
7 secondary outcomes
Adherence to medications for obstructive airway syndromes
Time frame: 18 months.
Adherence to physiotherapy
Time frame: 18 months
Adherence score evaluated by self-administered questionnaire
Time frame: 6 and 18 months
Cystic Fibrosis Knowledge Scale
Time frame: 6 and 18 months
Quality of life measured by Cystic fibrosis Questionnaire (CFQ-R)
Time frame: 6 and 18 months
Clinical evolution : Forced expiratory volume in 1 s as a percentage of predicted (%FEV1)
Time frame: 18 months
Clinical evolution : body mass index (BMI)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing " Information-Motivation-Behavioral skills " intervention. in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quitterie REYNAUD (4 78 86 13 56 ext. +33, Quitterie.reynaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (coverage rate) (time frame: 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.