Cystic FibrosisKINOBSNCT04217889
Cystic Fibrosis Adherence Study
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims to assess the role of some factors which can influence the chest physiotherapy adherence in adult with cystic fibrosis. At first, we are going to try to consider the adherence of chest physiotherapy. 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?
- Questionnaire
- How many people
- 197 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 2 Jun 2020
- Phase
- Observational
- 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
Study population: Cohort of adult patients with cystic fibrosis and follow-up at the Lyon Reference Center.
Who may be able to join
- respiratory symptoms
- subnormal respiratory function (FEV1 < 80%)
- without lung transplant
Who cannot join
- lung transplantation approach
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Référence de la Mucoviscidose Lyon à l'hôpital Lyon Sud
Pierre-Bénite
About this study
Official title: Study of the Adherence to Chest Physiotherapy in Patients With Cystic Fibrosis (CF) at the Adult CF Center in Lyon
This study aims to assess the role of some factors which can influence the chest physiotherapy adherence in adult with cystic fibrosis.
At first, we are going to try to consider the adherence of chest physiotherapy. Then, after dividing the patients into two groups - adherent or not adherent - we will attempt to identify the factors which can influence this adherence.
Read more
It consists in a short questionnaire that the patient will fill during usual visits.
The hypothesis is that the following factors can play a role in adherence of chest physiotherapy:
- Age
- Age of diagnostic
- Sex
- Fev1
- Number of antibiotic course
- Anxiety/depression
- Work time
- Socio-professional category
- Individual situation
- Physiotherapy with liberal physiotherapist and transport time
- Sport practice
- Family support
- Feeling of work time burden
- Feeling of physiotherapy efficiency
- Feeling of physiotherapy burden
- Conditions
- Cystic Fibrosis
- Being tested
- Questionnaire
- Keywords
- Cystic Fibrosis, Adherence to chest physiotherapy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Short questionnaire that can be completed during the usual consultation.
| Study group | Role | What they receive |
|---|---|---|
| Adherent patient | This group is composed of adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week. Receives: Other: Questionnaire | |
| Not-adherent patient | This group is composed of not-adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of chest physiotherapy
If the quantity of chest physiotherapy alone (do well) or/and with physiotherapist is above or egal at 3 per week, the patient is "adherent" If the quantity of chest physiotherapy is under 3 sessions per week, the patient is "not- adherent" Then we measure the proportion of each group for each secondary factors.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Nov 2019
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
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
- NCT04217889
- Sponsor's protocol ID
- 69HCL19_0410
- Acronym
- KINOBS
- Status last verified
- Jul 2021
- First submitted
- 2 Jan 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Adherence to Chest Physiotherapy in Patients With Cystic Fibrosis (CF) at the Adult CF Center in Lyon
- ClinicalTrials.gov ID
- NCT04217889
- Acronym / sponsor ID
- KINOBS / 69HCL19_0410
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Adherence to chest physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 6 Jan 2020 (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.
This study aims to assess the role of some factors which can influence the chest physiotherapy adherence in adult with cystic fibrosis.
At first, we are going to try to consider the adherence of chest physiotherapy. Then, after dividing the patients into two groups - adherent or not adherent - we will attempt to identify the factors which can influence this adherence.
It consists in a short questionnaire that the patient will fill during usual visits.
The hypothesis is that the following factors can play a role in adherence of chest physiotherapy:
- Age
- Age of diagnostic
- Sex
- Fev1
- Number of antibiotic course
- Anxiety/depression
- Work time
- Socio-professional category
- Individual situation
- Physiotherapy with liberal physiotherapist and transport time
- Sport practice
- Family support
- Feeling of work time burden
- Feeling of physiotherapy efficiency
- Feeling of physiotherapy burden
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherent patient | – | Other: QuestionnaireThis group is composed of adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week. |
| Not-adherent patient | – | Other: QuestionnaireThis group is composed of not-adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of adult patients with cystic fibrosis and follow-up at the Lyon Reference Center.
Key inclusion criteria (3 listed)
- respiratory symptoms
- subnormal respiratory function (FEV1 < 80%)
- without lung transplant
Key exclusion criteria (1 listed)
- lung transplantation approach
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 |
|---|---|---|
| QuestionnaireShort questionnaire that can be completed during the usual consultation. | Other | Adherent patient, Not-adherent patient |
Primary outcome
Quantity of chest physiotherapy
Time frame: 8 months
If the quantity of chest physiotherapy alone (do well) or/and with physiotherapist is above or egal at 3 per week, the patient is "adherent" If the quantity of chest physiotherapy is under 3 sessions per week, the patient is "not- adherent" Then we measure the proportion of each group for each secondary factors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of chest physiotherapy (time frame: 8 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 27 Jul 2021.