Cystic FibrosisTrans-AdTNCT06273566
French Validation of the AdT-Physio Scale
An observational study of Cystic Fibrosis, run by Pole Sante Grace de Dieu at 1 site in France.
Trial summary
The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Questionnaire
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires.
Who may be able to join
- The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
PSLA GDD
Caen, 14000
Guillaume GALLIOU, 0231834802, guillaume.galliou@gmail.com
About this study
Official title: French Validation of the AdT-Physio Scale for Assessing Adherence and Perception of the Intervention of a Physiotherapist in Patients With Cystic Fibrosis
The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.
participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire.
Read the detailed description
Cystic fibrosis is one of the most frequently encountered rare genetic diseases. In 2022, this pathology affected 7,743 people in the French population, i.e. 3% more than in 2021. Previously, this fatal disease only granted a few months of life to child carriers. Today, the median age at death is over 40 years old. The adult population suffering from cystic fibrosis has thus become more numerous than the pediatric population. Among existing treatments, respiratory and musculoskeletal massage physiotherapy occupies a central place in patients' lives. However, the level of adherence to massage physiotherapy is low among young adults (16 to 21 years old) compared to other types of treatments. Faced with epidemiological changes and the daily burden that this chronic pathology represents for those affected, therapeutic adherence should be a major concern for physiotherapists. Indeed, a low level of adherence would increase treatment failures, the risk of premature death, episodes of exacerbations and hospitalizations and would thus reduce quality of life. It is therefore crucial to have means of assessing this parameter in patients with cystic fibrosis. The AdT physio self-assessment questionnaire, validated in Spanish since 2020, has shown clinical validity and reliability for Spanish-speaking patients. Thus, a version of this scale translated and validated in French would offer physiotherapists a relevant tool allowing them to evaluate therapeutic adherence and the perception of their interventions with French-speaking patients suffering from cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- Questionnaire
- Keywords
- Translation, Cystic fibrosis
- 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
Participants will have to answer the socio-demographic questions (Age, weight, height, FEV1, FVC) and the AdT-Physio, Brief Cope and GSES questionnaires in random order.
What is being measured
The primary outcome is the main question the study is designed to answer.
AdT-Physio scale (Adherence to Treatment of Physiotherapy scale)
set of 15 questions divided into two sets, one focusing on patient adherence and the other on beliefs about the treatment and therapist (The total score on the final version of the AdT-Physio scale can range from 14 to 56, in which a high score is indicative of better adherence to physical therapy.)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (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.
- 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
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pole Sante Grace de Dieu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273566
- Sponsor's protocol ID
- 20230202
- Acronym
- Trans-AdT
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of the AdT-Physio Scale for Assessing Adherence and Perception of the Intervention of a Physiotherapist in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06273566
- Acronym / sponsor ID
- Trans-AdT / 20230202
- Conditions
- Cystic Fibrosis
- Keywords
- Translation, Cystic fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Pole Sante Grace de DieuUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Feb 2024 (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.
The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.
participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire.
Detailed description
Cystic fibrosis is one of the most frequently encountered rare genetic diseases. In 2022, this pathology affected 7,743 people in the French population, i.e. 3% more than in 2021. Previously, this fatal disease only granted a few months of life to child carriers. Today, the median age at death is over 40 years old. The adult population suffering from cystic fibrosis has thus become more numerous than the pediatric population. Among existing treatments, respiratory and musculoskeletal massage physiotherapy occupies a central place in patients' lives. However, the level of adherence to massage physiotherapy is low among young adults (16 to 21 years old) compared to other types of treatments. Faced with epidemiological changes and the daily burden that this chronic pathology represents for those affected, therapeutic adherence should be a major concern for physiotherapists. Indeed, a low level of adherence would increase treatment failures, the risk of premature death, episodes of exacerbations and hospitalizations and would thus reduce quality of life. It is therefore crucial to have means of assessing this parameter in patients with cystic fibrosis. The AdT physio self-assessment questionnaire, validated in Spanish since 2020, has shown clinical validity and reliability for Spanish-speaking patients. Thus, a version of this scale translated and validated in French would offer physiotherapists a relevant tool allowing them to evaluate therapeutic adherence and the perception of their interventions with French-speaking patients suffering from cystic fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires.
Key inclusion criteria (1 listed)
- The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QuestionnaireParticipants will have to answer the socio-demographic questions (Age, weight, height, FEV1, FVC) and the AdT-Physio, Brief Cope and GSES questionnaires in random order. | Other | – |
Primary outcome
AdT-Physio scale (Adherence to Treatment of Physiotherapy scale)
Time frame: 1 year
set of 15 questions divided into two sets, one focusing on patient adherence and the other on beliefs about the treatment and therapist (The total score on the final version of the AdT-Physio scale can range from 14 to 56, in which a high score is indicative of better adherence to physical therapy.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 Pole Sante Grace de Dieu 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AdT-Physio scale (Adherence to Treatment of Physiotherapy scale) (time frame: 1 year). 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 18 Sep 2026.