French Validation of the AdT-Physio Scale

Cystic Fibrosis Clinical Trial

— Trans-AdT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273566
• Other study ID #: 20230202
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Pole Sante Grace de Dieu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
France	PSLA GDD	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Pole Sante Grace de Dieu

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	1 year