NCT06273566

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

February 8, 2024

Last Update Submit

April 30, 2024

Conditions

Keywords

TranslationCystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSLA GDD

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 22, 2024

Study Start

April 1, 2024

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations