Adapting the FACETS Program to Sickle Cell Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVersailles Hospital
About this trial
Adaptation of a fatigue management program combining the principles of cognitive-behavioral therapy and energy conservation strategies (FACETS program) for a population of adult patients with sickle cell disease (Drépa-FACETS program).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant having freely given his oral agreement.
Participant with a major sickle cell syndrome, regardless of genotype (e.g. SS, SC, Sbeta).
Participant with a sufficient command of spoken and written French to take the assessments, complete the questionnaires, follow the program sessions and carry out the home exercises.
Disqualifiers
Participant with one or more severe psychiatric pathologies (e.g. severe depression, psychosis) that could interfere with the conduct of the study, in particular the primary and secondary endpoints.
Participants with another chronic pathology causing fatigue.
Participants in vaso-occlusive crisis (VOC) or hospitalization.
Participant under legal protection (guardianship, curatorship, safeguard of justice, deprived of liberty).
Trial design
Design model
Single group
Treatments tested in this trial
Drépa-FACETS Program
Other interventionDrépa-FACETS Program for Sickle Cell Disease
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Patients with sickle cell diseaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the FACETS program for adult sickle-cell patients
Main criterion is assessing feasibility. Composite criterion including three sub-criteria are : 1. Participation rate in the main sessions of the program. This criterion will be met if the participant attends at least 4 of the 6 sessions of the program. 2. Success rate in completing home exercises. This criterion will be met if the participant completes at least 50% of the home exercises assigned at the end of each session. 3. Acquisition of fatigue management skills. This criterion will be met if the participant has been able to implement one of the fatigue management techniques proposed by the Drépa-FACETS program in their daily life. The main criterion for evaluating the feasibility/acceptability of the DrépaFACETS program will be met if 2 of the 3 sub-criteria are met.
Time frame
From the enrollment to the end of the protocol visits (10 weeks)Sponsors and contacts
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Versailles Hospital
Lead sponsor
University Hospital, Grenoble
Collaborator
University Grenoble Alps
Collaborator
Paris Nanterre University
Collaborator
Source ClinicalTrials.gov