Adapting the FACETS Program to Sickle Cell Disease (Drépa-FACETS)

August 14, 2025 updated by: Michalina DANNOUNE, Versailles Hospital

Adapting the FACETS Fatigue Management Program to Sickle Cell Disease

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38000
      • Le Chesnay, France, 78150
        • Completed
        • Hospital Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with sickle cell disease
Other: Drépa-FACETS Program
Drépa-FACETS Program for Sickle Cell Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the FACETS program for adult sickle-cell patients
Time Frame: From the enrollment to the end of the protocol visits (10 weeks)

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.
From the enrollment to the end of the protocol visits (10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Collaborators

University Hospital, Grenoble
University Grenoble Alps
Paris Nanterre University

Investigators

  • Study Director: Marie-Claire GAY, Pr, Paris Nanterre University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

May 2, 2026

Study Completion (Estimated)

May 2, 2026

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23/09 - Drépa-FACETS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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