Adapting the FACETS Fatigue Management Program to Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Feasibility of the FACETS program for adult sickle-cell patients
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Feasibility of the FACETS program for adult sickle-cell patients
时间窗: 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.
Feasibility of the FACETS program for adult sickle-cell patients
时间窗: 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.
次要结局
未报告次要终点
研究者
Michalina DANNOUNE
Investigator Coordonnator
Versailles Hospital