Peer-supporting for Teenagers With Cystic Fibrosis in a Process of Transition of Care From Paediatric to Adult Services : a Mixed-method Pilot Study to Assess the Feasibility of the Peer-support Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 8
- 主要终点
- Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months
研究概览
简要总结
In patients with cystic fibrosis, a deterioration in lung function around age 18, the age of transfer from pediatrics to adult care services, has been observed. Transfer is only one step in a transition process from pediatric to adult care taking place from age 12 to 24. Adolescence is a period of identity construction during which the disease alters self-image and self-esteem, and a period of empowerment in the management of the disease involving a re-appropriation of it. During this period, coping strategies and psychosocial skills are important to face all the issues that the adolescent encounters. Interventions for youth with chronic illnesses rarely incorporate this dimension. Peer support or peer-mentoring is one avenue for developing these coping skills. Peer support encompasses mutual support between people who are coping or have coped with similar challenging life experiences. Individuals with similar experiences would represent more credible role models to stimulate positive change in their peers. The function of peer support are to provide emotional, experiential, informational support.The effect of peer support improves social integration, coping skills, sense of self-efficacy of the peers being helped. Promotion of healthy youth behaviors by youth is the most widely evaluated youth engagement strategy in the community health sector. Peer-assisted devices have been tested to improve medication adherence and health status with youth with juvenile arthritis, asthma, and liver transplant recipients. By sharing their experience of a successful transition, young adults with cystic fibrosis may be able to help their adolescent peers better understand this transition. Our hypothesis is that implementing peer support with adolescents with cystic fibrosis improves their sense of self-efficacy, a dimension of coping skills.To our knowledge, there are no research studies on peer support in cystic fibrosis in France or abroad. Patients are recognized as partners capable of sharing their experiential knowledge with patients with a similar disease.
But this raises questions about the recruitment, supervision, preparation for peer-help and the role of these patients; about the effects of their involvement for themselves (valorization, anxiety) and for their peers (re-assurance, feeling of personal effectiveness). This justifies conducting an exploratory study to assess the feasibility of a peer-support intervention for youth with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient affected by cystic fibrosis
- •patient able to understand and read French
- •patient from 15 to 19 years , in a process of transition on paediatric care to adult care
- •with a follow-up on a paediatric Cystic Fibrosis Centers Competences (CRCM)
- •did not participate in the Phase 1 co-construction workgroup
- •affiliated to the social security system
- •having agreed to participate and signed the consent for an adult patient, or legal guardian having agreed to participate and signed the consent for a minor patient
排除标准
- •patient with transplant
- •patient with cystic fibrosis transmembrane regulator-related disorders (CFTR RD) or Screen Positive Inconclusive Diagnosis (SPID) Cystic Fibrosis
- •patient with a curator, tutor or under the protection of a conservator
- •pregnant or breastfeeding patient
- •Concerning the mentor/peer-supporter (post period):
- •Inclusion Criteria * :
- •affected cystic fibrosis
- •able to understand and read French
- •young adult, 19 to 24 years old
- •with a follow-up on the adult CRCM (transition completed)
- •affiliated to the social security system
- •have agreed to participate and signed the consent form
- •did not participate in the Phase 1 co-construction workgroup
- •Exclusion Criteria * :
- •patient with transplant
- •patient with CFTR RD or SPID Cystic Fibrosis
- •patient with a curator, tutor or under the protection of a conservator
- •pregnant or breastfeeding patient
结局指标
主要结局
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months
时间窗: Baseline ; at 6 months
Change in Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months. The CFQ-R includes 34 cystic fibrosis-specific quality of life items, scored on a 4-modality scale, and exploring 9 dimensions including perceived health, burden of treatment, self-image (and body image in particular), emotional state, and social interaction that are particularly impacted by the transition period. The responses allow us to establish a score on a scale of 0 to 100, the higher the score the better the quality of life.
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 3 months
时间窗: Baseline ; at 3 months
Change in Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 3 months. The CFQ-R includes 34 cystic fibrosis-specific quality of life items, scored on a 4-modality scale, and exploring 9 dimensions including perceived health, burden of treatment, self-image (and body image in particular), emotional state, and social interaction that are particularly impacted by the transition period. The responses allow us to establish a score on a scale of 0 to 100, the higher the score the better the quality of life.
次要结局
- Effect of peer support model during pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents and non-sponsored adolescents) on their sense of self-efficacy(Measurement at inclusion, 3 months and 6 months)
- Fidelity of peer-assistance process in relation to what was planned (criteria collected in the "after" period only).(From inclusion to the end of pair-aidance, up to 8 months)
- Feasibility assessed by the number of questionnaires collected(From inclusion to the end of pair-aidance, up to 8 months)
- Feasibility assessed by the estimation of recruitment capacity(From inclusion to the end of pair-aidance, up to 8 months)
- Effect of peer support model during the pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents, included in the post period, and non-sponsored adolescents, included in the pre period) on sense of social integration.(Measurement at inclusion, 3 months and 6 months)
- Experience (Experience, Satisfaction, Acceptability) of peer support among sponsored adolescents, sponsors, parents and accompanying professionals by individual interviews 1 to 2 months after the end of peer support (collected in the "after" period).(From inclusion to the end of pair-aidance, up to 8 months)
- Effect of peer support model during pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents, included in post period, and non-sponsored adolescents, included in pre period) on management and therapeutic adherence(Measurement at inclusion, 3 months and 6 months)
- Feasibility assessed by the number of resources needed to implement the intervention - Number and profile of accompanying professionals involved(From inclusion to the end of pair-aidance, up to 8 months)
- Feasibility assessed by the number of resources needed to implement the intervention - Number of exchanges and time needed for supervision and training(From inclusion to the end of pair-aidance, up to 8 months)
- Feasibility assessed by the number of resources needed to implement the intervention - Collection of material resources needed(From inclusion to the end of pair-aidance, up to 8 months)
- Feasibility assessed by the estimation of the potential effect of the intervention on the feeling of self-efficacy measured by the GSE(From inclusion to the end of pair-aidance, up to 8 months)