Peer-supporting for Teenagers With Cystic Fibrosis in the Transition of Care From Paediatric to Adult Services

Official title

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

Overview

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.

Interventions

• Other Peer support program (intervention phase)
  Implementation and Evaluation: Intervention of mentor to provide peer support targeting psychosocial skills, coping and quality of life of adolescents with cystic fibrosis during the pediatric-adult transition The evaluation of the feasibility of the peer support program consists of assessing the effectiveness of its implementation in terms of its effect on the target audience, its acceptability to participants, and its implementation. The mentor and the mentee will be in contact once a month

Primary outcome measures

• 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 [Time frame: Baseline ; at 6 months]
• 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 [Time frame: Baseline ; at 3 months]

Secondary outcome measures (11)

• 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 [Time frame: Measurement at inclusion, 3 months and 6 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 [Time frame: Measurement at inclusion, 3 months and 6 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. [Time frame: 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). [Time frame: From inclusion to the end of pair-aidance, up to 8 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). [Time frame: From inclusion to the end of pair-aidance, up to 8 months]
• Feasibility assessed by the number of questionnaires collected [Time frame: From inclusion to the end of pair-aidance, up to 8 months]
• Feasibility assessed by the estimation of recruitment capacity [Time frame: 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 and profile of accompanying professionals involved [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From inclusion to the end of pair-aidance, up to 8 months]

Eligibility criteria

Concerning the patient /mentee:

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Other

Study locations

France · 4 centers

• CRCM Lyon pédiatrie - Hôpital Femme Mère Enfant, Hospices Civils de Lyon — Bron
• CRCM Grenoble adulte - Hôpital Albert Michallon — Grenoble
• CRCM Grenoble pédiatrie - Hôpital Albert Michallon — Grenoble
• CRCM Lyon adulte - Centre Hospitalier Lyon Sud, Hospices Civils de Lyon — Pierre-Bénite

Identifiers

NCT: NCT05795673 · 69HCL21_1096

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗