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

NCT ID: NCT05795673

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-09-01

Brief Summary

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group Peer support

Intervention of mentor to provide peer support

Group Type: OTHER

Peer support program (intervention phase)

Intervention Type: OTHER

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 for a minimum of 3 months and a maximum of 6 months by telephone.

The mentor will know the themes that the teenager would like to address in the context of peer support.

The mentee will complete the various questionnaires provided in the protocol to answer the primary and secondary endpoints.

Group Control

Usual practices of accompaniment of the pediatric-adult transition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 for a minimum of 3 months and a maximum of 6 months by telephone.

The mentor will know the themes that the teenager would like to address in the context of peer support.

The mentee will complete the various questionnaires provided in the protocol to answer the primary and secondary endpoints.

Intervention Type: OTHER

Eligibility Criteria

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

• 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 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):

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quitterie REYNAUD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

CRCM Lyon pédiatrie - Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, , France

CRCM Grenoble adulte - Hôpital Albert Michallon

Grenoble, , France

CRCM Grenoble pédiatrie - Hôpital Albert Michallon

Grenoble, , France

CRCM Lyon adulte - Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Countries

France

Central Contacts

Stéphanie POUPON-BOURDY

Role: CONTACT

stephanie.poupon-bourdy@chu-lyon.fr

0472115416 ext. +33

Sophie HOMMEY

Role: CONTACT

sophie.hommey@chu-lyon.fr

0472115760 ext. +33

Facility Contacts

Philippe REIX, Pr

Role: primary

philippe.reix@chu-lyon.fr

04.27.85.54.70 ext. +33

Rébecca HAMIDFAR, MD

Role: primary

RHamidfar@chu-grenoble.fr

04.76.76.75.93 ext. +33

Catherine Llerena, MD

Role: primary

CLlerena@chu-grenoble.fr

04 76 76 72 19 ext. +33

Quitterie REYNAUD, MD

Role: primary

quitterie.reynaud@chu-lyon.fr

04.78.86.15.54 ext. +33

Other Identifiers

69HCL21_1096

Identifier Type: -

Identifier Source: org_study_id