Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center

NCT ID: NCT05795686

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2026-04-20

Brief Summary

In France, more than 150,000 strokes occur each year. Stroke is a major risk factor for dependency, representing the leading cause of acquired non-traumatic disability in adults. Head injuries, which are also very frequent, can leave similar neuropsychiatric sequelae.

These events are brutal and their physical, psychological, emotional, social and financial consequences disrupt the lives of patients and their families. Thanks to improved access to thrombolysis and thrombectomy for the management of acute stroke, the prognosis has been profoundly improved. Nevertheless, the increase in post-stroke survival and the evolution of the type of after-effects require the development of support systems dedicated to these post-stroke patients. The same issues are raised for people who have suffered a head injury with similar consequences that require specialised care.

Currently, health care is well structured for the acute phase and there is an improvement in the provision of care in specialised rehabilitation services, but the dedicated medico-social provision for people returning home remains insufficient despite the significant needs. The ARRPAC association (Accompaniment, Rehabilitation, Respite after Stroke and Cerebral Palsy) is setting up a new comprehensive medico-social support programme in Lyon (AVanCer programme, opening in June 2022) to improve the autonomy and adaptation capacities of patients and to relieve the social and psycho-affective burden of carers. This experimental day centre, which complements functional rehabilitation and recurrence prevention care, offers adults with brain injury sequelae and their carers therapeutic education programmes, adapted physical activity, social and cognitive remediation and therapeutic workshops, as well as a place for patients and their carers to exchange information and listen. To achieve its ambition, ARRPAC and the AVanCer programme must be integrated into the existing support offer, create partnerships with care structures and evaluate its added value to ensure its sustainability. In case of efficiency and demonstrated benefits for patients, carers and the health system, such a structure could be deployed in other territories.

This study evaluates the implementation of the AVanCer programme in terms of its effect on the target audience, participants' experience and implementation according to the REAIM evaluative framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).

Conditions

Stroke; Brain Injury; Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients of program "AVanCer"

Patients included in program "AVanCer"

Group Type: OTHER

Evaluation of program "AVanCer"

Intervention Type: OTHER

Evaluation of program AVanCer with quantitative and qualitative approaches

Interventions

Evaluation of program "AVanCer"

Evaluation of program AVanCer with quantitative and qualitative approaches

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For patients :

• Male or female of legal age
• Patient who has been selected to start the AVanCer program at the ARRPAC center
• Patient who has agreed to participate in the PATIENT assessment component and has signed the consent form
• Patient able to speak and understand French both orally and in writing

For caregivers :

• Male or female of legal age
• Person who has agreed to participate in the CAREGIVING assessment component and has signed the consent form
• Person able to speak and understand French both orally and in writing

Population of the qualitative study :

• Voluntary patients and caregivers who participated in the quantitative part (follow-up by questionnaires)
• Partner professionals: a sample of 10 representatives of ARRPAC partners who referred people for support during the first 12 months, from the following structures: public Medicine, Surgery, Obstetric health institution, private Medicine, Surgery, Obstetric health institution, public Follow-up and Rehabilitation Care institution, private Follow-up and Rehabilitation Care institution, medico-social institution, town professionals and user associations.
• ARRPAC professionals: the 14 ARRPAC professionals involved in the day care centre will be interviewed in a semi-structured manner

Exclusion Criteria

• Pregnant women, parturient or breastfeeding mothers*
• Persons deprived of their liberty by a judicial or administrative decision
• Persons under psychiatric care
• Persons admitted to a health or social establishment for purposes other than research
• Persons of full age subject to a legal protection measure (guardian, curators)
• Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Accueil de jour ARRPAC

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie Haesebaert, MD

Role: CONTACT

julie.haesebaert01@chu-lyon.fr

06-51-42-97-43 ext. +33

Anne Termoz

Role: CONTACT

anne.termoz@chu-lyon.fr

04-27-85-63-00 ext. +33

Facility Contacts

Stéphanie Fanara

Role: primary

s.fanara@gcsms-arrpac.fr

04-82-90-54-83 ext. +33

Other Identifiers

69HCL22_0638

Identifier Type: -

Identifier Source: org_study_id