NCT05795686

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

February 7, 2023

Last Update Submit

June 24, 2024

Conditions

StrokeBrain InjuryRehabilitation

Keywords

StrokeBrain injuryRehabilitationAutonomyCaregivers

Outcome Measures

Primary Outcomes (1)

  • Goal Attainment Scaling (GAS)

    The GAS will quantify the achievement of the goals set by the patient. It will be calculated at the end of the programme (planned end or premature exit) on the basis of the objectives set when the patient was included in the programme. The objectives and the different steps to reach them are defined in consultation between the patient, the doctor and the nurse. It is a 5-point scale (-2, -1, 0, 1, 2); -2: level before participation, -1: less than expected; 0: expected goal achieved; +1: a little more than expected; +2: best possible outcome expected.

    Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)

Secondary Outcomes (24)

  • Quality of life of post-stroke patients measured by SIS (Stroke Impact Scale)

    Inclusion (Day 0) ; End of the program (between Month 2 and Month 4) ; 6 months after the end of the program (between Month 8 and Month 10)

  • Quality of life of post brain injury patients measured by QOLIBRI (Quality Of LIfe after BRain Injury)

    Inclusion (Day 0) ; End of the program (between Month 2 and Month 4) ; 6 months after the end of the program (between Month 8 and Month 10)

  • Depression and anxiety measured by HADS (Hospital Anxiety Depression Scale)

    Inclusion (Day 0) ; End of the program (between Month 2 and Month 4) ; 6 months after the end of the program (between Month 8 and Month 10)

  • Autonomy measured by modified Rankin score (mRS)

    Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)

  • Walking assessment by 6 MWT (6 Minutes Walking Test)

    End of the program (between Month 2 and Month 4)

  • +19 more secondary outcomes

Study Arms (1)

Patients of program "AVanCer"

OTHER

Patients included in program "AVanCer"

Other: Evaluation of program "AVanCer"

Interventions

Evaluation of program "AVanCer"OTHER

Evaluation of program AVanCer with quantitative and qualitative approaches

Patients of program "AVanCer"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accueil de jour ARRPAC

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

StrokeBrain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Julie Haesebaert, MD

CONTACT

06-51-42-97-43julie.haesebaert01@chu-lyon.fr

Anne Termoz

CONTACT

04-27-85-63-00anne.termoz@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: * Quantitative approach by monitoring the structure's operating indicators * Qualitative approach by semi-structured interviews with professionals of the structure For patients: * At inclusion:collection of socio-demographic and medical data,Quality of life (QoL) questionnaires,anxiety and depression,autonomy in health,adherence to treatment * At end of the program:QoL questionnaires,anxiety and depression,autonomy,autonomy in health,adherence to treatment,satisfaction,semi-structured interviews * 6 months post-program:data on retention and re-hospitalization,QoL questionnaires,anxiety and depression,autonomy in health,adherence to treatment For caregivers: * At inclusion:collection of socio-demographic data,QoL questionnaires,anxiety and depression,perceived burden * At the end of the program:QoL questionnaires,anxiety and depression,perceived burden,semi-structured interviews * 6 months post-program:data about new support,QoL questionnaires,anxiety and depression,perceived burden
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

April 3, 2023

Study Start

June 20, 2023

Primary Completion

April 20, 2026

Study Completion

April 20, 2026

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations

FR(1)