Clinical trial NCT05795686: Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center
Official title: Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Brain Injury
Rehabilitation
Keywords: Stroke
Brain injury
Rehabilitation
Autonomy
Caregivers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: * 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
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)
Secondary outcomes:
measure: Quality of life of post-stroke patients measured by SIS (Stroke Impact Scale)
timeFrame: 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)
measure: Quality of life of post brain injury patients measured by QOLIBRI (Quality Of LIfe after BRain Injury)
timeFrame: 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)
measure: Depression and anxiety measured by HADS (Hospital Anxiety Depression Scale)
timeFrame: 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)
measure: Autonomy measured by modified Rankin score (mRS)
timeFrame: Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)
measure: Walking assessment by 6 MWT (6 Minutes Walking Test)
timeFrame: End of the program (between Month 2 and Month 4)
measure: Autonomy in health assessed by the PAM-13 (Patient Activation Measure)
timeFrame: 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)
measure: Adhesion to preventive treatment assessed by the Girerd questionnaire
timeFrame: 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)
measure: Quality of life of caregivers measured by SF36 (Short Form Health Survey)
timeFrame: 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)
measure: Depression and anxiety of caregivers measured by HADS (Hospital Anxiety Depression Scale)
timeFrame: 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)
measure: Perceived burden of caregivers measured by the Zarit questionnaire
timeFrame: 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)
measure: Reaching the target population evaluated by : 1- The description of the active file : description of socio-demographic characteristics
timeFrame: Inclusion (Day 0)
measure: Reaching the target population evaluated by : 2-The description of medical characteristics
timeFrame: Inclusion (Day 0)
measure: Adoption : 1-Integration in the territory evaluated by the department of residence of patients
timeFrame: Inclusion (Day 0)
measure: Adoption : 2-Link with partners assessed by way of patient referral
timeFrame: Inclusion (Day 0)
measure: Adoption : 3-Perception of the structure by professionals
timeFrame: Through study completion, an average of 22 years
measure: Adoption : 4-Active patient file : number of inclusions per week
timeFrame: Through study completion, an average of 22 years
measure: Implementation 1-Number of patients present compared to the number of patients planned per activity
timeFrame: Through study completion, an average of 22 years
measure: Implementation : 2-Follow-up of programs (number of patients per programs)
timeFrame: Through study completion, an average of 22 years
measure: Implementation : 3-Deployment of therapeutic workshops : description of workshops
timeFrame: End of study (Month 22)
measure: Maintenance: 1-Over time at the organisational level by monitoring team meetings
timeFrame: End of the program (between Month 2 and Month 4) ; End of study (Month 22)
measure: Maintenance : 2-Evaluation of the sustainability of activities since the end of the program
timeFrame: 6 months after end of program (between Month 8 and Month 10)
measure: Cost
timeFrame: End of study (Month 22)
measure: Assessment of transferability
timeFrame: End of study (Month 22)
measure: Knowledge of the disease and treatments:
timeFrame: clusion (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)
Other outcomes:
Locations:
city: Bron
country: France
facility: Accueil de jour ARRPAC
Study officials:
References: