Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Evaluation of program "AVanCer"
Other interventionEvaluation of program AVanCer with quantitative and qualitative approaches
Treatment groups
162 Participants
are divided into 1 treatment groupGroup A: Patients of program "AVanCer"Other 1 intervention
Trial outcomes
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.
Time frame
Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)Secondary outcomes
1
Quality of life of post-stroke patients measured by SIS (Stroke Impact Scale)
This is a specific quality of life scale for patients post-stroke. The scale contains 64 items measuring 8 different domains (strength, hand functionality, Activities of Daily Living ADL/ Instrumental Activities of Daily Living IADL, mobility, communication, emotion, memory/thinking and social participation) and one item assessing overall recovery out of 100. The items are scored using a Likert scale with 5 response options. The score is reported out of 100 for each dimension (100 = no difficulties, 0= maximum difficulties)
Time frame
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)2
Quality of life of post brain injury patients measured by QOLIBRI (Quality Of LIfe after BRain Injury)
This is a specific quality of life scale for patients post brain injury. The scale contains 37 items measuring 6 different domains (cognitive, affective, functional, relational, physical and emotional). The items are scored using a Likert scale with 5 response options. The score is reported out of 100 (100 = best quality of life, 0 = worst quality of life)
Time frame
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)3
Depression and anxiety measured by HADS (Hospital Anxiety Depression Scale)
This is a specific depression and anxiety scale of 14 items. The scale contains 14 items of which 7 measure anxiety and 7 measure depression. The items are scored from 0 to 3, giving two scores out of 21 for each dimension; a score above 11 indicates an anxious or depressed state.
Time frame
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)4
Autonomy measured by modified Rankin score (mRS)
This is a validated 6-level global assessment scale. The score is between 0 et 6, a higher score is associated to a worse outcome.
Time frame
Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)Sponsors and contacts
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Source ClinicalTrials.gov