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

Stroke Clinical Trial

— Eval-ARRPAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795686
• Other study ID #: 69HCL22_0638
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: January 27, 2025

Study information

• Verified date: August 2023
• Source: Hospices Civils de Lyon
• Contact: Julie Haesebaert, MD
• Phone: 06-51-42-97-43
• Email: julie.haesebaert01[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: January 27, 2025
• Est. primary completion date: July 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Rehabilitation
• Stroke

Intervention

Other:
• Evaluation of program "AVanCer"
Evaluation of program AVanCer with quantitative and qualitative approaches

Locations

Country	Name	City	State
France	Accueil de jour ARRPAC	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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)
Secondary	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)	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)
Secondary	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.	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)
Secondary	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.	Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)
Secondary	Walking assessment by 6 MWT (6 Minutes Walking Test)	This is a functional walking test	End of the program (between Month 2 and Month 4)
Secondary	Autonomy in health assessed by the PAM-13 (Patient Activation Measure)	This is a test assessing skills, knowledge and knowledge, skills and confidence in managing one's health.; The scale contains 13 items scored on a 4-point Likert scale. The total score is reported out of 100 (100 = maximum activation, 0 = no activation)	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)
Secondary	Adhesion to preventive treatment assessed by the Girerd questionnaire	This is a specific self-questionnaire that assesses compliance in 6 items. Each item can be answered by yes or no. For each item, "Yes" scores 0 and "No" scores 1. A final score of 0 means a good observance, of 1 or 2 means a mild compliance problem, and of 3 or more means a poor compliance.	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)
Secondary	Quality of life of caregivers measured by SF36 (Short Form Health Survey)	This is a validated scale measuring health-related quality of life. Score is between 0 and 100, A higher score is associated to a better outcome.	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)
Secondary	Depression and anxiety of caregivers 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.	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)
Secondary	Perceived burden of caregivers measured by the Zarit questionnaire	This is a self questionnaire assessing the suffering of caregivers. Score is between 0 and 88. A higher score is associated to a worse outcome.	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)
Secondary	Reaching the target population evaluated by : 1- The description of the active file : description of socio-demographic characteristics	The indicators are obtained from data collected in the user file. The socio-demographic characteristics collected are: age, gender, family status, professional status, social status	Inclusion (Day 0)
Secondary	Reaching the target population evaluated by : 2-The description of medical characteristics	The indicators are obtained from data collected in the user file. Medical characteristics are type of stroke, treatment and sequelae	Inclusion (Day 0)
Secondary	Adoption : 1-Integration in the territory evaluated by the department of residence of patients	This indicator is obtained from data collected in the user file.	Inclusion (Day 0)
Secondary	Adoption : 2-Link with partners assessed by way of patient referral	This indicator is obtained from data collected in the user file. The type of practioner who referred the patient is collected	Inclusion (Day 0)
Secondary	Adoption : 3-Perception of the structure by professionals	The perception of the structure will be assessed through semi-structured interviews conducted by the research team. The questions focus on the professional's feelings about their participation in the facility and are 30 minutes long	Through study completion, an average of 22 years
Secondary	Adoption : 4-Active patient file : number of inclusions per week	This indicator is obtained from data collected in the user file.	Through study completion, an average of 22 years
Secondary	Implementation 1-Number of patients present compared to the number of patients planned per activity	This indicator is obtained from data collected in the user file.	Through study completion, an average of 22 years
Secondary	Implementation : 2-Follow-up of programs (number of patients per programs)	The follow-up of programs will be described, for each program, by the number of patients per program over time	Through study completion, an average of 22 years
Secondary	Implementation : 3-Deployment of therapeutic workshops : description of workshops	Description of workshops in terms of type of activity , rhythm	End of study (Month 22)
Secondary	Maintenance: 1-Over time at the organisational level by monitoring team meetings	Integration into the medico-social offer in the long term via the partnerships established and maintenance of the activities initiated during the program by the patients measured 6 months after the end of the program	End of the program (between Month 2 and Month 4) ; End of study (Month 22)
Secondary	Maintenance : 2-Evaluation of the sustainability of activities since the end of the program	One question will focus on the continuation of activities and the description of these activities	6 months after end of program (between Month 8 and Month 10)
Secondary	Cost	Average cost to produce all the support provided by the programme by modelling the pathways	End of study (Month 22)
Secondary	Assessment of transferability	Assessment of transferability using the ASTAIRE grid (Analysis of transferability and support for the adaptation of health promotion interventions) : it contains 4 categories of criteria: description of the population (descriptive criteria of the population), environment (environmental factors likely to influence the effects), implementation conditions (elements of implementation of the intervention, particularly with reference to aspects of planning and partnerships) and support for transfer (elements that make it possible to support the transfer of the intervention and contribute in particular to its adaptation to the new context.	End of study (Month 22)