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Clinical Trials/NCT05795686
NCT05795686
Recruiting
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country162 target enrollmentJune 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Hospices Civils de Lyon
Enrollment
162
Locations
1
Primary Endpoint
Goal Attainment Scaling (GAS)
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 20, 2023
End Date
April 20, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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 :

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

Outcomes

Primary Outcomes

Goal Attainment Scaling (GAS)

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

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.

Secondary Outcomes

  • Implementation : 3-Deployment of therapeutic workshops : description of workshops(End of study (Month 22))
  • Autonomy in health assessed by the PAM-13 (Patient Activation Measure)(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 caregivers measured by SF36 (Short Form Health Survey)(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))
  • 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))
  • 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))
  • Implementation 1-Number of patients present compared to the number of patients planned per activity(Through study completion, an average of 22 years)
  • Assessment of transferability(End of study (Month 22))
  • 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))
  • Reaching the target population evaluated by : 1- The description of the active file : description of socio-demographic characteristics(Inclusion (Day 0))
  • Reaching the target population evaluated by : 2-The description of medical characteristics(Inclusion (Day 0))
  • Adoption : 2-Link with partners assessed by way of patient referral(Inclusion (Day 0))
  • Implementation : 2-Follow-up of programs (number of patients per programs)(Through study completion, an average of 22 years)
  • Knowledge of the disease and treatments:(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))
  • Adhesion to preventive treatment assessed by the Girerd questionnaire(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 of caregivers 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))
  • Adoption : 1-Integration in the territory evaluated by the department of residence of patients(Inclusion (Day 0))
  • Maintenance : 2-Evaluation of the sustainability of activities since the end of the program(6 months after end of program (between Month 8 and Month 10))
  • Perceived burden of caregivers measured by the Zarit questionnaire(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))
  • Adoption : 3-Perception of the structure by professionals(Through study completion, an average of 22 years)
  • Adoption : 4-Active patient file : number of inclusions per week(Through study completion, an average of 22 years)
  • Maintenance: 1-Over time at the organisational level by monitoring team meetings(End of the program (between Month 2 and Month 4) ; End of study (Month 22))
  • Cost(End of study (Month 22))

Study Sites (1)

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