StrokeEval-ARRPACNCT05795686
Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center
A study testing Evaluation of program "AVanCer" in people with Stroke and Brain Injury, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brain Injury, Rehabilitation
- What is being tested?
- Evaluation of program "AVanCer"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2023to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Accueil de jour ARRPAC
Bron, 69500
Stéphanie Fanara, 04-82-90-54-83 ext. +33, s.fanara@gcsms-arrpac.fr
About this study
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.
Read more
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).
- Conditions
- Stroke, Brain Injury, Rehabilitation
- Being tested
- Evaluation of program "AVanCer"
- Keywords
- Stroke, Brain injury, Rehabilitation, Autonomy, Caregivers
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of program "AVanCer"Other
Evaluation of program AVanCer with quantitative and qualitative approaches
| Study group | Role | What they receive |
|---|---|---|
| Patients of program "AVanCer" | Other | Patients included in program "AVanCer" Receives: Other: Evaluation of program "AVanCer" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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.
Measured: 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)
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.
Measured: Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)
Walking assessment by 6 MWT (6 Minutes Walking Test)
This is a functional walking test
Measured: End of the program (between Month 2 and Month 4)
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)
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: Inclusion (Day 0)
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
Measured: Inclusion (Day 0)
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.
Measured: Inclusion (Day 0)
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
Measured: Inclusion (Day 0)
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
Measured: Through study completion, an average of 22 years
Adoption : 4-Active patient file : number of inclusions per week
This indicator is obtained from data collected in the user file.
Measured: Through study completion, an average of 22 years
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.
Measured: Through study completion, an average of 22 years
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
Measured: Through study completion, an average of 22 years
Implementation : 3-Deployment of therapeutic workshops : description of workshops
Description of workshops in terms of type of activity , rhythm
Measured: End of study (Month 22)
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
Measured: End of the program (between Month 2 and Month 4) ; End of study (Month 22)
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
Measured: 6 months after end of program (between Month 8 and Month 10)
Cost
Average cost to produce all the support provided by the programme by modelling the pathways
Measured: End of study (Month 22)
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.
Measured: End of study (Month 22)
Knowledge of the disease and treatments:
- Knowledge of the disease and treatments: using a knowledge of the disease and treatments questionnaire
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start20 Jun 2023
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795686
- Sponsor's protocol ID
- 69HCL22_0638
- Acronym
- Eval-ARRPAC
- Status last verified
- Jun 2024
- First submitted
- 7 Feb 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the AVanCer Program Provided by the ARRPAC Day Center
- ClinicalTrials.gov ID
- NCT05795686
- Acronym / sponsor ID
- Eval-ARRPAC / 69HCL22_0638
- Conditions
- Stroke, Brain Injury, Rehabilitation
- Keywords
- Stroke, Brain injury, Rehabilitation, Autonomy, Caregivers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients of program "AVanCer" | Other | Other: Evaluation of program "AVanCer"Patients included in program "AVanCer" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Male or female of legal age
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of program "AVanCer"Evaluation of program AVanCer with quantitative and qualitative approaches | Other | Patients of program "AVanCer" |
Primary outcome
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.
24 secondary outcomes
Quality of life of post-stroke patients measured by SIS (Stroke Impact Scale)
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)
Quality of life of post brain injury patients measured by QOLIBRI (Quality Of LIfe after BRain Injury)
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)
Depression and anxiety measured by HADS (Hospital Anxiety Depression Scale)
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)
Autonomy measured by modified Rankin score (mRS)
Time frame: Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)
Walking assessment by 6 MWT (6 Minutes Walking Test)
Time frame: End of the program (between Month 2 and Month 4)
Autonomy in health assessed by the PAM-13 (Patient Activation Measure)
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)
Adhesion to preventive treatment assessed by the Girerd questionnaire
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)
Quality of life of caregivers measured by SF36 (Short Form Health Survey)
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)
Depression and anxiety of caregivers measured by HADS (Hospital Anxiety Depression Scale)
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)
Perceived burden of caregivers measured by the Zarit questionnaire
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)
Reaching the target population evaluated by : 1- The description of the active file : description of socio-demographic characteristics
Time frame: Inclusion (Day 0)
Reaching the target population evaluated by : 2-The description of medical characteristics
Time frame: Inclusion (Day 0)
Adoption : 1-Integration in the territory evaluated by the department of residence of patients
Time frame: Inclusion (Day 0)
Adoption : 2-Link with partners assessed by way of patient referral
Time frame: Inclusion (Day 0)
Adoption : 3-Perception of the structure by professionals
Time frame: Through study completion, an average of 22 years
Adoption : 4-Active patient file : number of inclusions per week
Time frame: Through study completion, an average of 22 years
Implementation 1-Number of patients present compared to the number of patients planned per activity
Time frame: Through study completion, an average of 22 years
Implementation : 2-Follow-up of programs (number of patients per programs)
Time frame: Through study completion, an average of 22 years
Implementation : 3-Deployment of therapeutic workshops : description of workshops
Time frame: End of study (Month 22)
Maintenance: 1-Over time at the organisational level by monitoring team meetings
Time frame: End of the program (between Month 2 and Month 4) ; End of study (Month 22)
Maintenance : 2-Evaluation of the sustainability of activities since the end of the program
Time frame: 6 months after end of program (between Month 8 and Month 10)
Cost
Time frame: End of study (Month 22)
Assessment of transferability
Time frame: End of study (Month 22)
Knowledge of the disease and treatments:
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of program "AVanCer" in people with Stroke and Brain Injury, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Haesebaert, MD (06-51-42-97-43 ext. +33, julie.haesebaert01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (GAS) (time frame: Inclusion (Day 0) ; End of the program (between Month 2 and Month 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.