StrokeAVCAIDENCT04741451
The Experiences of Family Caregivers of Stroke Patients: A Cross-sectional Study of a French Cohort
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
Stroke is the most common cause of non-traumatic disability in adults and ranks second among causes of dementia and third among causes of death. In France, stroke affects around 140,000 patients each year and entails enormous economic costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jan 2021to 8 Jul 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients treated in the NeuroVasular Unit (UNV) of Saint-Joseph Hospital in Paris and consultant in the same department between 01/15/2021 and 05/31/2021 (usual post-stroke consultation) will be included
Who may be able to join
- For patients:
- Patient whose age is ≥ 18 years
- Patient having had a stroke
- Patient hospitalized in UNV
- Patient able to understand the information and no objection form
- Patient who did not need help before the onset of stroke (retrospective evaluation with a score <2 on the Rankin scale
Show all 13Show fewer
- Patient having spent at least 3 months at home (directly after hospitalization in UNV or after undergoing rehabilitation)
- Patient with sequelae upon discharge from hospital (score ≥ 2 on the Rankin scale)
- French-speaking patient
- For caregivers:
- Caregiver whose age is ≥ 18 years
- Caregiver of the patient with stroke
- Being a family caregiver according to Article L. 113-1 of the Social Action and Families Code for at least 3 months and at most 12 months
Who cannot join
- For patients:
- Patient who suffered from a transient ischemic attack
- Patient who has had two or more strokes
- Patient with a disability before the onset of stroke (score ≥2 on the Rankin scale)
- Patient under guardianship or curatorship
- Patient deprived of liberty
Show all 10Show fewer
- Patient under legal protection
- Patient objecting to the use of their data for this research
- For caregivers:
- Helping another person at the same time.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de Psychologie, Université de Paris
Boulogne, 92774
Groupe Hospitalier Paris Saint Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
About this study
Stroke is the most common cause of non-traumatic disability in adults and ranks second among causes of dementia and third among causes of death. In France, stroke affects around 140,000 patients each year and entails enormous economic costs. Given the average age of onset of stroke, its prevalence is expected to increase with increasing life expectancy and the advancing age of the population.
Clinically, depending on the region of the brain affected, stroke results in a sudden and abrupt onset of sensorimotor, cognitive, emotional and / or behavioral manifestations, associated with variable recovery from patient to patient. Stroke has psychological, social and family consequences. Indeed, its occurrence could affect patients on a physical and psychological level (direct physical and cognitive sequelae of stroke, decrease or even absence of autonomy and dependence of the entourage, associated psychological changes) and generate repercussions on the dynamics. family or that of the couple (ie, changes in activities, redistribution of tasks, changes or even inversion of roles, alteration of the intimate sphere), as well as professional and social life. This could hamper the quality of life of patients and their loved ones and cause collateral damage to their social or family environment.
Read more
After discharge from the hospital, the patient's relatives will play a major role in taking charge of home care (e.g. household activities and personal care around hygiene, food, mobility and administration. treatments) as well as in the community (eg purchase of clothes or food, accompaniment to medical visits), although these helpers do not have the professional knowledge and skills in care. Despite the positive effects that caregivers can have in connection with the care they provide (ie, feeling of accomplishment and usefulness, development of a sense linked to this helping role, better self-esteem, improvement of personal skills), their continued investment in their sick relatives could deprive them of their resources, making them "hidden or invisible patients / victims". In addition, the gap between caregiver capacities to provide care and the health needs of patients could result in caregiver burden (i.e., caregiving burden). Caregivers of stroke patients experience an impaired quality of life, neglect of their own health, reduced work and leisure activities, as well as psychological suffering involving feelings of abandonment, loneliness and helplessness. uncertainty. In the context of a stroke, caregivers may be overwhelmed by the emotions of their ill loved ones as well as their own emotions. Emotional regulation is essential in such a context rich in emotional experience; it is the set of strategies that enables individuals to influence the emotions they feel, when they appear, and how they experience and express them.
Reviews of the literature have highlighted the lack of studies addressing the burden on caregivers and the need for research to identify those at risk and implement appropriate interventions.
No French study has specifically addressed the notion of the burden of caregivers of stroke patients, their coping strategies, their experiences or emotional regulations. This type of study would however constitute a step towards the design and implementation of personalized care (eg: psychotherapies), by strengthening effective / adaptive strategies and modifying those which are less effective / poorly adaptive. This could improve the well-being of caregivers and their sick relatives, and direct health policies to reduce the economic impact of this aid.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Charge of assistance to family caregivers
This outcome corresponds to the support for caregivers using the Brief Burden Interview.
Measured: Month 3
Charge of assistance to family caregivers
This outcome corresponds to the support for caregivers using Caregiver Reaction Assessment.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start28 Jan 2021
- Primary completion31 May 2021
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Zuber, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741451
- Sponsor's protocol ID
- AVCAIDE
- Acronym
- AVCAIDE
- Status last verified
- Oct 2022
- First submitted
- 3 Feb 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blake H, Lincoln NB. Factors associated with strain in co-resident spouses of patients following stroke. Clin Rehabil. 2000 Jun;14(3):307-14. doi: 10.1191/026921500667530134.
PubMed 10868726Blake H, Lincoln NB, Clarke DD. Caregiver strain in spouses of stroke patients. Clin Rehabil. 2003 May;17(3):312-7. doi: 10.1191/0269215503cr613oa.
PubMed 12735539
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experiences of Family Caregivers of Stroke Patients: A Cross-sectional Study of a French Cohort
- ClinicalTrials.gov ID
- NCT04741451
- Acronym / sponsor ID
- AVCAIDE / AVCAIDE
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 5 Feb 2021 (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.
Stroke is the most common cause of non-traumatic disability in adults and ranks second among causes of dementia and third among causes of death. In France, stroke affects around 140,000 patients each year and entails enormous economic costs. Given the average age of onset of stroke, its prevalence is expected to increase with increasing life expectancy and the advancing age of the population.
Clinically, depending on the region of the brain affected, stroke results in a sudden and abrupt onset of sensorimotor, cognitive, emotional and / or behavioral manifestations, associated with variable recovery from patient to patient. Stroke has psychological, social and family consequences. Indeed, its occurrence could affect patients on a physical and psychological level (direct physical and cognitive sequelae of stroke, decrease or even absence of autonomy and dependence of the entourage, associated psychological changes) and generate repercussions on the dynamics. family or that of the couple (ie, changes in activities, redistribution of tasks, changes or even inversion of roles, alteration of the intimate sphere), as well as professional and social life. This could hamper the quality of life of patients and their loved ones and cause collateral damage to their social or family environment.
After discharge from the hospital, the patient's relatives will play a major role in taking charge of home care (e.g. household activities and personal care around hygiene, food, mobility and administration. treatments) as well as in the community (eg purchase of clothes or food, accompaniment to medical visits), although these helpers do not have the professional knowledge and skills in care. Despite the positive effects that caregivers can have in connection with the care they provide (ie, feeling of accomplishment and usefulness, development of a sense linked to this helping role, better self-esteem, improvement of personal skills), their continued investment in their sick relatives could deprive them of their resources, making them "hidden or invisible patients / victims". In addition, the gap between caregiver capacities to provide care and the health needs of patients could result in caregiver burden (i.e., caregiving burden). Caregivers of stroke patients experience an impaired quality of life, neglect of their own health, reduced work and leisure activities, as well as psychological suffering involving feelings of abandonment, loneliness and helplessness. uncertainty. In the context of a stroke, caregivers may be overwhelmed by the emotions of their ill loved ones as well as their own emotions. Emotional regulation is essential in such a context rich in emotional experience; it is the set of strategies that enables individuals to influence the emotions they feel, when they appear, and how they experience and express them.
Reviews of the literature have highlighted the lack of studies addressing the burden on caregivers and the need for research to identify those at risk and implement appropriate interventions.
No French study has specifically addressed the notion of the burden of caregivers of stroke patients, their coping strategies, their experiences or emotional regulations. This type of study would however constitute a step towards the design and implementation of personalized care (eg: psychotherapies), by strengthening effective / adaptive strategies and modifying those which are less effective / poorly adaptive. This could improve the well-being of caregivers and their sick relatives, and direct health policies to reduce the economic impact of this aid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the NeuroVasular Unit (UNV) of Saint-Joseph Hospital in Paris and consultant in the same department between 01/15/2021 and 05/31/2021 (usual post-stroke consultation) will be included
Key inclusion criteria (13 listed)
- Patient whose age is ≥ 18 years
- Patient having had a stroke
- Patient hospitalized in UNV
- Patient able to understand the information and no objection form
- Patient who did not need help before the onset of stroke (retrospective evaluation with a score <2 on the Rankin scale
Key exclusion criteria (10 listed)
- Patient who suffered from a transient ischemic attack
- Patient who has had two or more strokes
- Patient with a disability before the onset of stroke (score ≥2 on the Rankin scale)
- Patient under guardianship or curatorship
- Patient deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Charge of assistance to family caregivers
Time frame: Month 3
This outcome corresponds to the support for caregivers using the Brief Burden Interview.
Charge of assistance to family caregivers
Time frame: Month 3
This outcome corresponds to the support for caregivers using Caregiver Reaction Assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Results publication: PubMed 10868726Blake H, Lincoln NB. Factors associated with strain in co-resident spouses of patients following stroke. Clin Rehabil. 2000 Jun;14(3):307-14. doi: 10.1191/026921500667530134.
- Results publication: PubMed 12735539Blake H, Lincoln NB, Clarke DD. Caregiver strain in spouses of stroke patients. Clin Rehabil. 2003 May;17(3):312-7. doi: 10.1191/0269215503cr613oa.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Mathieu Zuber, MD principal investigator
Fondation Hôpital Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 2 sites 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 10 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: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Charge of assistance to family caregivers (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741451, which also lists 2 linked publications.
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 1 Nov 2022.