Stroke Patients and Their CaregiversTYBRANCT03217279
Needs Assessment and Quality of Life of Stroke Patients and Their Caregivers
An observational study of Stroke Patients and Their Caregivers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading cause of long-term disability. The specificity of stroke is the sequelae polymorphism that can occurs: physical disability, cognitive deficit and sensitive trouble. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Patients and Their Caregivers
- How many people
- 396 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 14 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hemorrhagic or ischemic stroke patients and their caregivers.
Who may be able to join
- Quantitative study : (patients included in Stroke 69 cohort study)
- Diagnosis of stroke confirmed by a neurologist or by an emergency doctor after brain imaging (CT or MRI scan)
- Patients admitted to an emergency department or a neurovascular unit in Rhône department whatever their geographical origin
- Concerning proxys : Caregivers of patients included in Stroke 69 cohort study and eligible to TYBRA study.
- Qualitative study : (patients included in Stroke 69 cohort study)
- Patients included in Stroke 69 cohort study with a diagnosis of stroke confirmed by brain imaging
- Minor stroke (Rankin <1)
- Proxys of minor stroke patients
Who cannot join
- Patients institutionalized before stroke and/or at 6 months and/or at 12 months
- Patients who have major cognitive trouble
- Stroke during hospitalisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers
The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading cause of long-term disability. The specificity of stroke is the sequelae polymorphism that can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large extend of sequelae may have a different impact on daily life. Therefore, we have to consider the individual's own resources and in his whole environment to face the situation. We suppose that each situation, each post-stroke disability will have a different social impact in stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the standards for the assessment of the stroke impact on survivors' daily life. However, what is the real impact of an activity limitation in daily life? How consider the psychosocial impact of stroke only with functional indicators? For this study we will consider handicap and disability in a societal way. In fact, the WHO developed in 2001 the International Classification of functioning, disability and health that allows to bring the concept of participation restriction, this is to say the consequences of a disability in the real life. The ICF allows to bring a conceptual framework of participation restriction.
Psychosocial consequences of stroke are relatively unknown especially in France. According to our hypothesis, patients with major disabilities and their caregivers will experience more psychosocial consequences and participation restriction in terms of emotional health, quality of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes in terms of psychosocial consequences, participation restriction and quality of life.
TYBRA study is a prospective multicentric cohort study that mixes qualitative and quantitative approaches. The first aim of the quantitative approach is to explore factors related to patients and their caregivers at 6 months that predict participation restriction at 12 months post-stroke. The first aim of the qualitative study is to explore the experience of stroke in minor stroke patients and their proxys.
- Conditions
- Stroke Patients and Their Caregivers
- Keywords
- stroke-participation, restriction-needs-cohort-patients-caregivers
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 6-month participation restriction at 12 months.
Patients will receive at home questionnaires about the psychosocial consequences of stroke for them and their caregivers at 6 months and 12 months post stroke.
Scale 2.0 at 12 months. The variable "participation" will be dichotomized in two scores : <50 and >50. A score <50 means that the person presents a significate participation restriction.
Measured: At 6 and 12 months post-stroke
Change from 6-month experience of minor stroke for patients and their proxys at 12 months.
Semi-structured interviews with stroke patients and their proxys.
Measured: Interviews at 6 and 12 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start2 Nov 2017
- Primary completion14 Feb 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Patients and Their CaregiversStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (actual)
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
- NCT03217279
- Sponsor's protocol ID
- 69HCL17_0444
- Acronym
- TYBRA
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT03217279
- Acronym / sponsor ID
- TYBRA / 69HCL17_0444
- Conditions
- Stroke Patients and Their Caregivers
- Keywords
- stroke-participation, restriction-needs-cohort-patients-caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 14 Jul 2017 (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.
The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading cause of long-term disability. The specificity of stroke is the sequelae polymorphism that can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large extend of sequelae may have a different impact on daily life. Therefore, we have to consider the individual's own resources and in his whole environment to face the situation. We suppose that each situation, each post-stroke disability will have a different social impact in stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the standards for the assessment of the stroke impact on survivors' daily life. However, what is the real impact of an activity limitation in daily life? How consider the psychosocial impact of stroke only with functional indicators? For this study we will consider handicap and disability in a societal way. In fact, the WHO developed in 2001 the International Classification of functioning, disability and health that allows to bring the concept of participation restriction, this is to say the consequences of a disability in the real life. The ICF allows to bring a conceptual framework of participation restriction.
Psychosocial consequences of stroke are relatively unknown especially in France. According to our hypothesis, patients with major disabilities and their caregivers will experience more psychosocial consequences and participation restriction in terms of emotional health, quality of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes in terms of psychosocial consequences, participation restriction and quality of life.
TYBRA study is a prospective multicentric cohort study that mixes qualitative and quantitative approaches. The first aim of the quantitative approach is to explore factors related to patients and their caregivers at 6 months that predict participation restriction at 12 months post-stroke. The first aim of the qualitative study is to explore the experience of stroke in minor stroke patients and their proxys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemorrhagic or ischemic stroke patients and their caregivers.
Key inclusion criteria (8 listed)
- Quantitative study : (patients included in Stroke 69 cohort study)
- Qualitative study : (patients included in Stroke 69 cohort study)
- Patients included in Stroke 69 cohort study with a diagnosis of stroke confirmed by brain imaging
- Minor stroke (Rankin <1)
- Proxys of minor stroke patients
Key exclusion criteria (3 listed)
- Patients institutionalized before stroke and/or at 6 months and/or at 12 months
- Patients who have major cognitive trouble
- Stroke during hospitalisation
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
Change from 6-month participation restriction at 12 months.
Time frame: At 6 and 12 months post-stroke
Patients will receive at home questionnaires about the psychosocial consequences of stroke for them and their caregivers at 6 months and 12 months post stroke. Scale 2.0 at 12 months. The variable "participation" will be dichotomized in two scores : <50 and >50. A score <50 means that the person presents a significate participation restriction.
Change from 6-month experience of minor stroke for patients and their proxys at 12 months.
Time frame: Interviews at 6 and 12 months post-stroke
Semi-structured interviews with stroke patients and their proxys.
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 20 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke Patients and Their Caregivers
Recruiting
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Stroke and Aphasia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Patients and Their Caregivers, 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 8 inclusion and 3 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 20 Aug 2019. 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?
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?
Change from 6-month participation restriction at 12 months. (time frame: At 6 and 12 months post-stroke). 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?
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 20 Aug 2019.