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Needs Assessment and Quality of Life of Stroke Patients and Their Caregivers

Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03217279
Acronym
TYBRA
Enrollment
396
Registered
2017-07-14
Start date
2017-11-02
Completion date
2018-09-14
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Patients and Their Caregivers

Keywords

stroke-participation, restriction-needs-cohort-patients-caregivers

Brief 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. 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.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients institutionalized before stroke and/or at 6 months and/or at 12 months * Patients who have major cognitive trouble * Stroke during hospitalisation

Design outcomes

Primary

MeasureTime frameDescription
Change from 6-month participation restriction at 12 months.At 6 and 12 months post-strokePatients 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.Interviews at 6 and 12 months post-strokeSemi-structured interviews with stroke patients and their proxys.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026