Needs Assessment and Quality of Life of Stroke Patients and Their Caregivers (TYBRA)
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|ClinicalTrials.gov Identifier: NCT03217279|
Recruitment Status : Not yet recruiting
First Posted : July 14, 2017
Last Update Posted : October 30, 2017
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.
|Condition or disease|
|Stroke Patients and Their Caregivers|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers|
|Estimated Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||July 2018|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217279
|Contact: Claire Della Vecchia||4 26 68 82 20 ext +email@example.com|
|Contact: Anne Termoz||4 27 85 63 00 ext +firstname.lastname@example.org|
|Hospices Civils de Lyon||Not yet recruiting|
|Lyon, France, 69003|
|Contact: Anne-Marie SCHOTT, MD 04 26 68 82 23 ext +33 email@example.com|
|Principal Investigator: Anne-Marie SCHOTT, MD|