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Needs Assessment and Quality of Life of Stroke Patients and Their Caregivers (TYBRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03217279
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : August 20, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease
Stroke Patients and Their Caregivers

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Study Type : Observational
Actual Enrollment : 396 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hemorrhagic or ischemic stroke patients and their caregivers.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03217279

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Hospices Civils de Lyon
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03217279     History of Changes
Other Study ID Numbers: 69HCL17_0444
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases