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

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.

Study Overview

• Status: Completed
• Conditions: Stroke Patients and Their Caregivers

• Study Type: Observational
• Enrollment (Actual): 396

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hemorrhagic or ischemic stroke patients and their caregivers.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Interviews at 6 and 12 months post-stroke

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): February 14, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: stroke-participation; restriction-needs-cohort-patients-caregivers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 69HCL17_0444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No