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.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Lyon、フランス、69003
- Hospices Civils De Lyon
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change from 6-month participation restriction at 12 months.
時間枠: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. |
At 6 and 12 months post-stroke
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Change from 6-month experience of minor stroke for patients and their proxys at 12 months.
時間枠:Interviews at 6 and 12 months post-stroke
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Semi-structured interviews with stroke patients and their proxys.
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Interviews at 6 and 12 months post-stroke
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 69HCL17_0444
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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