Stroke - 65 Plus. Continued Active Life. (Stroke65+)
Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke
調査の概要
詳細な説明
Background: Elderly adults represent the majority of stroke cases worldwide. Sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. This makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. Reintegration into the community post-stroke depends highly on support from the family. However, the stroke individual's closest relatives are at risk of developing anxiety and depression.
The aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke
Methods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.
During a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.
Study outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.
Patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.
Discussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hammel、デンマーク、8450
- Region Hospital Hammmel Neurorehabilitation
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Jutland
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Hammel、Jutland、デンマーク、8450
- Region Hospital Hammel Neurocentre
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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
説明
Inclusion Criteria:
- stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home
Exclusion Criteria:
- do not understand danish Montreal Cognitive assessment (MOCA) below 20
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
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Mentor
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors.
A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
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Traditional rehabilitation.
他の名前:
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アクティブコンパレータ:Traditional rehabilitation
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors.
A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
|
Traditional rehabilitation.
他の名前:
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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 |
|---|---|---|
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Stroke Self-efficacy questionnaire
時間枠:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of Self-efficacy
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Impact on participation and Autonomy Questionnaire
時間枠:Measured 3 and 9 months post discharged from rehabilitation hospital
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Change of Impact on participation and Autonomy
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Measured 3 and 9 months post discharged from rehabilitation hospital
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Stroke Specific Quality of Life Scale Questionnaire(short version)
時間枠:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of Specific Quality of Life
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Activity (accelerometers)
時間枠:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of activity
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Caregiver Burden Scale
時間枠:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of caregivers burden
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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協力者と研究者
捜査官
- 主任研究者:Hanne Pallesen, Post Doc、Hammel neurorehabilitation centre and university research clinic
出版物と役立つリンク
一般刊行物
- Pedersen SKS, Pallesen H. Stroke self-efficacy questionnaire - Denmark (SSEQ-DK): test-retest of the Danish version. Top Stroke Rehabil. 2023 Mar;30(2):193-202. doi: 10.1080/10749357.2021.2016097. Epub 2022 Jan 7.
- Sorensen SL, Pedersen SKS, Pallesen H. Social psychological mechanisms and processes in a novel, health professional-led, self-management intervention for older stroke individuals: a synthesis and phenomenological study. BMC Health Serv Res. 2019 May 22;19(1):320. doi: 10.1186/s12913-019-4150-x.
- Pallesen H, Naess-Schmidt ET, Kjeldsen SS, Pedersen SKS, Sorensen SL, Brunner I, Nielsen JF. "Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke. Trials. 2018 Nov 19;19(1):639. doi: 10.1186/s13063-018-2961-4.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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