インターネットを介した神経心理学的リハビリテーション (IRENE)
後天性脳損傷後の Web ベースの神経心理学的リハビリテーションの実現可能性と有効性
Helsinki University Hospital (HUS) has decided on a strategy to provide digital health care services for several medical specialties - a project called the Health Village (HealthVillage.fi). Within Health Village a specific digital My Path program, iRENE Digital Pathway, has been developed for web-based neuropsychological rehabilitation. iRENE Digital Pathway is a structured program for adults with an acquired brain injury (ABI), which utilizes psychoeducative information and self-evaluation questionnaires for attentional, memory and executive disorders with a feedback, and provides training for internal and external memory and other cognitive strategies. The current study will explore if web-based neuropsychological rehabilitation is a feasible and effective method for carrying out rehabilitation for adults with ABI.
調査の概要
詳細な説明
The IRENE study will explore the application, feasibility and effectiveness of web-based neuropsychological rehabilitation for working-aged patients with ABI during the first year of recovery. This study will adopt a 2-arm randomized controlled design with treatment-as-usual control.
The investigators will determine the feasibility and effectiveness of a web-based rehabilitation program for patients with ABI on their subjective memory difficulties, management of cognitive symptoms, self-efficacy, fatigue, mood, anxiety, quality of life and subjective working ability. The study will examine, if the method is accessible as well as if neurological patients are able and willing to use web-based rehabilitation. The potential health-economic benefits of the new rehabilitation program will be assessed with the duration of patients' sick leave after ABI and through the net benefit of neuropsychological rehabilitation resources.
A pilot randomized trial with 60 participants will be conducted to address the rate of recruitment of the participants, patient acceptability and adherence to study protocol, retention rates and feedback of the iRENE program as well as initial data on effectiveness of this new program. This pilot trial will use an unequal randomization 2:1 to maximize experiences in delivering the digital intervention to patients after ABI. The intervention group will participate in the iRENE Digital Pathway, a web-based rehabilitation program, that takes 2-3 months to complete. The control group attends treatment as usual, which includes necessary outpatient rehabilitation.
Outcome measures at baseline, post-intervention and 3-month follow-up after completing the intervention are gathered as self-assessments.
The participants are adult patients from neurological acute wards and outpatient clinics from HUS, Finland. Patients with ABI typically get referral to neuropsychological examination at the acute or the sub-acute phase of recovery. The examining clinical neuropsychologist offers a patient the possibility to get involved in the research. A neuropsychologist from the research group interviews voluntary patients at hospital or via telephone to confirm patient's interest and fulfillment of inclusion criteria.
Intervention group will go through a systematic web-based neuropsychological intervention program. Participants carry out the web-based intervention independently with their own digital appliance (computer, tablet or mobile phone) time and place of one's choice.
Control group attends the standard care of patients with ABI including all necessary outpatient rehabilitation visits. A possibility to attend to the iRENE Digital Pathway will be offered to control group participants after they have performed the 5-month assessment of the study.
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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Helsinki、フィンランド、FI-00029
- HUS Neurocenter, Helsinki University Hospital
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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:
- Acute neurological incident affecting cognition (stroke, encephalitis, traumatic brain injury, anoxia)
- Less than 6 months from occurrence of an acute neurological incident
- Mild to moderate cognitive deficits on a clinical neuropsychological assessment during inpatient or outpatient care after ABI
- Subjective cognitive symptoms following ABI
- Proficient in Finnish
- Must be able to use digital appliances
Exclusion Criteria:
- Not an acute neurological incident
- More than 6 months from an acute neurological incident
- Severe cognitive deficits on a clinical neuropsychological assessment during inpatient or outpatient care after ABI
- Not fluent in Finnish
- Not able to use digital appliances
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
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:Digital care pathway
Intervention group goes through a web-based neuropsychological intervention program. The program includes eight structured sessions regarding general neuropsychological symptoms after ABI - problems with fatigue, attention, executive functions and memory. A new session opens after the previous one is completed, and after a minimum of 3 days between the sessions. The intervention takes approximately 2 months depending on the progression pace of a patient. The eight sessions consist of psychoeducation, self-assessments, cognitive strategy training and feedback (automatic or given by a monitoring neuropsychologist). A neuropsychologist from HUS monitors patients' progression and provides personal feedback when needed. Participants can also be in contact with a monitoring neuropsychologist via message feature of the program. |
Sessions of the digital neuropsychological program:
他の名前:
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アクティブコンパレータ:Care as usual
Control group attends the standard care of patients with ABI in HUS including all necessary outpatient rehabilitation visits. When available, neuropsychological rehabilitation typically takes 1-2 months among the study target group. |
The standard care of patients with ABI including all necessary outpatient rehabilitation visits. Neuropsychological visits may include a short period of psychoeducation with a clinical neuropsychologist. |
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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Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Everyday Memory Questionnaire - Revised; The minimum total score is 0 and the maximum score is 52; The higher total score represents more severe subjective cognitive symptoms |
Baseline, Month 2, and Month 5
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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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Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Adaptation to Memory Difficulties Outcome Questionnaire; The questionnaire includes subscales assessing memory knowledge and emotional adjustment (15 questions), use of external memory aids (5 questions) and use of internal memory aids (5 questions); Each item will be scored on a 4-point scale 1-4; Each of the three parts of the questionnaire will be analyzed separately; A higher score would signify better adaptation. |
Baseline, Month 2, and Month 5
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Change of Baseline Perceived Self-Efficacy at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the New General Self-Efficacy Scale; The New General Self-Efficacy Scale is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties; The minimum total score is 1 and the maximum score is 5; The higher total score represents higher self-efficacy |
Baseline, Month 2, and Month 5
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Change of Baseline Perceived Anxiety at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Patient-Reported Outcomes Measurement Information System (PROMIS): anxiety; The minimum total raw score is 8 and the maximum score is 40; The higher total score represents higher anxiety |
Baseline, Month 2, and Month 5
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Change of Baseline Perceived Depression at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Patient-Reported Outcomes Measurement Information System (PROMIS): depression; The minimum total raw score is 8 and the maximum score is 40; The higher total score represents higher depression |
Baseline, Month 2, and Month 5
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Change of Baseline Perceived Quality of life at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Euro-Qol (EQ-5D) Questionnaire; The minimum total raw score is 0 and the maximum score is 100; The higher score represents higher quality of life in terms of self-perceived health |
Baseline, Month 2, and Month 5
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Change of Baseline Perceived Fatigue at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Fatigue Assessment Scale; The minimum total raw score is 10 and the maximum score is 50; The higher total score represents more severe fatigue |
Baseline, Month 2, and Month 5
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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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Change of Baseline Perceived Working ability at 2 months and 5 months
時間枠:Baseline, Month 2, and Month 5
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Administration of the Work Ability Index; The minimum total score is 0 and the maximum score is 24; The higher total score represents better self-perceived working ability |
Baseline, Month 2, and Month 5
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Length of sick leave of a patient
時間枠:Month 5
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Length of sick leave in days after acquired brain injury |
Month 5
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Intervention feedback questionnaire
時間枠:Month 2
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Feedback of the neuropsychological rehabilitation period offered during the study; Participants give their evaluation in a 5-point likert scale; The higher total score represents more positive evaluation; % of patients with positive and negative evaluation will be reported |
Month 2
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協力者と研究者
捜査官
- スタディディレクター:Marja Hietanen, PhD、Helsinki University Central Hospital
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- TYH2022304
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?
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