脳卒中後の障害を軽減するための新しい移行プログラム (COMPASS)
COMPASS: 脳卒中後の障害を軽減するための新しい移行プログラム
This study evaluates a program designed to help individuals transition home from inpatient rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.
調査の概要
詳細な説明
A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity. The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.
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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Missouri
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St Louis、Missouri、アメリカ、63108
- Washington University School of Medicine
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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:
- aged ≥50 years
- acute ischemic or hemorrhagic stroke diagnosis
- independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
- plan to discharge to home
Exclusion Criteria:
- severe terminal systemic disease that limits life expectancy to < 6 months
- previous disorder (e.g. dementia) that makes interpretation of the self-rated scales difficult or Short Blessed Test (SBT) score of 10 or less (indicating significant cognitive impairment)
- moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
- reside in congregate living facility.
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
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:COMPASS
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions. |
The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community. |
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偽コンパレータ:Education program
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided. |
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest. |
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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Reintegration to Normal Living Index (RNLI)
時間枠:Baseline and 12 months post-stroke
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The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living. |
Baseline and 12 months post-stroke
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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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Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
時間枠:Baseline and 12 months post-stroke
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The SIS is a health-related quality of life (HRQoL) measure that quantifies the impact of stroke on a client's life, via questionnaire. The Activities of Daily Living (ADL) domain was used to measure daily activity performance. The scale ranges from 0 to 100, with higher scores indicating less difficulty. |
Baseline and 12 months post-stroke
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In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
時間枠:Baseline and 12 months post-stroke
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The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant. |
Baseline and 12 months post-stroke
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In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
時間枠:Baseline and 12 months post-stroke
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The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating of up to 10 participant-prioritized activities on a scale from 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). Higher mean scores indicate better functional ability to perform tasks without difficulty. |
Baseline and 12 months post-stroke
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In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
時間枠:Baseline and 12-months post-stroke
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The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating of up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with their performance of the activity) to 5 (very satisfied with their performance of the activity). Higher mean scores indicate more satisfaction with self-rated activity performance. |
Baseline and 12-months post-stroke
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In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
時間枠:Baseline and 12-months post-stroke
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The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity ) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher sum scores indicate a greater need for assistance/less independence for completion of functional activities. There is no maximum score. |
Baseline and 12-months post-stroke
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協力者と研究者
捜査官
- 主任研究者:Susan Stark, PhD、Washington University School of Medicine
出版物と役立つリンク
一般刊行物
- Somerville E, Minor B, Keglovits M, Yan Y, Stark S. Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol. JAMA Netw Open. 2019 Oct 2;2(10):e1912356. doi: 10.1001/jamanetworkopen.2019.12356.
- Krauss MJ, Somerville E, Poiter C, Bollinger RM, Holden BM, Blenden G, Kretzer D, Stark SL. Functional performance of patients with stroke during inpatient rehabilitation: a cross-sectional study of home and access visits. BMC Health Serv Res. 2025 Jan 7;25(1):34. doi: 10.1186/s12913-024-12167-6.
- Bollinger RM, Krauss MJ, Somerville EK, Holden BM, Blenden G, Hollingsworth H, Keleman AA, Carter A, McBride TD, Barker AR, Yan Y, Stark SL. Rehabilitation Transition Program to Improve Community Participation Among Stroke Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2437758. doi: 10.1001/jamanetworkopen.2024.37758.
- Krauss MJ, Holden BM, Somerville E, Blenden G, Bollinger RM, Barker AR, McBride TD, Hollingsworth H, Yan Y, Stark SL. Community Participation Transition After Stroke (COMPASS) Randomized Controlled Trial: Effect on Adverse Health Events. Arch Phys Med Rehabil. 2024 Sep;105(9):1623-1631. doi: 10.1016/j.apmr.2024.05.015. Epub 2024 May 19.
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
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