Compass 3: A Novel Transition Program to Reduce Disability After Stroke

Официальное название

Compass 3: A Novel Transition Program to Reduce Disability After a Stroke

Обзор

This study evaluates a program designed to help individuals transition from inpatient rehabilitation to home 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.

Подробное описание

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.

Investigators will conduct a randomized, controlled multi-center trial (RCT) and concurrent implementation evaluation and review of process data to examine therapeutic efficacy, cost-effectiveness and implementation potential of a compensatory intervention (COMPASS) designed to improve daily activity performance and participation outcomes in persons transitioning home from inpatient rehabilitation (IR) following a stroke.

Вмешательства

• Поведенческое COMPASS
  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
• Поведенческое Education Program
  The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.

Первичные конечные точки

• Admission to SNF (skilled nursing facility) [Срок оценки: From enrollment to 12 months post-discharge from inpatient rehabilitation facility]

Критерии участия

Критерии включения

• Aged ≥55 years at the time of screening
• Acute stroke diagnosis (IS or ICH) verified by the stroke team or medical record
• Independent in activities of daily living (ADLs) prior to stroke (premorbid Modified Rankin Scale score ≤2)
• Plan to discharge to home from an IR
• Capable of giving informed consent which includes compliance with the requirements and duration of participation as listed in the Informed Consent Form (ICF).

Критерии исключения

• Life expectancy <6 months
• Cognitive impairment that the participant's stroke team or a research team member believes impairs their ability to provide informed consent or make reasoned choice including the interpretation of the self-rated scales
• Any communication problem that would prevent study completion
• Residence in a congregate living facility
• Not eligible for a therapeutic pass
• Residence outside of the designated catchment area (specific catchment distance to be determined by each site)
• Site investigator's judgment that the participant would not be able to complete research procedures or interventions
• Participation in another research study that in the site investigator's judgment could interfere or conflict with this research study's assessments or interventions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Missouri — Columbia
• Washington University in St. Louis — St Louis

Идентификаторы

NCT: NCT07069660 · 202501232 · 2R01HD092398-06A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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