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临床试验/NCT06314308
NCT06314308已完成不适用

Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke

Columbia University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Percentage of Intervention Completers to Demonstrate Feasibility

研究概览

简要总结

CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) guided by telehealth based Cognitive Behavioral Therapy (CBT) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity.

  1. To integrate and establish feasibility of CATCHES intervention. Hypothesis: A multidisciplinary team providing home based TST with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (FOF) among post-acute stroke patients returning home. Feasibility outcomes will include recruitment, retention, and fidelity of implementation.
  2. Test effects of the intervention on hypothesized treatment mechanism of fear of falling. Hypothesis: Therapy will reduce task specific fear of falling Primary outcome will be change in Activities-specific Balance Confidence Scale.
  3. Explore physical activity measures subjectively and objectively. Exploratory outcomes include pre and post Timed Up and Go test, patient reported outcome surveys and activity as measured by wearable devices.

详细描述

Stroke is a leading cause of disability in the country, and ethno-racial inequities are persistent. Almost two thirds of stroke patients are discharged home without effective rehabilitation or community-based support. Falls can occur at home, and associated fear of falling leads to avoidance behaviors that limit physical activity and community reintegration. Here the investigators propose a novel intervention in a feasibility study for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) in conjunction with telehealth based Cognitive Behavioral Therapy (CBT) with reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies to facilitate engagement in physical activity. The main objective is to assess the feasibility of this intervention. The secondary objective is to explore the underlying behavioral mechanism for behavior change and explore physical activity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged over 18 years
  • •Plan for discharge home after stroke and ability to provide consent
  • •Low balance confidence (Activities-specific Balance Confidence < 80)

排除标准

  • •Modified Rankin Scale > 2 at time of enrollment
  • •Severe Stroke (NIH Stroke Scale > 14 and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer)
  • •Legal blindness precluding ability to view infographic or education materials
  • •Terminal non-cardiovascular illness (life expectancy < 1 year)
  • •Co-morbid mental illness requiring hospitalization
  • •Unavailable for follow-up
  • •Non-English and non-Spanish speaking

研究组 & 干预措施

Intervention

Experimental

Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.

干预措施: CATCHES (Behavioral)

结局指标

主要结局

Percentage of Intervention Completers to Demonstrate Feasibility

时间窗: 3 months

This outcome is designed to measure intervention feasibility, which will take recruitment, retention, and fidelity of implementation into account. The participants who complete 100% of the study required procedures will be tallied.

次要结局

  • Change in Activities-specific Balance Confidence Scale Score(Baseline and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Imama A. Naqvi

Assistant Professor of Neurology at the Columbia University Medicine

Columbia University

研究点 (1)

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