Clinical trial NCT06314308: Community Health Worker Assisted Task Specific and Cognitive Therapy At Home with Exposure After Stroke
Official title: Community Health Worker Assisted Task Specific and Cognitive Therapy At Home with Exposure After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* 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

Primary outcomes:
measure: Percentage of intervention completers to demonstrate feasibility
timeFrame: 3 months
Secondary outcomes:
measure: Change in Activities-specific Balance Confidence Scale Score
timeFrame: Baseline and 3 months
Other outcomes:
measure: Timed Up and Go Test Score
timeFrame: Baseline, 3 months
Locations:
city: New York
country: United States
facility: The Neurological Institute of New York, Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Imama A Naqvi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: