Skip to main content
OpenTrials
Completed

NCT Number: NCT06314308

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Acute Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Neurological Institute of New York, Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CATCHES

Behavioral

At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.

Primary outcomes

  1. Percentage of Intervention Completers to Demonstrate Feasibility

    Time frame: 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.

Secondary outcomes

  1. Change in Activities-specific Balance Confidence Scale Score

    Time frame: Baseline and 3 months

    This outcome is designed to measure the change in fear of falling. This is a 16-item self-reported questionnaire with a score range of 1-100. 1 = no confidence and 100 = completely confident. The higher the score, the lesser the fear. Total scores are calculated by summing items (16-1600 range) and dividing by 16.

Other outcomes

  1. Change in Timed Up and Go Test Score

    Time frame: Baseline and 3 months

    This exploratory outcome is to measure change in physical function. The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. The test involves recording the length of time it takes a participant to stand from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Change in time to perform the test will be assessed. Measured in number of second taken to complete the test. When the number is negative, it means that the participant took less time to complete the test at 3 months compared to baseline.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: CATCHES

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.