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

NCT06314308 | Completed Results

• 2 other identifiers: AAAU81615P30AG064198-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Stroke, Acute Ischemic

Outcome Measures

Primary Outcomes (1)

• Percentage of Intervention Completers to Demonstrate Feasibility

  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.

  3 months

Secondary Outcomes (1)

• Change in Activities-specific Balance Confidence Scale Score

  Baseline and 3 months

Other Outcomes (1)

• Change in Timed Up and Go Test Score

  Baseline and 3 months

Study Arms (1)

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.

Behavioral: CATCHES

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Neurological Institute of New York, Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Imama A. Naqvi, MD, MS
• Organization: Columbia University

ian2108@cumc.columbia.edu

212-305-8389

Study Officials

• Imama A Naqvi, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology at the Columbia University Medicine

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: May 9, 2024
• Primary Completion: March 21, 2025
• Study Completion: May 31, 2025
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)