Stroke, Acute IschemicCATCHESNCT06314308
Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke
A study testing CATCHES in people with Stroke, Acute Ischemic, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- CATCHES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to 31 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Plan for discharge home after stroke and ability to provide consent
- Low balance confidence (Activities-specific Balance Confidence < 80)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Neurological Institute of New York, Columbia University
New York, New York, 10032
About this study
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.
- 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.
- 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.
- 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.
Read the 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.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- CATCHES
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATCHESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CATCHES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Change in Activities-specific Balance Confidence Scale Score
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start9 May 2024
- Primary completion21 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Imama A. Naqvi, Columbia University
- Investigators
- Imama A Naqvi, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314308
- Sponsor's protocol ID
- AAAU8161
- Other IDs
- 5P30AG064198-05
- Acronym
- CATCHES
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2024
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No