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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

About this study

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 groups in NCT06314308
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.

9 May 202431 May 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
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Natural History of Stroke: Cause and Development
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Prehospital Response and Emergency Stroke Transport Optimisation
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A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
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Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
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All Stroke, Acute Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke
ClinicalTrials.gov ID: NCT06314308
Acronym / sponsor ID: CATCHES / AAAU8161
Conditions: Stroke, Acute Ischemic
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 9 May 2024 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 31 May 2025 (actual)
First posted: 18 Mar 2024 (actual)
Results: Posted 20 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Behavioral: CATCHESTask 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CATCHESAt 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.	Behavioural	Intervention

Primary outcome

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.

1 secondary outcome

Change in Activities-specific Balance Confidence Scale Score
Time frame: Baseline and 3 months

Results and safety

Results posted to the registry on 20 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	22	19

Primary outcome: Percentage of Intervention Completers to Demonstrate Feasibility

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Intervention n = 22
Value	19

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stroke, Acute Ischemic

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Not yet recruiting
Prehospital Response and Emergency Stroke Transport Optimisation
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RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Imama A Naqvi, MD, MS principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CATCHES in people with Stroke, Acute Ischemic, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Intervention Completers to Demonstrate Feasibility (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06314308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.