Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke
Phase: NA
Conditions: Stroke, Acute Ischemic
Sponsor: Columbia University

NCT Number: NCT06314308 
Protocol: AAAU8161 
Effective Date: 09/16/2025 (IRB Approval) 
Principal Investigator: Syeda Imama Naqvi, MD, MS 
Protocol Title: Community health worker Assisted Task specific and Cognitive therapy at 
Home with Exposure after Stroke (CATCHES) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose: Stroke is a leading cause of disability, with more than 7 million survivors currently 
in the country and rising due to an aging population. Improvements in organized emergency 
systems of acute stroke treatments are contributing to declines in stroke mortality 
observed over the past decade. However, with increasing survival after stroke, the 
prevalence of stroke is projected to increase to 10 million by 2030.  
Ethno-racial inequities are persistent. Almost two thirds of stroke patients are discharged 
home without effective rehabilitation or community-based support. Fear of falling leads to 
avoidance behaviors that limit physical activity and community reintegration. Furthermore, 
acute stroke patients deemed “close to functional baseline” are discharged home directly 
from the hospital soon after the event. These minor stroke patients, in particular, must 
integrate back into their home environment, without considered rehabilitation for 
community reintegration. Physical inactivity in the immediate post-acute stroke period can 
exacerbate disability and impede community reintegration. Following stroke, many patients 
have limited access to outpatient care related to impaired mobility, access to transport, 
and lack of social support. These factors contribute to challenges in developing system-
level interventions for post-stroke care, amplified in underserved minorities. Physical 
inactivity after stroke is high in both inpatient and community settings and is associated 
with higher cardiovascular risk. Stroke patients have been reported as willing to improve 
physical activity with support from providers and caregivers. The ‘teachable moment’ 
concept indicates that people are particularly open to making behavioral changes following 
major life transitions or health events, such as after having a stroke; and timely clinician-
patient interactions are central for success. Fear of falling (FOF) is a psychological 
condition associated with excessive worrying about losing one’s balance. Individuals with 
fear of falling are occupied by negative emotions of fearful anticipation of falls, and 
physical harm that could occur. This leads to avoidance of engaging in day-to-day activities 
and adoption of overly cautious behaviors. Stroke patients are more likely to experience 
fear of falling compared to those without a stroke, with fear of falling reported among more 
than 50% stroke patients returning home after hospitalization.  
Rationale: Fear avoidance behaviors lead to physical inactivity. Fear alters perception, 
planning, and execution of motor skills. Impaired perceptual motor performance is likely 
mediated by decreased attentional capacity whereby attention is focused on the threat 
stimulus and/or attentional focus is directed internally which is known to degrade 
performance. Task Specific Training (TST) 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. 
Behavioral avoidance tends to increase fear of a situation and lessens the amount of 
critical task practice. Task specific training can target this cycle with safe, graded exposure 
and repetitive practice in threatening situations. It incorporates principles of motor learning 

to promote cortical reorganization and behavioral change and related to experience 
dependent neural plasticity. For stroke rehabilitation, it has been shown to improve 
physical function. Cognitive Behavioral Therapy (CBT) is a psychotherapeutic intervention 
that focuses on modifying individuals’ thoughts and behavior. People with fear of falling 
may have difficulty believing that they can accomplish daily tasks such as walking or going 
up and down stairs without falling. CBT with exposure therapy could help altering those 
beliefs and associated behaviors by directing safe physical activity while promoting self-
efficacy. It includes adaptive thought processes and behaviors, including effective coping 
skills, goal-setting and behavioral activation strategies for engaging in valued activities. It 
has been shown to be effective in reducing fear of falling and improving balance among 
older people. Among individuals with neurological conditions, telehealth delivered CBT 
been found effective and less time consuming. A previous study among chronic stroke 
patients, noted CBT with standard physiotherapy to show greater reduction in fear of falling 
and fear avoidance behaviors. Successful community-based interventions include support 
from community health workers (CHWs) in home-based stroke care. These can include 
trained health navigators or peer mentors from underserved communities. CHW based 
programs can facilitate delivery of health-related services at home and self-efficacy to 
improve community reintegration. However, less is known about their roles with training by 
professionals such as psychologists and physical therapists for rehabilitation. Among 
minor stroke patients, studies must address fear of falling to attain physical independence 
in underserved community setting– a central aim of this proposal. 
Study Design: Here we 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. Participants will be recruited from a single site, Columbia 
University Medical Center Comprehensive Stroke Center. 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. 
Statistical Procedures: Since this will be a pilot feasibility study, we did not conduct a 
formal power analysis. We aim to recruit at least 30 participants based on pragmatics, 

needs of the trial and previous pilot studies suggesting that this sample size is sufficient to 
provide an accurate indication of feasibility of study procedures. Specifically, a sample size 
calculation was based on feasibility measure of adherence rates to visits. It is felt that N = 
30 will be a large enough sample to inform about the practicalities of intervention delivery 
among patients returning home after an acute stroke. Specifically, with n = 25, there is 
about 85% power at 5% significance (one-sided) to demonstrate an adherence rate of 75% 
in an arm against a null rate of 50%. We note that in COMPASS-TC study only 35% attended 
a visit within three months after stroke. Therefore, setting the null rate at 50% is reasonable. 
WAll data will be combined, coded, and kept secure in a secure database such as REDCap. 
As this is a preliminary trial with a small sample, estimates derived will be used to (e.g., 
standard deviations, attrition rates) to help determine appropriate sample sizes for a future 
study that is powered to detect meaningful reductions in measures of fear of falling and 
avoidance. We will calculate the means and standard deviations (or medians and 
interquartile ranges if variables are non-normal) as well as frequencies and proportions to 
assess feasibility outcomes. T-tests or chi-square tests will be used to compare 
demographic and clinical characteristics of participants enrolled in the study, and those 
who did not complete the study. 
Study Procedures: 
To be included in the study, patients must be above 18 years of age, plan for discharge 
home in the local community after minor acute stroke as measured by modified Rankin 
Scale 2 with no more than slight disability, low balance confidence (Abilities specific 
Balance Confidence scale <80), and ability to provide consent. Exclusion criteria will 
include modified Rankin scale 2 at the time of enrollment (moderate or severely disabled), 
severe stroke (NIH Stroke Scale Score >14 and/or significant aphasia, dysarthria, or 
cognitive impairment precluding ability to complete study questionnaires as determined by 
interviewer), legal blindness, terminal non-cardiovascular illness (life expectancy <1 year), 
co-morbid mental illness, unavailable for follow-up, and/or non-English and non-Spanish 
speaking. 
Patients will be recruited prior to discharge home from Columbia University Irving Medical 
Center (CUIMC) Comprehensive Stroke Center in the underserved area of Northern 
Manhattan with a predominant Hispanic population. Dr. Naqvi is a Vascular Neurologist, 
attending stroke service in the hospital, and in outpatient stroke clinics affiliated that 
provide outpatient services after discharge to these patients. The stroke clinics provide 
care to patients in the catchment area of CIUMC which is notable for substantial racial, 
ethnic, and economic diversity. All baseline study procedures, including informed consent, 
and data collection, will be performed at bedside by trained research staff and will be 

available in English and Spanish. Baseline surveys will be conducted including IPAQ 
(International Physical Activity Questionnaire) and PROMIS-PF (Patient Reported Outcome 
Measures Information System) about self-reported physical activity and physical function 
respectively. Timed Up and Go (TUG) test will be performed, along with FitBit wear 
instructions and education on device navigation. Patients who qualify based on the 
inclusion criteria will be enrolled. Within the first two weeks they will receive intake visits 
with a neuropsychologist who will conduct an intake session through video to assess their 
cognitive barriers and fear of falling with consider techniques of cognitive restructuring, 
imaginative exposure, and relaxation techniques to target specific self- defeating beliefs 
associated with negative emotions. They will receive an in-home assessment with a 
physical therapist and community health worker to conduct an intake visit for task specific 
training. Further follow up study visits for a total of 7 study visits will be conducted by the 
community health worker where Treatment sessions will be tailored to a patient’s specific 
goals and individualized to allow for challenging practice while promoting successful 
performance to increase self-efficacy. Sessions will be followed by an interdisciplinary 
discussion for a patient-centered training plan. After study completion, participants and 
study personnel will be approached to asked to participate in focus groups for qualitative 
feedback on the intervention. These are expected to last up to 60 minutes and will be audio 
recorded. The audio of the call will be recorded using HIPAA enabled CUIMC Zoom on an 
encrypted CUIT-secured device and transcribed using Microsoft Stream or through human 
transcription. Upon receipt and validation o fthe transcript, the digital audio files will be 
retained for analysis. Notes will be taken to identify the key thematic content that emerged 
from the interviews. These notes will entered into an Excel spreadsheet as a code book, 
coded for meaning, then grouped according to shared properties and conceptual 
relationships, and themes will be identified and a codebook constructed from these 
groupings. The study team will review the initial codes for content validity. An iterative 
process will be used to allow dominant themes to emerge till saturation. Quotes that 
represent prevailing opinions and concerns will be identified. 
Describe how participants will be recruited: In CATCHES pilot trial, we will identify stroke 
patients hospitalized for ischemic and hemorrhagic stroke at Columbia University Irving 
Medical Center. Any person over the age of 18 who is hospitalized for an ischemic or a 
hemorrhagic stroke with minor symptoms with plan for safe discharge home will be 
considered for this study. People who are unable to consent will not be considered. A 
member of the provider team will ask the potential participant if they would be interested in 
participating in a research study. If yes, a study team member will approach the stroke 
patient and describe the study. A study team member will obtain one on one written 
consent to participate in the study. The informed consent process will begin with a concise 

and focused presentation of the key information about the research study. Potential 
subjects will have ample time and opportunity to discuss the information provided. 
Describe how participants' written consent will be obtained: A study team member will 
obtain one on one written consent to participate in the study once they have been 
approved to be approached in the hospital by the clinical care team prior to discharge. The 
informed consent process will begin with a concise and focused presentation of the key 
information in sufficient detail about the research study. Potential subjects will be given 
ample time with opportunity to discuss the information provided and agree or decline to 
participate. 
Only those participants who have completed the study, and study personnel who were 
engaged in the study will be invited to take part in providing their feedback regarding the 
intervention. It will be emphasized that they are not obligated to participate in providing 
their feedback about the intervention, and their further care will not be affected if they 
decide not to participate. It will be emphasized to study personnel that they are not 
obligated to participate to give their feedback regarding intervention processes to improve 
further iterations of the intervention. . Informed consent process will begin with a concise 
and focused presentation of the key information about the research study. Potential 
participants to the focus groups to give feedback will have the opportunity to discuss the 
information provided and provided contact details to do so. The informed consent process 
as a whole presents information in sufficient detail regarding the research study and the 
information sheet will be provided. 
Research Question(s)/Hypothesis(es): 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 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. 
Scientific Abstract: Stroke is a leading cause of disability, with more than 7 million survivors 
currently in the country and rising due to an aging population. Improvements in organized 
emergency systems of acute stroke treatments are contributing to declines in stroke 
mortality observed over the past decade. However, with increasing survival after stroke, the 
prevalence of stroke is projected to increase to 10 million by 2030. Moreover, ethno-racial 

inequities are persistent with the largest rises in stroke prevalence expected to be among 
those of Hispanic ethnicity and Black race. By 2030, almost a third of the population is 
projected to be Hispanic (21.1%) or Black (13.8%).Post stroke outcomes are the most 
optimal when care is focused on the crucial 3 months after stroke hospitalization. Early 
after a stroke is the “sensitive period” when both recovery potential and risk of further 
disability from recurrent stroke are greatest. Studies in humans and animal models show 
that most recovery from impairment occurs in the first 3 months after stroke from 
spontaneous recovery as well as increased responsiveness to enriched environments and 
training. Almost 70% of all stroke patients are discharged to a home setting, where they 
may not be prepared or equipped to return to their routines. Furthermore, acute stroke 
patients deemed “close to functional baseline” are discharged home directly from the 
hospital soon after the event. These minor stroke patients, in particular, must integrate 
back into their home environment, without considered rehabilitation for community 
reintegration. Physical inactivity in the immediate post-acute stroke period can exacerbate 
disability and impede community reintegration. Following stroke, many patients have 
limited access to outpatient care related to impaired mobility, access to transport, and lack 
of social support. These factors contribute to challenges in developing system-level 
interventions for post-stroke care, amplified in underserved minorities. Physical inactivity 
after stroke is high in both inpatient and community settings and is associated with higher 
cardiovascular risk. Stroke patients have been reported as willing to improve physical 
activity with support from providers and caregivers. The ‘teachable moment’ concept 
indicates that people are particularly open to making behavioral changes following major 
life transitions or health events, such as after having a stroke; and timely clinician-patient 
interactions are central for success. Fear of falling (FOF) is a psychological condition 
associated with excessive worrying about losing one’s balance. Individuals with fear of 
falling are occupied by negative emotions of fearful anticipation of falls, and physical harm 
that could occur. This leads to avoidance of engaging in day-to-day activities and adoption 
of overly cautious behaviors. Stroke patients are more likely to experience fear of falling 
compared to those without a stroke, with fear of falling reported among more than 50% 
stroke patients returning home after hospitalization. 
Lay Abstract: 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 we 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. 
All research personnel involved in the pilot study will have completed training in the 
intervention protocol. PI will be available for phone calls from research coordinators and 
other study personnel should any concerns for patient safety arise while interacting with 
patients over the course of this study. To minimize risks, all procedures will be performed in 
clinically stable patients who meet eligibility criteria for the pilot study and whose treating 
providers and/or clinic directors have given permission to be approached to participate in 
the evidence-based adherence intervention without requiring patient informed consent. 
Further risks specific to this study that will be addressed. Subjects will be assessed at each 
visit with a brief neurological history, blood pressure measurement, and NIH Stroke Scale 
(NIHSS). If a patient does report concerning symptoms with elevated blood pressure above 
180/110 or low blood pressures less than 80/50, their primary care and providers will be 
notified and the patient will be directed to the emergency department for clinical 
evaluation and advanced imaging, if clinically warranted. Breach of confidentiality is 
another potential risk, and secure data management strategies will be employed to prevent 
this. Participants will be excluded if they are at fall risk and have not been deemed to be 
safe to return home and ambulatory based on physical and occupational therapy 
evaluations in the hospital. 
They will also be assessed with Timed Up and Go test for balance, after they have been 
assessed for fall risk and deemed safe for discharge home. Potential risks will be mitigated 
as testers will be therapists skilled in these assessments to prevent falls. 
Improved physical activity: Patients may benefit from receiving the sessions to reduce fear 
of falling and may improve physical activity. This may help patients become more active 
and help with community reintegration. Patients may also benefit from the attention they 
receive from study personnel. Contributions to scientific/medical knowledge: While 
patients in this study may not directly benefit from their participation, we anticipate the 
results from this study will benefit future research seeking to identify strategies to optimize 
engagement of minor stroke patients into evidence-based behavioral interventions. The 
knowledge gained from this study will help us to better understand the strategies that are 
most effective at promoting engagement in behavioral interventions by minor stroke 
patients who are traditionally left to rehabilitate back into the community. In particular, we 
may learn that some theory-informed behavioral mechanisms of avoidance and related 

exposure therapy with task specific training as a potential intervention. message-framing 
strategies are more effective than others. We will also evaluate the feasibility of 
implementing this intervention for a future scaled intervention. 
Participants have the option of not participating or withdrawal form this research study at 
any time. 
Dr. Naqvi (study PI) will be responsible for ensuring subjects’ safety on a daily basis. Study 
PI will be immediately informed of unanticipated problems that may be related to the study 
protocol as soon as they occur, and will notify the CUIMC IRB, in compliance with their 
policies. The data safety and monitoring plan will include expedient reporting of 
unexpected and/or adverse events (i.e., within 48 hours of the research team’s knowledge) 
and a detailed plan to deal with adverse events that might arise during the conduct of the 
study with a step-by-step algorithm to deal with such events. The Data Safety Monitoring 
Plan for this study is approved by the National Institute on Aging (NIA). The study will also 
be monitored by an NIA approved Safety Officer at Columbia.