Home-Based Therapy for Stroke

(CATCHES Trial)

Overseen By Imama A Naqvi, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Severe stroke, Legal blindness, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home-based therapy called CATCHES (Community Health Worker Assisted Task Specific and Cognitive Therapy At Home with Exposure After Stroke) to boost stroke patients' confidence in their balance and reduce their fear of falling. It combines physical exercises and sessions led by a Community Health Worker, with support from a Physical Therapist and a psychologist via telehealth. The goal is to determine if this approach helps patients remain active after a stroke. Individuals who have experienced a stroke, plan to return home after recovery, and feel uncertain about their balance may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative therapy methods in a supportive home environment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CATCHES intervention is safe for stroke patients?

Research shows that the treatment being tested, called CATCHES, is a new method for assisting stroke survivors. It combines task-focused exercises with support from community health workers, all under the guidance of a physical therapist. Additionally, it includes cognitive behavioral therapy (CBT) provided through telehealth to address fears about movement.

Regarding safety, researchers have studied the individual components of this treatment separately. For example, task-specific training, which involves practicing a movement repeatedly, is generally safe and well-tolerated. Studies have shown that CBT delivered through telehealth can effectively manage anxiety without major safety concerns.

While the CATCHES approach as a whole is still in early testing, previous research has shown the techniques it uses to be safe. No major negative effects have been reported with these methods in other settings. Since this trial is in an early phase, it focuses on the practicality of the approach rather than confirming long-term safety. However, the individual components have a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CATCHES treatment for stroke recovery because it combines Task-Specific Training (TST) with Cognitive Behavioral Therapy (CBT) in a home-based setting. Unlike standard stroke rehabilitation therapies that typically focus on either physical or psychological aspects separately, CATCHES integrates both, allowing for a more holistic approach to recovery. TST emphasizes active, repeated practice of meaningful motor skills, while CBT with exposure helps modify thoughts and behaviors related to stroke recovery. This dual approach has the potential to enhance both physical rehabilitation and mental resilience, which could lead to more comprehensive and effective recovery outcomes for stroke patients.

What evidence suggests that the CATCHES intervention is effective for reducing fear of falling in stroke patients?

Research has shown that home therapy can aid stroke recovery. In this trial, participants will engage in Task Specific Training (TST), which involves practicing key movements to enhance physical skills. Additionally, Cognitive Behavioral Therapy (CBT), a component of the CATCHES program, helps reduce the fear of falling by safely addressing this fear. Studies have found that similar home rehab programs benefit stroke survivors. By combining these methods, CATCHES aims to boost confidence and physical activity in patients after a stroke. ^{1 2 3 4 6}

Who Is on the Research Team?

Imama A Naqvi, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals who have had an ischemic stroke and are dealing with fear of falling. Participants should be in a post-acute phase, returning home, and living in an underserved urban area. The study aims to help them engage more in physical activities.

Inclusion Criteria

I feel unsure about my balance in daily activities.

Plan for discharge home after stroke and ability to provide consent

I am over 18 years old.

Exclusion Criteria

Terminal non-cardiovascular illness (life expectancy < 1 year)

Unavailable for follow-up

Legal blindness precluding ability to view infographic or education materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial assessment by a physical therapist to tailor the Task Specific Training

1 week

1 visit (in-person)

Treatment

Task Specific Training and Cognitive Behavioral Therapy with exposure provided over 5 sessions

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in physical function and fear of falling

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CATCHES

Trial Overview The CATCHES program combines Task Specific Therapy at home led by Community Health Workers under a Physical Therapist's guidance, with Cognitive Behavioral Therapy via telehealth to address fears through exposure and behavior strategies.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The study involving 265 acute stroke patients found that combining home-based social worker-led case management with a website offering stroke-related information significantly improved physical health and patient activation compared to usual care or case management alone.

While the intervention showed positive effects on physical health and activation, it did not demonstrate any significant impact on mental health outcomes, indicating that additional support may be needed for mental well-being in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Michigan Stroke Transitions Trial. Reeves, MJ., Fritz, MC., Woodward, AT., et al.[2020]

Community health workers (ASHAs) successfully identified 85.23% of first-ever stroke patients in rural Ludhiana, demonstrating their feasibility in stroke surveillance and care pathways.

Despite a significant number of patients reaching healthcare facilities within the critical time window for treatment, none received thrombolysis, highlighting the need for improvements in the healthcare system to provide timely acute stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rural Stroke Surveillance and Establishment of Acute Stroke Care Pathway Using Frontline Health Workers in Rural Northwest India: The Ludhiana Experience. Singh, S., Kate, M., Samuel, C., et al.[2021]

A tailored community health worker (CHW) intervention significantly improved posthospital outcomes for low-socioeconomic status patients, increasing timely primary care follow-up from 47.9% to 60.0% and enhancing the quality of discharge communication.

The intervention also led to better mental health improvements and patient activation, while reducing the likelihood of multiple 30-day readmissions, indicating that CHWs can effectively address socioeconomic and behavioral factors affecting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. Kangovi, S., Mitra, N., Grande, D., et al.[2018]

A randomized controlled trial involving 126 stroke patients assessed the feasibility of conducting predischarge home visits by occupational therapists, with 90% of participants receiving the intervention.

While the study found no significant differences in daily living activities between those who received home visits and those who had structured hospital interviews, the high follow-up rate and resource implications suggest that further trials are justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy predischarge home visits for patients with a stroke (HOVIS): results of a feasibility randomized controlled trial. Drummond, AE., Whitehead, P., Fellows, K., et al.[2022]

A new instrument called BASH-TOP-Stroke was developed to identify barriers faced by individuals post-stroke in self-administering home-based rehabilitation tasks, based on input from stroke survivors and rehabilitation professionals.

The final version of the instrument contains 34 items with excellent content validity, ensuring it effectively captures relevant barriers to rehabilitation practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to self-administered home-based task-oriented practice post-stroke: development and content validity of a new instrument. Nascimento, JRT., Juncks, GN., Rodrigues, LC., et al.[2023]

Physiotherapists in New Zealand focus on helping stroke patients regain independence and confidence at home, addressing emotional challenges like fatigue and depression after discharge.

The effectiveness of home-based stroke rehabilitation is primarily measured by achieving personalized patient goals rather than relying solely on standardized outcome measures, highlighting the importance of individualized care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the content of physiotherapeutic home-based stroke rehabilitation in New Zealand. Hale, LA., Piggot, J.[2016]

Home-based rehabilitation for acute stroke patients can be a feasible alternative to prolonged hospital rehabilitation, as shown in a study of 16 patients with a mean age of 68.2 years, who were discharged early after an average hospital stay of 14 days.

The rehabilitation program included personalized task-specific activities and support for spouses, leading to improvements in lifestyle activities and motor capacity over 3, 6, and 12 months, similar to outcomes seen in traditional rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention design for rehabilitation at home after stroke. A pilot feasibility study. Widén Holmqvist, L., de Pedro-Cuesta, J., Holm, M., et al.[2006]

In a study of 93 stroke patients receiving home and community-based care in rural South Africa, significant functional improvement was observed, with the Barthel Index score increasing from 40.0 to 62.5, although many patients remained dependent on caregivers.

Despite some improvement, both patient and caregiver satisfaction with the home care services were low, with only 17.4% of patients and 46.9% of caregivers satisfied, highlighting the need for better training for community health workers and improved support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surviving a stroke in South Africa: outcomes of home-based care in a low-resource rural setting. Scheffler, E., Mash, R.[2020]

Home-based occupational therapy interventions for adults post-stroke show potential benefits in improving patient outcomes, although the number of efficacy studies is limited.

Current research lacks sufficient use of occupation-based assessments and methodologies, indicating a need for improved study designs and more high-quality research to better evaluate the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy Studies of Home-Based Occupational Therapy Services Following Stroke: A Scoping Review. Zachry, AH., Williams, L., Chen, M., et al.[2023]

A Community Health Worker (CHW)-based educational intervention significantly helped stroke survivors quit smokeless tobacco, with all participants in the intervention arm quitting by the 6-month follow-up, compared to only one relapse in the control group.

The intervention improved the quality of health education provided by CHWs, demonstrating that such programs are feasible and effective for secondary stroke prevention in resource-limited settings, although control of hypertension and diabetes did not show significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention of stroke by a primary health care approach: An open-label cluster randomised trial. Sylaja, PN., Singh, G., Sivasambath, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06314308

Community Health Worker Assisted Task Specific and ... CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of ...

2. dev-multi-sponsor-trials.xogene.com dev-multi-sponsor-trials.xogene.com/trials/6314308

AAAU8161 - GoodDay - Xogene CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11915546/

Virtually assisted home rehabilitation after acute stroke ... The objective of Virtually Assisted home rehabilitation after acute STroke was to offer a fully remote telerehabilitation intervention to stroke survivors.

4. tandfonline.com tandfonline.com/doi/full/10.1080/10833196.2023.2180710

Stroke survivor, caregiver and therapist experiences of ... This study aimed to explore what factors influence the experiences of stroke survivors, caregivers and therapists participating in home-based rehabilitation.

5. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000471

Nursing's Role in Psychosocial Health Management After a ... This scientific statement aims to evaluate 5 important aspects of psychosocial health (depression, stress, anxiety, fatigue, and quality of life) after a ...

6. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.029042

Telemedicine Cognitive Behavioral Therapy for Anxiety ... We developed a telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT) for anxiety after stroke (TASK-CBT).