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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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. 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. 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.

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 data supports the effectiveness of the treatment CATCHES for stroke?

Research suggests that home-based occupational therapy can improve outcomes for stroke patients, and community health worker interventions have been shown to help manage stroke risk factors and support behavior change. These components are part of the CATCHES treatment, indicating potential effectiveness. ^{1 2 3 4 5}

Is home-based therapy for stroke safe for humans?

The studies involving community health workers and home-based interventions for stroke patients suggest that these approaches are generally safe, as they focus on improving patient outcomes and do not report any significant safety concerns. ^{1 3 4 6 7}

How is the CATCHES treatment for stroke different from other treatments?

CATCHES is unique because it combines task-specific and cognitive therapy with the support of a community health worker, all delivered at home, which is different from traditional hospital-based rehabilitation. This approach focuses on personalized activities and includes caregiver training, aiming to improve self-efficacy and adherence to therapy. ^{2 3 8 9 10}

Research Team

Imama A Naqvi, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Michigan Stroke Transitions Trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy Studies of Home-Based Occupational Therapy Services Following Stroke: A Scoping Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Occupational therapy predischarge home visits for patients with a stroke (HOVIS): results of a feasibility randomized controlled trial. [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

Secondary prevention of stroke by a primary health care approach: An open-label cluster randomised trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Switzerland 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Barriers to self-administered home-based task-oriented practice post-stroke: development and content validity of a new instrument. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Exploring the content of physiotherapeutic home-based stroke rehabilitation in New Zealand. [2016]

10. Sweden pubmed.ncbi.nlm.nih.gov

Intervention design for rehabilitation at home after stroke. A pilot feasibility study. [2006]