Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314308
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-03-11
Brief Title:
Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATCHES
Brief 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 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P30AG064198-05 | NIH | None | httpsreporternihgovquickSearch5P30AG064198-05 |