Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479174
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-14
Brief Title:
Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke CHAMPS for Transgenerational Risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
CHAMPS-TR
Brief Summary:
People living with the cognitive effects of stroke are at risk for recurrent stroke and further cognitive decline Also problematic is that stroke risk clusters in families and biological family members of people who have ischemic stroke may also be at increased risk of stroke andor cognitive decline The primary goal of this study is to test the feasibility of a virtually delivered cognitive strategy training and health coaching program to reduce vascular risk and promote brain health in persons with stroke and their biological family members
Detailed Description:
CHAMPS for Transgenerational Risk TR Cognitive strategies for optimizing brain Health And Managing transgenerational vascular risk factors Post-Stroke a feasibility trial for preventing stroke and improving cognitive outcomes in persons with stroke and their families Stroke is used as a vector to identify both persons with post-stroke cognitive impairment and dementia PSCIDand a targeted family member who may be at risk and could benefit from vascular risk reduction intervention The investigators integrate the concept of a teachable moment where health events can lead to behavior change by targeting family members who are stroke-free but may have vascular risk factors putting them at risk for stroke and vascular cognitive impairment VCI in the future Recognizing that people with stroke frequently encounter barriers to community mobility the proposed trial will be offered virtually to give even those with difficulty accessing the community an equitable opportunity to participate in clinical research
In this feasibility trial the investigators will pilot test the CHAMPS-TR intervention which includes vascular risk reduction coaching and a metacognitive problem-solving protocol which contains guided discovery goal setting and strategy training Index persons with stroke and targeted family members ie biological child younger sibling who may be at heightened risk for stroke and VCI will receive the CHAMPS intervention which will be delivered remotely Participants will be split into two arms and either receive the virtual CHAMPS-TR intervention or CHAMPS-TR intervention plus remotely-supervised transcranial Direct Current Stimulation RS-tDCS based on eligibility and preference tDCS is a minimally invasive brain stimulation technique that may augment the effects of cognitive interventions alone It has strong evidence in stroke rehabilitation and RS-tDCS is a feasible approach in those with stroke and other clinical populations The overarching goal of this project is to rigorously test the custom-tailored intervention for families impacted by ischemic stroke
In this feasibility trial the investigators will pilot test the CHAMPS-TR intervention which includes vascular risk reduction coaching and a metacognitive problem-solving protocol which contains guided discovery goal setting and strategy training Index persons with stroke and targeted family members ie biological child younger sibling who may be at heightened risk for stroke and VCI will receive the CHAMPS intervention which will be delivered remotely Participants will be split into two arms and either receive the virtual CHAMPS-TR intervention or CHAMPS-TR intervention plus remotely-supervised transcranial Direct Current Stimulation RS-tDCS based on eligibility and preference tDCS is a minimally invasive brain stimulation technique that may augment the effects of cognitive interventions alone It has strong evidence in stroke rehabilitation and RS-tDCS is a feasible approach in those with stroke and other clinical populations The overarching goal of this project is to rigorously test the custom-tailored intervention for families impacted by ischemic stroke
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