Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke

Official title

Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke (CHAMPS for Transgenerational Risk)

Overview

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 and/or 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 (PSCID)and 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 (i.e., 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.

Interventions

• Behavioral CHAMPS-TR
  Persons with stroke ( n=20) and at least 1 targeted family member (TFM) (n=20) will engage with the CHAMPS-TR protocol which involves 10 virtual intervention sessions (bi-weekly for 5 weeks) with key elements including metacognitive problem-solving training (i.e., goal setting, guided discovery, strategy development) and vascular risk reduction coaching building on existing American Heart Association (AHA) LE8 content. Probands that are eligible for RS-tDCS (n=10) will receive 5x weekly (weeks 2

Primary outcome measures

• American Heart Association Life's Essential 8 Metrics [Time frame: baseline, up to 7 weeks, and up to 24 weeks]
• Cardiovascular risk factors, Aging, and Incidence of Dementia (CAIDE) [Time frame: baseline, up to 7 weeks, and up to 24 weeks]

Secondary outcome measures (6)

• Oral Trail Making Test Part B [Time frame: baseline and up to 24 weeks]
• Number Span Test Forward and Backward [Time frame: baseline and up to 24 weeks]
• Multiple Errands Test Home Version [Time frame: baseline and up to 24 weeks]
• Mark VCID2 Clinical Cognitive Assessment Battery [Time frame: baseline and up to 24 weeks]
• PROMIS Self-Efficacy for Managing Medications [Time frame: baseline, up to 7 weeks, and up to 24 weeks]
• PROMIS Self-Efficacy for Managing Symptoms [Time frame: baseline, up to 7 weeks, and up to 24 weeks]

Eligibility criteria

Inclusion criteria

• primary diagnosis of acute ischemic stroke,
• impairment of cognitive function (score >1 on Quick Executive Interview - telephone screener),
• absence of severe aphasia (score of 0 or 1 on NIH Stroke Scale),
• absence of pre-stroke dementia (client report),
• absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
• absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
• greater than 40 years of age,
• having a potential family member who meets targeted family member criteria,
• eligible for MRI and Remote Supervised-transcranial direct current stimulation (RS-tDCS) if in CHAMPS-TR plus RS-tDCS (e.g., not pregnant; no intracranial metal implants; no skin lesions on target sites for stimulation; no severe cardiopulmonary, renal or hepatic diseases; no pacemakers; no underlying medical reason for not engaging in MRI or tDCS).

The targeted family member will be:

• a minimum of 18 years of age,
• biological kin of person with stroke,
• absence of dementia (client report),
• absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
• absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
• greater than 18 years of age, and
• having a sibling or parent who had an ischemic stroke

Exclusion criteria

For all participants:

• not English speaking, reading, and understanding, and
• no access to video-conference software on a computer or smart device

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of New Mexico Health Sciences Center — Albuquerque

Identifiers

NCT: NCT06479174 · HRRCID 23-332

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗