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

Not Applicable

Recruiting

• Conditions: Stroke, Ischemic
• Interventions: Behavioral: CHAMPS-TR

• Registration Number: NCT06479174
• Lead Sponsor: University of New Mexico

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 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.

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-06-28
• Study Start: 2025-01-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. primary diagnosis of acute ischemic stroke,
2. impairment of cognitive function (score >1 on Quick Executive Interview - telephone screener),
3. absence of severe aphasia (score of 0 or 1 on NIH Stroke Scale),
4. absence of pre-stroke dementia (client report),
5. absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
6. absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
7. greater than 40 years of age,
8. having a potential family member who meets targeted family member criteria,
9. 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:

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

Exclusion Criteria

For all participants:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHAMPS-TR	CHAMPS-TR	Persons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training.
CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS)	CHAMPS-TR	Persons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training. Persons with stroke will also receive RS-tDCS.

Primary Outcome Measures

Name	Time	Method
American Heart Association Life's Essential 8 Metrics	baseline, up to 7 weeks, and up to 24 weeks	metric scores for vascular risk; score is calculated on a 0-100 scale where 100 is ideal
Cardiovascular risk factors, Aging, and Incidence of Dementia (CAIDE)	baseline, up to 7 weeks, and up to 24 weeks	Risk profile score for cognitive decline; score is composed of weightings by reference to age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity. Scores range from 0-15 with higher scores indicating greater risk.

Secondary Outcome Measures

Name	Time	Method
Number Span Test Forward and Backward	baseline and up to 24 weeks	Test of working memory; scored with number of correct trials (0-14), and longest span forward (0, 3-9) and longest span backward (0, 2-8). Higher numbers are greater number of correct items.
Mark VCID2 Clinical Cognitive Assessment Battery	baseline and up to 24 weeks	Test of cognitive impairment and dementia; total scores on all sub-scores for each included measure.
PROMIS Self-Efficacy for Managing Medications	baseline, up to 7 weeks, and up to 24 weeks	Test of self efficacy for managing medications; scoring with item-level calibrations using HealthMeasures Scoring Service
Multiple Errands Test Home Version	baseline and up to 24 weeks	Test of executive function impact on everyday life; total score of 0-14 with higher levels indicating less impairment; additional sub-scores for errors made and strategies used using total scores.
PROMIS Self-Efficacy for Managing Symptoms	baseline, up to 7 weeks, and up to 24 weeks	Test of self efficacy for managing symptoms; scoring with item-level calibrations using HealthMeasures Scoring Service
Oral Trail Making Test Part B	baseline and up to 24 weeks	Test of mental sequencing and switching; score with total number of seconds to complete up to 300, total number of errors, and total correct

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States