Cognitive training and health coaching for stroke survivors and their families

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

This study is testing a new online program that helps stroke survivors and their family members improve brain health and reduce stroke risk through cognitive training and health coaching.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of New Mexico (Academic / other)
• Locations: 1 site (Albuquerque, New Mexico)
• Trial ID: NCT06479174 on ClinicalTrials.gov

What this trial studies

This study aims to test a virtually delivered cognitive strategy training and health coaching program designed to reduce vascular risk and enhance brain health in individuals who have experienced a stroke and their biological family members. The intervention, known as CHAMPS-TR, focuses on both the stroke survivor and a targeted family member who may be at risk for stroke and cognitive decline. By utilizing a remote format, the study seeks to overcome barriers to participation for those with mobility challenges. The program includes coaching on vascular risk reduction and a metacognitive problem-solving protocol to promote effective behavior change.

Who should consider this trial

Good fit: Ideal candidates include individuals over 40 years old who have experienced an acute ischemic stroke and have cognitive impairments, along with a biological family member who may also be at risk.

Not a fit: Patients with severe aphasia, pre-stroke dementia, or major psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce the risk of recurrent strokes and cognitive decline in both stroke survivors and their family members.

How similar studies have performed: While the approach of integrating family members into stroke recovery programs is gaining attention, this specific intervention is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Albuquerque, New Mexico

• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (Recruiting)

Study contacts

• Study coordinator: Suzanne Burns, PhD

Conditions Stroke, Ischemic; risk reduction; cognition; executive function; cardiometabolic conditions