Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke (CHAMPS for Transgenerational Risk)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- American Heart Association Life's Essential 8 Metrics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •For all participants:
- •not English speaking, reading, and understanding, and
- •no access to video-conference software on a computer or smart device
研究组 & 干预措施
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.
干预措施: CHAMPS-TR (Behavioral)
CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS)
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.
干预措施: CHAMPS-TR (Behavioral)
结局指标
主要结局
American Heart Association Life's Essential 8 Metrics
时间窗: 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)
时间窗: 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.
次要结局
- Number Span Test Forward and Backward(baseline and up to 24 weeks)
- Mark VCID2 Clinical Cognitive Assessment Battery(baseline and up to 24 weeks)
- PROMIS Self-Efficacy for Managing Medications(baseline, up to 7 weeks, and up to 24 weeks)
- Multiple Errands Test Home Version(baseline and up to 24 weeks)
- PROMIS Self-Efficacy for Managing Symptoms(baseline, up to 7 weeks, and up to 24 weeks)
- Oral Trail Making Test Part B(baseline and up to 24 weeks)