Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
研究概览
简要总结
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
详细描述
Stable outpatients patients with co-morbid heart failure (HF) and mild cognitive impairment (MCI) (n=176) will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.
This study has the following objectives:
- To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
- To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
- To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will not be masked to intervention allocation. The PI, the co-investigators, and personnel responsible for data management and analysis will be blinded to participants' exposure status.
Unblinded personnel will include the PD, the RA, and the MT instructors. Blinding the PD would be impossible given that she will be responsible for randomization and AEs monitoring.
The RA will be responsible for data collection and will not be blinded. We note, however, that study participants will independently perform all assessments via computer interface with no RA involvement.
The mindfulness instructors will be aware of the allocation status of the participants but will remain masked to the study hypotheses.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •A documented diagnosis of HF
- •Access to a telephone
- •Mild cognitive impairment (MoCA score < = 26)
- •Ability to understand and speak English or Spanish
排除标准
- •Unwillingness/inability to provide informed consent
- •Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
- •Severe hearing impairment not allowing phone delivery
- •Suicidal ideation or plan
- •Current (at least once a month) mind/body practice
- •Planning to move out of the area during the study period
- •Severe cognitive impairment (MoCA scores < 15)
- •New York Heart Association (NYHA) class IV heart failure or clinically unstable
- •Ongoing psychiatric or neurologic conditions
- •Current enrollment in another study
研究组 & 干预措施
Enhanced Usual Care alone
Usual care.
干预措施: Enhanced Usual Care (Other)
Mindful Training + Enhanced Usual Care
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
干预措施: Mindfulness Training + Enhanced Usual Care (Behavioral)
结局指标
主要结局
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
时间窗: Baseline, 3 months, 9 months
The NIH Toolbox is comprised of seven cognitive tests, of which two measure crystallized cognitive ability (i.e., vocabulary and reading) and five tests measure fluid cognitive functioning (i.e., working memory, memory, speed of processing, and executive function). The fluid cognition composite score is obtained by averaging the normalized scores of the Fluid Cognition measures. Higher scores indicate higher levels of functioning. A score \~ 100 indicates average fluid cognitive ability compared with others nationally. Scores \~115 suggest above-average ability, while scores \~130 suggest superior ability. Conversely, a score in the range of 85 suggests below-average ability, and a score \~ 70 or below suggests significant impairment.
次要结局
- Change in average 6-min walk test (6MWT) distance.(Baseline, 3 months, 9 months)
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.(Baseline, 3 months, 9 months)
- Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.(Baseline, 3 months, 9 months)
- Change in average Heart Failure (HF) Self-Care total scores.(Baseline, 3 months, 9 months)
- Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).(Baseline, 3 months, 9 months)
- Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.(Baseline, 3 months, 9 months)
- Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.(Baseline, 3 months, 9 months)
研究者
Elena Salmoirago-Blotcher
Senior Research Scientist
The Miriam Hospital