Cognitive Intervention to Improve Memory in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Change in serum brain derived neurotrophic factor ( BDNF) Level
研究概览
简要总结
Cognitive Intervention to Improve Memory in Heart Failure patients
详细描述
A three arm randomized controlled trial of 276 heart failure patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Understands English
- •Has access to a telephone
- •Hears normal conversation
- •For patients with hearing aids, able to wear and hear through headsets
- •Diagnosis of chronic heart failure, stage C, NYHA I, II or III
- •Receiving guideline derived medical therapy
- •Heart failure validated by echocardiography or other method in past 2 years
- •Able to read a computer screen with or without glasses or lenses
排除标准
- •History of drug or alcohol abuse or major psychiatric diagnosis present before the heart failure diagnosis
- •Alzheimer or other dementia diagnosis or central nervous system degenerative disorder
- •Terminal cancer
- •Patients with baseline Montreal Cognitive Assessment (MoCA) score of less than 19
- •Supplement Eligibility: First 144 patients randomized in the parent trial.
研究组 & 干预措施
Computerized Cognitive Training Brain HQ
Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks
干预措施: Computerized Cognitive Training with Brain HQ (Behavioral)
Computerized Crossword Puzzles
General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks
干预措施: Computerized Crossword Puzzles (Behavioral)
Usual Care
No computerized cognitive intervention
结局指标
主要结局
Change in serum brain derived neurotrophic factor ( BDNF) Level
时间窗: At 8 months
Co-Primary Outcome
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
时间窗: At 8 months
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
次要结局
- Change in working memory as measured by CogState One Back Accuracy Task(At 8 months)
- Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire(At 8 months)
- Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs(At 8 months)
- Change in instrumental activities of daily living as measured by Everyday Problems Test(At 8 months)
研究者
Susan Pressler
Principal Investigator
Indiana University