Cognitive Training in Heart Failure Study (CogTrain-HF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Training effects
研究概览
简要总结
The daily routine in clinical settings often showed cognitive impairments in patients with congestive heart failure, particularly in terms of executive functions, episodic memory, perceptual speed and attention. It is assumed that cognitive impairments in patients with congestive heart failure may lead to deficits in medication-adherence and self-care abilities, resulting in increased healthcare costs. Recent studies reported performance improvements after cognitive training that transferred to new, untrained tasks and abilities in healthy subjects across a wide range of ages. This study investigates the effects of cognitive training in patients with congestive heart failure.
详细描述
Cognitive functions of patients with congestive heart failure (NYHA II-III) before (pretest) and after (posttest) cognitive-training intervention are investigated. Changes in cognitive functions are compared to changes in two control groups: 1) age and gender matched active control group 2) age and gender matched passive waiting list control group.
The neuropsychological test battery applied at pretest and posttest includes measures of episodic memory, working memory, short-term memory, executive functions, perceptual speed and intelligence. In addition, the investigators apply standardized questionnaires of self-assessed quality of life, cognitive functioning in daily life, selfcare, and psychological well-being (depression, anxiety and personality). Relevant physiological data such as ejection fraction, heartrate, N-terminal pro brain natriuretic peptide (NT-pro-BNP) as well as drug blood level are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants were enrolled in Treatment-Group, Waitinglist-Group, or Shamtraining-Group
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congestive heart failure
- •NYHA II-III
排除标准
- •Psychosis
- •Major depression
- •Reanimation (<3month)
- •Patients with assist device system
研究组 & 干预措施
Experimental group
Intervention: Cognitive Training
干预措施: Cognitive training (Behavioral)
Active control group
Intervention: Test of general knowledge
干预措施: Test of general knowledge (Behavioral)
Passive control group
No intervention
结局指标
主要结局
Training effects
时间窗: 3 weeks
Improvement in performance in the last trainingssession compared with the performance in the first trainingssession. Performance will be assessed by computesoftware.
次要结局
- Transfer effects(5 weeks)
- Changes in quality of life and psychological well-being(5 weeks)
- Long-term benefits of cognitive training in patients with congestive heart failure.(6 month)
- Compliance with medication(5 weeks)
研究者
Sonja Wedegärtner
Dipl. Psych.
Universität des Saarlandes