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临床试验/NCT03035565
NCT03035565
已完成
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Cognitive Intervention to Improve Memory in Heart Failure Patients

Indiana University2 个研究点 分布在 1 个国家目标入组 276 人2017年2月22日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Heart Failure NYHA Class II
发起方
Indiana University
入组人数
276
试验地点
2
主要终点
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
状态
已完成
最后更新
3年前

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.

注册库
clinicaltrials.gov
开始日期
2017年2月22日
结束日期
2021年9月30日
最后更新
3年前
研究类型
Interventional
研究设计
Factorial
性别
All

研究者

责任方
Principal Investigator
主要研究者

Susan Pressler

Principal Investigator

Indiana University

入排标准

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.

结局指标

主要结局

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

Change in serum brain derived neurotrophic factor ( BDNF) Level

时间窗: At 8 months

Co-Primary Outcome

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)

研究点 (2)

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