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临床试验/NCT05480969
NCT05480969已完成不适用

The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
2
主要终点
Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version

研究概览

简要总结

A randomized controlled study to examine the effect of a nurse-led, home/telephone or telephone-only educational intervention on outcomes of heart failure patients and their caregivers.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Men or women aged ≥18 years old.
  • Hospitalized for new-onset or decompensated chronic heart failure.

排除标准

  • Any severe neuromuscular disease or other disability or mobility problems that preclude performance of six-minute walk test.
  • Any severe cognitive dysfunction or psychiatric disease that limit ability to receive education.
  • Patients unable to be contacted by phone or other means.

结局指标

主要结局

Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version

时间窗: Baseline, 6 months

次要结局

  • Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6(Baseline, month 6)
  • Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6(Baseline, month 6)
  • Change in the EuroQol Health-Related Quality of Life Questionnaire EQ-5D three-level version (EQ-5D-3L) (Greek version) from baseline to month 6(Baseline, month 6)
  • Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6(Baseline, month 6)
  • Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6(Baseline, month 6)
  • Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6(Baseline, month 6)
  • Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6(Baseline, month 6)
  • Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6(Baseline, month 6)
  • Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6(Baseline, month 6)
  • Time to the first occurrence of a composite of all-cause death or heart failure hospitalization(Time from randomization to first occurrence (up to 6 months))
  • Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6(Baseline, month 6)

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Thodi

Registered Nurse

Attikon Hospital

研究点 (2)

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