跳至主要内容
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)

Loading locations...

相似试验

Nurse-led Educational Intervention on Heart Failure... | 临床试验