NCT01076465已完成不适用
Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Hospital de Meixoeiro2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2009年10月1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
- 700
- 试验地点
- 2
- 主要终点
- Mortality or readmission
研究概览
简要总结
The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.
METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.
The DMP will be conducted by a case manager, and will include three main components:
- patient education to improve disease' knowledge and self-care
- monitoring of clinical status
- therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:75 y or older
- •Co-morbidity or dependency. At least one of the following criteria: Charlson index >3, dependency in 2 or more basic activities of daily living,treatment with 5 or more drugs, urgent hospitalization in the last 3 months, three or more diseases with active treatment, limitation in daily living because of vision or hearing impairment, cognition deficit, Parkinson disease, diabetes mellitus, chronic obstructive lung disease, severe anemia, constitutional syndrome
- •Hospital admission with a main diagnosis of heart failure (according to the criteria of the European Society of Cardiology or Framingham criteria) in NYHA functional class II-IV.
排除标准
- •Participation refusal
- •Terminal illness
- •Cognitive decline or severe cognitive deficit, which does not permit a minimum knowledge of the disease, or lack of carers which give consent to study participation
- •Clinical instability as assessed with the Kosecof index
- •Being in waiting list for organ transplant or cardiac surgery
- •Inability to be followed-up because of other reasons (change of place of residence,..)
- •Institutionalization
结局指标
主要结局
Mortality or readmission
时间窗: one year
次要结局
- Health related quality of life(one year)
研究者
Carlos RodrÃ-guez Pascual
MD, PhD
Hospital de Meixoeiro
研究点 (2)
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