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临床试验/NCT04371731
NCT04371731已完成不适用

A Single-centre Research Study to Evaluate the Impact of a Novel Care Pathway for Patients Diagnosed With Heart Failure (HF) Within Chiltern CCG, Supported by an Integrated Clinical Patient Record. Assessment of Patient Outcomes Following Implementation of Care4Today® Heart Failure Platform.

Buckinghamshire Healthcare NHS Trust0 个研究点目标入组 182 人开始时间: 2015年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
主要终点
Hospital admissions

研究概览

简要总结

A research study to evaluate the impact of a novel care pathway for patients diagnosed with Heart Failure within Chiltern CCG, supported by an integrated clinical patient record. Assessment of patient outcomes following implementation of Care4Today(R) Heart Failure Platform.

详细描述

This is an exploratory study to evaluate the impact of the novel Care4Today HF platform on a set of outcomes including hospital admission rate (primary diagnosis), 30 days post discharge readmission rate, length of hospital stay for patients with HF (primary and secondary diagnosis), patient quality of life, and patient clinical metrics. The study design includes comparison of two parallel cohorts: one where patients will be managed via the Care4Today HF platform (active cohort) and a second, where patients will be managed as per existing standards of care (control cohort).

Evaluation phase:

The evaluation phase will be set up to assess the potential benefits of the Care4Today HF platform. This will be implemented across 10 GP practices who will be part of the active cohort, within the Chiltern CCG region. The outcomes for these patients will be compared with the outcomes of patients in the control cohort over a one year period.

Patients pathway (for the active cohort):

Once the diagnosis of HF is confirmed, a HF specialist project nurse will register the patient on the Care4Today platform and provide the patient with instructions on how to use the patient portal, where patients can input various clinical measures, communicate with HCPs and track their condition. Complex patients, and/or patients that are deteriorating are referred to the community HF specialist nurse team where they will be monitored and managed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Adults 18 years of age or older with the primary diagnosis of heart failure
  • Must have moderate to severe LVSD (ejection fraction <= 40%) confirmed by an echocardiogram and/or other cardiac imaging

排除标准

  • Patients with right heart failure as a consequence of respiratory disease
  • Patients with Heart Failure with preserved Ejection Fraction
  • Patients with significant learning disability, or severe mental health conditions
  • Patients with metabolic heart disease e.g. amyloid
  • Patients with severe non-operable valve disease

结局指标

主要结局

Hospital admissions

时间窗: 12 months

number of hospital admissions

次要结局

  • QOL(12 months)
  • mean number of heart failure readmissions within 30 days of discharge(30 days of discharge)
  • length of stay(12 months)
  • weight change(12 months)
  • all cause readmissions(12 months)
  • Blood pressure(12 months)
  • Hospital Anxiety and Depression Scale score(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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