跳至主要内容
临床试验/NCT05773768
NCT05773768招募中不适用

EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2024年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,300
试验地点
1
主要终点
Identification and management of risk factors and comorbidities

研究概览

简要总结

In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.

研究设计

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

入排标准

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

入选标准

  • Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
  • ≥65 years of age
  • Willing and able to participate and to attend the scheduled follow-up visits.

排除标准

  • Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
  • Life expectancy of less than 1 year
  • Participation in another clinical study (registry studies not included)
  • Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)

结局指标

主要结局

Identification and management of risk factors and comorbidities

时间窗: 6 months

The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial.

次要结局

  • HRQoL/utility(6 months)
  • Referrals to other disciplines(6 months)
  • AF symptom burden(6 months)
  • Quality of life (QoL)(6 months)
  • Patient and health care provider satisfaction(6 months)
  • Healthcare resource use/costs(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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