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临床试验/NCT04162548
NCT04162548已完成不适用

Reaching the Frail Elderly for the Management of Atrial Fibrillation

University Hospital Bispebjerg and Frederiksberg1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2020年3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
344
试验地点
1
主要终点
Time to diagnosis conclusion

研究概览

简要总结

The overall objective of the project is to develop a collaboration model between the patient, the patient's General Practitioner (GP) and the cardiologist at the hospital in a seamless collaborative model dubbed the "Cardio-relay model".

The specific purpose of the pilot project is to ease performing heart rhythm monitoring with focus on diagnosis and evaluation of atrial fibrillation (AF), for patients who have difficulties to attend repeated visits to the hospital-based outpatient clinic.

With available eHealth technologies the cardiologist can access data gathered at the patient's side to provide support to the GP for selecting patients with need for heart rhythm monitoring, plan further evaluations and guide therapeutic decisions. These patients can thereby receive support that without the burden of attending physical meetings at the cardiologist office. The investigators evaluate if the cardio-relay model allows to complete evaluation of frail patients compared to usual care and if patients experience are sufficiently confident accessing the cardiologist through the cardio-relay model.

详细描述

Hypothesis Our overall hypothesis is, that using the cardio-relay model it is possible to provide adequate treatment to frail patients that have difficulties to attend repeated visits at the hospital-based cardiologist office.

Our concrete hypothesis is that a larger number of frail patients reaches adequate treatment with the cardio-relay model compared with conventional treatment and the patient remains confident with the distant support by the cardiologist.

METHODS This is a pragmatic clinical trial that uses mixed methods in different stages of the project to test this hypothesis. Observational during the initial feasibility period, an open-label cluster-randomization trial and an iterative implementation period.

Phase 1 - Feasibility During this phase, a single GP clinic is used to establish the elements that permit to establish the cardio-relay model. Hence, a field study is required to initiate the study.

Subsequently, the first of such elements in the cardio-relay model is a text exchange initiated by the GP addressing a request to the cardiologist to assess the need for heart rhythm monitoring. This is a replacement of usual referral when the cardiologist is expected to plan an appointment for the patient In the cardiology outpatient clinic or reject the referral. In the cardio-relay model, through a text exchange. The GP may require further examinations and add eventual results available in the hospital electronic records from previous contacts. The GP, the cardiologist and the patient (welcoming help from relatives and carers) can then agree on need for heart rhythm monitoring. The GP has available compact Holter sensors, C3+, from Cortrium ApS and can immediately initiate recordings at their office or at the patient's home. The duration of the recording is 24 hours as standard, but can agreed to prolong or repeat between the GP, the cardiologist and the patient. C3+ has memory for continuous electrocardiogram recording and built-in accelerometer, for up to three weeks and battery capacity for one weeks. The finalized recordings can be uploaded to the cloud by the GP and the cardiologist provides the GP with a result of the recording and a proposal for treatment according to the findings or further evaluation, which continuous the dialogue across the sectors

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • "Frail elderly" are aged ≥ 65 years
  • Non-frail adults (> 18 years old)

排除标准

  • Not willingness to participate

结局指标

主要结局

Time to diagnosis conclusion

时间窗: six months follow-up

Completion of evaluation for definite or rule-out diagnosis within six weeks in 90% of patients included in the intervention arm compared to 70% within six weeks

次要结局

  • Identification of population that benefits with the cardio-relay model(six months follow-up)

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena DOMINGUEZ

MD, PhD, Associate Professor

University Hospital Bispebjerg and Frederiksberg

研究点 (1)

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