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临床试验/NCT05096819
NCT05096819已完成不适用

Evaluation of the Usefulness of Adopting Remote, Mobile-based 6MWT Among Hospital Outpatients (the 6-APPnow), Within the Constraints Imposed by the SARS-COV2 Pandemic

Oxford University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2021年9月1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
67
试验地点
1
主要终点
Number of Patients Undertaking an App-based 6MWT

研究概览

简要总结

The six-minute walk test (6MWT) is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as pulmonary hypertension (PAH) and measures how far a patient can walk in 6 minutes. The test is usually performed in the hospital, by walking along a hospital corridor. Since the outbreak of SARS-CoV-2, there has been a need to minimise patient contact with hospitals and their staff to reduce transmission of the virus. In a previous research project called 6APP, the investigators designed, developed and evaluated a mobile phone app, to allow them to perform the 6MWT in the community. Given the current circumstances, cardiovascular outpatients including patients in the PAH clinic at Oxford University Hospitals are being recommended to use an app derived from that project to provide their 6MWT distance to the clinical team for assessment, in addition to their symptoms and general well-being. This is felt to be more appealing to the patients, and would reduce the time spent in hospital on the day of their outpatient appointment. The investigators plan to measure the usefulness of adopting remote, mobile-based 6MWT among hospital outpatients, within the constraints imposed by the SARS-COV2 pandemic.

详细描述

Context:

Since the outbreak of SARS-CoV-2, health care systems have been subject to increased pressures. This is mainly due to infected patients being admitted to the medical wards and intensive care units, but also due to the requirement to reduce exposure of both healthcare professionals and patients to COVID by minimising contact. There are indications that reduced access to healthcare services during the pandemic is responsible for more than half of excess deaths in the United States. In response to this, the CDC is advocating the use of telemedicine to keep providing a remote version of healthcare services. A study of telemedicine services in China used during COVID-19 pandemic showed that they reduced burden on hospitals, prevented overcrowding, reduced the risk of cross-infection, and relieved patients' anxiety. The use of telemedicine is also being developed in Europe, where many patients are being denied the use of clinical services, like cardiac rehabilitation, because of centres being closed. In the context of the NHS, an increased use of telemedicine services is being observed. The NHS long-term plans do, in fact, include tele-consultations as a pillar for its sustainability. Healthwatch have produced useful advice for outpatient clinicians to consider avoiding asking patients to attend physical outpatient appointments where a clinically-appropriate and accessible alternative exists. Where an appointment is clinically necessary, the national benchmark is that at least 25% could be conducted by telephone or video including 60% of all follow-up appointments. Initial promising results are being seen in the context of diabetes, where virtual clinics are recommended as mitigation to the pandemic.

The 6MWT:

To assess patient's exercise capacity, the six-minute walk test (6MWT) is a standard method used in patients with cardiopulmonary disease such as Heart Failure (HF) or Pulmonary arterial Hypertension (PAH). The 6MWT measures how far a patient can walk in 6 minutes. Walking is an activity performed every day, by most patients except for those most severely limited. By assessing patients' ability to exercise, the 6MWT provides a global assessment of respiratory, cardiovascular, neuromuscular and cognitive function. The 6MWT does not differentiate what limits the patient, nor does it assess maximal exercise capacity. Instead, the 6MWT allows the patient to exercise at a daily functional level, and is a useful tool for assessing changes after a therapeutic intervention, and correlates with a subjective improvement in dyspnoea.

In PAH the 6MWT is used to evaluate patients' response to treatment, with an increase in 6MWT distance of greater than 42 m being considered a clinically significant improvement . Furthermore, change in 6MWT distance correlates with VO2 max, NYHA class and mortality in those patients, providing an objective assessment of disease progression, prognosis and response to treatment. It is a universally accepted test as it is safe and easily performed by the patient.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Being enrolled in Oxford clinics
  • Owning or having access to a smartphone with either Android or iOS
  • Being able to use a smartphone app
  • Being able to walk

排除标准

  • Long term oxygen therapy
  • Cognitive impairments
  • Cannot use a smartphone
  • Pregnancy
  • Not able to complete a 6MWT
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

结局指标

主要结局

Number of Patients Undertaking an App-based 6MWT

时间窗: At 3, 6, 9 and 12 months after the start of the study

Percentage of participants who perform at least one app-based 6MWT per month before patient consultation

次要结局

  • Accuracy of the App-based 6MWT Distance Measurement(1 year)
  • Number and Percentage of Logged Events That Were Triggered by Variations in the App-based 6MWD(At 3, 6, 9 and 12 months after the start of the study)
  • Usability and Acceptance of the App(12 months)
  • Comparison of 6MWT During Pandemic and Pre-pandemic(2018 (12 months, retrospectively collected) and 2022 (12 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Orchard

Primary Investigator

Oxford University Hospitals NHS Trust

研究点 (1)

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