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临床试验/NCT05492526
NCT05492526已完成不适用

Using Body Data for the Purpose of Contextualised Feedback to Enable Established Physical Activity Guidelines to be Delivered in a Free- Living Environment as Part of a Comprehensive Cardiac Rehabilitation Programme.

Liverpool University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor

研究概览

简要总结

KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.

详细描述

Cardiac rehabilitation (CR) after a heart attack has shown to be more effective than any other medication given after such an event. It is a recommended therapy by NICE. However, only 44% of eligible patients attend rehabilitation and only half of these complete the course. Novel ways to increase uptake and compliance are needed.

In this study, calorie burn and physical activity data will be collected using a validated, CE marked physical activity monitor, herein referred to as Ki monitor. Data can be uploaded to an online behaviour change platform that incorporates personalised feedback in the context of their bespoke requirements for CR to empower people to self-care at home using their personal everyday physical activity. This can be closely monitored and support can be given on the contextualised feedback by healthcare professionals. A small pilot study has been carried out to establish wearability of a physical activity monitor in a CR cohort, which has demonstrated a high level of acceptability.

We now wish to extend this pilot to a randomised study designed to test the effectiveness of using contextualised body data to influence physical activity in a free-living environment amongst patients undergoing CR, based on the current ACPICR standards for Daily Activity and At-home Training. All patients referred for CR will be invited to take part. These will be randomised to the usual care (UC) group or the contextualised data feedback (CDF) group. Both groups will wear the Ki monitor for eight weeks. The UC group will receive usual care, the CDF group will receive usual care with the addition of contextualised feedback on their activities based on the physical activity data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All patients referred to the cardiac rehab programme will be invited to take part in the study.

排除标准

  • •Individuals using a pacemaker or other internal medical device.
  • •Unable to access a computer or tablet with internet access to view the online platform.
  • •Unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor.
  • •Unwillingness to take part.

研究组 & 干预措施

Usual Cardiac Rehabilitation

Other

Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period.

干预措施: Ki Monitor without feedback (Device)

Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback

Experimental

Patient receives usual care and also wears Ki monitor and receives contextualised data feedback

干预措施: Ki monitor with contextualised data feedback (Device)

结局指标

主要结局

Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor

时间窗: 6 - 8 weeks

Objective measurement using Ki monitor.

次要结局

  • Total calories burned(6-8 weeks)
  • Completion of cardiac rehabilitation programme(6-8 weeks)
  • Exercise test result.(6-8 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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