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临床试验/NCT03464006
NCT03464006Unknown不适用

Online Support for Outpatient Peripheral Arterial Disease Self-management

McMaster University0 个研究点目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
Ankle Brachial Index

研究概览

简要总结

This study looks to examine whether an online patient tool to monitor factors affecting patients peripheral artery disease can lead to improvements in patients' disease and slow its progression.

详细描述

The objective of this project is to implement a program involving a new online patient-centred approach to assist in peripheral arterial disease (PAD) self-management in home and work environments, in collaboration with patient circles of care (patients, care-givers, physicians, and allied healthcare professionals). This program involves online modules tailored to the needs of specific patients and diseases, oriented to education, training, monitoring, and continuing support for lifestyle changes (smoking cessation, exercise, healthy diets, weight loss, etc.) and psycho-social needs such as social isolation and loneliness. The investigators have tested an online desk-top version for over 30 out-patients with PAD at St. Michael's Hospital in Toronto. The investigators propose to test its ability for improved outcomes and healthcare quality of life through a multi-centre randomized controlled trial for PAD and a frequently co-occurring chronic illness, high blood pressure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •Age greater than 18 years
  • •diagnosed with peripheral artery disease (ABI<0.9)

排除标准

  • •unable to communicate in English
  • •unwilling to participate
  • •patients with dementia or other cognitive impairment

研究组 & 干预措施

Online Support Module

Experimental

Patients in the online support module group will receive a tablet which has the developed peripheral arterial disease platform installed on it. The platform helps the patient to monitor factors related to their peripheral arterial disease such as exercise, smoking, and diet and helps them to track and modify these behaviours.

干预措施: Online Support Module (Other)

Standard of Care

Active Comparator

Patients in this arm will receive the standard of care as provided by the institution.

干预措施: Standard of Care (Other)

结局指标

主要结局

Ankle Brachial Index

时间窗: 1 year

The ankle brachial index will be measured to determine peripheral artery disease status and progression.

次要结局

  • Vascular Health(1 year)
  • Blood Pressure(1 year)
  • Health Related Quality of Life(1 year)
  • Diabetes Status(1 year)

研究者

申办方类型
Other
责任方
Sponsor

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