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临床试验/NCT04228549
NCT04228549终止不适用

My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease

McMaster University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
126
试验地点
2
主要终点
EQ-5D-5L Quality of Life Visual Result

研究概览

简要总结

The investigators have developed an online program to help people with peripheral arterial disease (PAD) in their extremities to better self-manage their condition. Some earlier testing has been done and the investigators now wish to try this system with participants who have this blood vessel disease as well as high blood pressure. Investigators are hoping to help these participants to achieve healthier lifestyles and improve their quality of life through education, monitoring and continuing support. A similar online desk-top version with over 30 participants has been tested at St. Michael's Hospital in Toronto. The investigators propose to test this newer mobile system with 210 outpatient participants from Hamilton General Hospital. Data collected will be analyzed following the (12 months for each participant) study, along with data recorded during clinical visits at baseline and twelve months for each participant. The objective is to evaluate changes to participant health and determine whether the health self-management process has been successful in improving participant lifestyles and quality of life, when compared to usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Out-patients with Peripheral Arterial Disease (Ankle Brachial Index < 0.90)
  • Attending the Hamilton General Hospital Outpatient Vascular Clinic
  • May be living alone or with one or more caregivers
  • Must have Internet access.

排除标准

  • Age < 18 years
  • Not diagnosed with PAD
  • Unable to communicate in English
  • Unwilling to participate
  • Patients with dementia.

结局指标

主要结局

EQ-5D-5L Quality of Life Visual Result

时间窗: 1 Year

Change in QoL Visual Result measured by questionnaire. Min = 0, Max = 100. Higher outcome scores are better

Systolic Blood Pressure

时间窗: 1 Year

Change in systolic blood pressure measured in clinic by blood pressure cuff

次要结局

  • Body Weight(1 year)
  • Smoking Cessation(1 year)
  • Ankle Brachial Index(1 year)
  • Social Isolation(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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