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Clinical Trials/NCT04228549
NCT04228549
Terminated
Not Applicable

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

McMaster University1 site in 1 country126 target enrollmentFebruary 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
McMaster University
Enrollment
126
Locations
1
Primary Endpoint
EQ-5D-5L Quality of Life Visual Result
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 24, 2021
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 Year

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

Systolic Blood Pressure

Time Frame: 1 Year

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

Secondary Outcomes

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

Study Sites (1)

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