MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

Overview

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

Full Title of Study: “My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2022

Interventions

  • Device: MyPADMGT
    • Online tracking and feedback to help patients adopt healthy lifestyles
  • Device: MyPADMGT + Nudging
    • Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions

Arms, Groups and Cohorts

  • No Intervention: Control
    • Usual care
  • Experimental: MyPADMGT
    • Online access to system, with ability to record and study progress with social interaction, diet, physical activity, smoking cessation, blood glucose, blood pressure and weight. Also access to educational content, journal recording, communication to others, setting target levels, contact support as needed.
  • Experimental: MyPADMGT + Nudging
    • Online access to system, with ability to record and study progress with social interaction, diet, physical activity, smoking cessation, blood glucose, blood pressure and weight. Also access to educational content, journal recording, communication to others, setting target levels, contact support as needed. In addition, nudging support available to help patients make better choices and decisions.

Clinical Trial Outcome Measures

Primary Measures

  • Systolic Blood Pressure
    • Time Frame: 1 Year
    • Reduction in systolic blood pressure measured in clinic by blood pressure cuff
  • EQ-5D-5L Quality of Life Visual Result
    • Time Frame: 1 Year
    • Increase in QoL Visual Result measured by questionnaire

Secondary Measures

  • Ankle Brachial Index
    • Time Frame: 1 year
    • Increase in ABI as measured in the clinic
  • Body Weight
    • Time Frame: 1 year
    • Reduction (or Increase) in Body Mass Index towards normal standard range
  • Social Isolation
    • Time Frame: 1 year
    • Increase in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire
  • Smoking Cessation
    • Time Frame: 1 year
    • Smoking Cessation by Smokers as self-reported by Smokers

Participating in This Clinical Trial

Inclusion Criteria

Any out-patients with Peripheral Arterial Disease (Ankle Brachial Index < 0.90) who attend the Hamilton General Hospital Outpatient Vascular Clinic. May be living alone or with one or more caregivers, and must have Internet access.

Exclusion Criteria

Age < 18 years; not diagnosed with PAD; unable to communicate in English; unwilling to participate; patients with dementia.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Stacey, MD, Principal Investigator, McMaster University
  • Overall Contact(s)
    • Norman P. Archer, PhD, 9055259140, archer@mcmaster.ca

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