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

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

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: MyPADMGT; Device: MyPADMGT + Nudging

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3Z5
      • General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: MyPADMGT; Online tracking and feedback to help patients adopt healthy lifestyles
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.	Device: MyPADMGT + Nudging; Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Change in systolic blood pressure measured in clinic by blood pressure cuff	1 Year
EQ-5D-5L Quality of Life Visual Result	Change in QoL Visual Result measured by questionnaire. Min = 0, Max = 100. Higher outcome scores are better	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Brachial Index	Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better	1 year
Body Weight	Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9	1 year
Social Isolation	Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better	1 year
Smoking Cessation	Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better	1 year

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Michael Stacey, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 8108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No