MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: MyPADMGT
* Device: MyPADMGT + Nudging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: MyPADMGT<br>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<br>* Online tracking and feedback to help patients adopt healthy lifestyles<br>|
| Experimental: MyPADMGT + Nudging<br>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<br>* Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions<br>|

What is the study measuring?
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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 |