Online Support for Outpatient Peripheral Arterial Disease Self-management

Study Overview
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Brief Summary
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This study looks to examine whether an online patient tool to monitor factors affecting patients peripheral artery disease can lead to improvements in patients' disease and slow its progression.

Detailed Description
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The objective of this project is to implement a program involving a new online patient-centred approach to assist in peripheral arterial disease (PAD) self-management in home and work environments, in collaboration with patient circles of care (patients, care-givers, physicians, and allied healthcare professionals). This program involves online modules tailored to the needs of specific patients and diseases, oriented to education, training, monitoring, and continuing support for lifestyle changes (smoking cessation, exercise, healthy diets, weight loss, etc.) and psycho-social needs such as social isolation and loneliness. The investigators have tested an online desk-top version for over 30 out-patients with PAD at St. Michael's Hospital in Toronto. The investigators propose to test its ability for improved outcomes and healthcare quality of life through a multi-centre randomized controlled trial for PAD and a frequently co-occurring chronic illness, high blood pressure.

Official Title
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Online Support for Outpatient Peripheral Arterial Disease Self-management

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Other: Online Support Module
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years diagnosed with peripheral artery disease (ABI<0.9) Exclusion Criteria: unable to communicate in English unwilling to participate patients with dementia or other cognitive impairment

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single centre, randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Support Module<br>Patients in the online support module group will receive a tablet which has the developed peripheral arterial disease platform installed on it. The platform helps the patient to monitor factors related to their peripheral arterial disease such as exercise, smoking, and diet and helps them to track and modify these behaviours. | Other: Online Support Module<br>* The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease<br>|
| Active Comparator: Standard of Care<br>Patients in this arm will receive the standard of care as provided by the institution. | Other: Standard of Care<br>* The normal care that patients receive at the institution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle Brachial Index | The ankle brachial index will be measured to determine peripheral artery disease status and progression. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Patient blood pressure. | 1 year | 
| Health Related Quality of Life | Quality of life measured using the EuroQol-5D (EQ-5D). The EQ-5D provides a variety of health states which can then be converted to an index score ranging from 0-1.0, with 0 indicating a poorer health state and 1.0 representing a better health state. | 1 year | 
| Diabetes Status | Diabetes status measured by hemoglobin A1C | 1 year | 
| Vascular Health | Measured using LDL, HDL, and total cholesterol | 1 year |