Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEMyPADMGT
Online tracking and feedback to help patients adopt healthy lifestyles
DEVICEMyPADMGT + Nudging
Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 1 Year | Change in systolic blood pressure measured in clinic by blood pressure cuff |
| EQ-5D-5L Quality of Life Visual Result | 1 Year | Change in QoL Visual Result measured by questionnaire. Min = 0, Max = 100. Higher outcome scores are better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Brachial Index | 1 year | Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better |
| Body Weight | 1 year | Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9 |
| Social Isolation | 1 year | Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better |
| Smoking Cessation | 1 year | Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better |
Countries
Canada
Outcome results
None listed