Online Support for Outpatient Peripheral Arterial Disease Self-management

Not Applicable

• Conditions: Peripheral Artery Disease
• Interventions: Other: Standard of Care; Other: Online Support Module

• Registration Number: NCT03464006
• Lead Sponsor: McMaster University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-13
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15
• Study Start: 2018-07
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age greater than 18 years
• diagnosed with peripheral artery disease (ABI<0.9)

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Exclusion Criteria

• unable to communicate in English
• unwilling to participate
• patients with dementia or other cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Patients in this arm will receive the standard of care as provided by the institution.
Online Support Module	Online Support Module	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.

Primary Outcome Measures

Name	Time	Method
Ankle Brachial Index	1 year	The ankle brachial index will be measured to determine peripheral artery disease status and progression.

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life	1 year	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.
Diabetes Status	1 year	Diabetes status measured by hemoglobin A1C
Vascular Health	1 year	Measured using LDL, HDL, and total cholesterol
Blood Pressure	1 year	Patient blood pressure.