Online Support for Outpatient Peripheral Arterial Disease Self-management

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Other: Online Support Module; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Online Support Module; The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease
Active Comparator: Standard of Care; Patients in this arm will receive the standard of care as provided by the institution.	Other: Standard of Care; The normal care that patients receive at the institution.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Reliq Health Technologies Inc.
• Investigators: Principal Investigator: Michael C Stacey, DS, McMast

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: February 1, 2018

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: PAD Management

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share patient level data.

Drug and device information, study documents

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