Online Support for Outpatient Peripheral Arterial Disease Self-management

Peripheral Artery Disease Clinical Trial

Official title:

Online Support for Outpatient Peripheral Arterial Disease Self-management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03464006
• Other study ID #: PAD Management
• Status: Not yet recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 14, 2018
• Start date: July 2018
• Est. completion date: June 2020

Study information

• Verified date: February 2018
• Source: McMaster University
• Contact: Steven Phillips, MSc
• Phone: 905-521-2100
• Email: phills3[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Online Support Module
The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease
• Standard of Care
The normal care that patients receive at the institution.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Reliq Health Technologies Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle Brachial Index	The ankle brachial index will be measured to determine peripheral artery disease status and progression.	1 year
Secondary	Blood Pressure	Patient blood pressure.	1 year
Secondary	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
Secondary	Diabetes Status	Diabetes status measured by hemoglobin A1C	1 year
Secondary	Vascular Health	Measured using LDL, HDL, and total cholesterol	1 year