Online Support for Outpatient Peripheral Arterial Disease Self-management
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 15, 2018
February 1, 2018
1.9 years
March 7, 2018
March 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Ankle Brachial Index
The ankle brachial index will be measured to determine peripheral artery disease status and progression.
1 year
Secondary Outcomes (4)
Blood Pressure
1 year
Health Related Quality of Life
1 year
Diabetes Status
1 year
Vascular Health
1 year
Study Arms (2)
Online Support Module
EXPERIMENTALPatients 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.
Standard of Care
ACTIVE COMPARATORPatients in this arm will receive the standard of care as provided by the institution.
Interventions
The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- diagnosed with peripheral artery disease (ABI\<0.9)
You may not qualify if:
- unable to communicate in English
- unwilling to participate
- patients with dementia or other cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Reliq Health Technologies Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael C Stacey, DS
McMast
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 13, 2018
Study Start
July 1, 2018
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
March 15, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share patient level data.