Online Support for Outpatient Peripheral Arterial Disease Self-management

NCT ID: NCT03464006

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single centre, randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Online Support Module

Intervention Type OTHER

The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease

Standard of Care

Patients in this arm will receive the standard of care as provided by the institution.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

The normal care that patients receive at the institution.

Interventions

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Online Support Module

The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease

Intervention Type OTHER

Standard of Care

The normal care that patients receive at the institution.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reliq Health Technologies Inc.

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael C Stacey, DS

Role: PRINCIPAL_INVESTIGATOR

McMast

Central Contacts

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Steven Phillips, MSc

Role: CONTACT

905-521-2100 ext. 44167

Other Identifiers

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PAD Management

Identifier Type: -

Identifier Source: org_study_id

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