MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

NCT ID: NCT04228549

Last Updated: 2023-04-25

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

TERMINATED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2022-06-30

Brief Summary

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The investigators have developed an online program to help people with peripheral arterial disease (PAD) in their extremities to better self-manage their condition. Some earlier testing has been done and the investigators now wish to try this system with participants who have this blood vessel disease as well as high blood pressure. Investigators are hoping to help these participants to achieve healthier lifestyles and improve their quality of life through education, monitoring and continuing support. A similar online desk-top version with over 30 participants has been tested at St. Michael's Hospital in Toronto. The investigators propose to test this newer mobile system with 210 outpatient participants from Hamilton General Hospital. Data collected will be analyzed following the (12 months for each participant) study, along with data recorded during clinical visits at baseline and twelve months for each participant. The objective is to evaluate changes to participant health and determine whether the health self-management process has been successful in improving participant lifestyles and quality of life, when compared to usual care.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

MyPADMGT

Online access to system, with ability to record and study progress with social interaction, diet, physical activity, smoking cessation, blood glucose, blood pressure and weight. Also access to educational content, journal recording, communication to others, setting target levels, contact support as needed.

Group Type EXPERIMENTAL

MyPADMGT

Intervention Type DEVICE

Online tracking and feedback to help patients adopt healthy lifestyles

MyPADMGT + Nudging

Online access to system, with ability to record and study progress with social interaction, diet, physical activity, smoking cessation, blood glucose, blood pressure and weight. Also access to educational content, journal recording, communication to others, setting target levels, contact support as needed. In addition, nudging support available to help patients make better choices and decisions.

Group Type EXPERIMENTAL

MyPADMGT + Nudging

Intervention Type DEVICE

Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions

Interventions

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MyPADMGT

Online tracking and feedback to help patients adopt healthy lifestyles

Intervention Type DEVICE

MyPADMGT + Nudging

Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Out-patients with Peripheral Arterial Disease (Ankle Brachial Index \< 0.90)
* Attending the Hamilton General Hospital Outpatient Vascular Clinic
* May be living alone or with one or more caregivers
* Must have Internet access.

Exclusion Criteria

* Age \< 18 years
* Not diagnosed with PAD
* Unable to communicate in English
* Unwilling to participate
* Patients with dementia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Stacey, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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General Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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8108

Identifier Type: -

Identifier Source: org_study_id

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