MyPADMGT Support of Out-Patients With Peripheral Arterial Disease (Final_PADHSS)

McMaster University

Status: Terminated

Conditions: Peripheral Arterial Disease

Treatments: Device: MyPADMGT; Device: MyPADMGT + Nudging

Study type: Interventional

Funder types: Other

Identifiers

NCT04228549

8108

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 3 patient groups

Control

No Intervention group

Description:

Usual care

MyPADMGT

Experimental group

Description:

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.

Treatment:

Device: MyPADMGT

MyPADMGT + Nudging

Experimental group

Description:

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.

Treatment:

Device: MyPADMGT + Nudging