MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

NCT04228549 | Terminated

• 1 other identifier: 8108
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure

  Change in systolic blood pressure measured in clinic by blood pressure cuff

  1 Year

• EQ-5D-5L Quality of Life Visual Result

  Change in QoL Visual Result measured by questionnaire. Min = 0, Max = 100. Higher outcome scores are better

  1 Year

Secondary Outcomes (4)

• Ankle Brachial Index

  1 year

• Body Weight

  1 year

• Social Isolation

  1 year

• Smoking Cessation

  1 year

Study Arms (3)

Control

NO INTERVENTION

Usual care

MyPADMGT

EXPERIMENTAL

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.

Device: MyPADMGT

MyPADMGT + Nudging

EXPERIMENTAL

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.

Device: MyPADMGT + Nudging

Interventions

MyPADMGT DEVICE

Online tracking and feedback to help patients adopt healthy lifestyles

MyPADMGT

MyPADMGT + Nudging DEVICE

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

MyPADMGT + Nudging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

General Hospital

Hamilton, Ontario, L8N3Z5, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Michael Stacey, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: February 24, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)