MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— Final_PADHSS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04228549
• Other study ID #: 8108
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• MyPADMGT
Online tracking and feedback to help patients adopt healthy lifestyles
• MyPADMGT + Nudging
Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions

Locations

Country	Name	City	State
Canada	General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Change in systolic blood pressure measured in clinic by blood pressure cuff	1 Year
Primary	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	Ankle Brachial Index	Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better	1 year
Secondary	Body Weight	Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9	1 year
Secondary	Social Isolation	Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better	1 year
Secondary	Smoking Cessation	Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better	1 year