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

Primary Purpose

Peripheral Arterial Disease

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MyPADMGT
MyPADMGT + Nudging
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

MyPADMGT

MyPADMGT + Nudging

Arm Description

Usual care

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.

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.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure
Change in systolic blood pressure measured in clinic by blood pressure cuff
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

Secondary Outcome Measures

Ankle Brachial Index
Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better
Body Weight
Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9
Social Isolation
Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better
Smoking Cessation
Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better

Full Information

First Posted
January 10, 2020
Last Updated
April 21, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04228549
Brief Title
MyPADMGT Support of Out-Patients With Peripheral Arterial Disease
Acronym
Final_PADHSS
Official Title
My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Outpatient clinic site unable to provide required recruits due to COVID 19 virus. Terminated June 30 2022. Actual enrolment 126. This information entered August 24, 2022.
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
MyPADMGT
Arm Type
Experimental
Arm 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.
Arm Title
MyPADMGT + Nudging
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
MyPADMGT
Intervention Description
Online tracking and feedback to help patients adopt healthy lifestyles
Intervention Type
Device
Intervention Name(s)
MyPADMGT + Nudging
Intervention Description
Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Change in systolic blood pressure measured in clinic by blood pressure cuff
Time Frame
1 Year
Title
EQ-5D-5L Quality of Life Visual Result
Description
Change in QoL Visual Result measured by questionnaire. Min = 0, Max = 100. Higher outcome scores are better
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Ankle Brachial Index
Description
Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better
Time Frame
1 year
Title
Body Weight
Description
Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9
Time Frame
1 year
Title
Social Isolation
Description
Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better
Time Frame
1 year
Title
Smoking Cessation
Description
Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stacey, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

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