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Final_PADHSS: MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

Sponsor
McMaster University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04228549
Collaborator
(none)
210
Enrollment
1
Location
3
Arms
23.2
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MyPADMGT
  • Device: MyPADMGT + Nudging
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Usual care
Experimental: 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.

Device: MyPADMGT
Online tracking and feedback to help patients adopt healthy lifestyles
Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Systolic Blood Pressure [1 Year]

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

  2. EQ-5D-5L Quality of Life Visual Result [1 Year]

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

Secondary Outcome Measures

  1. Ankle Brachial Index [1 year]

    Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better

  2. Body Weight [1 year]

    Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9

  3. Social Isolation [1 year]

    Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better

  4. Smoking Cessation [1 year]

    Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital Hamilton Ontario Canada L8N3Z5

Sponsors and Collaborators

  • McMaster University

Investigators

  • Principal Investigator: Michael Stacey, MD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT04228549
Other Study ID Numbers:
  • 8108
First Posted:
Jan 14, 2020
Last Update Posted:
Mar 10, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases

Study Results

No Results Posted as of Mar 10, 2021