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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228549
Recruitment Status : Suspended (Outpatient clinic site suspended temporarily due to COVID 19 virus)
First Posted : January 14, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
McMaster University

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
Peripheral Arterial Disease Device: MyPADMGT Device: MyPADMGT + Nudging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 1 Year ]
    Change in systolic blood pressure measured in clinic by blood pressure cuff

  2. EQ-5D-5L Quality of Life Visual Result [ Time Frame: 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 [ Time Frame: 1 year ]
    Change in ABI as measured in the clinic. Higher outcome scores are better

  2. Body Weight [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228549


Locations
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Canada, Ontario
General Hospital
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Michael Stacey, MD McMaster University
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04228549    
Other Study ID Numbers: 8108
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases