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Online Support for Outpatient Peripheral Arterial Disease Self-management

Primary Purpose

Peripheral Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Online Support Module
Standard of Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Age greater than 18 years
  • diagnosed with peripheral artery disease (ABI<0.9)

Exclusion Criteria:

  • unable to communicate in English
  • unwilling to participate
  • patients with dementia or other cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Online Support Module

    Standard of Care

    Arm Description

    Patients in the online support module group will receive a tablet which has the developed peripheral arterial disease platform installed on it. The platform helps the patient to monitor factors related to their peripheral arterial disease such as exercise, smoking, and diet and helps them to track and modify these behaviours.

    Patients in this arm will receive the standard of care as provided by the institution.

    Outcomes

    Primary Outcome Measures

    Ankle Brachial Index
    The ankle brachial index will be measured to determine peripheral artery disease status and progression.

    Secondary Outcome Measures

    Blood Pressure
    Patient blood pressure.
    Health Related Quality of Life
    Quality of life measured using the EuroQol-5D (EQ-5D). The EQ-5D provides a variety of health states which can then be converted to an index score ranging from 0-1.0, with 0 indicating a poorer health state and 1.0 representing a better health state.
    Diabetes Status
    Diabetes status measured by hemoglobin A1C
    Vascular Health
    Measured using LDL, HDL, and total cholesterol

    Full Information

    First Posted
    March 7, 2018
    Last Updated
    March 14, 2018
    Sponsor
    McMaster University
    Collaborators
    Reliq Health Technologies Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03464006
    Brief Title
    Online Support for Outpatient Peripheral Arterial Disease Self-management
    Official Title
    Online Support for Outpatient Peripheral Arterial Disease Self-management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    Reliq Health Technologies Inc.

    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
    This study looks to examine whether an online patient tool to monitor factors affecting patients peripheral artery disease can lead to improvements in patients' disease and slow its progression.
    Detailed Description
    The objective of this project is to implement a program involving a new online patient-centred approach to assist in peripheral arterial disease (PAD) self-management in home and work environments, in collaboration with patient circles of care (patients, care-givers, physicians, and allied healthcare professionals). This program involves online modules tailored to the needs of specific patients and diseases, oriented to education, training, monitoring, and continuing support for lifestyle changes (smoking cessation, exercise, healthy diets, weight loss, etc.) and psycho-social needs such as social isolation and loneliness. The investigators have tested an online desk-top version for over 30 out-patients with PAD at St. Michael's Hospital in Toronto. The investigators propose to test its ability for improved outcomes and healthcare quality of life through a multi-centre randomized controlled trial for PAD and a frequently co-occurring chronic illness, high blood pressure.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a single centre, randomized controlled trial.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Online Support Module
    Arm Type
    Experimental
    Arm Description
    Patients in the online support module group will receive a tablet which has the developed peripheral arterial disease platform installed on it. The platform helps the patient to monitor factors related to their peripheral arterial disease such as exercise, smoking, and diet and helps them to track and modify these behaviours.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will receive the standard of care as provided by the institution.
    Intervention Type
    Other
    Intervention Name(s)
    Online Support Module
    Intervention Description
    The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    The normal care that patients receive at the institution.
    Primary Outcome Measure Information:
    Title
    Ankle Brachial Index
    Description
    The ankle brachial index will be measured to determine peripheral artery disease status and progression.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Blood Pressure
    Description
    Patient blood pressure.
    Time Frame
    1 year
    Title
    Health Related Quality of Life
    Description
    Quality of life measured using the EuroQol-5D (EQ-5D). The EQ-5D provides a variety of health states which can then be converted to an index score ranging from 0-1.0, with 0 indicating a poorer health state and 1.0 representing a better health state.
    Time Frame
    1 year
    Title
    Diabetes Status
    Description
    Diabetes status measured by hemoglobin A1C
    Time Frame
    1 year
    Title
    Vascular Health
    Description
    Measured using LDL, HDL, and total cholesterol
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age greater than 18 years diagnosed with peripheral artery disease (ABI<0.9) Exclusion Criteria: unable to communicate in English unwilling to participate patients with dementia or other cognitive impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Steven Phillips, MSc
    Phone
    905-521-2100
    Ext
    44167
    Email
    phills3@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael C Stacey, DS
    Organizational Affiliation
    McMast
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to share patient level data.

    Learn more about this trial

    Online Support for Outpatient Peripheral Arterial Disease Self-management

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