CClinicalTrials.gg
Status unknownNCT03464006Updated Mar 15, 2018

Online Support for Outpatient Peripheral Arterial Disease Self-management

An interventional study of Online Support Module and Standard of Care in Peripheral Artery Disease, sponsored by McMaster University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.

Sponsored by McMaster University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Online Support Module

    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.

    Other: Online Support Module

  • Active comparator
    Standard of Care

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

    Other: Standard of Care

Interventions

  • OtherOnline Support Module

    The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease

  • OtherStandard of Care

    The normal care that patients receive at the institution.

05

What researchers measure

Primary outcomes

  1. Ankle Brachial Index

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

    Time frame: 1 year

Secondary outcomes

  1. Blood Pressure

    Patient blood pressure.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. Diabetes Status

    Diabetes status measured by hemoglobin A1C

    Time frame: 1 year

  4. Vascular Health

    Measured using LDL, HDL, and total cholesterol

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — There is no plan to share patient level data.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03464006
Lead sponsor
McMaster University
Collaborators
Reliq Health Technologies Inc.
Responsible party
Sponsor
First posted
Mar 13, 2018
Start date
Jul 2018 (estimated)
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Mar 15, 2018

Study contacts

Steven Phillips, MSc
Contact
phills3@mcmaster.ca
905-521-2100 ext. 44167
Michael C Stacey, DS
principal investigator · McMast

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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