Peripheral Artery DiseaseNCT03464006
Online Support for Outpatient Peripheral Arterial Disease Self-management
A study testing Online Support Module in people with Peripheral Artery Disease, run by McMaster University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Online Support Module
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- diagnosed with peripheral artery disease (ABI<0.9)
Who cannot join
- unable to communicate in English
- unwilling to participate
- patients with dementia or other cognitive impairment
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Online Support Module, Standard of Care
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Support ModuleOther
The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease
Standard of CareOther
The normal care that patients receive at the institution.
| Study group | Role | What they receive |
|---|---|---|
| Online Support Module | Experimental | 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. Receives: Other: Online Support Module |
| Standard of Care | Active comparator | Patients in this arm will receive the standard of care as provided by the institution. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Brachial Index
The ankle brachial index will be measured to determine peripheral artery disease status and progression.
Measured: 1 year
Secondary outcomes (4)
Blood Pressure
Patient blood pressure.
Measured: 1 year
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.
Measured: 1 year
Diabetes Status
Diabetes status measured by hemoglobin A1C
Measured: 1 year
Vascular Health
Measured using LDL, HDL, and total cholesterol
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startJul 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single centre, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Reliq Health Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Michael C Stacey, DS, Principal investigator, McMast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464006
- Sponsor's protocol ID
- PAD Management
- Status last verified
- Feb 2018
- First submitted
- 7 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share patient level data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Support for Outpatient Peripheral Arterial Disease Self-management
- ClinicalTrials.gov ID
- NCT03464006
- Acronym / sponsor ID
- PAD Management
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Reliq Health Technologies Inc.
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single centre, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Online Support Module | Experimental | Other: Online Support ModulePatients 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. |
| Standard of Care | Active comparator | Other: Standard of CarePatients in this arm will receive the standard of care as provided by the institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 18 years
- diagnosed with peripheral artery disease (ABI<0.9)
Key exclusion criteria (3 listed)
- unable to communicate in English
- unwilling to participate
- patients with dementia or other cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Support ModuleThe online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease | Other | Online Support Module |
| Standard of CareThe normal care that patients receive at the institution. | Other | Standard of Care |
Primary outcome
Ankle Brachial Index
Time frame: 1 year
The ankle brachial index will be measured to determine peripheral artery disease status and progression.
4 secondary outcomes
Blood Pressure
Time frame: 1 year
Health Related Quality of Life
Time frame: 1 year
Diabetes Status
Time frame: 1 year
Vascular Health
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No. There is no plan to share patient level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Stacey, DS principal investigator
McMast
Questions about this trial
What is this clinical trial studying?
A study testing Online Support Module in people with Peripheral Artery Disease, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Phillips, MSc (905-521-2100 ext. 44167, phills3@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Brachial Index (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.