Peripheral Arterial DiseaseFinal_PADHSSNCT04228549
MyPADMGT Support of Out-Patients With Peripheral Arterial Disease
A study testing MyPADMGT and MyPADMGT + Nudging in people with Peripheral Arterial Disease, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- MyPADMGT and MyPADMGT + Nudging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2021to 30 Jun 2022
- 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
- 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.
Who cannot join
- Age < 18 years
- Not diagnosed with PAD
- Unable to communicate in English
- Unwilling to participate
- Patients with dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- MyPADMGT, MyPADMGT + Nudging
- 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.
MyPADMGTDevice
Online tracking and feedback to help patients adopt healthy lifestyles
MyPADMGT + NudgingDevice
Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| MyPADMGT | Experimental | 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. Receives: Device: MyPADMGT |
| MyPADMGT + Nudging | Experimental | 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. Receives: Device: MyPADMGT + Nudging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Change in systolic blood pressure measured in clinic by blood pressure cuff
Measured: 1 Year
EQ-5D-5L Quality of Life Visual Result
Change in QoL Visual Result measured by questionnaire. Min = 0, Max = 100. Higher outcome scores are better
Measured: 1 Year
Secondary outcomes (4)
Ankle Brachial Index
Change in Ankle Brachial Index as measured in the clinic. Higher outcome scores are better
Measured: 1 year
Body Weight
Change in Body Mass Index towards normal healthy range. Adult healthy minimum is 18.5 and healthy maximum is 24.9
Measured: 1 year
Social Isolation
Change in Friendship Scale as measured by Hawthorne Friendship Scale Questionnaire. Min. = 0; Max. = 24. Higher outcome scores are better
Measured: 1 year
Smoking Cessation
Smoking Cessation by Smokers as self-reported by Smokers. More Cessations is better
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 posted14 Jan 2020
- Study start24 Feb 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Outpatient clinic site unable to provide required recruits due to COVID 19 virus. Terminated June 30 2022. Actual enrolment 126. This information entered August 24, 2022.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Stacey, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228549
- Sponsor's protocol ID
- 8108
- Acronym
- Final_PADHSS
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT04228549
- Acronym / sponsor ID
- Final_PADHSS / 8108
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Outpatient clinic site unable to provide required recruits due to COVID 19 virus. Terminated June 30 2022. Actual enrolment 126. This information entered August 24, 2022.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Jan 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| MyPADMGT | Experimental | Device: MyPADMGTOnline 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. |
| MyPADMGT + Nudging | Experimental | Device: MyPADMGT + NudgingOnline 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Age < 18 years
- Not diagnosed with PAD
- Unable to communicate in English
- Unwilling to participate
- Patients with dementia.
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 |
|---|---|---|
| MyPADMGTOnline tracking and feedback to help patients adopt healthy lifestyles | Device | MyPADMGT |
| MyPADMGT + NudgingOnline tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions | Device | MyPADMGT + Nudging |
Primary outcome
Systolic Blood Pressure
Time frame: 1 Year
Change in systolic blood pressure measured in clinic by blood pressure cuff
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
4 secondary outcomes
Ankle Brachial Index
Time frame: 1 year
Body Weight
Time frame: 1 year
Social Isolation
Time frame: 1 year
Smoking Cessation
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Outpatient clinic site unable to provide required recruits due to COVID 19 virus. Terminated June 30 2022. Actual enrolment 126. This information entered August 24, 2022.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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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 Stacey, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPADMGT and MyPADMGT + Nudging in people with Peripheral Arterial Disease, run by McMaster University at 1 site in Canada.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Outpatient clinic site unable to provide required recruits due to COVID 19 virus. Terminated June 30 2022. Actual enrolment 126. This information entered August 24, 2022.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 25 Apr 2023.