Peripheral Artery DiseaseNCT02472561
Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)
A study testing Fitbit Physical Activity Monitor, mHealth Glucometer and mHealth Blood Pressure in people with Peripheral Artery Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to understand the effects that a three month lifestyle-based mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in patients with PAD. 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?
- Fitbit Physical Activity Monitor, mHealth Glucometer and mHealth Blood Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 7 Nov 2017
- 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
- Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention
- A history of stable intermittent claudication for >2 months, and an ABI <0.9 at rest
- No contraindications to exercise training
- All subjects will be on the recommended regimen of statin and antiplatelet therapy
- Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
Who cannot join
- Present or a past history of gangrene, impending limb loss or osteomyelitis
- Severe peripheral neuropathy
- Any condition other than PAD that limits walking for example arthritis or chronic obstructive pulmonary disease (COPD)
- Unstable angina, history of significant left main disease or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent myocardial infarction (less than eight weeks)
- Chest pain during treadmill exercise which appears before the onset of claudication, or 2 mm ST depression during exercise regardless of the results of tests for myocardial ischemia
- Refusal or inability to give informed consent or inability or unwillingness to comply with the study requirements.
- Dementia that precludes ability to participate in and follow study protocols
- Enrollment in a clinical trial not approved for co-enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease
The purpose of this study is to understand the effects that a three month lifestyle-based mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in patients with PAD.
By testing a novel mHealth intervention focused on lifestyle modification, this trial will address a critical evidence gap in the care of PAD patients. PAD patients are not eligible for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these patients currently have no lifestyle-based care strategies to help them. The results of this study have the potential to lead to new sustainable and resource-efficient, lifestyle-based preventive care strategies for patients with stable PAD.
Read the detailed description
This is a single-center, randomized trial designed to examine the hypothesis that a lifestyle-based mHealth peripheral artery disease (PAD) prevention program will improve physical activity, fitness, important PAD risk factors and quality of life (QOL).
The investigators may enroll up to 55 men and women being evaluated for leg pain from Duke PAD cardiovascular clinics or after lower extremity angioplasty in the Duke catheterization laboratory. Of the 55 men and women volunteers who may be initially consented, the investigators anticipate a portion (potentially 20%) may drop out during the study timeline, and approximately 45 are expected to complete this study. Following informed consent and baseline testing, the participants will be randomized (1.25:1.00) into either a mHealth (N=25) or usual care group (N=20) [for comparison] for a 12-week period. All patients will be evaluated for walking ability on a treadmill test, quality of life questionnaires, health literacy related to PAD and the most important risk factors specific to PAD (blood glucose if diabetic, daily physical activity and blood pressure).
- Conditions
- Peripheral Artery Disease
- Being tested
- Fitbit Physical Activity Monitor, mHealth Glucometer, mHealth Blood Pressure
- Keywords
- Cardiology, Vascular, Peripheral Artery Disease, Artery, Mobile Health, Exercise, PAD
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Physical Activity MonitorOther
Physical Activity: The study team will provide an individualized goal of total number of steps to attain daily and will be monitored using a Fitbit activity tracker. The total daily step goal will be reviewed by study staff and modified at weeks 4 and 8.
mHealth GlucometerOther
Also called Diabetics Only
Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.
mHealth Blood PressureOther
Blood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health Application Group 1 | Experimental | Participants will wear a Fitbit Physical Activity Monitor to objectively quantify physical activity patterns. Once a week (± 3 days) during the 12 week mHealth intervention patients will measure and download their blood pressure and blood glucose (if diabetic) by means of a mHealth blood pressure cuff and mHealth glucometer. Medication adherence will be measured at baseline and 12-weeks by the Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire. Each participant will be provided with a electronic version of the book titled, "Your COMPLETE and EASY GUIDE to Understanding Peripheral Artery Disease"; patients will be asked to read approximately one chapter per week for educational purposes. Receives: Other: Fitbit Physical Activity Monitor; Other: mHealth Glucometer; Other: mHealth Blood Pressure |
| Usual Care Group 2 | No intervention | Participants will follow standard care as ordered by their individual, treating physician. Each participant will be given a paperback copy of the book, "Your COMPLETE and EASY GUIDE to Understanding Peripheral Artery Disease". All participants will be contacted by study personnel in order to schedule visits at baseline and 12-weeks for the outcome assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular fitness level measured by change score analysis of peak Volume of Oxygen (pVO2mL/kg/min) consumption measured during a cardiopulmonary exercise test (CPET).
peak VO2 mL/kg/min
Measured: Baseline and 12-week
Secondary outcomes (10)
Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey
Patient Satisfaction Survey
Measured: 12-week
Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction
Patient Satisfaction Survey
Measured: 12-week
Change in physical activity patterns (steps, time and distance)
Steps, time and distance per week
Measured: Baseline and 12-week
Change score analysis in Body Mass Index measurements
Ratio of height to weight
Measured: Baseline and 12-week
Change score analysis in Blood Glucose measurements
Fasting Plasma Glucose and Hemoglobin A1-C
Measured: Baseline and 12-week
Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)
Measured: Baseline and 12-week
Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire
Measured: Baseline and 12-week
Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire
Measured: Baseline and 12-week
Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire
Measured: Baseline and 12-week
Change score analysis in Systolic and Diastolic Blood Pressure measurements
Measured: Baseline and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
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 Duke 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Verizon Wireless
- Responsible party
- Sponsor
- Investigators
- Manesh R Patel, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472561
- Sponsor's protocol ID
- Pro00059885
- Status last verified
- Jan 2018
- First submitted
- 10 Jun 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT02472561
- Acronym / sponsor ID
- Pro00059885
- Conditions
- Peripheral Artery Disease
- Keywords
- Cardiology, Vascular, Peripheral Artery Disease, Artery, Mobile Health, Exercise, PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Verizon Wireless
- Study start
- Jul 2015
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- 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 purpose of this study is to understand the effects that a three month lifestyle-based mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in patients with PAD.
By testing a novel mHealth intervention focused on lifestyle modification, this trial will address a critical evidence gap in the care of PAD patients. PAD patients are not eligible for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these patients currently have no lifestyle-based care strategies to help them. The results of this study have the potential to lead to new sustainable and resource-efficient, lifestyle-based preventive care strategies for patients with stable PAD.
Detailed description
This is a single-center, randomized trial designed to examine the hypothesis that a lifestyle-based mHealth peripheral artery disease (PAD) prevention program will improve physical activity, fitness, important PAD risk factors and quality of life (QOL).
The investigators may enroll up to 55 men and women being evaluated for leg pain from Duke PAD cardiovascular clinics or after lower extremity angioplasty in the Duke catheterization laboratory. Of the 55 men and women volunteers who may be initially consented, the investigators anticipate a portion (potentially 20%) may drop out during the study timeline, and approximately 45 are expected to complete this study. Following informed consent and baseline testing, the participants will be randomized (1.25:1.00) into either a mHealth (N=25) or usual care group (N=20) [for comparison] for a 12-week period. All patients will be evaluated for walking ability on a treadmill test, quality of life questionnaires, health literacy related to PAD and the most important risk factors specific to PAD (blood glucose if diabetic, daily physical activity and blood pressure).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Application Group 1 | Experimental | Other: Fitbit Physical Activity Monitor, Other: mHealth Glucometer, Other: mHealth Blood PressureParticipants will wear a Fitbit Physical Activity Monitor to objectively quantify physical activity patterns. Once a week (± 3 days) during the 12 week mHealth intervention patients will measure and download their blood pressure and blood glucose (if diabetic) by means of a mHealth blood pressure cuff and mHealth glucometer. Medication adherence will be measured at baseline and 12-weeks by the Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire. Each participant will be provided with a electronic version of the book titled, "Your COMPLETE and EASY GUIDE to Understanding Peripheral Artery Disease"; patients will be asked to read approximately one chapter per week for educational purposes. |
| Usual Care Group 2 | No intervention | –Participants will follow standard care as ordered by their individual, treating physician. Each participant will be given a paperback copy of the book, "Your COMPLETE and EASY GUIDE to Understanding Peripheral Artery Disease". All participants will be contacted by study personnel in order to schedule visits at baseline and 12-weeks for the outcome assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention
- A history of stable intermittent claudication for >2 months, and an ABI <0.9 at rest
- No contraindications to exercise training
- All subjects will be on the recommended regimen of statin and antiplatelet therapy
- Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
Key exclusion criteria (8 listed)
- Present or a past history of gangrene, impending limb loss or osteomyelitis
- Severe peripheral neuropathy
- Any condition other than PAD that limits walking for example arthritis or chronic obstructive pulmonary disease (COPD)
- Unstable angina, history of significant left main disease or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent myocardial infarction (less than eight weeks)
- Chest pain during treadmill exercise which appears before the onset of claudication, or 2 mm ST depression during exercise regardless of the results of tests for myocardial ischemia
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 |
|---|---|---|
| Fitbit Physical Activity MonitorPhysical Activity: The study team will provide an individualized goal of total number of steps to attain daily and will be monitored using a Fitbit activity tracker. The total daily step goal will be reviewed by study staff and modified at weeks 4 and 8. | Other | Mobile Health Application Group 1 |
| mHealth GlucometerAlso: Diabetics OnlyBlood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app. | Other | Mobile Health Application Group 1 |
| mHealth Blood PressureBlood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app. | Other | Mobile Health Application Group 1 |
Primary outcome
Change in cardiovascular fitness level measured by change score analysis of peak Volume of Oxygen (pVO2mL/kg/min) consumption measured during a cardiopulmonary exercise test (CPET).
Time frame: Baseline and 12-week
peak VO2 mL/kg/min
10 secondary outcomes
Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey
Time frame: 12-week
Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction
Time frame: 12-week
Change in physical activity patterns (steps, time and distance)
Time frame: Baseline and 12-week
Change score analysis in Body Mass Index measurements
Time frame: Baseline and 12-week
Change score analysis in Blood Glucose measurements
Time frame: Baseline and 12-week
Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline and 12-week
Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire
Time frame: Baseline and 12-week
Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire
Time frame: Baseline and 12-week
Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire
Time frame: Baseline and 12-week
Change score analysis in Systolic and Diastolic Blood Pressure measurements
Time frame: Baseline and 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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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.
Manesh R Patel, MD principal investigator
Duke 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 Fitbit Physical Activity Monitor, mHealth Glucometer and mHealth Blood Pressure in people with Peripheral Artery Disease, run by Duke University at 1 site in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 5 Feb 2018. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cardiovascular fitness level measured by change score analysis of peak Volume of Oxygen (pVO2mL/kg/min) consumption measured during a cardiopulmonary exercise test (CPET). (time frame: Baseline and 12-week). 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 5 Feb 2018.