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Smartstep Smartphone PAD (SMARTSTEP)

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-enabled structured exercise therapy (SE-SET)
Standard exercise therapy
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Smartphone, Exercise, Functional capacity

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically stable intermittent claudication
  • Able to give informed consent
  • Age 18-89 years

And one of the following:

  • ABI < 0.9 after 10 minutes of rest OR
  • For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.

Exclusion Criteria:

Life-threatening process including:

  • Sepsis
  • Critical limb ischemia (Rutherford class 4-6)
  • Unstable angina
  • Active malignancy with life expectancy < 6 months
  • Severe NYHA Class IV heart failure

Condition other than PAD that limits walking before claudication onset

This includes, but is not limited to:

  • Severe angina or dyspnea
  • Arthritis
  • Muscle weakness/pain

Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation

Inability to attend study visits

Sites / Locations

  • Grady Health System (non-CRN)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smartphone-enabled structured exercise therapy (SE-SET)

Standard exercise therapy

Arm Description

This arm involves a smartphone app Movn - rehabilitation platform based on MULTIFIT, a case-management system for secondary prevention and patient surveillance after acute MI. The key features of the smartphone app include daily reminders to exercise, virtual diary for patients to enter data on exercise sessions, two-way secure messaging with the health coach, and educational videos on heart and vascular health.

Self-directed, unsupervised exercise as prescribed by the patient's physician.

Outcomes

Primary Outcome Measures

Change in 6-minute walk test (6MWT) distance completed
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Secondary Outcome Measures

Change in Walking Impairment Questionnaire (WIQ) score
WIQ measures self-reported walking distance, speed, and stair-climbing ability. In the WIQ distance score, the participant is asked to assess the degree of walking difficulty in walking specific distances on a scale from 0 to 4. A score of 0 represents the inability to walk the distance and a score of 4 represents no difficulty. WIQ speed score assesses the degree of difficulty in walking one block at specific speeds, ranging from walking slowly to jogging, on a scale of 0 to 4. In the WIQ stair-climbing score, the participant is asked to report the degree of difficulty climbing specific numbers of flights of stairs, ranging from one to three flights of stairs, on a scale of 0 to 4. This graded score is multiplied by a prespecified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform any of the tasks) to 100 (representing no difficulty).
Change in Physical Health Composite Score of SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to use special software. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Change in claudication onset time during 6MWT
One typical symptom of peripheral arterial occlusive disease' (PAOD) is claudication , which is defined as pain, cramps, numbness or a sense of fatigue in the muscles associated with walking, in one or both lower limbs, affecting either the distal or proximal muscle groups.
Change in ankle-brachial pressure index (ABPI)
The ankle-brachial pressure index (ABPI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABPI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.
Change in number of steps/week
Number of steps/week will be obtained from participants' fitness trackers
Critical Limb Ischemia
Number of Critical Limb Ischemia events reported by participants
Other Cardiovascular Outcomes
Number of Cardiovascular Outcomes other than Critical Limb Ischemia events reported by participants
Exercise-Related Injury
Number of Exercise-Related Injury events reported by participants
Mortality
Number of deaths

Full Information

First Posted
March 21, 2018
Last Updated
September 1, 2023
Sponsor
Emory University
Collaborators
Woodruff Health Sciences Center Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03479255
Brief Title
Smartstep Smartphone PAD
Acronym
SMARTSTEP
Official Title
Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Woodruff Health Sciences Center Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).
Detailed Description
Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone programs may increase the efficiency of such efforts. The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at Grady Memorial Hospital's vascular clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Smartphone, Exercise, Functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective clinical trial that will randomize patients in 1:1 ratio to smartphone-enabled structured exercise therapy (SE-SET) vs. standard exercise therapy (usual care)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone-enabled structured exercise therapy (SE-SET)
Arm Type
Experimental
Arm Description
This arm involves a smartphone app Movn - rehabilitation platform based on MULTIFIT, a case-management system for secondary prevention and patient surveillance after acute MI. The key features of the smartphone app include daily reminders to exercise, virtual diary for patients to enter data on exercise sessions, two-way secure messaging with the health coach, and educational videos on heart and vascular health.
Arm Title
Standard exercise therapy
Arm Type
Active Comparator
Arm Description
Self-directed, unsupervised exercise as prescribed by the patient's physician.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone-enabled structured exercise therapy (SE-SET)
Intervention Description
The SE-SET program lasts a total of 12 weeks per participant. During this time, the application will automatically track physical activity (steps) and subjects will be prompted to enter other health data such as blood pressure and weight, and watch brief educational videos on topics such as smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. Patients will be contacted by a member of the study team weekly via phone call in order to identify barriers to patient compliance (issues related to exercise tracking, medication issues that prevent patient from being active, high BP/weight issues) and help patients navigate those barriers. Movn participants can also send direct messages to the study team to ask about non-urgent issues related to their care.
Intervention Type
Behavioral
Intervention Name(s)
Standard exercise therapy
Intervention Description
The Standard exercise therapy lasts a total of 12 weeks per participant. Participants will be counseled by the physician to perform exercise at home, including 3 times per week of walking 30+ minutes; if applicable, the physician will also counsel on smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. These patients will be given a fitness band, which will be set up by the study team using a de-identified study account that will provide additional data on their progress over time.
Primary Outcome Measure Information:
Title
Change in 6-minute walk test (6MWT) distance completed
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time Frame
Immediately before and after the 12-week period
Secondary Outcome Measure Information:
Title
Change in Walking Impairment Questionnaire (WIQ) score
Description
WIQ measures self-reported walking distance, speed, and stair-climbing ability. In the WIQ distance score, the participant is asked to assess the degree of walking difficulty in walking specific distances on a scale from 0 to 4. A score of 0 represents the inability to walk the distance and a score of 4 represents no difficulty. WIQ speed score assesses the degree of difficulty in walking one block at specific speeds, ranging from walking slowly to jogging, on a scale of 0 to 4. In the WIQ stair-climbing score, the participant is asked to report the degree of difficulty climbing specific numbers of flights of stairs, ranging from one to three flights of stairs, on a scale of 0 to 4. This graded score is multiplied by a prespecified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform any of the tasks) to 100 (representing no difficulty).
Time Frame
Immediately before and after the 12-week period
Title
Change in Physical Health Composite Score of SF-36
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to use special software. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Time Frame
Immediately before and after the 12-week period
Title
Change in claudication onset time during 6MWT
Description
One typical symptom of peripheral arterial occlusive disease' (PAOD) is claudication , which is defined as pain, cramps, numbness or a sense of fatigue in the muscles associated with walking, in one or both lower limbs, affecting either the distal or proximal muscle groups.
Time Frame
Immediately before and after the 12-week period
Title
Change in ankle-brachial pressure index (ABPI)
Description
The ankle-brachial pressure index (ABPI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABPI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.
Time Frame
Immediately before and after the 12-week period
Title
Change in number of steps/week
Description
Number of steps/week will be obtained from participants' fitness trackers
Time Frame
Immediately before and after the 12-week period
Title
Critical Limb Ischemia
Description
Number of Critical Limb Ischemia events reported by participants
Time Frame
Over the 12-week study period
Title
Other Cardiovascular Outcomes
Description
Number of Cardiovascular Outcomes other than Critical Limb Ischemia events reported by participants
Time Frame
Over the 12-week study period
Title
Exercise-Related Injury
Description
Number of Exercise-Related Injury events reported by participants
Time Frame
Over the 12-week study period
Title
Mortality
Description
Number of deaths
Time Frame
Over the 12-week study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically stable intermittent claudication Able to give informed consent Age 18-89 years And one of the following: ABI < 0.9 after 10 minutes of rest OR For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing. Exclusion Criteria: Life-threatening process including: Sepsis Critical limb ischemia (Rutherford class 4-6) Unstable angina Active malignancy with life expectancy < 6 months Severe NYHA Class IV heart failure Condition other than PAD that limits walking before claudication onset This includes, but is not limited to: Severe angina or dyspnea Arthritis Muscle weakness/pain Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation Inability to attend study visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Shah, MD
Phone
404-727-8712
Email
ajshah3@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Shah, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System (non-CRN)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Shah, MD
Phone
404-727-8712
Email
ajshah3@emory.edu

12. IPD Sharing Statement

Learn more about this trial

Smartstep Smartphone PAD

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