Smartstep Smartphone PAD

NCT ID: NCT03479255

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2025-02-20

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smartphone-enabled structured exercise therapy (SE-SET)

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.

Group Type: EXPERIMENTAL

Smartphone-enabled structured exercise therapy (SE-SET)

Intervention Type: BEHAVIORAL

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 to identify barriers to patient compliance (issues related to exercise tracking, medication issues that prevent patients 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 matters related to their care.

Standard exercise therapy

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

Group Type: ACTIVE_COMPARATOR

Standard exercise therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Smartphone-enabled structured exercise therapy (SE-SET)

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 to identify barriers to patient compliance (issues related to exercise tracking, medication issues that prevent patients 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 matters related to their care.

Intervention Type: BEHAVIORAL

Standard exercise therapy

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woodruff Health Sciences Center Foundation

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Amit J. Shah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System (non-CRN)

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00102543

Identifier Type: -

Identifier Source: org_study_id