Smartstep Smartphone PAD (SMARTSTEP)

Emory University

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Behavioral: Standard exercise therapy; Behavioral: Smartphone-enabled structured exercise therapy (SE-SET)

Study type: Interventional

Funder types: Other

Identifiers

NCT03479255

IRB00102543

Details and patient eligibility

About

The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Smartphone-enabled structured exercise therapy (SE-SET)

Experimental group

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.

Treatment:

Behavioral: Smartphone-enabled structured exercise therapy (SE-SET)

Standard exercise therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard exercise therapy