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Smartstep Smartphone PAD

NCT03479255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-03-13

No results posted yet for this study

Summary

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

Conditions

  • Peripheral Arterial Disease

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Woodruff Health Sciences Center Foundation

    collaborator UNKNOWN

  • Emory University

    lead OTHER

Principal Investigators

  • Amit Shah, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2025-02-20
Completion
2025-02-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479255 on ClinicalTrials.gov