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Clinical Trials/NCT01673100
NCT01673100
Completed
Not Applicable

Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

University of Nebraska2 sites in 1 country50 target enrollmentMarch 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Nebraska
Enrollment
50
Locations
2
Primary Endpoint
Feasibility Aspects of the Physical Activity Telehealth Intervention
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (PCI).

Detailed Description

Regular physical activity is important in the maintenance of cardiovascular health, and is especially critical for previously sedentary individuals who have undergone percutaneous coronary intervention (PCI) procedures. Changing behavior to adopt and maintain recommended physical activity levels in this population is difficult. Interventions to accomplish behavior change will not work unless they can be adopted into a person's busy lifestyle. This proposed study fills a gap by testing the feasibility of an innovative, targeted intervention (Physical Activity Promotion Telehealth Intervention), delivered by a practical and feasible platform (cell phone). The asynchronous targeted daily interaction will consist of 5-6 text, picture, and/or video messages delivered to the subject's cell phone each day. Upon successful completion of this study, it is believed that these feasibility findings will provide a foundation for the testing of a larger clinical trial to promote physical activity in this population.

Registry
clinicaltrials.gov
Start Date
March 1, 2011
End Date
September 1, 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • First-time PCI cardiac revascularization
  • Age of 19 years or older
  • Residing in a rural community
  • Previously sedentary
  • Physician approval to participate in this study
  • Oriented to person, place, and time
  • Able to see and hear (able to read the screen of a cell phone, and hear audio over a cell phone)
  • Able to speak and read English.

Exclusion Criteria

  • Residing in area of Nebraska that does not have cell phone transmission
  • Physical impairments limiting participation in physical activity and exercise following PCI
  • Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as proposed in this study

Outcomes

Primary Outcomes

Feasibility Aspects of the Physical Activity Telehealth Intervention

Time Frame: 6 months

Evaluate the feasibility of each component of this pilot study, in order to refine the intervention for a larger clinical trial. This will include: * Evaluate all aspects of implementation (numbers of subjects contacted, enrollment, attrition; problems and solutions identified using the telehealth platform, time for delivery; subject acceptance and perception). * Evaluate feasibility of the data collection methods (time required for data collection, missing data, reliability estimates of outcomes). * Estimate effect sizes for sample size determinations for a future, larger clinical trial.

Secondary Outcomes

  • Physical Activity Measures(6 months)

Study Sites (2)

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