Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures|
- Feasibility Aspects of the Physical Activity Telehealth Intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
- Physical Activity Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Pilot test the impact of the Physical Activity Promotion Telehealth Intervention in post-PCI patients over time compared to patients receiving attention only, on the following outcomes:
- Movement through the stages of readiness for physical activity.
- Behavior change constructs (self efficacy for exercise, decisional balance, and use of processes for change).
- Amount of physical activity (estimated energy expenditure per day as measured by the actigraph accelerometer) and exercise (reported minutes exercising per day).
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Physical Activity Promotion Intervention
Subjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. These messages will be tips to help them engage in physical activity and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity.
Behavioral: Physical Activity Promotion Intervention
Subjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. Depending on the subject's responses to the questionnaires at baseline (stages and processes of change) they will be given tips to help them engage in physical activity (such as messages to increase their self-efficacy or confidence, walking with a friend or spouse, breaking up physical activity bouts into 10 minutes bouts, etc.) and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity.
No Intervention: Atttention Control
Subjects in the attention control group will receive only general health messages on their study cell phone (not physical activity promoting messages). They also will receive any usual post-PCI procedure care that all get.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673100
|Contact: Janet Nieveen, PhDemail@example.com|
|Contact: Lani Zimmerman, PhDfirstname.lastname@example.org|
|United States, Nebraska|
|Nebraska Heart Hospital||Recruiting|
|Lincoln, Nebraska, United States, 68526|
|Principal Investigator: Janet Nieveen, PhD|
|Bryan LGH Medical Center||Recruiting|
|Lincoln, Nebraska, United States, 68516|
|Principal Investigator: Janet Nieveen, PhD|
|Principal Investigator:||Janet L Nieveen, PhD, RN||University of Nebraska|