Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

Physical Activity Clinical Trial

Official title:

Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673100
• Other study ID #: 0178-09-FB
• Secondary ID: 5P20NR011404-03
• Status: Completed
• Phase: N/A
• Start date: March 1, 2011
• Est. completion date: September 1, 2014

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2014
• Est. primary completion date: September 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	Bryan LGH Medical Center	Lincoln	Nebraska
United States	Nebraska Heart Hospital	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Aspects of the Physical Activity Telehealth Intervention	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.	6 months
Secondary	Physical Activity Measures	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).	6 months