Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

NCT ID: NCT01673100

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-01
• Study Completion Date: 2014-09-01

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity Promotion Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet L Nieveen, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Bryan LGH Medical Center

Lincoln, Nebraska, United States

Nebraska Heart Hospital

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

5P20NR011404-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0178-09-FB

Identifier Type: -

Identifier Source: org_study_id