Completed

Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

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What is being tested

Physical Activity Promotion Intervention

Behavioral
Who is being recruted

Behavior+1

+ Cardiovascular Diseases

+ Heart Diseases

Over 19 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: March 2011
See protocol details

Summary

Principal SponsorUniversity of Nebraska
Last updated: September 6, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01673100
Principal SponsorUniversity of Nebraska
Last updated: September 6, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorCardiovascular DiseasesHeart DiseasesMotor Activity

Criteria

8 inclusion criteria required to participate
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
Age of 19 years or older
First-time PCI cardiac revascularization
Show More Criteria
3 exclusion criteria prevent from participating
Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as proposed in this study
Physical impairments limiting participation in physical activity and exercise following PCI
Residing in area of Nebraska that does not have cell phone transmission

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

No Intervention
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Bryan LGH Medical Center

Lincoln, United StatesOpen Bryan LGH Medical Center in Google Maps

Nebraska Heart Hospital

Lincoln, United States
Completed2 Study Centers