Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

NCT01673100 | Completed DMC

• 2 other identifiers: 0178-09-FB5P20NR011404-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Physical Activity

Keywords

physical activity; percutaneous coronary intervention; heart disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physical Activity Measures

  6 months

Study Arms (2)

Physical Activity Promotion Intervention

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.

Behavioral: Physical Activity Promotion Intervention

Atttention Control

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.

Interventions

Physical Activity Promotion Intervention 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.

Physical Activity Promotion Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Bryan LGH Medical Center

Lincoln, Nebraska, 68516, United States

Location

Nebraska Heart Hospital

Lincoln, Nebraska, 68526, United States

Location

MeSH Terms

Conditions

Motor Activity; Heart Diseases

Condition Hierarchy (Ancestors)

Behavior; Cardiovascular Diseases

Study Officials

• Janet L Nieveen, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: August 27, 2012
• Study Start: March 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

US (2)