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Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janet Nieveen, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01673100
First received: August 19, 2012
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention
Physical Activity
Behavioral: Physical Activity Promotion Intervention

Study Type: Interventional
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

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673100

Contacts
Contact: Janet Nieveen, PhD 402-472-7337 jlnievee@unmc.edu
Contact: Lani Zimmerman, PhD 402-472-3847 lzimmerm@unmc.edu

Locations
United States, Nebraska
Bryan LGH Medical Center Recruiting
Lincoln, Nebraska, United States, 68516
Principal Investigator: Janet Nieveen, PhD         
Nebraska Heart Hospital Recruiting
Lincoln, Nebraska, United States, 68526
Principal Investigator: Janet Nieveen, PhD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Janet L Nieveen, PhD, RN University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Janet Nieveen, Janet Nieveen, PhD, RN, UNMC College of Nursing, University of Nebraska
ClinicalTrials.gov Identifier: NCT01673100     History of Changes
Other Study ID Numbers: 178-09-FB, 5P20NR011404-03
Study First Received: August 19, 2012
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
physical activity
percutaneous coronary intervention
heart disease

ClinicalTrials.gov processed this record on November 27, 2014