<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673100</url>
  </required_header>
  <id_info>
    <org_study_id>0178-09-FB</org_study_id>
    <secondary_id>5P20NR011404-03</secondary_id>
    <nct_id>NCT01673100</nct_id>
  </id_info>
  <brief_title>Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures</brief_title>
  <official_title>Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the feasibility of using targeted daily cell phone&#xD;
      interaction to facilitate behavior change for physical activity in previously-sedentary&#xD;
      individuals who have recently undergone a percutaneous coronary intervention (PCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regular physical activity is important in the maintenance of cardiovascular health, and is&#xD;
      especially critical for previously sedentary individuals who have undergone percutaneous&#xD;
      coronary intervention (PCI) procedures. Changing behavior to adopt and maintain recommended&#xD;
      physical activity levels in this population is difficult. Interventions to accomplish&#xD;
      behavior change will not work unless they can be adopted into a person's busy lifestyle. This&#xD;
      proposed study fills a gap by testing the feasibility of an innovative, targeted intervention&#xD;
      (Physical Activity Promotion Telehealth Intervention), delivered by a practical and feasible&#xD;
      platform (cell phone). The asynchronous targeted daily interaction will consist of 5-6 text,&#xD;
      picture, and/or video messages delivered to the subject's cell phone each day. Upon&#xD;
      successful completion of this study, it is believed that these feasibility findings will&#xD;
      provide a foundation for the testing of a larger clinical trial to promote physical activity&#xD;
      in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2011</start_date>
  <completion_date type="Actual">September 1, 2014</completion_date>
  <primary_completion_date type="Actual">September 1, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility Aspects of the Physical Activity Telehealth Intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the feasibility of each component of this pilot study, in order to refine the intervention for a larger clinical trial. This will include:&#xD;
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).&#xD;
Evaluate feasibility of the data collection methods (time required for data collection, missing data, reliability estimates of outcomes).&#xD;
Estimate effect sizes for sample size determinations for a future, larger clinical trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Measures</measure>
    <time_frame>6 months</time_frame>
    <description>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:&#xD;
Movement through the stages of readiness for physical activity.&#xD;
Behavior change constructs (self efficacy for exercise, decisional balance, and use of processes for change).&#xD;
Amount of physical activity (estimated energy expenditure per day as measured by the actigraph accelerometer) and exercise (reported minutes exercising per day).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Physical Activity Promotion Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atttention Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity Promotion Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Physical Activity Promotion Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-time PCI cardiac revascularization&#xD;
&#xD;
          -  Age of 19 years or older&#xD;
&#xD;
          -  Residing in a rural community&#xD;
&#xD;
          -  Previously sedentary&#xD;
&#xD;
          -  Physician approval to participate in this study&#xD;
&#xD;
          -  Oriented to person, place, and time&#xD;
&#xD;
          -  Able to see and hear (able to read the screen of a cell phone, and hear audio over a&#xD;
             cell phone)&#xD;
&#xD;
          -  Able to speak and read English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residing in area of Nebraska that does not have cell phone transmission&#xD;
&#xD;
          -  Physical impairments limiting participation in physical activity and exercise&#xD;
             following PCI&#xD;
&#xD;
          -  Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as&#xD;
             proposed in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet L Nieveen, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bryan LGH Medical Center</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Heart Hospital</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>heart disease</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673100
org study id: 0178-09-FB
secondary id: 5P20NR011404-03
nct id: NCT01673100
lead sponsor: 
collaborator: 
has dmc: Yes
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility Aspects of the Physical Activity Telehealth Intervention
time frame: 6 months
description: 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.
measure: Physical Activity Measures
time frame: 6 months
description: 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).
arm group label: Physical Activity Promotion Intervention
arm group type: Experimental
description: 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.
arm group label: Atttention Control
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Physical Activity Promotion Intervention
description: 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.
arm group label: Physical Activity Promotion Intervention
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Janet L Nieveen, PhD, RN
role: Principal Investigator
affiliation: University of Nebraska
facility: 
facility: 
country: United States
responsible party type: Sponsor