Application for Self-Monitoring of Cardiovascular Risk
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      Patients who recently suffered a heart attack will use a smart-phone/computer application
      during cardiac rehabilitation to reduce their risk of a future attack, their
      re-hospitalizations, their cost of care, and increase their quality of life.
    

Detailed description: 
      The study will consist of two phases - an initial feasibility trial (Phase 1), followed by a
      randomized clinical trial (Phase 2). Once the Phase 1 trial is evaluated, Phase 2 will be
      implemented.

      Phase 1 will consist of up to 35 participants to ensure that the software application is
      user-friendly, properly stores pertinent data, and has no technical glitches. All
      participants in Phase 1 will have access to the software application and will be asked to
      complete online questionnaires, at baseline and post cardiac rehab, to assess their quality
      of life and also their satisfaction with their care and the software application itself.

      Phase 2 will consist of 65 participants. These participants will be randomized to either 1)
      Cardiac Rehab (CR) alone along with answering questionnaires regarding quality of life and
      satisfaction of care or 2) CR along with the software application and the quality of life,
      satisfaction of care and software application questionnaires. All participants (both Phase 1
      and Phase 2) enrolled into the study will be status-post percutaneous coronary intervention
      (PCI). The potential participants will be asked to participate while still in the hospital
      and will be approached as soon as possible after agreeing to participate in CR,. The
      participants who enroll in Phase 2 will be randomized prior to discharge from the hospital.

      All participants in Phase 1 and those in Phase 2 who randomize to the software application
      will be instructed on the use of either the desktop or smart-phone version of the software
      application. Baseline information, including participant name, date of birth, email address,
      and phone number, will be gathered from the participant at that time, and all characteristics
      will be entered by the participant and study coordinator into their own account in the
      application.

      The study will follow all Phase 1 participants and those in Phase 2 who randomize to the
      software application for three months after hospital dismissal and evaluate the following:

        -  Weight/BMI, blood pressure, and heart rate

        -  Usual lab values already gathered for the participant such as lipids, Complete Blood
           Count (CBC), and HgbA1C

        -  Quality of life, disposition, and mood

        -  Participant compliance, satisfaction, and adherence to the application

        -  Re-hospitalizations, participants phone calls, and cost of care

      During the second week of their CR an additional 30-60 minute educational session will be
      required so that the study coordinator can instruct the participant on the software
      application and how to use it.

      We will also ask that participants "log in" to their online account at least 3-4 times weekly
      for important reminders, care tips, and educational materials. This will last the duration of
      their cardiac rehabilitation program (approximately 12 weeks). Specific examples of sections
      within the software application will pertain to medication adherence, diet, exercise,
      educational materials, and reviews of your medical profile.

      Finally, we would ask that participants (all of Phase 1 and those who randomize to the
      software application in Phase 2) to complete online questionnaires, at baseline and post
      cardiac rehab. that assess their quality of life and also their satisfaction with their care
      and the software application itself. This will be used for both data purposes as well as in
      future improvements to the program. These individual surveys will take approximately 5
      minutes to complete. Phase 2 study participants who do not randomize to the software
      application will be sent the quality of life and satisfaction of care questionnaires.
    

Intervention name(s): Self Monitoring Software Application
Intervention type(s): Device
Intervention description(s): Computer Software application to track health progress after interventional surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Coronary artery disease; Percutaneous Intervention; Stent; Balloon angioplasty; Angiogram; Coronary angiogram