Application for Self-Monitoring of Cardiovascular Risk

This study is currently recruiting participants.
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Thomas G. Allison, Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01883050
First received: June 4, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease Which Requires Percutaneous Coronary Intervention(Balloon and/or Stent Treatment).
Device: Self Monitoring Software Application

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Application for Self-Monitoring of Cardiovascular Risk

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percentage of subjects who completed all tasks in the application. [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    These data will provide the best summary of usabilty of the application.


Secondary Outcome Measures:
  • User-reported satisfaction with application. [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    These data will provide additional insights into how users view the application interface and help us modify th edesign to enhance compliance.


Other Outcome Measures:
  • Body weight [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    Weight will be the most sensitive indicator that completion of the tasks assigned in the application lead to subsequent behavioral chance and reducton of cardiovascular risk.


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Self Monitoring of Software Application
log into self monitoring software application from a home computer. Log on 3-4 times weekly for 12 weeks for important reminders, care tips and educational materials.
Device: Self Monitoring Software Application
No Intervention: No Intervention
No Intervention

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) CR alone along with answering questionnaires regarding quality of life and satisfaction of care or 2) CR (Cardic Rehab), 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, CBC (Complete Blood Count), 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recently underwent PCI.
  • Are eligible for enrollment to the CVHC (Cardiovascular Health Clinic)
  • Do not have any physical impediments to physical activity
  • Do not have any impediments to physically attending the Mayo Clinic's CVHC
  • They are willing to incorporate the software application into their CR
  • They must have access to the internet

Exclusion Criteria:

  • - They are unable or unwilling to enroll in CR
  • They are unable to physically attend Mayo Clinic's CVHC CR Program
  • They are unwilling to incorporate the Personal Health Assistant into their CR
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01883050

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Pamela R Vega, B.S.    507-255-6884      
Principal Investigator: Thomas Allison, Ph.D         
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Thomas G. Allison, Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01883050     History of Changes
Other Study ID Numbers: 11-004546
Study First Received: June 4, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Coronary artery disease
Percutaneous Intervention
Stent
Balloon angioplasty
Angiogram
Coronary angiogram

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014