Application for Self-Monitoring of Cardiovascular Risk

This study has been completed.
Information provided by (Responsible Party):
Thomas G. Allison, Ph.D., Mayo Clinic Identifier:
First received: June 4, 2013
Last updated: September 30, 2015
Last verified: September 2015

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.

Enrollment: 80
Study Start Date: May 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 100 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01883050

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Thomas G. Allison, Ph.D., PI, Mayo Clinic Identifier: NCT01883050     History of Changes
Other Study ID Numbers: 11-004546
Study First Received: June 4, 2013
Last Updated: September 30, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on October 02, 2015