Application for Self-Monitoring of Cardiovascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
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

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

  Show Detailed Description

  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
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: 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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014