Application for Self-Monitoring of Cardiovascular Risk
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 23, 2018
March 1, 2018
2.1 years
June 4, 2013
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects who completed all tasks in the application.
These data will provide the best summary of usability of the application.
Baseline to 3 months
Secondary Outcomes (1)
User-reported satisfaction with application.
Baseline to 3 months
Other Outcomes (1)
Body weight
Baseline to 3 months
Study Arms (2)
Self Monitoring of Software Application
OTHERlog 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.
No Intervention
NO INTERVENTIONNo Intervention
Interventions
Computer Software application to track health progress after interventional surgery
Eligibility Criteria
You may qualify if:
- Recently underwent PCI.
- Are eligible for enrollment to the Cardiovascular Health Clinic (CVHC)
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (2)
Widmer RJ, Senecal C, Allison TG, Lopez-Jimenez F, Lerman LO, Lerman A. Dose-Response Effect of a Digital Health Intervention During Cardiac Rehabilitation: Subanalysis of Randomized Controlled Trial. J Med Internet Res. 2020 Feb 26;22(2):e13055. doi: 10.2196/13055.
PMID: 32130116DERIVEDWidmer RJ, Allison TG, Lennon R, Lopez-Jimenez F, Lerman LO, Lerman A. Digital health intervention during cardiac rehabilitation: A randomized controlled trial. Am Heart J. 2017 Jun;188:65-72. doi: 10.1016/j.ahj.2017.02.016. Epub 2017 Feb 20.
PMID: 28577682DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas G Allsion, PHD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 21, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 23, 2018
Record last verified: 2018-03