Supporting Post Myocardial Infarction (MI) Risk Modification Intervention Via Telemedicine Evaluation
NCT00901277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416
Last updated 2014-09-08
Summary
The study is a three-arm design where up to 600 patients hospitalized post-MI are recruited from a large hospital and randomized to either the education group (control group) or one of the two intervention groups. Patients randomized to one of the intervention groups will receive a nurse-administered intervention plus the use of Microsoft's HealthVault web-based platform or solely the use of Microsoft's HealthVault web-based platform and web-based behavioral intervention, both of which includes a behavioral/medication management component. The 12 months effects of the intervention will be evaluated.
For baseline and outcome assessments we will obtain BP, nonfasting LDL, and Hb A1c. Patients will also be surveyed about demographics and health behaviors during the baseline and 12 months. Study personnel serve as a liaison between subjects and their providers; however, all decisions related to clinical care are ultimately left up to the patient's provider. Subjects with serious adverse effects will be advised and assisted in seeking emergency medical care.
Conditions
Interventions
- BEHAVIORAL
-
web intervention
A multi-behavioral, comprehensive approach is proposed addressing up to 13 health behaviors focused on improving subject management of CVD and related health behaviors. This is a web-based intervention.
- BEHAVIORAL
-
nurse intervention
A multi-behavioral, comprehensive approach is proposed addressing up to 13 health behaviors focused on improving subject management of CVD and related health behaviors given by the nurse via phone.
Sponsors & Collaborators
- collaborator OTHER
- lead OTHER
Principal Investigators
-
Hayden Bosworth, Ph.D. · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2013-07-31
- Completion
- 2013-07-31
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