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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901277 on ClinicalTrials.gov