Supporting Post Myocardial Infarction (MI) Risk Modification Intervention Via Telemedicine Evaluation (SPRITE)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00901277
First received: May 11, 2009
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Behavioral: web intervention
Behavioral: nurse intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Supporting Post MI Risk Modification Intervention Via Telemedicine Evaluation

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-MI patients who receive the nurse administered intervention will have their LDL-C reduced by 20 mg/dl more than education control patients over 12 months of follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Post-MI patients with diabetes who receive the nurse-administered intervention will have their Hb A1c reduced by 0.5% more compared to education control patients over 12 months of follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The reduction of systolic blood pressure in the web-administered intervention will be significantly more than those patients randomized to an education control group over 12 months of follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Post-MI patients who receive the nurse-administered intervention will have higher use of evidence-based medical therapies (e.g., anti-platelets, statins, and ACE-I) compared with control patients at 12 months follow- up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Post-MI patients who receive either intervention will have improved health behaviors (e.g., physical activity, improved diet, lower body mass index) as compared with control patients over 12 months of follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 416
Study Start Date: June 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual Care
Experimental: Web Intervention
Web-based: interactive web-based tool based on Microsoft's HealthVault technology for data transmission, tracking and communication of cardiac risk factors (e.g. home BP monitors for all in this intervention arm)
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.
Experimental: Nurse Intervention
Nurse: an interactive web-based tool based on Microsoft's HealthVault technology for data transmission, tracking and communication of cardiac risk factors (e.g. home BP monitors for all in this intervention arm)
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to Duke University Medical Center (DUMC) with both the diagnosis of acute MI (ICD code 410.01-410.91) and hypertension (ICD-9 code 401.X or clinical diagnosis)
  • A cardiac catheterization at DUMC within the past 3 years
  • Age > 18 years
  • Established or planned follow-up with a primary care/cardiology provider within the Duke University Health System or its Affiliated Clinics

Exclusion Criteria:

Medical Records Exclusion (occurs prior to mailing invitation):

  • Diagnosis of metastatic cancer in the past 6 months
  • Active diagnosis of psychosis or dementia
  • Currently receiving hemodialysis
  • Patients who have had a transplant

Patient-Level Exclusion (occurs at initial interview):

  • Does not have access to a telephone
  • Does not have access to a computer
  • Refusal to provide informed consent
  • Resident in nursing home or receiving home health care
  • Severely impaired hearing or speech (patients must be able to respond to phone calls)
  • Participating in another study (i.e., pharmaceutical trial)
  • NYHA class IV heart failure
  • Does not plan to have long-term follow-up with a primary care provider cardiologist
  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: NCT00901277

Sponsors and Collaborators
Duke University
American Heart Association
Investigators
Principal Investigator: Hayden Bosworth, Ph.D. Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00901277     History of Changes
Other Study ID Numbers: Pro00010063, 0875143N
Study First Received: May 11, 2009
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Post MI

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014