NCT00901277

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Status
completed

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

First Submitted

Initial submission to the registry

May 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

4.1 years

First QC Date

May 11, 2009

Last Update Submit

September 5, 2014

Conditions

Cardiovascular Disease

Keywords

Post MI

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (5)

  • 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.

    12 months

  • 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.

    12 months

  • 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.

    12 months

  • 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

    12 months

  • 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

    12 months

Study Arms (3)

Control

NO INTERVENTION

Usual Care

Web Intervention

EXPERIMENTAL

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

Nurse Intervention

EXPERIMENTAL

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

Interventions

web interventionBEHAVIORAL

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.

Web Intervention
nurse interventionBEHAVIORAL

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.

Nurse Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Zullig LL, Peterson ED, Shah BR, Grambow SC, Oddone EZ, McCant F, Lindquist JH, Bosworth HB. Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE): A randomized trial to improve post myocardial infarction management. Patient Educ Couns. 2022 Sep;105(9):2962-2968. doi: 10.1016/j.pec.2022.05.011. Epub 2022 May 18.

    PMID: 35618550DERIVED

  • Zullig LL, Shaw RJ, Crowley MJ, Lindquist J, Grambow SC, Peterson E, Shah BR, Bosworth HB. Association between perceived life chaos and medication adherence in a postmyocardial infarction population. Circ Cardiovasc Qual Outcomes. 2013 Nov;6(6):619-25. doi: 10.1161/CIRCOUTCOMES.113.000435. Epub 2013 Nov 12.

    PMID: 24221839DERIVED

  • Shah BR, Adams M, Peterson ED, Powers B, Oddone EZ, Royal K, McCant F, Grambow SC, Lindquist J, Bosworth HB. Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):235-42. doi: 10.1161/CIRCOUTCOMES.110.951160.

    PMID: 21406672DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Hayden Bosworth, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 8, 2014

Record last verified: 2014-09