Heart Failure Clinical Trial

Aetna_Intel Medicare Home Biomonitoring Study

Summary

The hypothesis is that use of Internet-connected home biomonitoring of weight, blood pressure and other indicators, in conjunction with nurse case management, will result in improved outcome for Medicare beneficiaries with with Congestive Heart Failure; compared to case management assistance without the biomonitoring device.

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Full Description

Goals of the Study:

Demonstrate synergy between the Intel® Health Guide home biomonitoring and nurse case management. Measure positive impact on member engagement and clinical outcomes for members with Heart Failure.
Quantify the potential to avoid costly re-hospitalization based on the Intel® Health Guide - enhanced case management interaction through early alerts and early intervention.

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Eligibility Criteria

Inclusion Criteria:

Aetna Medicare (PFFS, HMO/PPO fully insured) Individual members, plus Medicare members from any plan sponsor that has agreed it would like its members to be included
Member meets Aetna Health Profile Database criteria for Chronic Heart Failure (Disease Management Eligibility = Y) with a disease risk stratification score of 3 - 5 (moderately severe to severe). These proprietary criteria yield a group of individuals for whom historical claims data estimates a substantial risk of hospital readmission within the coming 6 months.
Acute inpatient admission or 2 or more emergency room visits within 6 months prior to identification
Residence in the designated geographic areas selected for the study (The planned source population is all New Jersey, New York, Pennsylvania and North Central Aetna Individual Medicare members and North Central. If members identified from these states have not filled the study within three months, the source population may be expanded to include Aetna's North Central region members in Illinois and Ohio. These North Central members would include all Aetna Medicare Individual members in these areas, plus any Group Medicare members from Groups whose Plan Sponsors agree that the study may be offered to the members.)
Member may be currently open/ active in case management

Responds telephonic outreach to offer study participation, or to Interactive Voice Response outreach call, and confirms each of:

Their own identity {secure Health Insurance Portability Accountability Act (HIPAA) compliant acknowledgement to caller}
That they have been told of having a heart condition
Interest in hearing more and possibly participating in the study

Exclusion Criteria:

Member had case management and this was closed within the 30 days prior to identification for the study
End-of life, terminal cancer, end stage renal disease, hospice, late stage Alzheimer's disease, dementia, ventricular assist device, heart transplant or active in heart transplant program. Excluded diagnoses or conditions will be identified where it is evident through Aetna's Health Profile Data diagnoses in claims, or upon case management assessment.
Chronic or ongoing intravenous heart failure medication
Any response to Interactive Voice Response outreach call other than "Yes, I am interested"

Study is for people with:

Heart Failure

Estimated Enrollment:

316

Study ID:

NCT01105572

Recruitment Status:

Completed

Sponsor:

Aetna, Inc.

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There is 1 Location for this study

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Aetna
Princeton New Jersey, 08540, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

316

Study ID:

NCT01105572

Recruitment Status:

Completed

Sponsor:


Aetna, Inc.

How clear is this clinincal trial information?

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