Aetna_Intel Medicare Home Biomonitoring Study

Completed · Not applicable

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID: NCT01105572
Run by: Aetna, Inc.
People needed: 316
Starts: 2008-11-01
Expected to finish: 2010-04-01
Last updated by the study team: 2010-04-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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"

Where it is running

Aetna — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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