Aetna_Intel Medicare Home Biomonitoring Study

NCT ID: NCT01105572

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-04-30

Brief 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.

Detailed 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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Intel Home Health Guide

Participants in the intervention group will receive the use of the Intel Healthguide, an Internet-connected device with member-customized protocols and response algorithms. Participants interact with the Intel HealthGuide device, receiving immediate feedback when transmitting blood pressure, weights and responses to questions to a site monitored by their nurse case manager. Medicare Case Managers review and coordinate services for members with multiple and complex needs with identified gaps in their care. Medicare Case Management staff strives to enhance the member's quality of life, support continuity of care, facilitate provision of services in the appropriate setting and manage cost and resource allocation to promote quality, cost-effective outcomes.

Group Type: EXPERIMENTAL

Intel Health Guide

Intervention Type: DEVICE

An Internet-connected device with member-customized protocols and response algorithms. Participants interact with the Intel HealthGuide device, receiving immediate feedback, and also transmitting blood pressure, weights and responses to questions to a site monitored by their nurse case manager.

Case Management Only

All participants in the comparison group, are identified for outreach and assistance by a nurse case manager. Specialized Medicare Case Managers review and coordinate services for members with multiple and complex needs with identified gaps in their care. Medicare Case Management staff strives to enhance the member's quality of life, support continuity of care, facilitate provision of services in the appropriate setting and manage cost and resource allocation to promote quality, cost-effective outcomes.

Group Type: NO_INTERVENTION

Case Management

Intervention Type: OTHER

Specialized Medicare Case Managers review and coordinate services for members with multiple and complex needs with identified gaps in their care Medicare Case Management staff strives to enhance the member's quality of life, support continuity of care, facilitate provision of services in the appropriate setting and manage cost and resource allocation to promote quality, cost-effective outcomes. Specially trained Medicare Case Managers collaborate with the member, family, caregiver, member authorized representative, treating practitioner, health care provider, community services and other Aetna programs to coordinate care, with a focus on member education and maximizing quality outcomes.

Interventions

Intel Health Guide

An Internet-connected device with member-customized protocols and response algorithms. Participants interact with the Intel HealthGuide device, receiving immediate feedback, and also transmitting blood pressure, weights and responses to questions to a site monitored by their nurse case manager.

Intervention Type: DEVICE

Case Management

Specialized Medicare Case Managers review and coordinate services for members with multiple and complex needs with identified gaps in their care Medicare Case Management staff strives to enhance the member's quality of life, support continuity of care, facilitate provision of services in the appropriate setting and manage cost and resource allocation to promote quality, cost-effective outcomes. Specially trained Medicare Case Managers collaborate with the member, family, caregiver, member authorized representative, treating practitioner, health care provider, community services and other Aetna programs to coordinate care, with a focus on member education and maximizing quality outcomes.

Intervention Type: OTHER

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"

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intel Corporation

INDUSTRY

Sponsor Role: collaborator

Aetna, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Aetna, Inc

Principal Investigators

Marcia Wade, MD

Role: PRINCIPAL_INVESTIGATOR

Aetna, Inc.

Locations

Aetna

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

Biomonitoring099

Identifier Type: -

Identifier Source: org_study_id