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Intel Health Guide, Usual Care

Phase 2

Health Care Quality | Unknown | Other |GE HealthCare Technologies Inc.|Last Updated: Feb 8, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment205
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01056640Telemonitoring Versus Usual CarePHASE2 COMPLETED 205Nov 1, 2009Sep 1, 2011Feb 8, 20131 United States
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Study Endpoints
Primary Endpoints
Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease.
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Home TelemonitoringEXPERIMENTALThe Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Usual CareACTIVE_COMPARATORThe usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Interventions
NameTypeDescription
Intel Health GuideDEVICEThe Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
Usual CareOTHERThe usual care intervention will include appropriate primary care and specialty office practice visits as required.
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion: 1. at least 60 years of age; 2. have an Elder Risk Assessment (ERA) Index score of 16 or greater; 3. Are able to participate fully in all aspects of the study; 4. Have been provided with, understand, and have signed the informed consent; Exclusion: 1. patients who are currently residin...

Countries:United States
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