Health Care Quality Clinical Trial
Official title:
A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
Background: Older adults with multiple chronic illnesses are at risk for worsening
functional and medical status with ensuing hospitalization. One goal of medical care is to
prevent this decline. One method that may help slow this functional and medical decline is
home telemonitoring.
Specific aim: To determine the effectiveness of home telemonitoring compared to usual care
in reducing combined outcomes of hospitalization and emergency room visits in an at risk
population over 60 years of age.
Materials and Methods: This will be a randomized trial of 200 patients into one of two
interventions. Home telemonitoring involves the use of a computer device at home which
records biometric and symptom data from patients. This information is monitored by mid level
providers associated with the primary care medical practice. Usual care involves patients
who make appointments with their providers as problems arise and utilize ongoing support
like a 24 hours nurse line. The study participants are adults over 60 years of age within
the highest 10% on elderly risk assessment (ERA) scores. Patients will have initial
evaluations of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9.
Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency
room visits. Secondary analysis will include quality of life, compliance with the device and
attitudes about telemonitoring. Sample size is based upon an 80% power to detect a 36%
difference between the groups. The primary analysis will involve Cox proportional time to
event analysis comparing both interventions for telemonitoring or usual care. Secondary
analysis will use T-test comparisons for continuous variables (quality of life, attitudes)
and chi square for proportional analysis.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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