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A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
Sponsor study identifier
interventional
205
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 25, 2010
Actual (reported)January 26, 2010
Actual (reported)September 2011
Actual (reported)September 2011
Actual (reported)February 8, 2013
Actual (reported)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
The 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.
The 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.
The 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.
The usual care intervention will include appropriate primary care and specialty office practice visits as required.
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Takahashi PY, Pecina JL, Upatising B, Chaudhry R, Shah ND, Van Houten H, Cha S, Croghan I, Naessens JM, Hanson GJ. A randomized controlled trial of telemonitoring in older adults with multiple health issues to prevent hospitalizations and emergency department visits. Arch Intern Med. 2012 May 28;172(10):773-9. doi: 10.1001/archinternmed.2012.256.
Takahashi PY, Hanson GJ, Pecina JL, Stroebel RJ, Chaudhry R, Shah ND, Naessens JM. A randomized controlled trial of telemonitoring in older adults with multiple chronic conditions: the Tele-ERA study. BMC Health Serv Res. 2010 Sep 1;10:255. doi: 10.1186/1472-6963-10-255.
Patients in the usual care group had access to a tertiary care hospital and to some case management for treatment of heart failure and diabetes. These services may have biased the results to show no difference between the groups.
Paul Takahashi, MD
Mayo Clinic
205 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
February 8, 2013
Results First Posted
February 8, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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