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.
Full Title of Study: “A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2011
- Device: Intel Health Guide
- 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.
- Other: Usual Care
- The usual care intervention will include appropriate primary care and specialty office practice visits as required.
Arms, Groups and Cohorts
- Experimental: Home Telemonitoring
- 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.
- Active Comparator: Usual Care
- 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.
Clinical Trial Outcome Measures
- 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.
- Time Frame: 12 months
Participating in This Clinical Trial
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 residing in a nursing home 2. patients with a clinical diagnosis of dementia 3. patients with a score of ≤29 on the Kokmen short test of mental status 4. patients for whom we cannot obtain informed consent. 5. patient under the age of 60 will also be excluded from participating. 6. patients who have not granted Universal Research Authorization to use medical records. 7. patients will also be excluded if the subject would not be able to use the interventional machine
Gender Eligibility: All
Minimum Age: 60 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Mayo Clinic
- GE Healthcare
- Provider of Information About this Clinical Study
- Principal Investigator: Paul Takahashi,, MD – Mayo Clinic
- Overall Official(s)
- Paul Takahashi, MD, Principal Investigator, Mayo Clinic
Citations Reporting on Results
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.
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