Telemonitoring Versus Usual Care

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Paul Takahashi,, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01056640
First received: January 25, 2010
Last updated: January 7, 2013
Last verified: January 2013

January 25, 2010
January 7, 2013
November 2009
September 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To evaluate the effectiveness of telemonitoring for reducing hospitalizations, ER visits, and the composite outcomes of hospitalizations and ED visits compared to usual care in a high risk group of adults ≥ 60 years of age with mixed chronic disease. [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01056640 on ClinicalTrials.gov Archive Site
Not Provided
  • To evaluate the effectiveness of telemonitoring for improving functional status, quality of life, patient attitudes, behaviors, compliance, mood, & cognitive status compared to usual care among individuals ≥ 60 years of age with mixed chronic disease [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • To evaluate the effectiveness of home telemonitoring for decreasing total health care costs, 30 day rehospitalization rates, and hospital bed days of care compared to usual care among individuals ≥ 60 years of age with mixed chronic disease [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • To evaluate the effectiveness of home telemonitoring for improving provider satisfaction compared to usual care among a group of primary care providers. [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Telemonitoring Versus Usual Care
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Health Care Quality
  • Health Care Access
  • 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.
  • 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.
    Intervention: Device: Intel Health Guide
  • 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.
    Intervention: Other: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01056640
09-005259
No
Paul Takahashi,, Mayo Clinic
Mayo Clinic
GE Healthcare
Principal Investigator: Paul Takahashi, MD Mayo Clinic
Mayo Clinic
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP