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Telemonitoring Versus Usual Care

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ClinicalTrials.gov Identifier: NCT01056640
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : February 8, 2013
Last Update Posted : February 8, 2013
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Paul Takahashi,, Mayo Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Health Care Quality Health Care Access Device: Intel Health Guide Other: Usual Care Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
Study Start Date : November 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
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.
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.

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.
Other: Usual Care
The usual care intervention will include appropriate primary care and specialty office practice visits as required.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056640


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
GE Healthcare
Investigators
Principal Investigator: Paul Takahashi, MD Mayo Clinic

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Takahashi,, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01056640     History of Changes
Other Study ID Numbers: 09-005259
First Posted: January 26, 2010    Key Record Dates
Results First Posted: February 8, 2013
Last Update Posted: February 8, 2013
Last Verified: January 2013

Keywords provided by Paul Takahashi,, Mayo Clinic:
telemonitoring
usual care
elderly
hospitalization
Emergency room visits