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
  Purpose

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 Intervention Phase
Health Care Quality
Health Care Access
Device: Intel Health Guide
Other: Usual Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary 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 ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Mayo Clinic

Additional 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
Study First Received: January 25, 2010
Results First Received: November 6, 2012
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014