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
Results First Received: November 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Health Care Quality
Health Care Access
Interventions: Device: Intel Health Guide
Other: Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began on 11/21/09 and completed on 08/07/10. Interested subjects who passed a phone prescreen were seen at the study center or in their homes for consenting and additional study procedures to determine eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If study subjects consented to be in study and were found to be eligible, they were randomized to be in study. If they were randomized to receive the telemonitor, within 3-5 days the study team make arrangements to go to their home to install the telemonitor.

Reporting Groups
  Description
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.

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.

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.

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


Participant Flow:   Overall Study
    Home Telemonitoring     Usual Care  
STARTED     102     103  
COMPLETED     76     91  
NOT COMPLETED     26     12  
Withdrawal by Subject                 11                 8  
Death                 15                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.

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

Total Total of all reporting groups

Baseline Measures
    Home Telemonitoring     Usual Care     Total  
Number of Participants  
[units: participants]
  102     103     205  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     3     8  
>=65 years     97     100     197  
Age  
[units: years]
Mean ± Standard Deviation
  80.3  ± 8.9     80.2  ± 7.6     80.3  ± 8.2  
Gender  
[units: participants]
     
Female     52     59     111  
Male     50     44     94  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paul Takahashi
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: takahashi.paul@mayo.edu


No publications provided by Mayo Clinic

Publications automatically indexed to this study:

Responsible Party: Paul Takahashi,, 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