Telemonitoring Versus Usual Care

NCT ID: NCT01056640

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-09-30

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.

Conditions

Health Care Quality; Health Care Access

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intel Health Guide

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Paul Takahashi,

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Takahashi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22507696 (View on PubMed)

Takahashi PY, Hanson GJ, Pecina JL, Stroebel RJ, Chaudhry R, Shah ND, Naessens JM. A randomized controlled trial of telemonitoring in older adults with multiple chronic conditions: the Tele-ERA study. BMC Health Serv Res. 2010 Sep 1;10:255. doi: 10.1186/1472-6963-10-255.

Reference Type: DERIVED

PMID: 20809953 (View on PubMed)

Other Identifiers

09-005259

Identifier Type: -

Identifier Source: org_study_id