Telemonitoring Versus Usual Care

NCT01056640 | Completed Phase 2 Results

• 1 other identifier: 09-005259
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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

Keywords

telemonitoring; usual care; elderly; hospitalization; Emergency room visits

Outcome Measures

Primary Outcomes (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.

  12 months

Study Arms (2)

Home Telemonitoring

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Intel Health Guide 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.

Home Telemonitoring

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 60 years of age;
• have an Elder Risk Assessment (ERA) Index score of 16 or greater;
• Are able to participate fully in all aspects of the study;
• Have been provided with, understand, and have signed the informed consent;

You may not qualify if:

• patients who are currently residing in a nursing home
• patients with a clinical diagnosis of dementia
• patients with a score of ≤29 on the Kokmen short test of mental status
• patients for whom we cannot obtain informed consent.
• patient under the age of 60 will also be excluded from participating.
• patients who have not granted Universal Research Authorization to use medical records.
• patients will also be excluded if the subject would not be able to use the interventional machine

Sponsors & Collaborators

• Mayo Clinic: lead
• GE Healthcare: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 22507696 RESULT

• 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.

  PMID: 20809953 DERIVED

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Paul Takahashi
• Organization: Mayo Clinic

takahashi.paul@mayo.edu

507-284-2511

Study Officials

• Paul Takahashi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 8, 2013
• Results First Posted: February 8, 2013

Record last verified: 2013-01

Locations

US (1)