Telemonitoring Versus Usual Care

Health Care Quality Clinical Trial

Official title:

A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056640
• Other study ID #: 09-005259
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 25, 2010
• Last updated: January 7, 2013
• Start date: November 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Care Access
• Health Care Quality

Intervention

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.

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 depart — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		12 months	No