Clinical trial NCT01056640: Telemonitoring Versus Usual Care
Official title: A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Health Care Quality
Health Care Access
Keywords: telemonitoring
usual care
elderly
hospitalization
Emergency room visits
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2010-01-26
Enrollment: 205
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul Takahashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.