Health Care Access, Health Care Quality
Conditions
Keywords
telemonitoring, usual care, elderly, hospitalization, Emergency room visits
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.
Interventions
DEVICEIntel 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.
OTHERUsual Care
The usual care intervention will include appropriate primary care and specialty office practice visits as required.
Sponsors
GE Healthcare
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| 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. | 103 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 15 | 4 |
| Overall Study | Withdrawal by Subject | 11 | 8 |
Baseline characteristics
| Characteristic | Home Telemonitoring | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 97 Participants | 100 Participants | 197 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Age Continuous | 80.3 years STANDARD_DEVIATION 8.9 | 80.2 years STANDARD_DEVIATION 7.6 | 80.3 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 52 Participants | 59 Participants | 111 Participants |
| Sex: Female, Male Male | 50 Participants | 44 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 102 | 0 / 103 |
| serious Total, serious adverse events | 15 / 102 | 4 / 103 |
Outcome results
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
Population: This study utilized an intent-to-treat method. Everyone randomized to study was included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Telemonitoring | 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. | 65 hospitalizations | Standard Deviation 63.7 |
| Usual Care | 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. | 59 hospitalizations | Standard Deviation 57.3 |
Comparison: All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.p-value: 0.0595% CI: [0.747, 2.297]Wilcoxon (Mann-Whitney)