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NCT01056640 · ClinicalTrials.gov registry record · Phase 2
Telemonitoring Versus Usual Care
A Phase 2 study of Health Care Quality and Health Care Access, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
- 1
- Study location
NCT01056640 is a Phase 2 study of Health Care Quality and Health Care Access that has completed, run by Mayo Clinic. The registered enrollment target is 205 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01056640, a Phase 2 study of Health Care Quality and Health Care Access, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Usual Care
- DEVICE Intel Health Guide
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01056640
The ClinicalTrials.gov registry entry for NCT01056640 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Health Care Quality appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT01056640 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01056640 about?
NCT01056640 is a clinical study titled "Telemonitoring Versus Usual Care". 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:...
What is the current status of trial NCT01056640?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2009-11. Estimated completion is 2011-09.
What conditions does trial NCT01056640 study?
This clinical trial studies the following conditions: Health Care Quality, Health Care Access.
What interventions are being tested in trial NCT01056640?
The interventions under investigation include: Usual Care (OTHER), Intel Health Guide (DEVICE).
Who is sponsoring clinical trial NCT01056640?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01056640 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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