Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
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.


Options:
A: Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Treatment as usual | Arm Label: A; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse-led case management | Intervention Type: BEHAVIORAL; Name: Nurse-led case management; Assigned to Arm(s): A | Intervention Type: BEHAVIORAL; Name: Treatment as usual; Assigned to Arm(s): B
B: Arm Label: Patient Navigator; Type: EXPERIMENTAL; Interventions: Other: Patient Navigator, Other: Usual care | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Patient Navigator; Assigned to Arm(s): Patient Navigator | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Patient Navigator
C: Arm Label: Home Telemonitoring; Type: EXPERIMENTAL; Interventions: Device: Intel Health Guide | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Intervention Type: DEVICE; Name: Intel Health Guide; Assigned to Arm(s): Home Telemonitoring | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care
D: Arm Label: Diabetes-Specific CBT (DS-CBT); Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes-Specific CBT (DS-CBT) | Arm Label: Standard Diabetes Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Diabetes Education | Intervention Type: BEHAVIORAL; Name: Diabetes-Specific CBT (DS-CBT); Assigned to Arm(s): Diabetes-Specific CBT (DS-CBT) | Intervention Type: BEHAVIORAL; Name: Standard Diabetes Education; Assigned to Arm(s): Standard Diabetes Education

Answer: C