Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs
Brief Summary: Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are at high risk for cardiovascular disease and death. Most of this risk is mediated through high blood pressure (BP). However, seniors are also at risk for side effects from BP lowering medication. These can be life threatening and costly. Therefore, BP monitoring is required to ensure BP levels are in the recommended range (neither too high nor low).

Home BP monitoring can be used to ensure that BP is in the right range and is recommended for all patients with high BP. Studies in other health care systems show that, to optimally perform home monitoring, the readings should be teletransmitted (electronically sent to the care provider). Additional studies indicate that BP control improves when health care providers (usually pharmacists or nurses) are specifically assigned to review teletransmitted BP readings and, using protocols, make therapeutic adjustments. However, a study needs to be conducted within the Canadian healthcare system to prove that telemonitoring±case management is cost-effective. In addition, proof that seniors consider telemonitoring to be usable and acceptable is required.

The investigators will conduct a 200 patient randomized trial in community-dwelling seniors that will compare home BP monitoring alone to telemonitoring plus case management, to comprehensively assess cost-effectiveness, usability, and acceptability. Our partners include TeleMED, a medium sized Canadian technology company with a wealth of experience in medical data management and transmission; Pharmacare, which will provide case-management services. The study will take place in seniors' supportive living residences; by virtue of residing in these institutions, these seniors have complex care needs. This intervention, if effective, cost-effective and safe, can be widely implemented.


Options:
A: Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Telemonitoring and Case Management; Type: ACTIVE_COMPARATOR; Interventions: Device: Telemonitoring, Other: Case Management | Intervention Type: DEVICE; Name: Telemonitoring; Assigned to Arm(s): Telemonitoring and Case Management | Intervention Type: OTHER; Name: Case Management; Assigned to Arm(s): Telemonitoring and Case Management
B: Arm Label: Standard glycemic control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Arm Label: Intensive glycemic control; Type: EXPERIMENTAL; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Glimepiride; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Rosiglitazone; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control
C: Arm Label: Insulin glargine + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: omega-3 polyunsaturated fatty acids (PUFA), Device: reusable pen device for insulin injection | Arm Label: Insulin glargine + placebo; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: placebo, Device: reusable pen device for insulin injection | Arm Label: Standard care + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: omega-3 polyunsaturated fatty acids (PUFA) | Arm Label: Standard care + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: insulin glargine (HOE901); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo | Intervention Type: DRUG; Name: omega-3 polyunsaturated fatty acids (PUFA); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Standard care + omega-3 polyunsaturated fatty acids | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Insulin glargine + placebo, Standard care + placebo | Intervention Type: DEVICE; Name: reusable pen device for insulin injection; Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo
D: N/A

Answer: A