Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs
NCT02721667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2020-11-04
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.
Conditions
Interventions
- DEVICE
-
Telemonitoring
Secure, wireless transmission of home blood pressure measurements that are summarized in a secure health portal for healthcare providers use for clinical management decisions, including calculation of mean BP and graphing of temporal trends.
- OTHER
-
Case Management
Case managers work collaboratively with patients and physicians to optimize health behaviours, monitor risk factors, implement therapeutic adjustments, encourage adherence, and coordinate follow-up care.
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Alberta Innovates Health Solutions
collaborator OTHER -
University of Alberta
lead OTHER
Principal Investigators
-
Raj Padwal, MD, Msc · University of Alberta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2020-05-15
- Completion
- 2020-05-15
Countries
- Canada
Study Locations
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