Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs

NCT02721667 | Completed DMC

• 1 other identifier: CIHR EH2-143571
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Blood pressure; Telemonitoring; Case management; Seniors

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM))

  Proportion of patients with overall 24-hour ABPM in the optimal range (110-129 mmHg in patients 65-79y and 110-139 mmHg in patients 80 y or older)

  one year

Secondary Outcomes (6)

• Blood Pressure

  one year

• Postural Blood pressure changes

  one year

• Antihypertensive Medications

  one year

• Incidence of Treatment-Emergent Adverse Events

  one year

• Cognition

  one year

Other Outcomes (6)

• Cardiovascular Risk Factors

  one year

• Depression

  one year

• Frailty

  one year

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

Participants receive a home BP monitor, are taught how to measure home BP and are encouraged to take BP readings to appointments with their providers. In addition, they will be reminded to perform a home BP series each quarter for study outcome purposes, which will encourage self-monitoring. Home BP readings will be teletransmitted for data collection purposes but neither participants nor providers will have access to the these readings. High BP levels that trigger safety alerts to research personnel are the only exception - participants and their primary care providers will be made aware of these.

Telemonitoring and Case Management

ACTIVE COMPARATOR

Home BP series mean, trends and individual readings will be generated for use by the case manager. Participants in this arm will each be assigned a pharmacist case manager who holds full prescribing privileges and who will: 1. Administer health behaviour modification counselling, teach BP self-monitoring, and monitor medication adherence; 2. Review telemonitored health portal BP summaries and make medication regimen adjustments according to guideline-concordant study protocol; 3. Fax a summary of these adjustments to the participant's primary care provider (to make them aware of treatment changes); and 4. Facilitate communication between participants and providers.

Device: Telemonitoring; Other: Case Management

Interventions

Telemonitoring DEVICE

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.

Telemonitoring and Case Management

Case Management OTHER

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.

Telemonitoring and Case Management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Documented diagnosis of hypertension.
• Adequate English fluency (both verbal and written).

You may not qualify if:

• Systolic BP level \>220 mmHg or diastolic BP level \>110 mmHg on screening BP measurement (WatchBP \[Microlife Corp., Widnau, Switzerland\]).
• Heart failure
• Severe cognitive impairment, defined as a score of ≥ 5 on the Short Portable Mental Status Questionnaire.
• Severe depression (Patient Health Questionnaire \[PHQ-8\] ≥15).
• Foreshortened life expectancy (\<1y).
• Participation in a concurrent cardiovascular trial.
• Currently receiving case management services for cardiovascular risk factor control.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Innovates Health Solutions: collaborator

Study Sites (1)

Seniors independent living or supportive living residences in greater Edmonton.

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Padwal R, McAlister FA, Wood PW, Boulanger P, Fradette M, Klarenbach S, Edwards AL, Holroyd-Leduc JM, Alagiakrishnan K, Rabi D, Majumdar SR. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial. JMIR Res Protoc. 2016 Jun 24;5(2):e107. doi: 10.2196/resprot.5775.

  PMID: 27343147 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Case Management

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Raj Padwal, MD, Msc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Medicine and Dentistry

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 29, 2016
• Study Start: September 1, 2016
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)