Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM))
研究概览
简要总结
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.
详细描述
Objective:
Assess the 'real world' effectiveness, safety and cost-effectiveness of home BP telemonitoring in combination with protocolized pharmacist case management in community-dwelling seniors with diabetes and hypertension.
Background:
Hypertension, present in over 70% of seniors, causes devastating cardiovascular complications and premature death. Despite its critical importance to health, high BP is uncontrolled in about 35% of seniors with diabetes (i.e., undertreatment). Conversely, antihypertensive drug therapy can excessively lower BP, causing serious adverse effects that warrant drug discontinuation or dose reduction (i.e., overtreatment). Both undertreatment and overtreatment lead to potentially preventable harms and thus need to be minimized.
Office BP measurements are currently used to monitor the vast majority of Canadians with hypertension; however, they are inaccurate and Canadian guidelines (May 2015) instead strongly endorse use of home BP because home readings are more accurate and more convenient to measure. Home readings can be taken in 3 ways: 1. by the patient alone (who bears responsibility for giving the readings to their provider); 2. via telemonitoring, in which readings are automatically summarized and sent to the care provider; 3. through telemonitoring plus protocolized case management, in which the summarized readings are reviewed by a case manager (usually a nurse or pharmacist) authorized to adjust treatments. Telemonitoring and case management is not being used in Canada because validation data in this country are lacking and the pre-requisite tech infrastructure does not exist. The patient alone method is being used exclusively but has many barriers and pitfalls (including failure to take the proper number of readings, report all readings, calculate mean BP, or use this information to optimally manage both inappropriately high and low BP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of hypertension.
- •Adequate English fluency (both verbal and written).
排除标准
- •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.
结局指标
主要结局
Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM))
时间窗: one year
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)
次要结局
- 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)
- Cost-Effectiveness of Telemonitoring(one year)
研究者
Raj Padwal
Professor, Faculty of Medicine and Dentistry
University of Alberta