A Randomised Controlled Trial to Improve Hypertension Outcomes Using Wireless Home Blood Pressure Monitoring With Automatic Outcome-based Feedback and Financial Incentives
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Change in Systolic Blood Pressure (SBP)
研究概览
简要总结
Hypertension is a major risk factor for cardiovascular morbidity and mortality. Despite the risks of hypertension and availability of effective treatment, a substantial number of patients have uncontrolled Blood Pressure (BP). Systematic reviews have shown that Home Blood Pressure Monitoring (HBPM) produces modest improvements in BP control and that HBPM yields greater benefits when combined with other interventions such as remote titration change or adherence-enhancing strategies.
The investigators propose a Wireless HBPM System comprising of a Wireless Home Blood Pressure Monitor and a Study Application that aims to: provide text messaging on BP advice and reminders on BP management based on BP readings; promote adherence to BP monitoring and adherence to medication; flag patients for counselling on medication adherence and remote titration (by doctor) during in-between visits; cut the response time in case of emergency; and skip polyclinic visits for well-managed patients.
An additional arm will include the the addition of modest financial incentives for participants when they monitor their BP. This arm is subdivided into two sub-arms (Instant Reward and Health Capital) where patients are eligible to receive the same incentive amounts but framed differently.
This study is novel in its comprehensive approach to patient disease self-management and remote provision of medical care, potentially reducing the burden on the health system and improving patient health outcomes.
详细描述
Hypertension is a major risk factor for cardiovascular morbidity and mortality. The ultimate goal of hypertension treatment is to lower blood pressure (BP) and thereby reduce cardiovascular risk. Despite the risks of hypertension and availability of effective treatment, a substantial number of patients have uncontrolled BP. Systematic reviews have shown that Home Blood Pressure Monitoring (HBPM) produces modest improvements in BP control and that HBPM yields greater benefits when combined with other interventions such as remote titration change or adherence-enhancing strategies.
The effectiveness of HBPM is tempered because many patients with access to home BP monitors fail to regularly measure their BP or respond appropriately to high readings. New technology has made tele-monitoring of patient health feasible and has allowed for measurement and transmission of patient BP and other patient information from the home to a health care provider. An additional strategy to further improve the compliance of the patients with their hypertension management plan is to provide them with a clearer short term benefit, rewarding compliance. For example, those who achieve BP within the target range could receive a financial incentive.
The investigators' strategy to improve the effectiveness of HBPM to reduce BP is to use the full potential of wireless and mobile technology to create automatic feedback loops between the patient and the health care provider. The investigators propose a 6-month randomized controlled trial with 224 hypertensive patients with uncontrolled BP from the SingHealth Polyclinics in Bedok and Marine Parade, Singapore. The proposed trial will be a parallel study with one control arm and two intervention arms in ratio of 2:3:3 with the objective of measuring the incremental effectiveness and cost-effectiveness of an intervention with Wireless HBPM System, with and without financial incentives, compared to non-wireless HBPM alone.
Specifically, the investigators have the following primary aims and hypotheses:
A1: Determine whether a Wireless HBPM System with and without financial incentives is effective at reducing systolic blood pressure (SBP) compared to a non-wireless HBPM that relies on patient self-reporting and best practices (Usual Care, UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known hypertensive patients on at least one anti-hypertensive medication
- •SBP more than or equal to 140 mmHg or DBP more than or equal to 90 mmHg for patients without diabetes, SBP more than or equal to 140 mmHg or DBP more than or equal to 85 mmHg for patients with diabetes, as verified by the average of the last 2 of 3 BP readings taken, on the day of polyclinic visit, at 3 minutes interval using the Omron HEM-7130
- •Aged between 21 to 70 years of age;
- •Singaporean citizens or Permanent Residents;
- •Able to converse in English or Mandarin;
- •Has a compatible smartphone (iOS Versions 8.0 and higher or Android Versions 5.0 and higher) with data plan or regular Wi-Fi access
- •Ability to perform self-monitoring of BP as assessed by the CRC
- •Expecting to be a patient of Bedok or Marine Parade Polyclinics for the duration of the trial
排除标准
- •SBP equal or greater than 180mmHg or DBP equal or greater than 110mmHg, as verified by the average of the last 2 of 3 BP readings taken, on the day of polyclinic visit, at 3 minutes interval using the Omron HEM-7130
- •pregnancy
- •clinically unstable heart failure
- •advanced kidney disease, i.e. eGFR < 30 ml/min
- •known liver disease
- •Atrial Fibrillation
- •underwent Double Mastectomy
- •any other major debilitating disease or mental illness that precludes validity of informed consent or would result in the patient being unable to take their BP independently.
- •started on angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin- receptor blockers (ARB) within the last 3 months
- •on Warfarin or anti-coagulants (e.g. NOACs: Novel Oral Anticoagulants)
- •known allergy to epoxy resin
- •discharged from hospital within the last 3 months for complications related to hypertension
- •newly referred to Specialist Outpatient Clinics (SOCs) or on follow-up for complications related to hypertension
- •severe or overt macro albuminuria (urine ACR>30mg/mmol or PCR>0.5)
- •confirmed glomerulonephritis
- •living in a household where another member has been recruited into the trial
研究组 & 干预措施
Usual Care
Usual care from SingHealth Polyclinics which includes non-wireless HBPM. In addition, participants will receive a medication event monitoring system and will be on ambulatory blood pressure monitoring at baseline and Month 6.
干预措施: Usual Care (Other)
Wireless HBPM System
Usual care from SingHealth Polyclinics with wireless HBPM system. In addition, participants will receive a medication event monitoring system and will be on ambulatory blood pressure monitoring at baseline and Month 6.
干预措施: Wireless HBPM System (Other)
Wireless HBPM System
Usual care from SingHealth Polyclinics with wireless HBPM system. In addition, participants will receive a medication event monitoring system and will be on ambulatory blood pressure monitoring at baseline and Month 6.
干预措施: Usual Care (Other)
Wireless HBPM System and Incentives
Usual care from SingHealth Polyclinics with wireless HBPM system and BP monitoring incentives. In addition, participants will receive a medication event monitoring system and will be on ambulatory blood pressure monitoring at baseline and Month 6.
干预措施: Usual Care (Other)
Wireless HBPM System and Incentives
Usual care from SingHealth Polyclinics with wireless HBPM system and BP monitoring incentives. In addition, participants will receive a medication event monitoring system and will be on ambulatory blood pressure monitoring at baseline and Month 6.
干预措施: Wireless HBPM System (Other)
Wireless HBPM System and Incentives
Usual care from SingHealth Polyclinics with wireless HBPM system and BP monitoring incentives. In addition, participants will receive a medication event monitoring system and will be on ambulatory blood pressure monitoring at baseline and Month 6.
干预措施: BP Monitoring Incentives (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP)
时间窗: Between baseline and Month 6
Change in average SBP between baseline and Month 6 as measured by ambulatory blood pressure monitoring using the Welch Allyn ABPM 7100 monitor. At each time point (baseline and Month 6), ABPM frequency will be set at one BP measurement every 30 minutes for a duration of 12 waking hours, and average SBP will be calculated.
次要结局
- Change in Diastolic Blood Pressure (DBP)(Between baseline and Month 6)
- Mean weekly number of missing BP readings(from Month 1 to Month 6)
- Mean proportion of antihypertensive medication doses not taken(during Month 6)
研究者
Marcel Bilger
Assistant Professor
Duke-NUS Graduate Medical School