Hypertension Clinical Trial
Official title:
A Randomised Controlled Trial to Improve Hypertension Outcomes Using Wireless Home Blood Pressure Monitoring With Automatic Outcome-based Feedback and Financial Incentives
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.
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).
H1a: The average reduction in SBP at 6 months will be greater for the patients in the
intervention arms (Wireless HBPM System with and without Incentives) compared to UC patients.
H1b: The average reduction in SBP at 6 months will be greater for the patients in the
Wireless HBPM System with incentives arm compared to those in the Wireless HBPM System
without incentives arm.
As well as the following secondary aims and hypotheses:
A2: Determine whether a Wireless HBPM System with and without financial incentives is
effective at reducing diastolic blood pressure (DBP) compared to a non-wireless HBPM that
relies on patient self-reporting and best practices (Usual Care, UC).
H2a: The average reduction in DBP at 6 months will be greater for the patients in the
intervention arms (Wireless HBPM System with and without incentives) compared to UC patients.
H2b: The average reduction in DBP at 6 months will be greater for the patients in the
Wireless HBPM System with incentives arm compared to those in the Wireless HBPM System
without incentives arm.
A3: Quantify the incremental cost-effectiveness of Wireless HBPM System without incentives
compared with UC, and of Wireless HBPM System with incentives compared to Wireless HBPM
without Incentives.
H3a: The Incremental Cost-Effectiveness Ratio (ICER) of Wireless HBPM System without
incentives compared to UC will be favorable relative to international benchmarks for
cost-effectiveness analysis.
H3b: The ICER of Wireless HBPM System with incentives compared to Wireless HBPM System
without incentives will be favorable relative to other published RCTs with primary aim of
reducing SBP.
A4: Determine whether a Wireless HBPM System with and without financial incentives is
effective at decreasing patient non-adherence to BP self-monitoring and hypertensive
medicines compared to a non-wireless HBPM that relies on patient self-reporting and best
practices (Usual Care, UC).
H4a, H4b: The average number of missing BP measurements (H4a) and percentage of medication
doses not taken (H4b) during the last month of the study will be smaller for the patients in
the intervention arms (Wireless HBPM System with and without incentives) compared to UC
patients.
H4c, H4d: The average number of missing BP measurements (H4c) and percentage of medication
doses not taken (H4d) during the last month of the study will be smaller for the patients in
the Wireless HBPM System with incentives arm compared to those in the Wireless HBPM System
without incentives arm.
A5: Determine whether financial incentives framed as health capital is effective at
decreasing patient non-adherence to BP self-monitoring compared to financial incentives
framed as a reward.
H5: The average number of missing BP measurements over the intervention period will be
smaller for the patients in the Health Capital sub-arm compared to those in the Instant
Reward sub-arm.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Recruiting |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
| Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
| Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
| Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
| Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
| Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
| Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
| Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
| Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |