WIreless Monitoring and Financial Incentives for Uncontrolled HYpertension (WIFHY) Study

NCT03368417 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-03-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Usual Care

Participants will be advised to measure their BP at least 3 times a week and record their results on a form. The participants will be educated on how to interpret their BP according to standard self-monitoring practice guidelines. As part of the study, participants without a HBPM will be provided with the Omron HEM 7130. Adherence to hypertensive medicines will be monitored using the medication event monitoring system eCAP™. In addition, the participants will be asked to undertake ambulatory blood pressure monitoring (using the Welch Allyn ABPM 7100 monitor) at Baseline and Month 6 for a duration of 12 hours, during their waking hours.

OTHER

Wireless HBPM System

BP will be monitored using the iHealth KN-550BT wireless HBPM and transmitted to the study application via the iHealth mobile application. The Wireless HBPM System consists of: i) Instant BP feedback: Classification of each BP reading with feedback SMS. CRC will call the patient in case of alarming BP readings. ii) Weekly HBPM adherence feedback: Participants receive praise, encouraging, or reminder SMSes. iii) Continuous assessment: Based on average BP over the last 4 weeks, participants will be categorized and flagged for the CRC to follow clinical protocols. Protocols include asking patients to immediately come to the clinic, checking for alarm symptoms and discussing adherence over the phone, remote titration, and cancelling 1 clinic visit in case of good BP control.

BEHAVIORAL

BP Monitoring Incentives

Participants will receive an intervention identical to those in the Wireless HBPM System, with financial incentives for BP monitoring. This arm is further randomly subdivided into the Instant Reward and Health Capital arms in a 1:1 ratio. Instant Reward sub-arm: * Participants receive SGD 3 for each day they measure their BP, up to three times per week. * Participants do not receive financial incentive if they do not measure their BP. Health Capital sub-arm: * Participants receive an initial health capital of SGD 72 * Participants' health capital increases by SGD 6 on each week where they measure their BP on at least 3 different days and decreases weekly by 10% per missing BP reading.

Sponsors & Collaborators

  • SingHealth Polyclinics

    collaborator OTHER
  • Duke-NUS Graduate Medical School

    lead OTHER

Principal Investigators

  • Dr Marcel Bilger · Duke-NUS Graduate Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2019-01-27
Completion
2019-01-27

Countries

  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368417 on ClinicalTrials.gov