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

NCT03368417 | Terminated

• 1 other identifier: HSRG13MAY009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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

Hypertension

Keywords

Hypertension; Wireless Home Blood Pressure Monitoring; Medication Adherence; Medication Titration; Financial Incentives; Ambulatory Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP)

  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.

  Between baseline and Month 6

Secondary Outcomes (4)

• Change in Diastolic Blood Pressure (DBP)

  Between baseline and Month 6

• Mean weekly number of missing BP readings

  during 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

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Wireless HBPM System

EXPERIMENTAL

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.

Other: Usual Care; Other: Wireless HBPM System

Wireless HBPM System and Incentives

EXPERIMENTAL

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.

Other: Usual Care; Other: Wireless HBPM System; Behavioral: BP Monitoring Incentives

Interventions

Usual Care OTHER

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.

Usual Care; Wireless HBPM System; Wireless HBPM System and Incentives

Wireless HBPM System OTHER

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.

Wireless HBPM System; Wireless HBPM System and Incentives

BP Monitoring Incentives BEHAVIORAL

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.

Wireless HBPM System and Incentives

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• SingHealth Polyclinics: collaborator

Study Sites (2)

Marine Parade Polyclinic

Singapore, 440080, Singapore

Location

Bedok Polyclinic

Singapore, 469662, Singapore

Location

Related Publications (9)

• MacMahon S, Peto R, Cutler J, Collins R, Sorlie P, Neaton J, Abbott R, Godwin J, Dyer A, Stamler J. Blood pressure, stroke, and coronary heart disease. Part 1, Prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet. 1990 Mar 31;335(8692):765-74. doi: 10.1016/0140-6736(90)90878-9.

  PMID: 1969518 BACKGROUND

• Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, Eberlein KA, Godwin J, Qizilbash N, Taylor JO, Hennekens CH. Blood pressure, stroke, and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet. 1990 Apr 7;335(8693):827-38. doi: 10.1016/0140-6736(90)90944-z.

  PMID: 1969567 BACKGROUND

• Wolf-Maier K, Cooper RS, Banegas JR, Giampaoli S, Hense HW, Joffres M, Kastarinen M, Poulter N, Primatesta P, Rodriguez-Artalejo F, Stegmayr B, Thamm M, Tuomilehto J, Vanuzzo D, Vescio F. Hypertension prevalence and blood pressure levels in 6 European countries, Canada, and the United States. JAMA. 2003 May 14;289(18):2363-9. doi: 10.1001/jama.289.18.2363.

  PMID: 12746359 BACKGROUND

• Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.

  PMID: 15652604 BACKGROUND

• Bray EP, Holder R, Mant J, McManus RJ. Does self-monitoring reduce blood pressure? Meta-analysis with meta-regression of randomized controlled trials. Ann Med. 2010 Jul;42(5):371-86. doi: 10.3109/07853890.2010.489567.

  PMID: 20504241 BACKGROUND

• Fahey T, Schroeder K, Ebrahim S. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD005182. doi: 10.1002/14651858.CD005182.

  PMID: 15654709 BACKGROUND

• Ogedegbe G, Schoenthaler A. A systematic review of the effects of home blood pressure monitoring on medication adherence. J Clin Hypertens (Greenwich). 2006 Mar;8(3):174-80. doi: 10.1111/j.1524-6175.2006.04872.x.

  PMID: 16522994 BACKGROUND

• AbuDagga A, Resnick HE, Alwan M. Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. Telemed J E Health. 2010 Sep;16(7):830-8. doi: 10.1089/tmj.2010.0015.

  PMID: 20815751 BACKGROUND

• Bilger M, Koong AYL, Phoon IKY, Tan NC, Bahadin J, Bairavi J, Batcagan-Abueg APM, Finkelstein EA. Wireless Home Blood Pressure Monitoring System With Automatic Outcome-Based Feedback and Financial Incentives to Improve Blood Pressure in People With Hypertension: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jun 9;10(6):e27496. doi: 10.2196/27496.

  PMID: 34106085 DERIVED

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dr Marcel Bilger

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 11, 2017
• Study Start: December 20, 2017
• Primary Completion: January 27, 2019
• Study Completion: January 27, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)