NCT03698890

Brief Summary

This study evaluates the impact of the use of a technology-enabled home blood pressure monitor amongst hypertensive patients in primary care. Half of the patients will receive the blood pressure monitor for home monitoring, while the other half will receive usual care at the polyclinic. The hypothesis is tele-monitoring along with nurse led tele-support and medical review (i.e. tele-treatment) can enhance primary care management of hypertension by improving patient outcomes and reducing health costs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

October 1, 2018

Last Update Submit

October 10, 2018

Conditions

Keywords

HypertensionTelehealthPrimary careTeamlet

Outcome Measures

Primary Outcomes (1)

  • Blood pressure control

    Change in systolic and diastolic blood pressure (in mmHg) after 6 months. Readings will be obtained monthly from the MHS portal.

    6 months

Secondary Outcomes (9)

  • Time to blood pressure control

    6 months

  • Proportion of participants with controlled blood pressure

    6 months

  • Healthcare utilization of participants

    6 & 12 months

  • Healthcare costs incurred by participants

    6 & 12 months

  • Number of medications prescribed to participants

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Usual care of 3 to 6-monthly clinic visit

Intervention

EXPERIMENTAL

Network-based home blood pressure monitor (Fora P20b Blood Pressure Monitor) and telephone consult with care team

Device: Network-based home blood pressure monitor

Interventions

A network-based home blood pressure monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the portal for care managers (CM) to review blood pressure readings and provide updates to the patient on blood pressure control. If a patient's blood pressure is elevated, the CM can titrate medications over the phone and provide follow up tele-consultation and necessary treatment.

Also known as: Fora P20b Blood Pressure Monitor
Intervention

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Patients with hypertension only, or hypertension and hyperlipidemia
  • Patients who are cared for by teamlets
  • Patients who are technology savvy and are able and willing to use telemedicine devices, or have a family member who is willing to assist in using telemedicine for blood pressure control
  • Clinic teams who are directly involved in patient care

You may not qualify if:

  • Patients who have cognitive impairment
  • Pregnant patients
  • Patients with hypertension and other chronic illnesses other than hyperlipidemia, such as diabetes.
  • Patients with a history of ischemic heart disease, congestive heart failure, stroke, transient ischemic attack, atrial fibrillation and renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ang Mo Kio Polyclinic

Singapore, 569666, Singapore

RECRUITING

Related Publications (5)

  • Duan Y, Xie Z, Dong F, Wu Z, Lin Z, Sun N, Xu J. Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. J Hum Hypertens. 2017 Jul;31(7):427-437. doi: 10.1038/jhh.2016.99. Epub 2017 Mar 23.

    PMID: 28332506BACKGROUND
  • Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.

    PMID: 24606887BACKGROUND
  • Chandak A, Joshi A. Self-management of hypertension using technology enabled interventions in primary care settings. Technol Health Care. 2015;23(2):119-28. doi: 10.3233/THC-140886.

    PMID: 25515051BACKGROUND
  • Bosworth HB, Olsen MK, Grubber JM, Neary AM, Orr MM, Powers BJ, Adams MB, Svetkey LP, Reed SD, Li Y, Dolor RJ, Oddone EZ. Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):687-95. doi: 10.7326/0003-4819-151-10-200911170-00148.

    PMID: 19920269BACKGROUND
  • Teo SH, Chew EAL, Ng DWL, Tang WE, Koh GCH, Teo VHY. Implementation and use of technology-enabled blood pressure monitoring and teleconsultation in Singapore's primary care: a qualitative evaluation using the socio-technical systems approach. BMC Prim Care. 2023 Mar 16;24(1):71. doi: 10.1186/s12875-023-02014-8.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Valerie Teo

    National Healthcare Group Polyclinics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Physician, Associate Consultant, Deputy Head, Ang Mo Kio Polyclinic

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 9, 2018

Study Start

September 17, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations