Engaging Home-monitored Assessment to Navigate Clinical Decision-making (ENHANCe)

February 2, 2026 updated by: SingHealth Polyclinics

Engaging Home-monitored Assessment to Navigate Clinical Decision-making -The ENHANCe Study

This study is testing a new app called ENHANCe, which is designed to help family doctors manage patients with high blood pressure using readings taken at home.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The researchers want to find out if the app is easy to use in everyday clinic settings, whether doctors find it helpful and are willing to use it, and if it helps improve care. The study will involve 16 doctors and 100 patients with high blood pressure, split into two groups at two clinics. One group will use the ENHANCe app, which can read blood pressure data from different sources-including handwritten notes-and give doctors advice based on that information. The other group will receive regular care without the app. Over six months, researchers will collect feedback from doctors through surveys and group discussions at the end of the study. They'll also track how many people complete the study, how long clinic visits take, whether doctors follow the app's advice, and how well patients' blood pressure is controlled. The goal is to see if the app can help doctors make faster, better decisions and improve health outcomes for people managing their blood pressure at home.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
    • Singapore
      • Singapore, Singapore, Singapore, 150167
        • SingHealth Polyclinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For primary care physicians:

  • PCPs aged 21 years and above.
  • Involved in the clinical management of patients with hypertension in the past six months.

For patients:

  • Patients aged 21 years and above
  • Documentation of hypertension diagnosis in EMR
  • Owns an HBP monitoring device

Exclusion Criteria for patients:

  • Documentation of dementia diagnosis in EMR
  • Audio or visual impairments
  • Hypertensive urgency or emergency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hypertension management using the Clinical Decision Support System
All patients will have access to online educational resources throughout the study. After recruitment, they will receive a nurse-led education on HBP monitoring. The research team will train all primary care physicians (PCPs) on managing patients with hypertension using HBP records. The PCPs in the intervention group will be briefed on how the ENHANCe app works, and its recommendations. The ENHANCe app will be installed on designated mobile phones, and research staff will analyse HBP records during visits, documenting the output for PCPs to use. Based on the app's recommendations, patients will consult with intervention group PCPs 2-3 times throughout the study, with the last follow-up at 6 months. PCPs will complete a consult checklist after each visit. FGDs will be conducted with PCPs at the end of the study. The interviews will be recorded and transcribed for analysis.
Device: ENHANCe app
ENHANCe app is a prototype; it is a smartphone based clinical decision support (CDS) tool to manage patients with hypertension using their home blood pressure. The app will scan patients' home BP records from paper or mobile phone, and provide a recommendation to the doctor on how to manage their blood pressure. The patient will not need to use the device during the study period. However, the recommendation from the ENHANCe app will be available to the doctor to manage your blood pressure during the study period if the patient is in the intervention group.
Other: Teaching and training
All patients will have access to online educational resources throughout the study. After recruitment, they will receive a nurse-led education on HBP monitoring. The research team will train all primary care physicians (PCPs) on managing patients with hypertension using HBP records.
Other: Hypertension management as per usual care without a clinical decision support system
All patients will have access to online educational resources throughout the study. After recruitment, they will receive a nurse-led education on HBP monitoring. The research team will train all primary care physicians (PCPs) on managing patients with hypertension using HBP records. Control group PCPs will manage patients using HBP records at their discretion, with a final follow-up scheduled at 6 months. PCPs will complete a consult checklist after each visit. Research staff will use the ENHANCe app to analyse BP diaries and document outcomes, but control group PCPs will not have access to the app or its results.
Other: Teaching and training
All patients will have access to online educational resources throughout the study. After recruitment, they will receive a nurse-led education on HBP monitoring. The research team will train all primary care physicians (PCPs) on managing patients with hypertension using HBP records.
Other: Usual care
Physicians manage patients using HBP records at their discretion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Response rate of participants
Time Frame: 6 months
Participants agreeable to participate in the study
6 months
Agreement with the CDSS recommendation among PCPs
Time Frame: 6 months
Proportion of PCPs who agree with the CDSS recommendation in the two groups
6 months
Withdrawal rate
Time Frame: 6 months
Proportion of participants who withdrew
6 months
Study completion rate
Time Frame: 6 months
Proportion of participants who completed the intervention
6 months
Adverse event rates
Time Frame: 6 months
Proportion of adverse events reported in the two groups
6 months
Consult duration
Time Frame: 6 months
Consult time in the groups
6 months
Ease of home blood pressure record assessment among PCPS
Time Frame: 6 months
Ease of home blood pressure record assessment among PCPS in the two arms
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of CDSS recommendation followed by the PCPS
Time Frame: 6 months
Proportion of ENHANCe recommendations followed by the PCPs among the two groups
6 months
Blood pressure control status
Time Frame: 6 months
Blood pressure control status among patients in the two groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SingHealth Polyclinics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nanyang Polytechnic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-4269-APP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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