Engaging Home-monitored Assessment to Navigate Clinical Decision-making

Official title

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

Overview

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.

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.

Interventions

• 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
• 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

Primary outcome measures

• Response rate of participants [Time frame: 6 months]
• Agreement with the CDSS recommendation among PCPs [Time frame: 6 months]
• Withdrawal rate [Time frame: 6 months]
• Study completion rate [Time frame: 6 months]
• Adverse event rates [Time frame: 6 months]
• Consult duration [Time frame: 6 months]
• Ease of home blood pressure record assessment among PCPS [Time frame: 6 months]

Secondary outcome measures (2)

• Proportion of CDSS recommendation followed by the PCPS [Time frame: 6 months]
• Blood pressure control status [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Singapore · 1 center

• SingHealth Polyclinics — Singapore

Identifiers

NCT: NCT07399912 · 2024-4269-APP1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗