Engaging Home-monitored Assessment to Navigate Clinical Decision-making -The ENHANCe Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Response rate of participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Patient Participants will be blinded to the group they are allocated to
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •for patients:
- •Documentation of dementia diagnosis in EMR
- •Audio or visual impairments
- •Hypertensive urgency or emergency
研究组 & 干预措施
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.
干预措施: ENHANCe app (Device)
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.
干预措施: Teaching and training (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.
干预措施: Teaching and training (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.
干预措施: Usual care (Other)
结局指标
主要结局
Response rate of participants
时间窗: 6 months
Participants agreeable to participate in the study
Agreement with the CDSS recommendation among PCPs
时间窗: 6 months
Proportion of PCPs who agree with the CDSS recommendation in the two groups
Withdrawal rate
时间窗: 6 months
Proportion of participants who withdrew
Study completion rate
时间窗: 6 months
Proportion of participants who completed the intervention
Adverse event rates
时间窗: 6 months
Proportion of adverse events reported in the two groups
Consult duration
时间窗: 6 months
Consult time in the groups
Ease of home blood pressure record assessment among PCPS
时间窗: 6 months
Ease of home blood pressure record assessment among PCPS in the two arms
次要结局
- Proportion of CDSS recommendation followed by the PCPS(6 months)
- Blood pressure control status(6 months)