Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
A Randomized Controlled Trial to Evaluate the Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
The chronic disease burden is increasing worldwide leading to a rise in the demand for primary healthcare and a shortage of primary care physicians. Addressing this shortage entails a multi-prong approach with innovations in care delivery, greater use of healthcare technology, and more efficient use of all healthcare providers on the care team.
We previously developed an interactive self-service healthcare kiosk (Self-empowering and enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. A feasibility study using SEEK showed high levels of acceptance and satisfaction from patients and healthcare providers.
The aim of this follow-up study is to evaluate the health outcomes of patients with stable chronic disease who are on kiosk management compared to patients who are on routine management by nurse clinicians. We hypothesize that patients who are managed by the kiosk continue to maintain good disease control that are comparable to patients who are managed by a nurse clinician.
研究概览
详细说明
Patients who seek primary healthcare vary in their time and resource requirements. Patients with acute medical conditions or poorly controlled chronic disease typically require more time and attention compared to patients with stable chronic disease.
Patients with chronic disease routinely make follow-up visits to their primary care provider for assessment of their chronic disease status and for changes to their medications as necessary. Patients with well-controlled stable chronic disease may go through several visits to their primary care provider in 3 or 4-monthly intervals with little or no change to their medication regimen. These patients have to wait in line with the rest of the patient crowd for a doctor's consultation before getting their regular supply of medications. We hence saw the potential of replacing some of these physician visits with an automated healthcare kiosk so that if the disease condition of such patients remained stable, they can continue on their current medications without having to see a doctor.
We previously described the feasibility of using an automated healthcare kiosk (SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. We propose a follow-up study to show equivalence of health outcomes for patients managed with SEEK compared to the current standard of care. The study will be a 2-armed randomized controlled trial of 120 patients with stable chronic disease on 4-monthly follow-up visits over a 12-month period. Patients will be assigned randomly to intervention or control groups to receive kiosk or nurse management respectively. The main primary outcome measure is the overall chronic disease control of the patients. Other primary outcome measures are the blood pressure and low-density lipoprotein cholesterol levels for patients without diabetes; and blood pressure, low-density lipoprotein cholesterol and hemoglobin A1c levels for patients with diabetes. Secondary outcome measures are visit duration, patient satisfaction with the management process, health-related quality of life, and the occurrence of any adverse event.
The potential benefits from the use of SEEK are:
- Appropriate stratification of patient care needs so that more time and resources can be channeled to patients with complex or acute needs;
- Patient empowerment in the management of their chronic health conditions, with flexibility of self-care and monitoring and decreased dependency on healthcare providers;
- Substitution of nurse clinicians for the management of stable chronic disease;
- Reduction in the number of doctor visits per year for patients with stable chronic disease.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Singapore、新加坡
- 招聘中
- SingHealth Polyclinics - Punggol
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接触:
- Executive
- 电话号码:6643 6969
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- are between the ages of 21 and 75 years
- have at least one chronic medical condition that includes hypertension, hyperlipidemia, diabetes mellitus
- have blood pressure, low-density lipoprotein cholesterol (LDL-C) and HbA1c levels within the recommended targets according to the Ministry of Health Singapore clinical practice guidelines for their current and last follow-up visits
- are able to provide informed consent.
Exclusion Criteria:
- have serum creatinine more than 140 mmol/L (from tests done within the past year)
- have serum potassium less than 3.5 mmol/L or more than 5 mmol/L (from tests done within the past year)
- have overt proteinuria (urine protein:creatinine ratio more than 0.5)
- were discharged from hospital or specialist follow-up within the last 6 months
- have any pending laboratory or investigation result
- are scheduled for any laboratory investigation within the next 4 months (except HbA1c or panel test)
- have any new complaint related to their chronic medical conditions
- have a known history of white coat hypertension
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Kiosk intervention group
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SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:
其他名称:
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无干预:Nurse clinician control group
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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血压
大体时间:12个月
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12个月
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血红蛋白 A1c
大体时间:12个月
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12个月
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Disease control
大体时间:12 months
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12 months
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Low-density lipoprotein cholesterol
大体时间:12 months
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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不良事件
大体时间:12个月
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12个月
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Visit duration
大体时间:8 months
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8 months
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Patient satisfaction questionnaire
大体时间:12 months
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The following areas of patient satisfaction will be scored on a Likert scale: convenience of visit schedule, location of kiosk or nurse consultation, appropriateness of management, duration of time spent in kiosk usage or nurse consultation, and the replacement of a doctor's visit by the kiosk or nurse clinician.
Qualitative feedback will be captured via free-text inputs.
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12 months
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Health-related quality of life questionnaire
大体时间:12 months
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Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
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12 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Kiosk intervention group的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的