TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
试验速览
- 阶段
- 不适用
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
研究概览
简要总结
TEC4Home Heart Failure is a randomized controlled trial (RCT) that examines how home health monitoring (HHM) can support Heart Failure (HF) patients during the transition of care from hospital to home. The HHM solution includes a weight scale, blood pressure cuff, pulse oximeter and tablet computer, which patients use daily for 60 days to record these metrics and answer questions on their symptoms. This data is sent to a nurse who is able to monitor the patient's condition remotely. The hypothesis is that the TEC4Home HHM solution will be a cost-effective strategy to decrease 90-day Emergency Department (ED) revisits and hospital admission rates, and improve quality of life and self-management for patients living with Heart Failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 19 years of age or older (age of majority in British Columbia)
- •Have one or more typical symptoms of Heart Failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) AND
- •Have one or more typical signs of Heart Failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) AND
- •Have one or more objective measures of heart failure:
- •Radiological congestion.
- •Elevated BNP ≥ 400 pg/mL or NT-proBNP ≥ 1000 pg/mL.
- •Reduced left ventricular ejection fraction <40% (or <45%) in previous 12 months.
- •Diastolic dysfunction including tissue Doppler E/e' ratio > 15 in previous 12 months.
- •Pulmonary capillary wedge pressure >20 mmHg.
- •Diuretic therapy. The additional value of diuretic therapy (IV or oral) is debatable, as presumably unlikely (or unsafe) that patient with genuine HF will be discharged without diuretic.
排除标准
- •Physical barriers e.g. unable to stand on scales.
- •Cognitive impairment (e.g. MMSE <20), unless suitable caregiver support.
- •Language (must be able to read and understand English), unless suitable caregiver support.
- •Documented history of current and active substance misuse (within 3 months).
- •Lack digital connectivity or landline phone connection.
- •No regular care provider e.g. GP, or at least regular walk-in clinic.
- •Existing intensive system of care: LVAD, transplant, dialysis.
- •Anticipated improvement due to revascularization (PCI/CABG) or valve intervention during index hospitalization.
- •Anticipated survival <90 days. Active palliative care, less-than level III care, disseminated malignancy.
结局指标
主要结局
Change in the number of emergency department visits 90 days pre to 90 days post enrollment.
时间窗: 90 days
Hospital administrative data will be reviewed to assess the change in the number of emergency department visits 90 day pre to 90 days post enrollment and between study groups.
Change in the number of hospitalizations 90 days pre to 90 days post enrollment.
时间窗: 90 days
Hospital administrative data will be reviewed to assess the number of hospitalizations 90 day pre and 90 days post enrollment and between study groups.
Change in the length (in days) of hospital stays 90 days pre to 90 days post enrollment.
时间窗: 90 days
Hospital administrative data will be reviewed to assess the change in length of stay (measured in days) 90 day pre and 90 days post enrollment and between study groups.
Mortality rate
时间窗: 90 days
Administrative will be reviewed to determine the number of participants who passed away between study groups.
次要结局
- Difference in quality of life (general) scores as assessed by the EuroQol- 5 Dimension Survey (EQ-5D).(90 days)
- Difference in quality of life (HF-specific) scores as assessed by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) scale.(90 days)
- Difference in self-care efficacy scale scores as assessed by the European Heart Failure Self-care Behaviour Scale.(90 days)
- Difference in costs and savings via administrative data and a self-report healthcare utilization survey.(90 days)
- Impact on communication between healthcare providers and patients via surveys.(90 days)
- Impact on communication between healthcare providers and patients via interviews.(90 days)
研究者
Kendall Ho
Lead, Digital Emergency Medicine; Professor, Department of Emergency Medicine, Faculty of Medicine, UBC
University of British Columbia