A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
研究概览
简要总结
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).
详细描述
The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of significant vision, hearing, or other communication deficits
- •English speaking;
- •Capable and willing to give informed consent;
- •Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
- •Living in a private home;
- •Hospital admission for Heart Failure or decompensation in the previous 12 months
- •New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
- •Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
- •Left ventricular ejection fraction <40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
- •NYHA class II-III who had an ejection fraction >40% and evidence of diastolic left ventricular dysfunction.
- •Optional subject with a diagnosis of diabetes (indicated by HbA1c >7).
排除标准
- •Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
- •Females who are pregnant, planning to become pregnant within 3 months, or lactating;
- •Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
- •Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
- •End-stage heart failure requiring regular inotropic drug infusions;
- •Chronic renal failure requiring dialysis treatment and
- •Unstable angina.
结局指标
主要结局
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
时间窗: 31 days
31 days post discharge with a heart failure-related hospital re-hospitalization.
次要结局
- Health-related quality of life Questionnaire(31 days)
- Communication with healthcare provider or emergency department(31 days)
- Number of non-conformity issues(31 days)
- Physician satisfaction Questionnaire(31 days)
- Cost of system and intervention per subjects(31 days)
- Subject satisfaction Questionnaire(31 days)