A Patient-centered Mobile Intervention to Promote Self-management and Improve Patient Outcomes in Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- Minnesota Living with Heart Failure Questionnaire (MLHFQ)
研究概览
简要总结
In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.
详细描述
HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management.
All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 years old or older
- •Left ventricular ejection fraction </= 40% or an LVEF > 40% (with left atrial size >40mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml)
- •Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks.
- •Smartphone (iOS or Android) with home wifi
排除标准
- •Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI)
- •Primary valvular heart disease
- •Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus)
- •Uncorrected thyroid disease
- •Advanced renal disease (dialysis or creatinine >4.0 mg/dL)
- •End-stage HF (hospice candidate, home milrinone or dobutamine)
- •Active cancer
- •Pulmonary fibrosis
- •Discharge to a setting other than home
结局指标
主要结局
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
时间窗: Change from Baseline MLHFQ at Week 12
MLHFQ is a quality of life questionnaire for heart failure.
次要结局
- Hospitalizations(Over 12 weeks)
- Self-Care Heart Failure Index (SCHFI)(Change from Baseline SCHFI at Week 12)
- Mortality(Over 12 weeks)
研究者
Todd M Koelling, MD
Professor of Internal Medicine
University of Michigan