A Multicenter Randomized Controlled Evaluation of Heart Failure Disease Management Using Advanced Telecommunications Within a Diverse Provider Network: The Specialized Primary and Networked Care in HF (SPAN-CHF) III Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Number of days hospitalized for heart failure per patient-year of follow-up
研究概览
简要总结
This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a tablet computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
- •Patient able to consent
- •A diagnosis of heart failure with at least one of the following risk factors:
- •Hospitalization for heart failure within the prior year
- •NYHA class III-IV symptoms
- •Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment
排除标准
- •Acute myocardial infarction, PCI or CABG within 30 days before enrollment
- •Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
- •Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
- •Severe angina as the principal cause of limitation
- •Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
- •Moderate to severe dementia such that unable to participate in disease management program
- •Severe visual or auditory disability such that unable to participate in disease management program
- •Hospice care
- •Listed for heart transplantation
- •No access to a working telephone
- •Homeless or no stable home environment
- •Not speaking a language in which the educational documents have been translated
研究组 & 干预措施
Expanded technology disease management
After an initial visit where the program is introduced and education regarding adherence, methods for self-monitoring and early reporting of changes in status are reviewed, patients randomized to this arm will be given tablet computers with a web-based heart failure disease management application. Patients will be asked to interact with the system daily with transmission of weight, heart rate, blood pressure and symptom reports to the nurse manager. A nurse manager will check the data daily and contact patients if any parameters exceed pre-specified parameters. Nurse managers will also touch base with the participants at regular intervals as in the control arm. In addition, educational modules will be placed onto individual tablet computers and given to each patient.
干预措施: Expanded technology disease management (Other)
telephonic disease management
After an initial visit where the program is introduced and education regarding adherence, methods for self-monitoring and early reporting of changes in status are reviewed, the nurse manager will telephone participants weekly for the first month followed by either every two weeks or monthly calls depending on clinical status with the goal of transitioning all participants to monthly calls. During these phone calls the nurse manager will focus on identifying changes in clinical condition and education reinforcement. Participants will be instructed to check and record their weight, heart rate and blood pressure daily and will be encouraged to call if there are any changes in their clinical status.
干预措施: Telephonic disease management (Other)
结局指标
主要结局
Number of days hospitalized for heart failure per patient-year of follow-up
时间窗: 90 days
次要结局
- Cardiovascular Mortality(90 days)
- Change in health status as assessed by the SF-12(90 days)
- Number of days hospitalized for any cause(90 days)
- Number of days hospitalized for cardiovascular causes at 90 days(90 days)
- Change in self-care as assessed by the SCHFI(90 days)
- All Cause Mortality(90 days)