NCT00182182Unknown2 期
Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of:
研究概览
简要总结
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
详细描述
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Educational Counseling Training
- 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
- •Men and women, age more or equal to 65 years AND
- •Diagnosis of HF confirmed with the following criteria:
- •Previous hospital admission for HF OR
- •Definite HF confirmed with the Boston HF criteria OR
- •Possible HF confirmed with the Boston HF criteria AND evidence of left ventricular systolic dysfunction (left ventricular ejection function <40%) on echocardiography, radionuclide angiography, or left ventricular angiogram documented in the patient's family physicians clinic chart.
排除标准
- •Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
- •Patients in a long-term-care facility with nursing care.
- •Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
- •Patients expected to be away from the country during the intervention period for a duration of >3 months.
- •Patients unable or refusing to sign consent.
- •Patients currently followed in the Hamilton Health Sciences HF clinic. These patients are excluded as they are currently enrolled in a HF disease management strategy.
- •Patients currently enrolled in another clinical trial.
结局指标
主要结局
Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of:
ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
Each component of the score will be given one point.
次要结局
- NYHA functional class.
- Other outcomes
- Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
- All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
- Hospitalizations for HF: > 24-hour hospital stay including the time spent in the emergency room with clinical evidence of HF including at least one of the following: increased dyspnea on exertion, orthopnea, nocturnal dyspnea, elevated jugular venous
- Emergency room visits for deterioration of HF requiring IV or additional PO diuretics: <24-hour stay in hospital/emergency room with clinical evidence of HF.
- Referral to Hamilton Health Sciences HF clinic or other institution.
- Quality adjusted survival
- Overall costs
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Integrated Disease Management of Heart Failure in Primary CareHeart FailureNCT04066907Lawson Health Research Institute225
Unknown
4 期
Implementing Standards of Care for Heart Failure Patients in General Practice - A Regional Disease Management ProgramHeart FailureNCT04334447KU Leuven200
Enrolling By Invitation
不适用
Effect Evaluation of Chain Quality Control Management on Patients With Heart FailureHeart FailureNCT05538611Liangying300
已完成
不适用
Economic Evaluation of Heart Failure Management in Colombian ClinicsHeart FailureAsthmaNCT01084564AstraZeneca300
已完成
不适用
Management of patients with heart failure with preserved ejection fraction: what do patients and providers need and want?Heart failure with preserved ejection fraction, impact of COVID-19 (SARS-CoV-2 infection) pandemic on healthcare received and providedCirculatory SystemHeart failureISRCTN13471603Cambridge University Hospitals NHS Foundation Trust50