TELEHEART-Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Hospitalization for cardiac reasons
研究概览
简要总结
Objective: to evaluate the possibilities and effect of telemedicine monitoring and management of patients with CHF (compared to patients with CHF without intensive telemedicine monitoring) on quality of life, prognosis and the presence of complications and hospitalisations.
Patients with a stable form of congestive heart failure will be gradually included in the study. Half of them will be defined by random selection to intervention group. Parameters, that can be measured at home will be periodically telemedical monitored. In according with at home monitored data, the own physician will be able to intervene with change of medical treatment in the case of non-physiological deviations in order to improve the health status as well as the prognosis of the patient with CHF.
详细描述
Inclusion criteria:
- Age between 45 and 75
- Congestive heart failure (CHF), NYHA II - VI (any genesis)
- EF less then 45%, any rhythm (sinus or atrial fibrillation)
- More as two months stable condition
- Complete treatment according to recommendations (guidelines): ACEI (alternatively ARNI / sartan) + diuretics + betablockers (as alternative digitalis)
- Without hospitalization with CHF decompensation more as two months before enrolment
- No severe liver disease and hemodialysis treatment
- No planned any cardio-surgery intervention in the next six months
- No a serious valvular defects
Input and output surveys (measurements, tests) upon enrollment and after half a year ECHOCG (mandatory parameters: EF, LVDd, IVCT, E/A, LA diameter, LA area planimetrically) Blod pressure, frequency, ECG (PQ, QT, description: blockages, STT segment changes) Six minutes walking test Serum analysis: NTproBNP, CRP, natrium, potassium, urea, creatinine
Questionnaires:
- Kansas Quality of Life Questionnaire (KCCQ)
- Questionnaire SF 36 (perception of illness)
- Beck's Depression Inventory (21 questions) - depression questionnaire
- Beck's Anxiety Inventory (21 questions) - anxiety questionnaire (standardized questionnaires translated into Slovak)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congestive heart failure (CHF), NYHA II - VI (any genesis)
- •EF less then 45%, any rhythm (sinus or atrial fibrillation)
- •More as two months stable condition
- •Complete treatment according to recommendations (guidelines): ACEI (alternatively ARNI / sartan) + diuretics + betablockers (as alternative digitalis)
- •Without hospitalization with CHF decompensation more as two months before enrolment
排除标准
- •malignant diseases
- •planned cardiac surgery
结局指标
主要结局
Hospitalization for cardiac reasons
时间窗: 6 months
Visit to the emergency room (urgent)
时间窗: 6 months
次要结局
- Calling Quick Medical Assistance home(6 months)
- Fundamental change of treatment (new type of drug, change of drug group, increased dose)(6 months)
- Unplanned visit to cardiology / internist(6 months)
- Fundamental changes in the quality of life according to questionnaires(6 months)