Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in treatment adherence
研究概览
简要总结
This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •were over 18 years with a primary diagnosis of HF,
- •had been hospitalized at least once time as a consequence of a HF decompensation,
- •had a Smartphone,
- •had access to WiFi,
- •had access to a weight scale and to a blood-pressure monitor
排除标准
- •illiterate patients,
- •had learning difficulties,
- •had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.
研究组 & 干预措施
Telemonitoring
干预措施: Home Telemonitoring System (HTS) (Other)
Usual Care
结局指标
主要结局
Changes in treatment adherence
时间窗: 3-month
Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
Changes in self-care
时间窗: 3-month
Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire
次要结局
- Rate of Rehospitalizations(3-month)
研究者
Lucía María Yanicelli
PhD in Exact Sciences and Engineering
Universidad Nacional de Tucuman