Early Detection of Anemizations in Primary Care Using Hemoglobinometer: Randomized Clinical Trial Protocol.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Mean Number of hospital admissions
研究概览
简要总结
Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia.
Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. The study randomizes 138 patients with chronic anemia. In the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. If a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. Social, demographic and quality of life variables will be collected from all participants.
Hypothesis:
The results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. The improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. Furthermore, the management of the different interventions by the Case Management Nurse (EGC), in this regard, improves the current fragmentation of the different levels of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People over 40 years old
- •Had received 2 or more red blood cell transfusions due to chronic disease, during a year.
- •The health provider in Primary Care is the Institut Català de la Salut.
排除标准
- •Presenting kidney failure on hemodialysis treatment.
- •Being in palliative care situation
- •Presenting a moderate-severe cognitive impairment, with a Pfeiffer scale score higher than
- •Not having a caregiver able to detect signs of decompensation.
结局指标
主要结局
Mean Number of hospital admissions
时间窗: 6 and 12 months.
Anual mean of hospital admissions caused by haemoglobin concentration decline.
Mean Number of visits to the emergency room
时间窗: 6 and 12 months.
Anual mean of visits to the emergency room caused by haemoglobin concentration decline.
次要结局
- Quality of life self-assessment.(6 and 12 months.)
- Satisfaction with the intervention.(6 and 12 months.)