Evaluation of the Effectiveness of Phone Calls Intervention (TelessaúdeRS) on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Glycemic Control
研究概览
简要总结
The study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group).
详细描述
The investigators designed a randomized controlled trial. Patients with stable and controlled type 2 diabetes, and considered to be eligible to discharge from specialized care to primary care will be included. Patients with severe neuropathy, not controlled ischemic heart disease and nephropathy stage IV/V will be excluded. Enrolled patients will be randomized in two groups: follow-up supported by periodic nurse phone calls plus primary care (intervention group) or followed by primary care team (control group). The intervention group will receive regular telephone calls (every 3 months for 1 year) and will have a toll-free number to resolve questions about the disease management. Main outcome is the glycemic control between groups after 1 year of follow-up. Secondary outcomes include: rate of hypoglycaemia, blood pressure control,emergency visits, nephropathy progression and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes;
- •Patients who met discharges criteria according to endocrinology team;
- •Patients with HbA1C < 8%.
排除标准
- •Patients with stage IV or V nephropathy;
- •Patients with not controlled Ischemic heart disease;
- •Patients with severe autonomous or peripheral neuropathy.
研究组 & 干预措施
Primary Care
Patients will be followed by primary care team exclusively.
干预措施: Primary Care (Other)
Phone Calls Support and Primary Care
Patients will be followed by primary care team and supported by periodic nurse phone calls.
干预措施: Phone Calls Support and Primary Care (Other)
结局指标
主要结局
Glycemic Control
时间窗: 1 year
Evaluation after 1 year of discharge with HbA1c
次要结局
- Visits to the doctor, nurse, nutritionist, psychologist(1 year)
- Death(1 year)
- Care satisfaction with diabetes treatment(1 year)
- Emergency visits because of diabetes acute complications(1 year)
- Antiplatelet therapy/ statin use(1 year)
- Major cardiovascular events(1 year)
- Retinopathy emergence or worsening(1 year)
- Rate of referring to tertiary care(1 year)
- Hypoglycaemic rate(1 year)
- Treatment adherence(1 year)
- Lipid control(1 year)
- Nephropathy emergence or worsening(1 year)