Structuring Diabetes Care in Primary Health Care With Individualized Goals and Multidisciplinary Integration: A Cluster-randomized Clinical Trial for
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Number of patients who achieved individualized target HbA1c
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of reorganization in Primary Health Care teams and individualized glycemic targets for type 2 diabetes.
详细描述
The prevalence of diabetes is increasing in parallel with the obesity epidemic. Diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. Also, it has significant social cost related to reduction of productivity. This study will evaluate the effectiveness of a multimodal intervention for Primary Health Care (PHC) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in Porto Alegre, Brazil. Two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in PHC.
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
- 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
- •Health care unit:
- •Inclusion criteria
- •Health unit has registered at least 50 users diagnosed with type 2 diabetes
排除标准
- •Health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study.
- •Individuals:
- •Inclusion criteria
- •Individuals with type 2 diabetes for at least one year
- •In person diabetes consultation in the last six months
- •Exclusion criteria:
- •Expected survival < one year
研究组 & 干预措施
Intervention
Multimodal intervention in the primary care team that includes: redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of minimum care recommendations
干预措施: Redistribution of diabetes care between nurses and physicians (Other)
Intervention
Multimodal intervention in the primary care team that includes: redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of minimum care recommendations
干预措施: Individualized glycemic target (Other)
Intervention
Multimodal intervention in the primary care team that includes: redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of minimum care recommendations
干预措施: Minimum care recomendations (Other)
Control
Usual follow-up in Primary Health Care (no intervention in the teams)
干预措施: No intervention (Other)
结局指标
主要结局
Number of patients who achieved individualized target HbA1c
时间窗: 12 months
Number of patients who achieved the individualized target HbA1c defined at baseline
次要结局
- Percentage of clinical consultations carried out by nurses(12 months)
- Foot evaluation(12 months)