NCT05969015已完成不适用
Educação em saúde Intensiva na atenção primária à saúde em Pacientes Com Diabetes Mellitus Tipo 2: um Ensaio clínico Randomizado - The Diabetes Care (D-CARE) Study
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude3 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2022年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 3
- 主要终点
- Glycemic control
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.
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
- •Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
- •To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
- •Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
- •T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);
排除标准
- •Pregnant women;
- •People living with HIV/AIDS;
- •T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
- •T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
- •T2DM patients with severe eye and retine disease;
- •Patients participating in another study simultaneously;
- •Patients living with others in the same place.
结局指标
主要结局
Glycemic control
时间窗: at 3-monthly intervals during 18 month
Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)
次要结局
- Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs(at 6-monthly intervals during 18 month)
- All-cause number of health care settings visits(at 6-monthly intervals during 18 month)
- Blood Pressure control(at 6-monthly intervals during 18 month)
- Body mass index(at 6-monthly intervals during 18 month)
- Abdominal circumference(at 6-monthly intervals during 18 month)
- High density lipoprotein levels - HDL-C(at 3-monthly intervals during 18 month)
- Diabetes Attitude Questionnaire (ATT-19)(at 6-monthly intervals during 18 month)
- Attributable number of health care settings visits to type 2 diabetes mellitus(at 6-monthly intervals during 18 month)
- Weight(at 6-monthly intervals during 18 month)
- Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form(at 6-monthly intervals during 18 month)
- Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)(at 6-monthly intervals during 18 month)
- Total cholesterol levels - TC(at 3-monthly intervals during 18 month)
- Height(at 6-monthly intervals during 18 month)
- Depression scores by Hamilton Depression Rating Scale - HDR-S(at 6-monthly intervals during 18 month)
- Creatinine levels(at 3-monthly intervals during 18 month)
- Low density lipoprotein levels - LDL-C(at 3-monthly intervals during 18 month)
- Total triglycerides levels - TG(at 3-monthly intervals during 18 month)
- MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil(at 6-monthly intervals during 18 month)
- Diabetes Mellitus knowledge (DKN-A)(at 6-monthly intervals during 18 month)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
A Study of Attitudes About the Risk of Developing Type 2 DiabetesPrediabetic StateNCT00323349Eastern Virginia Medical School276
招募中
不适用
High-intensity Interval Training Prescriptions to Reduce the Risk of Complications Linked to Type 2 Diabetes: the Role of Interval Length on Clinical Benefits and on Physiological MechanismsDiabetes Mellitus, Type 2NCT04986345Université de Sherbrooke15
已完成
不适用
Healthcare Intervention Program on Treatment Adherence in People With Newly Diagnosed Type 2 Diabetes Mellitus.Treatment AdherenceQuality of LifeGlucose Metabolism Disorders (Including Diabetes Mellitus)NCT05719675Universidad Nacional Autonoma de Mexico24
已完成
1 期
Stem Cell Educator Therapy in Type 2 DiabetesType 2 DiabetesNCT01415726University of Illinois at Chicago25
Unknown
不适用
Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health CareType2 DiabetesEndocrine System DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders (Including Diabetes Mellitus)Diabetes MellitusDiabetes Mellitus, Type 2NCT05090488Indonesia University200