Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,334
- 试验地点
- 2
- 主要终点
- Change in Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
Objective:
- To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
- To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.
Methodology:
Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participating FCUs were not told about their intervention assignment (groups 1-4) until the last patient agreed to participate at every FCU. To warrant patient participation and cooperation, interventions could neither be blinded to patients nor to healthcare professionals. Data analysis is blinded to the intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM diagnosis
- •aged between 18 and 65
- •Health professionals:
- •primary health care teams (PHCT) comprising a primary care physician and a nurse practitioner associated to a patient will be selected
- •must have a permanent position or a stable substitute position
排除标准
- •peripheral vascular disease
- •diabetic nephropathy and/or chronic kidney disease
- •cognitive impairment, dementia
- •major depression
- •insufficient level of Spanish
- •to be pregnant or planning to become pregnant in the next 6 months
- •cancer last 5 years
- •ischemic disease or heart failure
- •proliferative diabetic retinopathy
结局指标
主要结局
Change in Glycosylated hemoglobin (HbA1c)
时间窗: Baseline and 12 months
Change in Glycosylated hemoglobin from baseline to 12 months
次要结局
- Change in HDL level(Baseline and 6, 12 and 24 months)
- Change in LDL level(Baseline and 6, 12 and 24 months)
- Change in Total cholesterol level(Baseline and 6, 12 and 24 months)
- Medication administration(Baseline and 6, 12, 18 and 24 months)
- Change in Weight(Baseline and 3, 6, 12, 18 and 24 months)
- Change in ADDQoL score(Baseline and 6, 12, 18 and 24 months)
- Change in tabacco consumption(Baseline and 3, 6, 12, 18 and 24 months)
- Acceptability of interventions and satisfaction (INDICA-SATP)(24 months)
- Change in Diabetes Knowledge(Baseline, 12 and 24 months)
- Change in Glycosylated hemoglobin (HbA1c)(Baseline and 3, 6, 18 and 24 months)
- Change in Waist circumference(Baseline and 3, 6, 12, 18 and 24 months)
- Change in Body Mass Index (BMI)(Baseline and 3, 6,12, 18 and 24m)
- Change in Triglycerides(Baseline and 6, 12 and 24 months)
- Change in International Physical Activity Questionnarie (IPAQ) score(Baseline and 6, 12, 18 and 24 months)
- Change in Diabetes Empowerment Scale - Short Form (DES-SF) score(Baseline, 12 and 24 months)
- Change in Basal glucose(Baseline and 3, 6, 12, 18 and 24 months)
- Change in EQ-5D index(Baseline and 6, 12, 18 and 24 months)
- Change in Mediterranean Diet Adherence Screener (MEDAS) score(Baseline and 6, 12, 18 and 24 months)
- Change in Stait-Trait Anxiety Inventory (STAI) score(Baseline, 12 and 24 months)
- Change in Beck Depression Inventory - II (BDI-II) score(Baseline, 12 and 24 months)
- Change in Diabetes Distress Scale (DDS2) score(Baseline, 12 and 24 months)
- Change in Morisky Compliance Scale(Baseline and 6, 12, 18 and 24 months)