Effectiveness of a Diabetes Education Program Based on Tailored Interventions in the Andalusian Public Health and Social System (Edep-Ti Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months
研究概览
简要总结
GOALS:
PRIMARY:
- Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure).
SECONDARY: 2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height). 3. Analyze the impact of the program on the quality of life related to health. 4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.
DESIGN: Cluster randomized controlled trial
详细描述
The reference population will be patients with a diagnosis of diabetes mellitus in treatment with oral antidiabetics, excluding the insulinized patients. They will then be randomly assigned by cluster, to the intervention group (individual education) or control (usual care) in the context of each health center participating in the project. After randomization centers, all professionals who decide to cooperate receive a training process on methodology for measuring results (clinical and questionnaire variables), while assigned to the experimental intervention, will also receive training on how to carry out the program of diabetologic education proposed. The follow-up period for both groups is 18 months obtained as clinical determinations: glycosylated hemoglobin (metabolic control), blood pressure, lipid profile, smoking and BMI; and as results reported by the patient through questionnaires: quality of life related to health, level of physical activity performed or adherence to the Mediterranean diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type II Diabetes Mellitus diagnosed <10 years and classified in a computerized clinical history with poor metabolic control (HbA1c> 7% or BMI > 27.5) and in treatment with oral antidiabetics.
排除标准
- •Diabetes Mellitus type 1
- •Insulinized patients.
- •Patients who have received some type of structured educational intervention in the last year according to the data obtained in their clinical history.
- •Patients with some type of sensory or mental disability.
- •Gestational diabetes.
- •Patients with age equal to or greater than 75 years of age or minors.
- •Patients with inability to travel to their Health Center.
结局指标
主要结局
Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months
时间窗: 0,6,12 and18 months
Determination of HbA1c measured as a percentage
Lipidic profile:change from basal triglyceride (TG) levels at 6 months, change from basal TG levels at 12 months and change from baseline TG levels at 18 months.
时间窗: 0,6,12 and18 months
Determination of TG measured in milligrams per deciliter (mg/dl).
Change from baseline systolic blood pressure (SBP) at 6 months, change from baseline systolic blood pressure at 12 months and change from baseline systolic blood pressure at 18 months.
时间窗: 0,6,12 and18 months
Determination of systolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.
Lipidic profile: change from baseline LDL cholesterol (LDLc) at 6 months, change from baseline LDLc at 12 months and change from baseline LDL cholesterol at 18 months.
时间窗: 0,6,12 and18 months
Determination of LDLc measured in milligrams per deciliter (mg/dl).
Lipidic profile: change from basal total cholesterol (TC) at 6 months, change from total basal cholesterol at 12 months and change from total basal cholesterol at 18 months.
时间窗: 0,6,12 and18 months
Determination of total cholesterol (TC) values measured in milligrams per deciliter (mg/dl).
Change from baseline diastolic blood pressure (DBP) at 6 months, change from baseline diastolic blood pressure at 12 months and change from baseline diastolic blood pressure at 18 months.
时间窗: 0,6,12 and18 months
Determination of diastolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.
次要结局
- Smoking rate(0,6,12 and18 months)
- Change from baseline weight at 6 months, change from baseline weight at 12 months and change from baseline weight at 18 months.(0,6,12 and18 months)
- Change from the basal level of physical activity to 6 months, change from the basal level of physical activity to 12 months and change from the basal level of physical activity to 18 months.(0,6,12 and18 months)
- Development in smoking habits(0,6,12 and18 months)
- Change from the baseline level of adherence to the diet at 6 months, change from the baseline level of adherence to the diet at 12 months and change from the baseline level of adherence to the diet at 18 months.(0,6,12 and18 months)
- Change in the quality of life related to health (HRQoL) from the baseline determination at 6 months, change in the HRQoL from the baseline determination at 12 months and change in the HRQoL from the baseline determination at 18 months.(0,6,12 and18 months)
研究者
JOSE MIGUEL MORALES ASENCIO
Professor
University of Malaga