Impact of Pharmaceutical Education on Medication Adherence in Patients With Type 2 Diabetes Mellitus and Systemic Arterial Hypertension Treated at the Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Medication adherence
研究概览
简要总结
Purpose. To evaluate the impact of pharmaceutical education in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension on their medication adherence.
Material and research methods. Randomized clinical trial with a control group with a duration of 6 months of follow-up. Patients with a diagnosis of Type 2 Diabetes Mellitus andWE Systemic Arterial Hypertension treated in the internal medicine outpatient of a school hospital will be included. Adherence to medication will be evaluated using Morisky's 8-item medication adherence scale.
The investigators believe that Pharmaceutical education increases therapeutic adherence in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.
详细描述
Patients and study design In this randomized and controlled clinical trial, patients will be assigned to two study groups: intervention group and control group; The patients will be followed for 6 months, considering evaluations at 0, 3 and 6 months.
To improve patient adherence to treatment, the investigators will provide a pocket card with an up-to-date list of the patient's prescribed medications along with recommendations for follow-up care. For the evaluation of adherence to treatment, © MMAS is used, it is authorized: MMAR, LLC., Donald E. Morisky # 6533-7069-1342-3041-5361, 294 Lindura Court, Las Vegas, Nevada 89138-4632.
Variables analyzed After randomization, the investigator will interview patients to obtain demographic data and their medical history. Data such as: time of evolution of the disease, number of prescribed medications, family support, cost of drug treatments will be collected, and the levels of glycosylated hemoglobin, fasting plasma glucose, cholesterol and triglycerides will be determined.
Medication adherence Adherence to medication will be evaluated using the Morisky method of 8 items, which is a validated indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale It is a generic scale to evaluate the patient's behavior regarding adherence to treatment, the points obtained with MMAS-8 are added to give a range of low, medium and high adherence scores. The total score is a sum of the 8 items and ranges between 0 and 8: values with a score greater than 8 reflect high adherence to medication, values between 6 and 7 reflect medium adherence and values below 6 reflect low adherence.
Sample size calculation A sample size calculation shows that a sample of 38 patients in each group is sufficient to find a difference in adherence to treatment with an alpha error of 0.05 and a power of 0.80 of the test, contemplating a 20% loss. The calculation was performed with the expected proportions formula.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients cared for by the internal medicine outpatient area of the OPD Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca "
- •18-60 years
- •Both genres
- •With a diagnosis of type 2 diabetes mellitus and systemic arterial hypertension
- •That they gave their consent under information
排除标准
- •Inpatients on the day of their internal medicine outpatient appointment.
- •Patients for whom pharmacological treatment was not prescribed for the treatment of DM2 and SAH.
- •Patients who do not speak Spanish.
- •Patients who could not or could not read.
结局指标
主要结局
Medication adherence
时间窗: 6 months
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
次要结局
未报告次要终点
研究者
Abelardo Contreras Vergara
Principal Investigator
Hospital Civil Juan I. Menchaca