Impact of Pharmaceutical Education on Medication Adherence
Condition: Type 2 Diabetes; Systemic Arterial Hypertension; Medication Adherence
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Statistical analysis The investigators will report categorical variables as frequencies and
      percentages and analyzed with χ2 or Fisher's exact tests as necessary; quantitative variables
      will be presented as mean and standard deviation. The investigators will use the Wilcoxon
      test for intragroup comparisons and the Mann-Whitney U test for intergroup comparisons. The
      results will be considered significant at a two-sided p value of <0.05, with a 95% confidence
      interval. The statistical analyzes will be carried out using Statistical Solutions for
      Products and Services version 24.0.
    

Intervention name(s): pharmaceutical education
Intervention type(s): Behavioral
Intervention description(s): The patients who were assigned to the intervention group will receive a didactic talk from the research pharmacist. In addition, the patient will be given an updated list of their prescribed medications on a wallet card.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients assigned to the intervention group will receive from the research pharmacist, a didactic talk (of at least 10 and up to 20 minutes), where they will be provided information about type 2 diabetes mellitus and Systemic Arterial Hypertension, causes of the disease and consequences of poor control, on its pharmacological treatments, changes in lifestyle and diet. In addition, the patient will be given an updated list of their prescribed medications on a wallet card.
Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmaceutical education; Type 2 Diabetes Mellitus; Systemic Arterial Hypertension; Medication adherence