Impact of Pharmaceutical Education on Medication Adherence

Type 2 Diabetes Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202067
• Other study ID #: 0269/18/HCJIM/01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2022
• Source: Hospital Civil Juan I. Menchaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension
• Medication Adherence
• Systemic Arterial Hypertension
• Type 2 Diabetes

Intervention

Behavioral:
• pharmaceutical education
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.

Locations

Country	Name	City	State
Mexico	Hospital civil de Guadalajara "Dr. Juan I. Menchaca"	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Civil Juan I. Menchaca	Drake University

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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.	Basal
Primary	Medication adherence	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.	3 months
Primary	Medication adherence	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.	6 months