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Impact of Pharmaceutical Education on Medication Adherence

Primary Purpose

Type 2 Diabetes, Systemic Arterial Hypertension, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
pharmaceutical education
Sponsored by
Hospital Civil Juan I. Menchaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Pharmaceutical education, Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Medication adherence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital civil de Guadalajara "Dr. Juan I. Menchaca"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

pharmaceutical education

control

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2021
Last Updated
January 20, 2022
Sponsor
Hospital Civil Juan I. Menchaca
Collaborators
Drake University
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1. Study Identification

Unique Protocol Identification Number
NCT05202067
Brief Title
Impact of Pharmaceutical Education on Medication Adherence
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"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil Juan I. Menchaca
Collaborators
Drake University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Systemic Arterial Hypertension, Medication Adherence
Keywords
Pharmaceutical education, Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Medication adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pharmaceutical education
Arm Type
Experimental
Arm 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.
Arm Title
control
Arm Type
No Intervention
Arm Description
Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician.
Intervention Type
Behavioral
Intervention Name(s)
pharmaceutical education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication adherence
Description
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.
Time Frame
Basal
Title
Medication adherence
Description
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.
Time Frame
3 months
Title
Medication adherence
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SELENE v HUERTA, PhD
Organizational Affiliation
Universidad De Guadalajara (UDG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital civil de Guadalajara "Dr. Juan I. Menchaca"
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18453793
Citation
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. doi: 10.1111/j.1751-7176.2008.07572.x.
Results Reference
result

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Impact of Pharmaceutical Education on Medication Adherence

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