NCT05202067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

December 22, 2021

Last Update Submit

January 20, 2022

Conditions

Type 2 DiabetesSystemic Arterial HypertensionMedication Adherence

Keywords

Pharmaceutical educationType 2 Diabetes MellitusSystemic Arterial HypertensionMedication adherence

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

pharmaceutical education

EXPERIMENTAL

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.

Behavioral: pharmaceutical education

control

NO INTERVENTION

Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician.

Interventions

pharmaceutical educationBEHAVIORAL

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.

pharmaceutical education

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients cared for by the internal medicine outpatient area of the OPD Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca "
  • years
  • Both genres
  • With a diagnosis of type 2 diabetes mellitus and systemic arterial hypertension
  • That they gave their consent under information

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

Related 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. doi: 10.1111/j.1751-7176.2008.07572.x.

    PMID: 18453793RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • SELENE v HUERTA, PhD

    Universidad De Guadalajara (UDG)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 21, 2022

Study Start

January 1, 2019

Primary Completion

June 30, 2019

Study Completion

December 30, 2019

Last Updated

February 3, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)