Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes

November 8, 2018 updated by: Srećko Marušić, University Hospital Dubrava

Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes Mellitus Patients: Prospective, Randomized Study

Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400 million people worldwide. There are a few studies evaluating ADRs in diabetics. Many patients experience ADRs soon after hospital discharge which can be attributed to the changes in the pharmacotherapy during hospitalization. Education and counseling of diabetic patients has been shown to improve medication adherence and clinical outcomes. Studies that included medical patients revealed that education can significantly reduce risk of ADRs after hospital discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics that is focused on a proper use of medications, prevention and early detection of ADRs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400 million people worldwide. Besides adapting their lifestyle, a large majority of diabetic patients needs pharmacotherapy to achieve adequate glycaemic control. Additional pharmacotherapy is usually needed for the treatment of concomitant diseases and risk factors. This can result in polytherapy which puts patients et risk of adverse drug reactions (ADRs). There are a few studies evaluating ADRs in diabetics. A prospective observation study reported ADRs in 11.8% of diabetic patients in tertiary care hospital. Many patients experience ADRs soon after hospital discharge which can be attributed to the changes in the pharmacotherapy during hospitalization. These ADRs can result in early readmission and emergency department (ED) visits. In an Italian study, ADRs were reported in 73.8% of patients taking oral antidiabetics drugs within one month of study enrollment. It is estimated that between 11-38% of ambulatory ADRs are preventable. Medication adherence plays an important role in the treatment of T2DM because it clearly improves glycaemic control and clinical outcomes and lowers medical costs. Adherence rates to DM medications vary from 31% to 87% in retrospective studies and 53% to 98% in prospective studies. It is affected by many factors such as age, race, health beliefs, medication cost, co-pays, etc. Adherence is lower in the case of ADRs, when medications are taken more than twice daily, with concomitant depression and skepticism about the importance of medication. In recent years, 30-day readmission rate has been emphasised as a measure of healthcare quality. Diabetic patients have higher readmission rate compared to patients without DM. In the study by Ostling and al., 30-day readmission rate for patients with DM was 26%. Many readmissions are drug-related and can be caused by ADRs and non-adherence. These readmissions are potentially preventable. It is estimated that between 40%-57.1% of readmissions caused by ADRs and all readmissions caused by non-adherence are preventable. Education and counseling of diabetic patients has been shown to improve medication adherence and clinical outcomes. Studies that included medical patients revealed that education can significantly reduce risk of ADRs after hospital discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics that is focused on a proper use of medications, prevention and early detection of ADRs. The aim of this study was to evaluate the impact of pharmacotherapeutic education on 30-day post discharge medication adherence and adverse outcomes (ADRs, readmissions, ED visits and death) in diabetic patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Dubrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 years or older,
  • diagnosis of T2DM and
  • hospital discharge to the community.

Exclusion Criteria:

  • cognitive disorders that would interfere with patient's participation,
  • diagnosis of a terminal illness with a life expectancy <1 month,
  • discharge to a long-term care facility or
  • inability to be followed-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Patients in both groups received diabetes education during the hospital stay. Standardized diabetes education includes education regarding the disease, diet, physical activity, alcohol intake, smoking, education regarding diabetes medication, self monitoring of glucose, and education regarding acute and chronic complications.
Experimental: Intervention group
Patients in both groups received diabetes education during the hospital stay. Standardized diabetes education includes education regarding the disease, diet, physical activity, alcohol intake, smoking, education regarding diabetes medication, self monitoring of glucose, and education regarding acute and chronic complications. Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
Behavioral: Education
Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication adherence assessment method
Time Frame: one month
The medication adherence of the two diabetic patients groups (intervention group and group without intervention) 30 days after the recruitment in the study was assessed by the pill count method. Where adherence was in the range from 80% to 100% the patients were categorized as adherent, and where adherence was less than 80% or more than 100% the patients were categorized as non-adherent.
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events questionnaire
Time Frame: one month
The number of participants with treatment-related adverse events in the two diabetic patients groups (intervention group and group without intervention) 30 days after the recruitment in the study was compared using the questionnaire method which was conducted by the physician. The physician noted cause of the adverse event and marked its probability using the Naranjo adverse drug reaction probability scale. The Naranjo adverse drug reaction probability scale consists of 10 questions that are answered as either "Yes", "No", or "Do not know". Different point values (-1, 0, +1 or +2) are assigned to each answer. The adverse drug reaction is considered "definite" if the score is 9 or higher, "probable" if 5 to 8, "possible" if 1 to 4, and "doubtful" if 0 or less.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Dubrava

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Srećko Marušić, University Hospital Dubrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDUDIABETES2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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