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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

130

Phase

  • 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

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
Intervention / Treatment
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

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

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

University Hospital Dubrava

Investigators

  • 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)

April 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 9, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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