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

Primary Purpose

Diabetes Mellitus, Type 2, Education, Drug-Related Side Effects and Adverse Reactions

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Education
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Dubrava

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Medication adherence assessment method
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.

Secondary Outcome Measures

Adverse events questionnaire
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.

Full Information

First Posted
September 20, 2017
Last Updated
November 8, 2018
Sponsor
University Hospital Dubrava
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1. Study Identification

Unique Protocol Identification Number
NCT03438162
Brief Title
Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes
Official Title
Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes Mellitus Patients: Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Education, Drug-Related Side Effects and Adverse Reactions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
Primary Outcome Measure Information:
Title
Medication adherence assessment method
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Adverse events questionnaire
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srećko Marušić
Organizational Affiliation
University Hospital Dubrava
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30610771
Citation
Marusic S, Melis P, Lucijanic M, Grgurevic I, Turcic P, Neto PRO, Bilic-Curcic I. Impact of pharmacotherapeutic education on medication adherence and adverse outcomes in patients with type 2 diabetes mellitus: a prospective, randomized study. Croat Med J. 2018 Dec 31;59(6):290-297. doi: 10.3325/cmj.2018.59.290.
Results Reference
derived

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

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