NCT03438162

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

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

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

September 20, 2017

Last Update Submit

November 8, 2018

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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.

    one month

Secondary Outcomes (1)

  • Adverse events questionnaire

    one month

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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

Interventions

EducationBEHAVIORAL

Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.

Intervention group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 30610771DERIVED

MeSH Terms

Conditions

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

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Srećko Marušić

    University Hospital Dubrava

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 20, 2017

First Posted

February 19, 2018

Study Start

April 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)