Diabetes Mellitus, Type 2NCT03438162
Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes
A study testing Education in people with Diabetes Mellitus, Type 2 and Education, run by University Hospital Dubrava at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Education, Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older,
- diagnosis of T2DM and
- hospital discharge to the community.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (1)
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Apr 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srećko Marušić, University Hospital Dubrava
- Investigators
- Srećko Marušić, Study chair, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438162
- Sponsor's protocol ID
- EDUDIABETES2017
- Status last verified
- Nov 2018
- First submitted
- 20 Sep 2017
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30610771
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes Mellitus Patients: Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03438162
- Acronym / sponsor ID
- EDUDIABETES2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: EducationPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older,
- diagnosis of T2DM and
- hospital discharge to the community.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationPatients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician. | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Adverse events questionnaire
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 30610771Marusic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srećko Marušić study chair
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Diabetes Mellitus, Type 2 and Education, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence assessment method (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.