Medication AdherenceNCT06700642
Individual Education on Rational Drug Use in Primary Healthcare for Patients on Long-Term Medication
A study testing Educational intervention in people with Medication Adherence and Patient Compliance, run by Gülşah Onur at 1 site in Turkey (Türkiye).
Trial summary
Irrational medication use is a common problem in Turkiye and worldwide. Educational interventions are essential to promote rational drug use. This study was conducted to evaluate the effect of individual education on rational drug use given to individuals aged 45-74 years with at least one continuously used medication… Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Patient Compliance, Drug Utilization Review
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 16 Apr 2024
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Taking at least one medication continuously (Individuals with taking at least one medication that 'has been used every day for a minimum of 3 months and should be used for at least 1 year' were defined as 'continuous medication users'. Patients' declarations of continuous medication use were verified through the Family Medicine Information System).
- To be between 45-74 years old
- Not being dependent on another individual in terms of medication use
- Being co-operative and orientated (The Mini Mental Test is routinely administered to individuals over the age of 65 who are registered in the Family Medicine Training Unit and the results of this test can be seen in the Family Medicine Information System. In our study, those with normal scores (between 24-30 points) were considered to be co-operative and orientated).
- To be at least primary school graduate
- To agree to participate in the study
Who cannot join
- Not to have a medication that is used continuously
- Under 45 years of age or 75 years of age or older
- Being a cancer patient in active treatment
- Being pregnant or breastfeeding
- Having a severe psychiatric disorder
- Uncooperative or disorientated
Show all 10Show fewer
- Not having completed primary school education
- Getting help from another person for the use of medicines
- In the recruitment of volunteers for the control arm to the 36 groups formed according to the distribution of gender, age groups and education levels of the research arm, the absence of a participant suitable for the characteristics of the group (In order to stabilise the effect of possible confounding variables between the two arms, each participant in the research arm was matched one-to-one with the participants in the control arm in terms of three sociodemographic variables. In the recruitment of volunteers to the control arm, if there was no participant matched to the age group, gender and education level of the participant in the research arm, the participants who were last included in the study in the research arm and could not be matched were excluded from the study).
- Development of a medical condition that prevented participation in the final visit within the three-month follow-up period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Medicine, Department of Family Medicine, Family Medicine Training Unit
Ankara
About this study
Official title: The Impact of Individual Education on Rational Drug Use in Primary Care for Patients on Long-Term Medication: an Intervention Study
Irrational medication use is a common problem in Turkiye and worldwide. Educational interventions are essential to promote rational drug use. This study was conducted to evaluate the effect of individual education on rational drug use given to individuals aged 45-74 years with at least one continuously used medication who applied to a primary health care institution on their rational drug use level. The hypothesis of the study was that individual training on rational drug use given to individuals using medication continuously is effective in increasing rational drug use.
Read the detailed description
Incorrect, unnecessary, ineffective and high-cost drug use is a significant problem all over the world. The adherence of patients to the treatment recommended by the healthcare professional depends on the improvement of their knowledge, attitudes and behaviours about rational drug use (RDU) in the correct direction. There is a need for educational interventions that will increase the knowledge and awareness of the society on this matter and encourage RDU. This study was conducted in Hacettepe University Faculty of Medicine, Family Medicine Training Unit to evaluate the effect of RDU education in individuals aged 45-74 years who were continuously taking medication. In this non-randomised matched controlled intervention study, participants who met the criteria were non-randomly divided into two groups (research and control arm). Firstly, volunteers for the research arm started to be included in the study. According to the distribution of gender, age groups and education levels of the research arm, a one-to-one matching was made to the control arm in terms of these qualifications. In this way, the effects of three possible confounding variables for the two arms were controlled through group matching. In the first visit, data were collected from the research and control arms with questionnaire forms including sociodemographic information and the Rational Drug Use Scale (RDUS). In the first visit after the completion of the questionnaire form, each individual in the research arm was given individual-patient education on rational drug use and patient brochure by the researcher. The control arm received no educational intervention and was not given a brochure at the first visit. The final visit was conducted with both the research and control arms 3 months after the first visit of each individual. The effect of the educational intervention on RDU was evaluated with the RDUS. In this visit, the individuals in the control arm were also given a patient brochure in line with the 'principle of equality'.
- Being tested
- Educational intervention
- Keywords
- family practice, rational drug use, medication adherence, controlled clinical trials, aging, noncommunicable diseases
- Medical subject headings
- Medication Adherence, Patient Compliance, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
In this study, 3 intervention tools were developed by the researchers. The first of these, 'Rational Drug Use Trainer Guide', was used for trainer training and standardisation of the education given to patients. The sample rational drug use presentations prepared by the Ministry of Health, Turkiye Medicines and Medical Devices Agency, Department of Rational Drug Use were combined in terms of content, enriched with information obtained from the literature and developed for the use of family physicians working in primary health care institutions in their clinical practices.
'Rational Drug Use Individual Education Presentation' was prepared by the researchers in line with the 'Rational Drug Use Trainer Guide'. It has been prepared in a format suitable for individual education presentation with the most concise and understandable content suitable for use during primary healthcare service delivery.
'Rational Drug Use Patient Brochure' was prepared by the researchers in a similar content.
| Study group | Role | What they receive |
|---|---|---|
| Research Arm | Active comparator | Individuals in this arm were given individual education on rational drug use by the researcher at the first visit. 'Individual Training Presentation on Rational Drug Use' consisting of visual and written content was used for patient education intervention. After the education, 'Rational Drug Use Patient Brochure' was given to all participants in this arm. Receives: Other: Educational intervention |
| Control Arm | No intervention | No educational intervention was made in the control arm and no brochure was given at the first visit. In line with the principle of equality, participants in this arm were given a patient brochure at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of individual education on rational drug use status
Rational drug use status of the participants was measured with the Rational Drug Use Scale (RDUS). The RDUS consists of 21 questions and a single dimension. In this 5-point Likert-type scale, the answers for each item are never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). Only the 17th item in the scale is reverse scored. After the reverse scoring process, the 'total scale score' is calculated by summing the scores of all items of the scale. As the total score obtained from RDUS increases, rational drug use also increases.
This scale was applied to both arms in both first visit and final visit, and the effect of the educational intervention was evaluated through this scale.
Measured: 3 months after the first visit of each individual with both the research and control arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Mar 2023
- Primary completion12 Jan 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- In the design of the study, in order to fix the effect of possible confounding variables for the research and control arms, 36 groups formed according to the distribution of gender, age groups and education levels of the research arm were matched to the control arm in terms of these characteristics.
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülşah Onur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülşah Onur, Hacettepe University
- Investigators
- Gülşah Onur, Research Assistant Dr., Principal investigator, Hacettepe University Faculty of Medicine, Department of Family MedicineDuygu Ayhan Başer, Assoc. Prof., Study director, Hacettepe University Faculty of Medicine, Department of Family MedicineBahar (Güçiz) Doğan, Prof., Principal investigator, Hacettepe University Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700642
- Sponsor's protocol ID
- HUTF-FM-GODAB-01
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Individual Education on Rational Drug Use in Primary Care for Patients on Long-Term Medication: an Intervention Study
- ClinicalTrials.gov ID
- NCT06700642
- Acronym / sponsor ID
- HUTF-FM-GODAB-01
- Keywords
- family practice, rational drug use, medication adherence, controlled clinical trials, aging, noncommunicable diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Gülşah OnurUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 22 Nov 2024 (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.
Irrational medication use is a common problem in Turkiye and worldwide. Educational interventions are essential to promote rational drug use. This study was conducted to evaluate the effect of individual education on rational drug use given to individuals aged 45-74 years with at least one continuously used medication who applied to a primary health care institution on their rational drug use level. The hypothesis of the study was that individual training on rational drug use given to individuals using medication continuously is effective in increasing rational drug use.
Detailed description
Incorrect, unnecessary, ineffective and high-cost drug use is a significant problem all over the world. The adherence of patients to the treatment recommended by the healthcare professional depends on the improvement of their knowledge, attitudes and behaviours about rational drug use (RDU) in the correct direction. There is a need for educational interventions that will increase the knowledge and awareness of the society on this matter and encourage RDU. This study was conducted in Hacettepe University Faculty of Medicine, Family Medicine Training Unit to evaluate the effect of RDU education in individuals aged 45-74 years who were continuously taking medication. In this non-randomised matched controlled intervention study, participants who met the criteria were non-randomly divided into two groups (research and control arm). Firstly, volunteers for the research arm started to be included in the study. According to the distribution of gender, age groups and education levels of the research arm, a one-to-one matching was made to the control arm in terms of these qualifications. In this way, the effects of three possible confounding variables for the two arms were controlled through group matching. In the first visit, data were collected from the research and control arms with questionnaire forms including sociodemographic information and the Rational Drug Use Scale (RDUS). In the first visit after the completion of the questionnaire form, each individual in the research arm was given individual-patient education on rational drug use and patient brochure by the researcher. The control arm received no educational intervention and was not given a brochure at the first visit. The final visit was conducted with both the research and control arms 3 months after the first visit of each individual. The effect of the educational intervention on RDU was evaluated with the RDUS. In this visit, the individuals in the control arm were also given a patient brochure in line with the 'principle of equality'.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the design of the study, in order to fix the effect of possible confounding variables for the research and control arms, 36 groups formed according to the distribution of gender, age groups and education levels of the research arm were matched to the control arm in terms of these characteristics.
| Arm | Type | Receives |
|---|---|---|
| Research Arm | Active comparator | Other: Educational interventionIndividuals in this arm were given individual education on rational drug use by the researcher at the first visit. 'Individual Training Presentation on Rational Drug Use' consisting of visual and written content was used for patient education intervention. After the education, 'Rational Drug Use Patient Brochure' was given to all participants in this arm. |
| Control Arm | No intervention | –No educational intervention was made in the control arm and no brochure was given at the first visit. In line with the principle of equality, participants in this arm were given a patient brochure at the end of the study. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Taking at least one medication continuously (Individuals with taking at least one medication that 'has been used every day for a minimum of 3 months and should be used for at least 1 year' were defined as 'continuous medication users'. Patients' declarations of continuous medication use were verified through the Family Medicine Information System).
- To be between 45-74 years old
- Not being dependent on another individual in terms of medication use
- Being co-operative and orientated (The Mini Mental Test is routinely administered to individuals over the age of 65 who are registered in the Family Medicine Training Unit and the results of this test can be seen in the Family Medicine Information System. In our study, those with normal scores (between 24-30 points) were considered to be co-operative and orientated).
- To be at least primary school graduate
Key exclusion criteria (10 listed)
- Not to have a medication that is used continuously
- Under 45 years of age or 75 years of age or older
- Being a cancer patient in active treatment
- Being pregnant or breastfeeding
- Having a severe psychiatric disorder
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 |
|---|---|---|
| Educational interventionIn this study, 3 intervention tools were developed by the researchers. The first of these, 'Rational Drug Use Trainer Guide', was used for trainer training and standardisation of the education given to patients. The sample rational drug use presentations prepared by the Ministry of Health, Turkiye Medicines and Medical Devices Agency, Department of Rational Drug Use were combined in terms of content, enriched with information obtained from the literature and developed for the use of family physicians working in primary health care institutions in their clinical practices. 'Rational Drug Use Individual Education Presentation' was prepared by the researchers in line with the 'Rational Drug Use Trainer Guide'. It has been prepared in a format suitable for individual education presentation with the most concise and understandable content suitable for use during primary healthcare service delivery. 'Rational Drug Use Patient Brochure' was prepared by the researchers in a similar content. | Other | Research Arm |
Primary outcome
The effect of individual education on rational drug use status
Time frame: 3 months after the first visit of each individual with both the research and control arm
Rational drug use status of the participants was measured with the Rational Drug Use Scale (RDUS). The RDUS consists of 21 questions and a single dimension. In this 5-point Likert-type scale, the answers for each item are never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). Only the 17th item in the scale is reverse scored. After the reverse scoring process, the 'total scale score' is calculated by summing the scores of all items of the scale. As the total score obtained from RDUS increases, rational drug use also increases. This scale was applied to both arms in both first visit and final visit, and the effect of the educational intervention was evaluated through this scale.
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 22 Nov 2024.
- 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.
Gülşah Onur, Research Assistant Dr. principal investigator
Hacettepe University Faculty of Medicine, Department of Family Medicine
Duygu Ayhan Başer, Assoc. Prof. study director
Hacettepe University Faculty of Medicine, Department of Family Medicine
Bahar (Güçiz) Doğan, Prof. principal investigator
Hacettepe University Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Medication Adherence and Patient Compliance, run by Gülşah Onur at 1 site in Turkey (Türkiye).
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 6 inclusion and 10 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 22 Nov 2024. 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 Turkey (Türkiye). 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?
The effect of individual education on rational drug use status (time frame: 3 months after the first visit of each individual with both the research and control arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.