Individual Education on Rational Drug Use in Primary Healthcare for Patients on Long-Term Medication

NCT ID: NCT06700642

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-04-16

Brief 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 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'.

Conditions

Medication Adherence; Patient Compliance; Drug Utilization Review

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Research Arm

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.

Group Type: ACTIVE_COMPARATOR

Educational intervention

Intervention Type: OTHER

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.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gülşah Onur

OTHER

Sponsor Role: lead

Responsible Party

Gülşah Onur

Research Assistant Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gülşah Onur, Research Assistant Dr.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Faculty of Medicine, Department of Family Medicine

Duygu Ayhan Başer, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University Faculty of Medicine, Department of Family Medicine

Bahar (Güçiz) Doğan, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Institute of Public Health

Locations

Hacettepe University Faculty of Medicine, Department of Family Medicine, Family Medicine Training Unit

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HUTF-FM-GODAB-01

Identifier Type: -

Identifier Source: org_study_id