Clinical trial NCT06700642: Individual Education on Rational Drug Use in Primary Healthcare for Patients on Long-Term Medication
Official title: The Impact of Individual Education on Rational Drug Use in Primary Care for Patients on Long-Term Medication: an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Patient Compliance
Drug Utilization Review
Keywords: family practice
rational drug use
medication adherence
controlled clinical trials
aging
noncommunicable diseases
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 365
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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'.

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

Primary outcomes:
measure: The effect of individual education on rational drug use status
timeFrame: 3 months after the first visit of each individual with both the research and control arm
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine, Department of Family Medicine, Family Medicine Training Unit
Study officials:
affiliation: Hacettepe University Faculty of Medicine, Department of Family Medicine
name: Gülşah Onur, Research Assistant Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Medicine, Department of Family Medicine
name: Duygu Ayhan Başer, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University Institute of Public Health
name: Bahar (Güçiz) Doğan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: