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

NCT06700642 | Completed

• 1 other identifier: HUTF-FM-GODAB-01
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Patient Compliance; Drug Utilization Review

Keywords

family practice; rational drug use; medication adherence; controlled clinical trials; aging; noncommunicable diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after the first visit of each individual with both the research and control arm

Study Arms (2)

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.

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.

Interventions

Educational intervention 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.

Research Arm

Eligibility Criteria

• Age: 45 Years - 74 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gülşah Onur: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medication Adherence; Patient Compliance; Noncommunicable Diseases

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Gülşah Onur, Research Assistant Dr.

  Hacettepe University Faculty of Medicine, Department of Family Medicine

  PRINCIPAL INVESTIGATOR

• Duygu Ayhan Başer, Assoc. Prof.

  Hacettepe University Faculty of Medicine, Department of Family Medicine

  STUDY DIRECTOR

• Bahar (Güçiz) Doğan, Prof.

  Hacettepe University Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Dr.

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: March 1, 2023
• Primary Completion: January 12, 2024
• Study Completion: April 16, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)