The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis Patients
Haemodialysis
Principal Investigator
2 other identifiers
interventional
70
1 country
1
Brief Summary
Patients with chronic kidney disease may show altered pharmacokinetic and pharmacodynamic response to many drugs compared to patients with normal renal function. Therefore, effective and safe drug use is difficult in patients with chronic kidney disease and especially in dialysis patients. In addition, some drugs may have nephrotoxic effects by causing further deterioration in renal function, especially in high-risk renal patients. Prevention of problems related to drug use in haemodialysis patients will be possible with rational drug use (RUD). RDM is defined as 'the set of rules to be followed in order for patients to take medicines in accordance with their clinical needs, in doses that meet their personal needs, in sufficient time, at the lowest cost to themselves and the society'. Rational drug use has become an increasingly important concept today. In studies investigating rational drug use, problems such as incorrect use of drugs, prescribing more drugs than necessary, unnecessary injection recommendation/administration, unnecessary antibiotic consumption, and unnecessary use of expensive drugs have been identified. As a result of incorrect drug use, poisoning or decreased sensitivity to drugs are observed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedStudy Start
First participant enrolled
November 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedNovember 14, 2024
November 1, 2024
1 month
November 13, 2024
November 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rationanl Drug use Scale
The Rational Drug Use Scale (RUDS) consists of 21 items and one dimension (Appendix 3). The items are scored on a 5-point Likert-type scale (1-Never, 2-Rarely, 3-Sometimes, 4-Most of the time and 5-Always) according to their fulfilment of the statements. Only the 17th item in the scale is reversed. After the reversed item is reversed, the sum of all scale items gives the 'total scale score'. The total score of the EHRS varies between 21 and 105. As the total score obtained from AİKÖ increases, rational drug use increases. When evaluating the total score obtained from AİKÖ; if the total score obtained is between 21- 52, it is scored as low level, between 53-67 as medium level, and between 68-105 as high level.
two months
Study Arms (1)
Randomized
EXPERIMENTALThe Effect of Education Based on Self-Care Deficiency Theory on Rational Drug Use in Patients Receiving Haemodialysis In the study, which will last for 2 months, the patients in the intervention group will receive pre-test training based on the Self-Care Deficiency Theory. Also weekly reminder messages will be sent regularly. Other Names: Education Based on Self-Care Deficiency Theory on Rational Drug Use
Interventions
Rational Drug Use Training and Tele-monitoring will include information on drugs and their importance, rational drug use, rational drug use in haemodialysis patients, harms of irrational drug use, benefits of rational drug use, obstacles encountered in rational drug use, ways to overcome obstacles encountered in rational drug use, and increasing self-efficacy. The first training is planned to last approximately 30-35 minutes for each patient and the second training (summary training) is planned to last approximately 15-20 minutes. With telemonitoring, reminder messages will be sent to patients' phones at intervals.
Eligibility Criteria
You may qualify if:
- years of age or older,
- No communication or medically recognised mental problems,
- Patients receiving haemodialysis treatment for 6 months or longer were included in the study.
You may not qualify if:
- Diagnosed with psychiatric illness
- Diagnosed with malignancy
- Individuals who do not allow access to their information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Burdur Mehmet Akif Ersoy University
Burdur, Bucak, 15300, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asisstant Professor
Study Record Dates
First Submitted
November 13, 2024
First Posted
November 14, 2024
Study Start
November 15, 2024
Primary Completion
December 15, 2024
Study Completion
January 15, 2025
Last Updated
November 14, 2024
Record last verified: 2024-11