- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06689228
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bucak
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Burdur, Bucak, Turkey, 15300
- Burdur Mehmet Akif Ersoy University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- Diagnosed with psychiatric illness
- Diagnosed with malignancy
- Individuals who do not allow access to their information.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Randomized
The 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 |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rationanl Drug use Scale
Time Frame: two months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023/197
- Hatice CEYLAN (Registry Identifier: The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceiv)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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