NCT06689228

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 13, 2024

Last Update Submit

November 13, 2024

Conditions

Keywords

haemodialysisOremRational Drug useNurses

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

EXPERIMENTAL

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

Other: Rational Drug Use Training

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.

Also known as: Tele-monitoring
Randomized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Orem's Self-Care Deficit Theory and Tele-Monitoring
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

Locations