HaemodialysisHaemodialysisNCT06689228
The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis Patients
A study testing Rational Drug Use Training in people with Haemodialysis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis
- What is being tested?
- Rational Drug Use Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with psychiatric illness
- Diagnosed with malignancy
- Individuals who do not allow access to their information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, Bucak, 15300
About this study
Official title: 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.
Read the detailed description
The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis Patients
- Conditions
- Haemodialysis
- Being tested
- Rational Drug Use Training
- Keywords
- haemodialysis, Orem, Rational Drug use, Nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rational Drug Use TrainingOther
Also called Tele-monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Rational Drug Use Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Orem's Self-Care Deficit Theory and Tele-Monitoring
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice CEYLAN, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689228
- Sponsor's protocol ID
- 2023/197
- Other IDs
- Hatice CEYLAN
- Acronym
- Haemodialysis
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT06689228
- Acronym / sponsor ID
- Haemodialysis / 2023/197
- Conditions
- Haemodialysis
- Keywords
- haemodialysis, Orem, Rational Drug use, Nurses
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis Patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Orem's Self-Care Deficit Theory and Tele-Monitoring
| Arm | Type | Receives |
|---|---|---|
| Randomized | Experimental | Other: Rational Drug Use TrainingThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with psychiatric illness
- Diagnosed with malignancy
- Individuals who do not allow access to their information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rational Drug Use TrainingAlso: Tele-monitoringRational 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 | Randomized |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rational Drug Use Training in people with Haemodialysis, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rationanl Drug use Scale (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.