Kidney TransplantationNCT06015984
Renal Transplantation Nurse Training on Patient-Centered Care Competence and Counseling Skills
A study testing Traning in people with Kidney Transplantation and Nursing, run by Istanbul Gedik University.
Trial summary
There are two main treatments for end-stage renal disease (ESRD): dialysis and transplantation.Renal transplantation is the best and most preferred treatment for ESRD patients.Self management after renal transplantation is difficult. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Nursing, Education
- What is being tested?
- Traning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a maximum of 3 years of working experience in the Renal Transplantation clinic
- Having a bachelor's degree in nursing
Who cannot join
- Nurses not completing all web-based nursing education modules
- It will be caused by nurses not completing the 20-minute website usage period determined for each training module.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Web-Based Renal Transplantation Nurse Training on Patient-Centered Care Competence and Counseling Skills
There are two main treatments for end-stage renal disease (ESRD): dialysis and transplantation.Renal transplantation is the best and most preferred treatment for ESRD patients.Self management after renal transplantation is difficult. Individuals need appropriate care,education, counseling and support in order to change their behavior to cope with health problems during the transplantation process.The aim of nursing care and education is to enable the individual to acquire the knowledge, skills and attitude to independently carry out daily life activities and to adopt this as a lifestyle.Nursing care and education requires an interdisciplinary teamwork, and in this process, the nurse plays a key role as she constantly interacts with the donor, recipient and family.The research was designed as a randomized controlled experimental study with pretest-posttest design.A total of 60 nurses, 30 in the control group and 30 in the intervention group,who met the criteria for inclusion in the study, will form the sample of the study.After obtaining consent from the nurses in the intervention and control groups, they will be asked to fill out the Nurse InformationForm, the Patient-Centered Care Competency Scale and the Nurses Counseling Skills Scale. Aftercompleting the web-based training, intervention group nurses will be asked to fill in the Patient Centered Care Competency Scale and the Counseling Skills in Nurses Scale at the 1st and 3rd months. No training will be given to the nurses in the control group and they will be asked to fill the Patient-Centered Care Competency Scale and the Counseling Skills for Nurses Scale again.
Read the detailed description
There are two main treatments for end-stage renal disease (ESRD): dialysis and transplantation. Renal transplantation (RTx) is the best and most preferred treatment for ESRD patients. A successful RTx, made from a living or cadaver donor, improves the quality of life compared to dialysis and fully fulfills the function of the kidney.Self-management after renal transplantation is difficult. Individuals need appropriate care, education, counseling and support in order to change their behavior to cope with health problems during the transplantation process. The aim of nursing care and education is to enable the individual to acquire the knowledge, skills and attitude to independently carry out daily life activities and to adopt this as a lifestyle. Nursing care and education requires an interdisciplinary teamwork, and in this process, the nurse plays a key role as she constantly interacts with the donor, recipient and family.Today, technology-based methods are used to increase compliance with transplantation and are increasingly seen as valuable tools. The aim of this research is to develop and implement a web-based nurse training program for renal transplantation nurses and to examine the effect of this training on nurses' patient-centered care competence and counseling skills. The research was designed as a randomized controlled experimental study with pretest-posttest design.
The population of the research will be 1870 nurses registered to the Turkish Nephrology, Dialysis and Transplantation Nurses Association. A total of 60 nurses, 30 in the control group and 30 in the intervention group, who met the criteria for inclusion in the study, will form the sample of the study.The research will be carried out on the website www.bobreknakliokulu.com, which will be developed after a preliminary interview with the nurses working in the renal transplantation clinics between April and August 2023, and they will be included in the web-based training as self-managed and asynchronous for 8 weeks.After obtaining consent from the nurses in the intervention and control groups, they will be asked to fill out the Nurse Information Form, the Patient-Centered Care Competency Scale and the Nurses Counseling Skills Scale. After completing the web-based training, intervention group nurses will be asked to fill in the Patient-Centered Care Competency Scale and the Counseling Skills in Nurses Scale at the 1st and 3rd months. No training will be given to the nurses in the control group and they will be asked to fill the Patient-Centered Care Competency Scale and the Counseling Skills for Nurses Scale again.It is expected that the renal transplantation nurses who receive this training will contribute positively to the increase of evidence-based knowledge and the development of clinical practices, the competence of patient-centered care and the management of counseling skills in line with clinical guidelines.
- Conditions
- Kidney Transplantation, Nursing, Education, Care, Counseling
- Being tested
- Traning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraningBehavioural
In order to participate in the training module, a user name and password will be given to the initiative group, the link to be used in the self-managed and asynchronous training platform will be shared, and it will be ensured that it participates in the web-based nurse training, and the training will last for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based 8-week Asynchronous Renal Transplantation Nurse Training | Experimental | 1. Week: application of pre-tests
1. Month: administration of post-tests 3. Month: administration of post-tests Receives: Behavioral: Traning |
| non-trained nurse group | No intervention | 1. Week: application of pre-tests 1. Month: administration of post-tests 3. Month: administration of post-tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Centered Care Competency Scale
Scale, by Hwang (2015); It was developed in order to determine the competencies of nurses in patient-centered care. The Turkish validity and reliability of the scale was made by Arslanoğlu and Kırılmaz (2019). The Cronbach Alpha coefficient is 0.850. Patient-centered care competence consists of 17 questions and 4 sub-dimensions. Sub-dimensions; respecting the point of view (perspective) of patients (item 1-6), encouraging patient participation in care processes (items 7 and 11), ensuring patient comfort (items 12 and 14), and defending the rights of patients (15. - Article 17). Scale; It was designed as a 5-point Likert scale: 1-Strongly Disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Strongly Agree.
Measured: 3 months
Secondary outcomes (1)
Counseling Skills Scale for Nurses
After the item pool created by Avcı and Kumcagiz in 2019 was finalized, it was applied to 204 nurses for explanatory factor analysis. The scale consists of 10 items and is a single factor. Afterwards, confirmatory factor analysis (CFA) was performed on 200 nurses. With confirmatory factor analysis, the fit index values of the single factor structure were found to be within acceptable limits (χ2=94,785, sd=33, χ2/sd= 2.872, RMSEA=0.097, GFI=0.92, AGFI=0.86, CFI=0.92 and IFI=0.92) . The validity of the scale was examined by performing EFA and CFA. The reliability of the scale was examined with Cronbach's alpha coefficient and Split-half. Cronbach alpha was calculated as 0.88 and Split-half as 0.86.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Gedik University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emek Bakanoğlu Kalkavan, Principal investigator, Istanbul Gedik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015984
- Sponsor's protocol ID
- EBK-01
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiaranai C. The Lived Experience of Patients Receiving Hemodialysis Treatment for End-Stage Renal Disease: A Qualitative Study. J Nurs Res. 2016 Jun;24(2):101-8. doi: 10.1097/jnr.0000000000000100.
PubMed 26275156Samarehfekri A, Dehghan M, Arab M, Ebadzadeh MR. Effect of Foot Reflexology on Pain, Fatigue, and Quality of Sleep after Kidney Transplantation Surgery: A Parallel Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 1;2020:5095071. doi: 10.1155/2020/5095071. eCollection 2020.
PubMed 32831868Mathes T, Grosspietsch K, Neugebauer EAM, Pieper D. Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials. Syst Rev. 2017 Nov 29;6(1):236. doi: 10.1186/s13643-017-0633-1.
PubMed 29187249Kleber J, Cohen B. Reducing Waste and Increasing Sustainability in Health Care Settings. Am J Nurs. 2020 Apr;120(4):45-48. doi: 10.1097/01.NAJ.0000660032.02514.ec.
PubMed 32218047Kohler B, Kellerer C, Schultz K, Wittmann M, Atmann O, Linde K, Hapfelmeier A, Schneider A. An Internet-Based Asthma Self-Management Program Increases Knowledge About Asthma. Dtsch Arztebl Int. 2020;117(5):64-71. doi: 10.3238/arztebl.2020.0064.
PubMed 32070472Coresh J, Hu JR, Bello AK, Feldman HI, Fogo AB, Ganji MR, Harris DC, Levey AS, Okpechi IG, Stengel B, Thomas B, Wiecek A, Gansevoort RT. Action plan for determining and monitoring the prevalence of chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):63-70. doi: 10.1016/j.kisu.2017.07.002. Epub 2017 Sep 20.
PubMed 30675421Chisholm-Burns M, Pinsky B, Parker G, Johnson P, Arcona S, Buzinec P, Chakravarti P, Good M, Cooper M. Factors related to immunosuppressant medication adherence in renal transplant recipients. Clin Transplant. 2012 Sep-Oct;26(5):706-13. doi: 10.1111/j.1399-0012.2011.01589.x. Epub 2012 Feb 10.
PubMed 22324912Zala P, Schmid-Mohler G. Patients' Experiences of a Nurse-Led Self-Management Intervention After Kidney Transplantation. Nephrol Nurs J. 2022 Jan-Feb;49(1):45-57.
PubMed 35225495Horka K. Optimizing Care in Kidney Transplantation. Crit Care Nurs Clin North Am. 2022 Dec;34(4):443-451. doi: 10.1016/j.cnc.2022.08.003. Epub 2022 Oct 12.
PubMed 36336434
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Renal Transplantation Nurse Training on Patient-Centered Care Competence and Counseling Skills
- ClinicalTrials.gov ID
- NCT06015984
- Acronym / sponsor ID
- EBK-01
- Conditions
- Kidney Transplantation, Nursing, Education, Care, Counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Gedik UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Aug 2023 (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.
There are two main treatments for end-stage renal disease (ESRD): dialysis and transplantation.Renal transplantation is the best and most preferred treatment for ESRD patients.Self management after renal transplantation is difficult. Individuals need appropriate care,education, counseling and support in order to change their behavior to cope with health problems during the transplantation process.The aim of nursing care and education is to enable the individual to acquire the knowledge, skills and attitude to independently carry out daily life activities and to adopt this as a lifestyle.Nursing care and education requires an interdisciplinary teamwork, and in this process, the nurse plays a key role as she constantly interacts with the donor, recipient and family.The research was designed as a randomized controlled experimental study with pretest-posttest design.A total of 60 nurses, 30 in the control group and 30 in the intervention group,who met the criteria for inclusion in the study, will form the sample of the study.After obtaining consent from the nurses in the intervention and control groups, they will be asked to fill out the Nurse InformationForm, the Patient-Centered Care Competency Scale and the Nurses Counseling Skills Scale. Aftercompleting the web-based training, intervention group nurses will be asked to fill in the Patient Centered Care Competency Scale and the Counseling Skills in Nurses Scale at the 1st and 3rd months. No training will be given to the nurses in the control group and they will be asked to fill the Patient-Centered Care Competency Scale and the Counseling Skills for Nurses Scale again.
Detailed description
There are two main treatments for end-stage renal disease (ESRD): dialysis and transplantation. Renal transplantation (RTx) is the best and most preferred treatment for ESRD patients. A successful RTx, made from a living or cadaver donor, improves the quality of life compared to dialysis and fully fulfills the function of the kidney.Self-management after renal transplantation is difficult. Individuals need appropriate care, education, counseling and support in order to change their behavior to cope with health problems during the transplantation process. The aim of nursing care and education is to enable the individual to acquire the knowledge, skills and attitude to independently carry out daily life activities and to adopt this as a lifestyle. Nursing care and education requires an interdisciplinary teamwork, and in this process, the nurse plays a key role as she constantly interacts with the donor, recipient and family.Today, technology-based methods are used to increase compliance with transplantation and are increasingly seen as valuable tools. The aim of this research is to develop and implement a web-based nurse training program for renal transplantation nurses and to examine the effect of this training on nurses' patient-centered care competence and counseling skills. The research was designed as a randomized controlled experimental study with pretest-posttest design.
The population of the research will be 1870 nurses registered to the Turkish Nephrology, Dialysis and Transplantation Nurses Association. A total of 60 nurses, 30 in the control group and 30 in the intervention group, who met the criteria for inclusion in the study, will form the sample of the study.The research will be carried out on the website www.bobreknakliokulu.com, which will be developed after a preliminary interview with the nurses working in the renal transplantation clinics between April and August 2023, and they will be included in the web-based training as self-managed and asynchronous for 8 weeks.After obtaining consent from the nurses in the intervention and control groups, they will be asked to fill out the Nurse Information Form, the Patient-Centered Care Competency Scale and the Nurses Counseling Skills Scale. After completing the web-based training, intervention group nurses will be asked to fill in the Patient-Centered Care Competency Scale and the Counseling Skills in Nurses Scale at the 1st and 3rd months. No training will be given to the nurses in the control group and they will be asked to fill the Patient-Centered Care Competency Scale and the Counseling Skills for Nurses Scale again.It is expected that the renal transplantation nurses who receive this training will contribute positively to the increase of evidence-based knowledge and the development of clinical practices, the competence of patient-centered care and the management of counseling skills in line with clinical guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based 8-week Asynchronous Renal Transplantation Nurse Training | Experimental | Behavioral: Traning1. Week: application of pre-tests 1. Month: administration of post-tests 3. Month: administration of post-tests |
| non-trained nurse group | No intervention | –1. Week: application of pre-tests 1. Month: administration of post-tests 3. Month: administration of post-tests |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Having a maximum of 3 years of working experience in the Renal Transplantation clinic
- Having a bachelor's degree in nursing
Key exclusion criteria (2 listed)
- Nurses not completing all web-based nursing education modules
- It will be caused by nurses not completing the 20-minute website usage period determined for each training module.
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 |
|---|---|---|
| TraningIn order to participate in the training module, a user name and password will be given to the initiative group, the link to be used in the self-managed and asynchronous training platform will be shared, and it will be ensured that it participates in the web-based nurse training, and the training will last for eight weeks. | Behavioural | Web-Based 8-week Asynchronous Renal Transplantation Nurse Training |
Primary outcome
Patient-Centered Care Competency Scale
Time frame: 3 months
Scale, by Hwang (2015); It was developed in order to determine the competencies of nurses in patient-centered care. The Turkish validity and reliability of the scale was made by Arslanoğlu and Kırılmaz (2019). The Cronbach Alpha coefficient is 0.850. Patient-centered care competence consists of 17 questions and 4 sub-dimensions. Sub-dimensions; respecting the point of view (perspective) of patients (item 1-6), encouraging patient participation in care processes (items 7 and 11), ensuring patient comfort (items 12 and 14), and defending the rights of patients (15. - Article 17). Scale; It was designed as a 5-point Likert scale: 1-Strongly Disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Strongly Agree.
1 secondary outcome
Counseling Skills Scale for Nurses
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 26275156Chiaranai C. The Lived Experience of Patients Receiving Hemodialysis Treatment for End-Stage Renal Disease: A Qualitative Study. J Nurs Res. 2016 Jun;24(2):101-8. doi: 10.1097/jnr.0000000000000100.
- Background: PubMed 32831868Samarehfekri A, Dehghan M, Arab M, Ebadzadeh MR. Effect of Foot Reflexology on Pain, Fatigue, and Quality of Sleep after Kidney Transplantation Surgery: A Parallel Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 1;2020:5095071. doi: 10.1155/2020/5095071. eCollection 2020.
- Background: PubMed 29187249Mathes T, Grosspietsch K, Neugebauer EAM, Pieper D. Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials. Syst Rev. 2017 Nov 29;6(1):236. doi: 10.1186/s13643-017-0633-1.
- Background: PubMed 32218047Kleber J, Cohen B. Reducing Waste and Increasing Sustainability in Health Care Settings. Am J Nurs. 2020 Apr;120(4):45-48. doi: 10.1097/01.NAJ.0000660032.02514.ec.
- Background: PubMed 32070472Kohler B, Kellerer C, Schultz K, Wittmann M, Atmann O, Linde K, Hapfelmeier A, Schneider A. An Internet-Based Asthma Self-Management Program Increases Knowledge About Asthma. Dtsch Arztebl Int. 2020;117(5):64-71. doi: 10.3238/arztebl.2020.0064.
- Background: PubMed 30675421Coresh J, Hu JR, Bello AK, Feldman HI, Fogo AB, Ganji MR, Harris DC, Levey AS, Okpechi IG, Stengel B, Thomas B, Wiecek A, Gansevoort RT. Action plan for determining and monitoring the prevalence of chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):63-70. doi: 10.1016/j.kisu.2017.07.002. Epub 2017 Sep 20.
- Background: PubMed 22324912Chisholm-Burns M, Pinsky B, Parker G, Johnson P, Arcona S, Buzinec P, Chakravarti P, Good M, Cooper M. Factors related to immunosuppressant medication adherence in renal transplant recipients. Clin Transplant. 2012 Sep-Oct;26(5):706-13. doi: 10.1111/j.1399-0012.2011.01589.x. Epub 2012 Feb 10.
- Background: PubMed 35225495Zala P, Schmid-Mohler G. Patients' Experiences of a Nurse-Led Self-Management Intervention After Kidney Transplantation. Nephrol Nurs J. 2022 Jan-Feb;49(1):45-57.
- Background: PubMed 36336434Horka K. Optimizing Care in Kidney Transplantation. Crit Care Nurs Clin North Am. 2022 Dec;34(4):443-451. doi: 10.1016/j.cnc.2022.08.003. Epub 2022 Oct 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Emek Bakanoğlu Kalkavan principal investigator
Istanbul Gedik University
Questions about this trial
What is this clinical trial studying?
A study testing Traning in people with Kidney Transplantation and Nursing, run by Istanbul Gedik University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emek Bakanoğlu Kalkavan (05447683055, emekkalkavan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Centered Care Competency Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015984, which also lists 9 linked publications.
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 29 Aug 2023.