Attitudes and Knowledge of Dialysis Patients Towards Kidney Transplantation

Kidney Transplant Clinical Trial

Official title:

Attitudes and Knowledge of Dialysis Patients Towards Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148116
• Other study ID #: KAAFMWLNZ/34/0/2023
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Andrzej Frycz Modrzewski Krakow University
• Contact: Paulina Kurleto, PhD
• Phone: 0048502279152
• Email: pkurleto[@]afm.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In Poland, approximately 4.2 million people suffer from chronic kidney disease [1]. In December 2022, a total of 20,198 patients were dialyzed in the country, of which 96% by hemodialysis (HD) and 4% by peritoneal dialysis (DO). In 2022, kidney transplantation was performed in 2.6% of patients dialyzed using the HD method and in 15.4% of patients dialyzed using the DO method [2]. According to the data of the Organizational and Coordination Center for Transplantation "Poltransplant", in 2022 on the national waiting list 1,119 people were registered for kidney transplantation. The average age of those waiting was 49 years [3]. In Poland, according to data from 2022, the average waiting time for transplantation in the case of the first transplant from the moment of registration on the waiting list was 387 days, and 1,106 days from the start of dialysis. Data show that only 5.5% of patients undergoing renal replacement therapy are on the waiting list [3].

Therefore, a study was designed to examine the knowledge and attitudes towards kidney transplantation among dialysis patients. The study will include a representative group of dialysis patients from all voivodeships and aims to identify positive and negative aspects related to patients' attitudes towards kidney transplantation.

The scientific value of the study is worth emphasizing, because so far in Poland no research has been conducted on the knowledge and attitudes towards kidney transplantation among dialysis patients in all voivodeships in the country. The study will identify the level of knowledge and attitudes of dialysis patients towards transplantation. The results of this study may contribute to the development and implementation of new educational and information programs that may increase the level of knowledge and influence attitudes towards transplantation, which may largely contribute to the increase in transplantation among people with chronic kidney disease.

References:

1. Gellert R, Durlik M, Małgorzewicz S. Raport 2019. Ogólnopolskie Badanie Pacjentów Nefrologicznych. Forum Nefrologiczne. 2020;13(3):149-63.

2. Dębska-Ślizień A, Rutkowski B, Rutkowski P et al. (2022). Aktualny stan leczenia nerkozastępczego w Polsce-2022. Nefrol Dializoter Pol, 26: 21-38.

3. Centrum Organizacyjno- Koordynacyjne do spraw transplantacji-Poltransplant. Biuletyn Informacyjny 2023. https://files.poltransplant.org.pl/Biuletyn_2023_www.pdf Accessed 13 November 2023.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(1) patients on dialysis for at least 3 months; (2) patients who have no medical contraindications to kidney transplantation and patients who are temporarily suspended from KLO; (3) voluntary consent to participate in the study; (4) communicative knowledge of Polish

Exclusion Criteria:

(1) inability to make an informed and independent decision; (2) patients with absolute medical contraindications to kidney transplantation, i.e. recently diagnosed or disseminated cancer, persistent untreated infection, severe irreversible systemic disease, expected short life span, lack of cooperation (alcohol and drug addiction, mental illness)

Related Conditions & MeSH terms

• Kidney Transplant

Locations

Country	Name	City	State
Poland	Andrzej Frycz Modrzewski Krakow University	Krakow	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Andrzej Frycz Modrzewski Krakow University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitudes and Knowledge of Dialysis Patients Towards Kidney Transplantation	Attitudes and Knowledge will be measured using a 51-item self-report questionnaire with single and multi-choice questions.	16 months
Primary	Intensity of pain and attitudes towards kidney transplantation.	To investigate the relationship between the intensity of pain in dialysis patients and their attitudes towards kidney transplantation.; Standardized tool will be the Numeric Rating Scale (NRS). Pain intensity will be assessed using the NRS, where 0 meant no pain and 10 maximum pain. Numeric scores of 1-3, 4-6, and 7-10 corresponded to mild, moderate and severe pain	16 months
Primary	Anxiety and Depression	To investigate the relationship between the level of anxiety and depression of dialysis patients and their attitudes towards kidney transplantation.; Emotional state will be evaluated using HADS [21, 22], which was validated for Polish conditions. It consists of 7 items grouped in sub-scales: anxiety and depression. The answers describe the patient's well-being over the last week and are coded on a scale of 0-3 points. The total score amounts to 0-21 points (0-7 points = norm, 8-10 = borderline, =11 points = clinical levels of symptoms).	16 months
Primary	Acceptance of the disease	To measure it, the Acceptance of Illness Scale (AIS), by Felton, Revenson and Hinrichsen, in the Polish adaptation by Juczynski was used [4]. It consists of 8 questions describing the consequences of poor health. The questions concerned the limitations imposed by the disease, lack of self-sufficiency, feeling of dependence on others and reduced self-esteem. Questions contained a five-point scale, and the person described their current health condition by marking the number: 1 - I strongly agree, 2 - I agree, 3 - I don't know, 4 - I disagree, 5 - I strongly disagree. Strong consent meant poor adaptation to the disease, while lack of consent meant acceptance of the disease. The degree of acceptance of the current health condition was the sum of all points, ranging from 8 to 40 points. Three point ranges were created to determine the degree of acceptance, where the number of points: 8-18 meant lack of acceptance of the disease, 19-29 - average acceptance, 30-40 - good acceptance.	16 months
Primary	Patient Request Form	To investigate the relationship between patient expectations and their attitudes towards kidney transplantation. Patient expectations will be measured using the Patient Request Form - the scale consists of 18 statements regarding expectations towards the doctor/medical staff related to explaining the disease, seeking support and obtaining information about tests and treatment. The theoretical range of the scale is from 0 to 12 points. The higher the score, the greater the patient's expectations for specific help.	16 months