Clinical trial NCT06959914: The Effect of Arteriovenous Fistula Care Training Given to Hemodialysis Patients on Quality of Life, Comfort and Self-Care Behaviours
Official title: The Effect of Arteriovenous Fistula Care Training Given to Hemodialysis Patients on Quality of Life, Comfort and Self-Care Behaviours
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis Patient
Hemodialysis Catheter
Keywords: Arteriovenous Fistula
Qualitiy of life
Comfort
Self-care
Hemodialysis
Hemodialysis access
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate the effect of Arterio-Venous Fistula (AVF) care training given to hamodialysis patients on quality of life, comfort and self-care behaviours. Patient education is one of the practices that help patients to gain self-care behaviours as well as reducing the cost of health expenditures. Nurses are health professionals who play an important role in patient education. Nurses provide patient education by using different materials. These materials can sometimes be mobile phones, videos, web-based applications, sometimes face-to-face interviews with patients, brochures or written materials. In this study, a training programme for AVF care will be developed. In addition, it is expected that the AVF care training to be given to HD patients will increase the quality of life and comfort areas, and increase the awareness and well-being levels of patients in self-care behaviours. The effectiveness of the study will be expanded by presenting the results of the research as a paper in an international comprehensive congress. An article of the study will be published in a journal scanned in international indexes and will be included in the literature.

Detailed description: This study will be conducted to determine the effect of Arterio-Venous Fistula (AVF) care training given to haemodialysis patients on quality of life, comfort and self-care behaviours.

The research will be conducted as an experimental, pre-test post-test randomised controlled experimental study.

Hypotheses:

H0: AVF care training given to haemodialysis patients has no effect on patients' quality of life, comfort and self-care behaviours.

H1: AVF care training given to haemodialysis patients affects patients' quality of life.

H2: AVF care training given to haemodialysis patients affects patients' comfort.

H3: AVF care training given to haemodialysis patients affects patients' self-care behaviours.

The research population will consist of a total of 67 patients receiving HD treatment in the Dialysis Unit and having AVF. Similar study data were taken into consideration in the selection of the research sample. As a result of the power analysis performed in the G\*Power version 3.1.9.7 programme, it was determined that a total of 52 participants, at least one person for each of the intervention and control groups, should be included in the sample size, 95% confidence interval, 95% test power (1-ß), 0.05% margin of error level.

Randomisation and Blinding Simple random sampling method will be used for randomisation of the study. In order to avoid interactions between the patients participating in the study, they will be grouped according to the days of HD treatment sessions. In Group I: Patients receiving HD treatment on Mondays, Wednesdays and Fridays, and in Group II; patients receiving HD treatment on Tuesdays, Thursdays and Saturdays. Which group will be the control group and which will be the intervention group will be decided by drawing lots.

Inclusion Criteria for the Study:

* Volunteering to participate in the study,
* Speak Turkish.
* Being 18 years old and above
* Having an AVF
* Being on the floor for HD at least 3 times in 6 weeks
* Not having treatments or mental problems that prevent participation in the study

Exclusion Criteria for the Study:

* Not consenting to participate in the study
* Having a diagnosed psychiatric illness,
* Having a visual, hearing, speech, physical or mental disability,
* Dropping out of education. Data Collection Tools Data will be collected using the "Patient Information Form", "SF-12 Quality of Life Short Form ", "Comfort Scale for Hemodialysis Patients" and "Self-Care Behavior Assessment Scale for Arteriovenous Fistula in Hemodialysis Patients".

Data Collection / Intervention Procedure First, patients will be informed about the study and will be asked to sign an informed consent form. Then, all participants will fill out the questionnaire forms as a pre-test application.

No training will be given to the patients in the control group and the questionnaire forms will be applied again after 8 weeks. The patients in the intervention group will be given 8 weeks of AVF care training. At the end of the training, the questionnaire forms will be applied to the patients again and the effectiveness of the training will be evaluated.

Training Booklet Content The training booklet will be prepared using literature reviews, research results, and evidence-based practice guides. After the training booklet is created, it will be sent for expert opinion. The training booklet will include topics on fluid control, diet, and medication management.

Training Program Goals

* Knowing the functions of the kidneys
* Knowing the treatment options for chronic renal failure
* Knowing the vascular access routes used in hemodialysis
* Knowing arteriovenous fistula care
* Knowing the medications frequently used
* Knowing the meanings of laboratory findings
* Knowing the problems frequently encountered and solution suggestions

Eligibility criteria: Inclusion Criteria:

* -Volunteering to participate in the research,
* Speaking Turkish.
* 18 years of age or older
* Having AVF
* Receiving HD treatment 3 times a week for at least 6 months
* Not having cognitive and mental problems that prevent participation in the study

Exclusion Criteria:

* Not consenting to participate in the study

  * Being a diagnosed psychiatric individual,
  * Having a visual, hearing, speech, physical or mental disability,
  * Being incomplete in their education.

Primary outcomes:
measure: Evaluation of Self-Care Behaviours Regarding Arteriovenous Fistula in Hemodialysis Patients
timeFrame: eight weeks
measure: Comfort Scale for Haemodialysis Patients (HCP)
timeFrame: eight weeks
measure: SF-12 Quality of Life Short Form
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Shamasneh AO, Atieh AS, Gharaibeh KA, Hamadah A. Perceived barriers and attitudes toward arteriovenous fistula creation and use in hemodialysis patients in Palestine. Ren Fail. 2020 Nov;42(1):343-349. doi: 10.1080/0886022X.2020.1748650.
citation: Al-Balas A, Shariff S, Lee T, Young C, Allon M. Clinical Outcomes and Economic Impact of Starting Hemodialysis with a Catheter after Predialysis Arteriovenous Fistula Creation. Am J Nephrol. 2019;50(3):221-227. doi: 10.1159/000502050. Epub 2019 Aug 8.