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Hemodialysis PatientFistula careNCT06959914

The Effect of Arteriovenous Fistula Care Training Given to Hemodialysis Patients on Quality of Life, Comfort and Self-Care Behaviours

A study testing Training group in people with Hemodialysis Patient and Hemodialysis Catheter, run by Kafkas University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hemodialysis Patient, Hemodialysis Catheter
What is being tested?
Training group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2025to Sep 2026
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zümrüt Akgün Şahin, Doctorate contact

+905057763209

zumrut8136@hotmail.com

About this study

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.

Read the 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
Being tested
Training group
Keywords
Arteriovenous Fistula, Qualitiy of life, Comfort, Self-care, Hemodialysis, Hemodialysis access
Medical subject headings
Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training groupOther

    Patients in the intervention group will receive AVF care training. The training will last for 8 weeks and is planned to be given once a week. In the first session, the patients in the intervention group will be introduced. Afterwards, general information will be provided about the purpose and applications of AVF training and the importance of participation in training will be emphasized. Afterwards, patients who agree to participate in the study will sign an informed consent form. In addition, the Patient Information Form, SF-12 Quality of Life Short Form, the Comfort Scale for Hemodialysis Patients and the Scale for Assessing Self-Care Behaviors Related to Arteriovenous Fistula in Hemodialysis Patients will be given and asked to answer. For those who cannot read or write, the researchers will read the survey forms. In the first session, the pre-test data of the patients will be collected and then the training books will be given.

Study groups in NCT06959914
Study groupRoleWhat they receive
Control groupActive comparatorHD patients who fulfil the inclusion criteria will be met face-to-face. Patients who agree to participate in the study will be asked to sign an informed consent form. Afterwards, Patient Information Form, SF-12 Quality of Life Short Form, Comfort Scale for Hemodialysis Patients and Scale for Evaluation of Self-Care Behaviours Regarding Arteriovenous Fistula in Hemodialysis Patients will be given to the patients and those who can read and write will be asked to fill them in by themselves. For illiterate patients, pre-test data will be collected by reading the questionnaire forms by the investigators. No treatment will be applied to the participants in this group. At the end of 8 weeks, all participants will be asked to fill in the Patient Information Form, SF-12 Quality of Life Short Form, Comfort Scale for Hemodialysis Patients and Self-Care Behaviour Assessment Scale for Arteriovenous Fistula in Hemodialysis Patients as a post-test application.
Receives: Other: Training group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Self-Care Behaviours Regarding Arteriovenous Fistula in Hemodialysis Patients

    The scale was developed by Sousa et al. to evaluate patients' care behaviors related to arteriovenous fistula and to follow up patients' education. The scale was developed in Portuguese and its validity and reliability for the Turkish society was performed by İkiz and Usta. It is a 16-item, 5-point Likert scale consisting of single-sentence phrases. The scale consists of two sub-dimensions as symptom and "Symptom Management" and "Prevention of Complications". The item numbers of the Symptom and Symptom Management sub-dimension of the scale are 1,3,6,11,13,16 and the item numbers of the Complication Prevention sub-dimension are 2,4,5,7,8,9,10,12,14,15.22. The time required to administer the scale is about 2-3 minutes. While 16 indicates the lowest possible score in the scoring of the scale, 80 indicates the highest score. The lowest possible score from the symptom and symptom management sub-dimension is 6 and the highest score is 30. The lowest score that can be obtained from the sub-d

    Measured: eight weeks

  2. Comfort Scale for Haemodialysis Patients (HCP)

    It was revised by Orak et al. (2017) by using the General Comfort Scale developed by Kolcaba (1992) and later comfort scales developed specifically for certain situations. The scale consists of 9 items and 2 sub-dimensions (overcoming and relaxing). The responses given to the 4th item of the 5-point Likert-type scale are scored as "never" 1 point, "very rarely" 2 points, "sometimes" 3 points, "very often" 4 points and "always" 5 points. The scores given to the other items (1-3, 5-9) are scored in reverse: "never" 5 points, "very rarely" 4 points, "sometimes" 3 points, "very often" 2 points and "always" 1 point. The evaluation of the scale is determined by calculating the average score, the lowest score that can be obtained from the scale is 1, the highest score is 5. The comfort level increases as the score gets closer to 5. The scale has two sub-dimensions: "Relaxation" (items 7-9) and "Overcoming" (items 1-6).

    Measured: eight weeks

  3. SF-12 Quality of Life Short Form

    SF-12 was developed by Ware et al. (1996). The Turkish version of the scale was developed by Soylu and Kütük. The scale is an outcome measure filled out by the patient, evaluating the impact of health on the individual's daily life. SF-12 is basically a shortened version of SF36, consisting of 8 sub-dimensions and a total of 12 items. This scale evaluates physical functioning with 2 items, physical role with 2 items, body pain with 1 item, general health with 1 item, energy with 1 item, social functioning with 1 item, emotional role with 2 items, and mental health with 2 items.

    Measured: eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959914
Sponsor's protocol ID
0000-0001-7141-273X
Acronym
Fistula care
Status last verified
May 2025
First submitted
21 Apr 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sousa CN, Apostolo JL, Figueiredo MH, Dias VF, Teles P, Martins MM. Construction and validation of a scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis. Hemodial Int. 2015 Apr;19(2):306-13. doi: 10.1111/hdi.12249. Epub 2014 Dec 5.

    PubMed 25477007
  • Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.

    PubMed 34325496
  • Dilbilir Y, Kavurmaci M. Determining the effect of arteriovenous fistula care training on the self-care behaviors of hemodialysis patients. Ther Apher Dial. 2024 Dec;28(6):893-903. doi: 10.1111/1744-9987.14174. Epub 2024 Jun 13.

    PubMed 38872366
  • Wang J, Yue P, Huang J, Xie X, Ling Y, Jia L, Xiong Y, Sun F. Nursing Intervention on the Compliance of Hemodialysis Patients with End-Stage Renal Disease: A Meta-Analysis. Blood Purif. 2018;45(1-3):102-109. doi: 10.1159/000484924. Epub 2017 Dec 12.

    PubMed 29241195
  • Ramezani T, Sharifirad G, Rajati F, Rajati M, Mohebi S. Effect of educational intervention on promoting self-care in hemodialysis patients: Applying the self-efficacy theory. J Educ Health Promot. 2019 Mar 14;8:65. doi: 10.4103/jehp.jehp_148_18. eCollection 2019.

    PubMed 31008132
  • Casey JR, Hanson CS, Winkelmayer WC, Craig JC, Palmer S, Strippoli GF, Tong A. Patients' perspectives on hemodialysis vascular access: a systematic review of qualitative studies. Am J Kidney Dis. 2014 Dec;64(6):937-53. doi: 10.1053/j.ajkd.2014.06.024. Epub 2014 Aug 10.

    PubMed 25115617
  • 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.

    PubMed 32338112
  • 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.

    PubMed 31394548

Questions about this trial

What is this clinical trial studying?

A study testing Training group in people with Hemodialysis Patient and Hemodialysis Catheter, run by Kafkas 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 May 2025. 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?

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?

Contact Zümrüt Akgün Şahin, Doctorate (+905057763209, zumrut8136@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Self-Care Behaviours Regarding Arteriovenous Fistula in Hemodialysis Patients (time frame: eight weeks). The study lists 3 primary outcomes in all. 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 NCT06959914, which also lists 8 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 13 May 2025.

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