NCT06959914

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

April 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

April 21, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

Arteriovenous FistulaQualitiy of lifeComfortSelf-careHemodialysisHemodialysis access

Outcome Measures

Primary Outcomes (3)

  • 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

    eight weeks

  • 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).

    eight weeks

  • 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.

    eight weeks

Study Arms (1)

Control group

ACTIVE COMPARATOR

HD 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.

Other: Training group

Interventions

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the research,
  • Speaking Turkish.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 25477007BACKGROUND
  • 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.

    PMID: 34325496BACKGROUND
  • 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.

    PMID: 38872366BACKGROUND
  • 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.

    PMID: 29241195BACKGROUND
  • 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.

    PMID: 31008132BACKGROUND
  • 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.

    PMID: 25115617BACKGROUND
  • 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.

    PMID: 32338112BACKGROUND
  • 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.

    PMID: 31394548BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Zümrüt Akgün Şahin, Doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 7, 2025

Study Start

September 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share