NCT05962268

Brief Summary

Objective: This study aimed to determine the effect of face-to-face and video-based education for fistula care on hemodialysis patients' self-care behaviors. Methods: The study was conducted as a randomized controlled experimental study. Fistula care training was given to the patients in the control group using face-to-face education technique. Fistula care training was given to the patients in the experimental group using a video based technique.

Trial Health

87
On Track

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
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

June 19, 2023

Last Update Submit

July 24, 2023

Conditions

Keywords

fistula careeducationself care

Outcome Measures

Primary Outcomes (2)

  • Patient Information Form

    The form consists of 12 items related to patients' gender, age, marital status, educational status, occupation, income status, duration of chronic renal failure (CRF), duration of hemodialysis, number of weekly hemodialysis, first AVF cannulation, number of AVFs, previous AVF care, and status or receiving education on kidney failure. It consists of 12 questions that determine the educational status.

    10 minutes

  • Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF)

    The scale developed by Sousa et al. (2015) can be used for the education and follow-up of patients, in addition to evaluating the care behaviors of patients towards their AVF. Each item is scored according to the its reverse statement. On the scale, a score of 1 indicates that the specified self-care behavior has never developed, and a score of 5 indicates that the specified self-care behavior is always present. The scale is concluded by summing the scores from each statement. The minimum score that can be obtained from the scale is 16, and the maximum score is 80. As the score increases, the self-care behaviors of the person improve. The validity and reliability of the scale for the Turkish population were determined by İkiz and Yıldırım Usta (2016), and the Cronbach alpha coefficient of the scale was reported to be 0.91.

    10 minutes

Study Arms (2)

Video based education

EXPERIMENTAL

The video was prepared by the researchers in line with the literature. Expert opinion was obtained from 10 individuals with at least a doctorate and studies on the subject of video content. In line with expert opinions, the video content was updated and finalized. Patient education with the prepared video was provided by one of the researchers involved in the study. The video education took 20 minutes in total. Topics: Video recordings on of fistula care was done by the researchers in the vocational skills laboratory. The video flow plan included the introduction of the materials to be used in fistula care as well as the researcher's presentation of how to manage the fistula. Fistula care steps were performed on the simulation model. In addition, the precautions to be taken during the application and what to do in case of possible complications were also shown.

Other: Video based education

Face to face education

EXPERIMENTAL

The patients were trained on fistula care by the researcher. Fistula care training was given to the patients in the control group using face-to-face education technique. In this training, researcher verbally explained fistula care to patients. The training was conducted one-on-one with the patient in the patient's room and lasted 10 minutes. The training was presented to the patient through the lecture method. The training was also supported by the question-and-answer method. The training was given twice, one week apart, when patients came for hemodialysis treatment after the condition of the patients on dialysis stabilized.

Other: Face to face education

Interventions

The video was prepared by the researchers in line with the literature. Expert opinion was obtained from 10 individuals with at least a doctorate and studies on the subject of video content. In line with expert opinions, the video content was updated and finalized. Patient education with the prepared video was provided by one of the researchers involved in the study. The video education took 20 minutes in total.

Video based education

The patients were trained on fistula care by the researcher. Fistula care training was given to the patients in the control group using face-to-face education technique. In this training, researcher verbally explained fistula care to patients. The training was conducted one-on-one with the patient in the patient's room and lasted 10 minutes. The training was presented to the patient through the lecture method. The training was also supported by the question-and-answer method. The training was given twice, one week apart, when patients came for hemodialysis treatment after the condition of the patients on dialysis stabilized.

Face to face education

Eligibility Criteria

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

You may qualify if:

  • Being 18 years or older,
  • Receiving hemodialysis treatment for more than 6 months,
  • Having arteriovenous fistula,
  • Being able to read, understand and speak Turkish,
  • Not having any physical, mental or mental disability restricting daily activities,
  • Having no visual-hearing impairment, perception and psychiatric problems,
  • Volunteering to participate in the study

You may not qualify if:

  • Not having arteriovenous fistula,
  • Declining to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Dialysis Center

Kayseri, Talas, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Izmir Bakircay University

Study Record Dates

First Submitted

June 19, 2023

First Posted

July 27, 2023

Study Start

October 1, 2022

Primary Completion

December 15, 2022

Study Completion

December 30, 2022

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Information can be obtained from the principal investigator via e-mail.

Locations