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Not yet recruitingNCT06391281Updated Apr 30, 2024

Effect of Fistula Training in Hemodialysis Patients

An interventional study of Education in Hemodialysis, sponsored by Kırklareli University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Kırklareli University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

It was planned to examine the effect of fistula-related education given to patients receiving hemodialysis treatment on their self-care behaviors.

Nurse-led education about fistula for hemodialysis patients affects fistula self-care behaviors.

Nurse-led training regarding fistula to hemodialysis patients does not affect fistula self-care behaviors.

Read the detailed description

Hemodialysis patients in the experimental group will be given face-to-face training in 2 sessions. Patients will also receive an educational brochure on fistula self-care. Simultaneously, patients will receive routine treatment and care.

No intervention will be performed on patients in the control group. These patients will receive normal treatment and care.

A pre-test will be applied to both groups at the first meeting and their self-care behaviors related to fistula will be examined. Three months later, fistula-related self-care behaviors will be evaluated again with the relevant scale.

02

Conditions studied

  • Hemodialysis

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Keywords

  • hemodialysis
  • Fistula
  • self care
  • education
03

In context

Fistula

219 studies on the registry are indexed under Fistula; 49 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 152 interventional studies indexed under Fistula.

Browse Fistula studies →

Lead sponsor

Kırklareli University is the lead sponsor of 49 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years and over,with chronic kidney disease
  • Having a fistula as a vascular access route
  • Receiving hemodialysis treatment for at least 6 months

Exclusion criteria

Exclusion Criteria:

  • Those with acute renal failure,
  • Having a graft and catheter as a vascular access route,
  • Not volunteering to participate in the research
  • Those with communication problems (hearing, language, understanding, etc.)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • No intervention
    Control

    routine care

  • Experimental
    Education

    The patient receiving hemodialysis treatment will be given fistula self-care training in 2 sessions. An educational booklet will be provided after the training.

    Other: Education

Interventions

  • OtherEducation

    The patient receiving hemodialysis treatment will be given fistula self-care training in 2 sessions. An educational booklet will be provided after the training.And routine care

    Also known as: experimental

06

What researchers measure

Primary outcomes

  1. Patient Information Form

    Contains disease-related and sociodemographic information

    Time frame: 1-3 month

  2. Self-Care Behavior Assessment Scale Regarding Arteriovenous Fistula in Hemodialysis Patients

    he scale was adapted from Sousa et al. Developed by. Turkish validity and reliability, İkiz et al. It was done by. The scale consists of the subscales "management of symptoms and signs" and "prevention of complications". An increase in the score indicates that the person's self-care behaviors regarding fistula care are improving

    Time frame: 1-3 month

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2024; primary completion for Aug 2024, 4 months later.

Of 45 non-industry interventional studies with no phase under Fistula, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 56. This study's planned 4 months is below that.

Counting every sponsor, half of 51 studies reached it within 23 months; a quarter within 14 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
Apr 30, 2024
StartEst.
Apr 26, 2024
Primary completionEst.
Aug 30, 2024
CompletionEst.
Sep 15, 2024
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06391281
Lead sponsor
Kırklareli University
Responsible party
Özlem Özdemir (Dr. lecturer, Kırklareli University) — Principal investigator
First posted
Apr 30, 2024
Start date
Apr 26, 2024 (estimated)
Primary completion
Aug 30, 2024 (estimated)
Completion
Sep 15, 2024 (estimated)
Last update
Apr 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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