HemodialysisNCT06391281
Effect of Fistula Training in Hemodialysis Patients
A study testing Education in people with Hemodialysis, run by Kırklareli University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and over,with chronic kidney disease
- Having a fistula as a vascular access route
- Receiving hemodialysis treatment for at least 6 months
Who cannot join
- 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.)
About this study
Official title: The Effect of Fistula Education Given to Patients Receiving Hemodialysis Treatment on Self-Care Behaviors
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.
- Conditions
- Hemodialysis
- Being tested
- Education
- Keywords
- hemodialysis, Fistula, self care, education
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Also called experimental
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | routine care |
| Education | Experimental | The patient receiving hemodialysis treatment will be given fistula self-care training in 2 sessions. An educational booklet will be provided after the training. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
Contains disease-related and sociodemographic information
Measured: 1-3 month
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
Measured: 1-3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start26 Apr 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Özdemir, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391281
- Sponsor's protocol ID
- Kirklareli Ozlem Ozdemir
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fistula Education Given to Patients Receiving Hemodialysis Treatment on Self-Care Behaviors
- ClinicalTrials.gov ID
- NCT06391281
- Acronym / sponsor ID
- Kirklareli Ozlem Ozdemir
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, Fistula, self care, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 26 Apr 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –routine care |
| Education | Experimental | Other: EducationThe patient receiving hemodialysis treatment will be given fistula self-care training in 2 sessions. An educational booklet will be provided after the training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and over,with chronic kidney disease
- Having a fistula as a vascular access route
- Receiving hemodialysis treatment for at least 6 months
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationAlso: experimentalThe 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 | Other | Education |
Primary outcome
Patient Information Form
Time frame: 1-3 month
Contains disease-related and sociodemographic information
Self-Care Behavior Assessment Scale Regarding Arteriovenous Fistula in Hemodialysis Patients
Time frame: 1-3 month
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Hemodialysis, run by Kırklareli 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 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: 1-3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.