HemolysisNCT05962268
The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs
A study testing Video based education and Face to face education in people with Hemolysis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemolysis
- What is being tested?
- Video based education and Face to face education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Dec 2022
- 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
- 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
Who cannot join
- Not having arteriovenous fistula,
- Declining to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs Patıents' Self-Care Behavıors: A Randomızed Controlled Study
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.
Read the detailed description
Experimental group: The researcher provided the patient education the on fistula care. In this training, the researcher first verbally explained fistula care to the patients. After the verbal training, a video recording about fistula care was shown to the patients. The patients watched the video recording during dialysis using the TV unit at the bedside. The training took 20 minutes. Patients were allowed to watch the training video twice, at a one-week interval, when they came for hemodialysis treatment after the condition of the patients on dialysis stabilized.
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.
Literature review, research results, clinicians' opinions, and experts and practices were used in editing the content of verbal training and video recording,
- Conditions
- Hemolysis
- Being tested
- Video based education, Face to face education
- Keywords
- fistula care, education, self care
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video based educationOther
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.
Face to face educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Face to face education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Oct 2022
- Primary completion15 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seda şahan, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962268
- Sponsor's protocol ID
- E-64577500-050.99-30751
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information can be obtained from the principal investigator via e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs Patıents' Self-Care Behavıors: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT05962268
- Acronym / sponsor ID
- E-64577500-050.99-30751
- Conditions
- Hemolysis
- Keywords
- fistula care, education, self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 Jul 2023 (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.
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.
Detailed description
Experimental group: The researcher provided the patient education the on fistula care. In this training, the researcher first verbally explained fistula care to the patients. After the verbal training, a video recording about fistula care was shown to the patients. The patients watched the video recording during dialysis using the TV unit at the bedside. The training took 20 minutes. Patients were allowed to watch the training video twice, at a one-week interval, when they came for hemodialysis treatment after the condition of the patients on dialysis stabilized.
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.
Literature review, research results, clinicians' opinions, and experts and practices were used in editing the content of verbal training and video recording,
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video based education | Experimental | Other: Video based educationThe 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. |
| Face to face education | Experimental | Other: Face to face educationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- Not having arteriovenous fistula,
- Declining to participate in the study
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 |
|---|---|---|
| Video based educationThe 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. | Other | Video based education |
| Face to face educationThe 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 |
Primary outcome
Patient Information Form
Time frame: 10 minutes
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.
Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF)
Time frame: 10 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No. Information can be obtained from the principal investigator via e-mail.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video based education and Face to face education in people with Hemolysis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 10 minutes). 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 27 Jul 2023.