Nursing CariesNCT04925635
Fistula Care and Mobile Health Applications in Hemodialysis Patients
An observational study of Nursing Caries and Arterio-venous Fistula, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Caries, Arterio-venous Fistula, mHealth
- What is being tested?
- experimental group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Oct 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The population of the study consisted of individuals with arteriovenous fistula who applied to Private Hope Dialysis Center and Private Almet Dialysis Center for hemodialysis between June 2020 and October 2020. In the study, the experimental and control groups were selected from two different dialysis centers in order to eliminate the bias and considering the control group's exposure to the interference.
Who may be able to join
- Over 18 years old,
- Literate (can understand and speak Turkish),
- Do not have a diagnosed mental and psychological disease,
- Hearing or visually impaired,
- Open to communication and cooperation,
- Having arteriovenous fistula,
- Having a smart phone,
- Individuals willing to participate in the research will be included.
Who cannot join
- Those with arteriovenous graft,
- Those with a catheter,
- Those receiving peritoneal dialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fistula Care Training With Mobile Health Application on Hemodialysis Patients' Adaptation and Self-Care Behaviors
In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can reach at any time and place, have not been found. Based on this, it was planned to increase the knowledge level of arteriovenous fistula care and examine their self-care behaviors and their adaptation to the disease with the mobile application developed with a focus on education on fistula care, which can be used independently by machine-dependent hemodialysis patients. In this context, it is aimed that dialysis patients will benefit especially in arteriovenous fistula care applications, thanks to the ever-increasing mobile applications in daily use with the developing technology. It is thought that the use of these technology-based trainings will be more comfortable, useful and encouraging for their own self-care. It is planned to be a guide for healthcare professionals.
Read the detailed description
Chronic renal failure is a clinical picture characterized by chronic, progressive deterioration in metabolic and endocrine functions, in adjusting the fluid-electrolyte balance of the kidney as a result of a decrease in glomerular filtration value. When the glomerular filtration value decreases to 5-10 ml/minute, end-stage renal failure develops. Renal replacement therapies such as hemodialysis, peritoneal dialysis and kidney transplantation are applied in patients diagnosed with end-stage renal disease. Renal replacement therapies are life-sparing treatments and the most common method applied is hemodialysis. The success of dialysis, which is a highly effective medical technology, in saving lives is indisputable. Arteriovenous fistula opened for hemodialysis is the lifeline of sick individuals, and hemodialysis is a critical treatment method based on the vascular access pathway. In this context, compliance with treatment is of vital importance in individuals with a diagnosis of end-stage renal disease, and lack of vascular access can reduce its efficiency in a short time. Studies show that only 25% of hemodialysis patients can take care of themselves.
The inadequacy of the individual's knowledge and behaviors of arteriovenous fistula care impairs adherence to treatment, reduces the effectiveness of the treatment and increases the cost. Interventions that encourage changes in health behavior and encourage individuals to change their lifestyle should be integrated into daily life, and there should be support for when and where individuals can make decisions that may affect their health. Mobile technologies, such as smart mobile phones, that individuals regularly carry, can be an effective platform for encouraging health behavior change, especially since they are likely to be with the individual when they need it.
In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can reach at any time and place, have not been found. Based on this, it was planned to increase the knowledge level of arteriovenous fistula care and examine their self-care behaviors and their adaptation to the disease with the mobile application developed with a focus on education on fistula care, which can be used independently by machine-dependent hemodialysis patients. In this context, it is aimed that dialysis patients will benefit especially in arteriovenous fistula care applications, thanks to the ever-increasing mobile applications in daily use with the developing technology. It is thought that the use of these technology-based trainings will be more comfortable, useful and encouraging for their own self-care. It is planned to be a guide for healthcare professionals.
- Conditions
- Nursing Caries, Arterio-venous Fistula, mHealth
- Being tested
- experimental group, control group
- Keywords
- Hemodialysis, nursing, arteriovenous fistula, care, compliance, mobile health application
- Medical subject headings
- Arteriovenous Fistula, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupBehavioural
The arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group. Arteriovenous fistula care mobile health application will be installed in daytime groups during working hours during or at the end of dialysis according to the patient's request. In addition, the information contained in the arteriovenous care mobile health application will be verbally explained to the patients and their relatives, as well as shown in practice. The training results were evaluated by the researcher in the 1st and 3rd months in the "Scale for Evaluation of Self-Care Behaviors Related to Arteriovenous Fistula in Hemodialysis Patients", "Final Level of Renal Failure Compliance Scale", "Arteriovenous Fistula Care Education Knowledge Level Evaluation Form (Post-Training Section)" and " Visual Benchmarking Scale ".
control groupBehavioural
Patients in the control group will receive arteriovenous fistula care training and a training booklet will be given. The information contained in the booklet will be explained orally to the patients and their relatives by the researcher, and will also be shown in practice. The results of the training were determined by the researcher at the 1st and 3rd months of the "Self-Care Behaviors Scale for Arteriovenous Fistula in Hemodialysis Patients", "End Stage Renal Failure Compliance Scale", "Arteriovenous Fistula Care Training Information Level Assessment Form (Post-training section)" and "Visual It will be evaluated with the "Comparison Scale".
| Study group | Role | What they receive |
|---|---|---|
| experimental group | The arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group. Receives: Behavioral: experimental group | |
| control group | Patients in the control group will receive arteriovenous fistula care training and a training booklet will be given. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care behavior
Patients were informed about the Self-Care Behaviors Assessment Scale for Arteriovenous Fistula in Hemodialysis Patients. (The scale consisting of 16 items in total; Each item is scored according to the statements opposite. A minimum of 1 point indicates that the specified self-care behavior never develops, and the highest 5 points indicate that the specified self-care behavior always exists. The minimum score that can be obtained from the scale is 16, and the maximum score is 80.As the score increases, it is evaluated that the person's self-care behaviors are positive.)
Measured: 5 month
adaptation to illness
Patients were informed about the End Stage Renal Failure Compliance Scale. (It consists of 5 chapters and 46 items. The total score that can be obtained from the scale varies between 0 and 1200. As the score obtained from the scale increases, the level of adherence to treatment increases.)
Measured: 5 month
knowledge level
Patients were informed about the Arteriovenous Fistula Care Education Evaluation Form. (It states that there is no "0 point" information when scoring the form, but "1 point" information. The total score that can be obtained from the form varies between 0 and 13. The higher the score, the higher the AVF care knowledge level.)
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jun 2020
- Primary completion20 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cevriye Ozdemir, Saglik Bilimleri Universitesi
- Investigators
- Cevriye Ozdemir, Lecturer, Principal investigator, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925635
- Sponsor's protocol ID
- i060708c.A
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fistula Care Training With Mobile Health Application on Hemodialysis Patients' Adaptation and Self-Care Behaviors
- ClinicalTrials.gov ID
- NCT04925635
- Acronym / sponsor ID
- i060708c.A
- Conditions
- Nursing Caries, Arterio-venous Fistula, mHealth
- Keywords
- Hemodialysis, nursing, arteriovenous fistula, care, compliance, mobile health application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 14 Jun 2021 (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.
In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can reach at any time and place, have not been found. Based on this, it was planned to increase the knowledge level of arteriovenous fistula care and examine their self-care behaviors and their adaptation to the disease with the mobile application developed with a focus on education on fistula care, which can be used independently by machine-dependent hemodialysis patients. In this context, it is aimed that dialysis patients will benefit especially in arteriovenous fistula care applications, thanks to the ever-increasing mobile applications in daily use with the developing technology. It is thought that the use of these technology-based trainings will be more comfortable, useful and encouraging for their own self-care. It is planned to be a guide for healthcare professionals.
Detailed description
Chronic renal failure is a clinical picture characterized by chronic, progressive deterioration in metabolic and endocrine functions, in adjusting the fluid-electrolyte balance of the kidney as a result of a decrease in glomerular filtration value. When the glomerular filtration value decreases to 5-10 ml/minute, end-stage renal failure develops. Renal replacement therapies such as hemodialysis, peritoneal dialysis and kidney transplantation are applied in patients diagnosed with end-stage renal disease. Renal replacement therapies are life-sparing treatments and the most common method applied is hemodialysis. The success of dialysis, which is a highly effective medical technology, in saving lives is indisputable. Arteriovenous fistula opened for hemodialysis is the lifeline of sick individuals, and hemodialysis is a critical treatment method based on the vascular access pathway. In this context, compliance with treatment is of vital importance in individuals with a diagnosis of end-stage renal disease, and lack of vascular access can reduce its efficiency in a short time. Studies show that only 25% of hemodialysis patients can take care of themselves.
The inadequacy of the individual's knowledge and behaviors of arteriovenous fistula care impairs adherence to treatment, reduces the effectiveness of the treatment and increases the cost. Interventions that encourage changes in health behavior and encourage individuals to change their lifestyle should be integrated into daily life, and there should be support for when and where individuals can make decisions that may affect their health. Mobile technologies, such as smart mobile phones, that individuals regularly carry, can be an effective platform for encouraging health behavior change, especially since they are likely to be with the individual when they need it.
In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can reach at any time and place, have not been found. Based on this, it was planned to increase the knowledge level of arteriovenous fistula care and examine their self-care behaviors and their adaptation to the disease with the mobile application developed with a focus on education on fistula care, which can be used independently by machine-dependent hemodialysis patients. In this context, it is aimed that dialysis patients will benefit especially in arteriovenous fistula care applications, thanks to the ever-increasing mobile applications in daily use with the developing technology. It is thought that the use of these technology-based trainings will be more comfortable, useful and encouraging for their own self-care. It is planned to be a guide for healthcare professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Behavioral: experimental groupThe arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group. |
| control group | – | Behavioral: control groupPatients in the control group will receive arteriovenous fistula care training and a training booklet will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population of the study consisted of individuals with arteriovenous fistula who applied to Private Hope Dialysis Center and Private Almet Dialysis Center for hemodialysis between June 2020 and October 2020. In the study, the experimental and control groups were selected from two different dialysis centers in order to eliminate the bias and considering the control group's exposure to the interference.
Key inclusion criteria (8 listed)
- Over 18 years old,
- Literate (can understand and speak Turkish),
- Do not have a diagnosed mental and psychological disease,
- Hearing or visually impaired,
- Open to communication and cooperation,
Key exclusion criteria (3 listed)
- Those with arteriovenous graft,
- Those with a catheter,
- Those receiving peritoneal dialysis.
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 |
|---|---|---|
| experimental groupThe arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group. Arteriovenous fistula care mobile health application will be installed in daytime groups during working hours during or at the end of dialysis according to the patient's request. In addition, the information contained in the arteriovenous care mobile health application will be verbally explained to the patients and their relatives, as well as shown in practice. The training results were evaluated by the researcher in the 1st and 3rd months in the "Scale for Evaluation of Self-Care Behaviors Related to Arteriovenous Fistula in Hemodialysis Patients", "Final Level of Renal Failure Compliance Scale", "Arteriovenous Fistula Care Education Knowledge Level Evaluation Form (Post-Training Section)" and " Visual Benchmarking Scale ". | Behavioural | experimental group |
| control groupPatients in the control group will receive arteriovenous fistula care training and a training booklet will be given. The information contained in the booklet will be explained orally to the patients and their relatives by the researcher, and will also be shown in practice. The results of the training were determined by the researcher at the 1st and 3rd months of the "Self-Care Behaviors Scale for Arteriovenous Fistula in Hemodialysis Patients", "End Stage Renal Failure Compliance Scale", "Arteriovenous Fistula Care Training Information Level Assessment Form (Post-training section)" and "Visual It will be evaluated with the "Comparison Scale". | Behavioural | control group |
Primary outcome
self-care behavior
Time frame: 5 month
Patients were informed about the Self-Care Behaviors Assessment Scale for Arteriovenous Fistula in Hemodialysis Patients. (The scale consisting of 16 items in total; Each item is scored according to the statements opposite. A minimum of 1 point indicates that the specified self-care behavior never develops, and the highest 5 points indicate that the specified self-care behavior always exists. The minimum score that can be obtained from the scale is 16, and the maximum score is 80.As the score increases, it is evaluated that the person's self-care behaviors are positive.)
adaptation to illness
Time frame: 5 month
Patients were informed about the End Stage Renal Failure Compliance Scale. (It consists of 5 chapters and 46 items. The total score that can be obtained from the scale varies between 0 and 1200. As the score obtained from the scale increases, the level of adherence to treatment increases.)
knowledge level
Time frame: 5 month
Patients were informed about the Arteriovenous Fistula Care Education Evaluation Form. (It states that there is no "0 point" information when scoring the form, but "1 point" information. The total score that can be obtained from the form varies between 0 and 13. The higher the score, the higher the AVF care knowledge level.)
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 16 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Cevriye Ozdemir, Lecturer principal investigator
Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nursing Caries and Arterio-venous Fistula, run by Saglik Bilimleri Universitesi 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 8 inclusion and 3 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 16 Jun 2021. 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?
self-care behavior (time frame: 5 month). The study lists 3 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 16 Jun 2021.