Cronich Kidney DiseaseNCT06293183
The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management
A study testing Mobile app in people with Cronich Kidney Disease, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cronich Kidney Disease
- What is being tested?
- Mobile app
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 28 Apr 2025
- 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,
- Conscious and able to communicate,
- Having received hemodialysis treatment for the last 3 months,
- Able to use an Android-based phone (for those who do not have a personal mobile phone, an application will be installed on the primary caregiver\'s phone),
- Having a digital literacy scale score over 17,
- Patients who agree to participate in the research will be included in the research.
Who cannot join
- Patients diagnosed with acute renal failure
- Having vision problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Daviva Buca Dialysis Centre
Izmir, Buca
About this study
Official title: The Effect of Artificial Intelligence Supported Mobile Learning Developed for Hemodialysis Patients on Nutrition/Fluid Intake Control and Individual Management
The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients\' quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized.
This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management.
Read the detailed description
Chronic kidney disease (CKD) in the late stage is defined as the progressive and irreversible loss of renal functions due to various reasons leading to a decrease in glomerular filtration rate (GFR). It is estimated that there are 37 million diagnosed cases of CKD worldwide, with CKD ranking ninth among the leading causes of death in the United States. Among the treatment options for end-stage renal failure are hemodialysis (HD), peritoneal dialysis (PD), and transplantation (TX), with HD being the most preferred method by patients. According to the 2022 registration data from the Turkish Society of Nephrology, there were a total of 86,665 CKD patients by the end of 2022, with 71.22% of these patients (n: 61,723) receiving HD treatment.
In patients undergoing HD treatment, the weight gained between two dialysis sessions is defined as interdialytic weight gain (IDWG). The development of hypervolemia due to excessive weight gain can lead to both systemic illnesses and problems during the treatment process. Particularly, cardiovascular problems rank first among systemic illnesses (43%), leading to complications related to excessive ultrafiltration (UF) during the treatment process (hypotension, muscle cramps, nausea-vomiting). Elevated IDWG generally leads to hypertension, left ventricular hypertrophy, pulmonary edema, congestive heart failure, and higher mortality rates due to all these cardiac problems. The ideal IDWG is expected to be in the range of 1-2 kg or 3-5%. In a study, it was reported that 85% of HD patients had an IDWG of \>1.5 kg, especially young, male, and diabetic patients tend to have high IDWG, which leads to an increase in mortality rates due to cardiovascular diseases. Similar results have been reported in many other studies. According to estimates from the United States Renal Data System, cardiovascular events account for 40% of deaths. The 2022 data from the Turkish Society of Nephrology reports that cardiovascular diseases were the leading cause of death (46.3%) among HD patients in our country by the end of 2022. Similar results have been reported in many other studies.
The concept of individual management is defined as the ability of patients with a chronic disease to manage their illness, change their lifestyle, and therefore, live with a chronic disease. Individual management in HD patients requires various skills, including adherence to recommended treatment (e.g., weight gain, nutrition), effective symptom management, problem-solving ability, disease control, decision-making, and communication with the healthcare team. Therefore, increasing individual management in HD patients is known to be associated with increased treatment adherence and better clinical outcomes. In a study, it was found that a mobile application-based individual management program developed to determine the effects of HD patient role behaviors, basic psychological needs, and individual management was effective in increasing patients individual management.
- Conditions
- Cronich Kidney Disease
- Being tested
- Mobile app
- Keywords
- Hemodialysis, mobile learning, hydration, nutrition, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appOther
Participants in the intervention group will be expected to watch the training video in the mobile application installed on their phones or tablets and then regularly enter all the food and liquid amounts they consume during the day into this application. In the mobile application data entry area, visuals that will be included in the application showing the amount and types of foods consumed by the participants during the day (1 soup bowl, 1 vegetable dish plate, 1 meat dish plate, 1 water glass, 1 tea glass, tablespoon, dessert spoon, teaspoon, ladle). etc.) will choose through. The mobile application will calculate the total amount of liquid consumed by the participants in 24 hours, and will give a yellow warning when the amount of liquid consumed is 2-2.5 liters, an orange warning when it is 2.5-3 liters, and a red warning when it is 3 liters and above. This will contribute to reducing the amount of fluid intake of participants between two dialysis sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | After the purpose and method of the research are explained, a written informed consent form will be obtained and the Patient Introduction Form will be filled out. Mobile phone usage skills of patients undergoing hemodialysis treatment will be evaluated using the Digital Literacy Scale. Individuals in the initiative group will be given individual training on how to use the application through the application demo. Individuals in the initiative group will be given consultancy by the researcher while downloading the application and logging in with their username. Questionnaires and scale forms will be applied to the patients in the control group on the 0th day, the 14th day, and at the 1st, 2nd and 3rd months. Laboratory values and intradialytic weight information will be obtained from patient files. Receives: Other: Mobile app |
| Control group | No intervention | After the purpose and method of the research are explained, a written informed consent form will be obtained and the Patient Introduction Form will be filled out. No intervention will be made to the participants in this group. Questionnaires and scale forms will be applied to the patients in the control group on the 0th day, 14th day, 1st, 2nd and 3rd months. Laboratory values and intradialytic weight information will be obtained from patient files. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid intake compliance
Nutrition (for nutrition, Nutritional Behavior Scale in Hemodialysis Patients score) and fluid intake compliance (for fluid compliance, Nutritional Behavior Scale in Hemodialysis Patients score) of the patients included in the study will be evaluated. In addition, the entry kilogram information of the patients participating in the study will be taken from the patient files before the dialysis session. .
Fluid Control Scale in Hemodialysis Patients: It consists of a total of 24 items and three sub-dimensions (knowledge, behavior and attitude), the lowest score from the scale is 24 and the highest score is 72. As the score increases, patients' compliance with fluid control also increases.
Nutritional Behavior Scale of Hemodialysis Patients: It was developed to evaluate the nutritional behavior of patients receiving hemodialysis treatment. The scale score is between 13-65. The higher the score, the more "good behavior" is considered.
Measured: 4 months
Secondary outcomes (1)
Change of individual management
Individual management of patients will be evaluated with the "Hemodialysis Self-Management Instrument (HDSMI-18)" scale.
Individual Management Scale for Hemodialysis Patients: The tool measuring the individual management behaviors of hemodialysis patients was developed to evaluate the individual management behaviors of patients. The scale includes four subheadings and 20 items describing the patient's disease management behaviors in the last 3 months. Scale; It is a four-point Likert type ranging from never (1 point), rarely (2 points), sometimes (3 points) and always (4 points), and each item is rated with a total of 4 points. The total score range varies between 20-80, with higher scores indicating higher levels of individual management behavior.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Nov 2024
- Primary completion20 Feb 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cronich Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Tüzün Özdemir, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293183
- Sponsor's protocol ID
- EGE-HEM-STO-01
- Status last verified
- Aug 2025
- First submitted
- 15 Feb 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the study is completed and published, other researchers who will need research data will be able to contact me in case of any request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artificial Intelligence Supported Mobile Learning Developed for Hemodialysis Patients on Nutrition/Fluid Intake Control and Individual Management
- ClinicalTrials.gov ID
- NCT06293183
- Acronym / sponsor ID
- EGE-HEM-STO-01
- Conditions
- Cronich Kidney Disease
- Keywords
- Hemodialysis, mobile learning, hydration, nutrition, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 5 Mar 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.
The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients\' quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized.
This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management.
Detailed description
Chronic kidney disease (CKD) in the late stage is defined as the progressive and irreversible loss of renal functions due to various reasons leading to a decrease in glomerular filtration rate (GFR). It is estimated that there are 37 million diagnosed cases of CKD worldwide, with CKD ranking ninth among the leading causes of death in the United States. Among the treatment options for end-stage renal failure are hemodialysis (HD), peritoneal dialysis (PD), and transplantation (TX), with HD being the most preferred method by patients. According to the 2022 registration data from the Turkish Society of Nephrology, there were a total of 86,665 CKD patients by the end of 2022, with 71.22% of these patients (n: 61,723) receiving HD treatment.
In patients undergoing HD treatment, the weight gained between two dialysis sessions is defined as interdialytic weight gain (IDWG). The development of hypervolemia due to excessive weight gain can lead to both systemic illnesses and problems during the treatment process. Particularly, cardiovascular problems rank first among systemic illnesses (43%), leading to complications related to excessive ultrafiltration (UF) during the treatment process (hypotension, muscle cramps, nausea-vomiting). Elevated IDWG generally leads to hypertension, left ventricular hypertrophy, pulmonary edema, congestive heart failure, and higher mortality rates due to all these cardiac problems. The ideal IDWG is expected to be in the range of 1-2 kg or 3-5%. In a study, it was reported that 85% of HD patients had an IDWG of \>1.5 kg, especially young, male, and diabetic patients tend to have high IDWG, which leads to an increase in mortality rates due to cardiovascular diseases. Similar results have been reported in many other studies. According to estimates from the United States Renal Data System, cardiovascular events account for 40% of deaths. The 2022 data from the Turkish Society of Nephrology reports that cardiovascular diseases were the leading cause of death (46.3%) among HD patients in our country by the end of 2022. Similar results have been reported in many other studies.
The concept of individual management is defined as the ability of patients with a chronic disease to manage their illness, change their lifestyle, and therefore, live with a chronic disease. Individual management in HD patients requires various skills, including adherence to recommended treatment (e.g., weight gain, nutrition), effective symptom management, problem-solving ability, disease control, decision-making, and communication with the healthcare team. Therefore, increasing individual management in HD patients is known to be associated with increased treatment adherence and better clinical outcomes. In a study, it was found that a mobile application-based individual management program developed to determine the effects of HD patient role behaviors, basic psychological needs, and individual management was effective in increasing patients individual management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Mobile appAfter the purpose and method of the research are explained, a written informed consent form will be obtained and the Patient Introduction Form will be filled out. Mobile phone usage skills of patients undergoing hemodialysis treatment will be evaluated using the Digital Literacy Scale. Individuals in the initiative group will be given individual training on how to use the application through the application demo. Individuals in the initiative group will be given consultancy by the researcher while downloading the application and logging in with their username. Questionnaires and scale forms will be applied to the patients in the control group on the 0th day, the 14th day, and at the 1st, 2nd and 3rd months. Laboratory values and intradialytic weight information will be obtained from patient files. |
| Control group | No intervention | –After the purpose and method of the research are explained, a written informed consent form will be obtained and the Patient Introduction Form will be filled out. No intervention will be made to the participants in this group. Questionnaires and scale forms will be applied to the patients in the control group on the 0th day, 14th day, 1st, 2nd and 3rd months. Laboratory values and intradialytic weight information will be obtained from patient files. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and over,
- Conscious and able to communicate,
- Having received hemodialysis treatment for the last 3 months,
- Able to use an Android-based phone (for those who do not have a personal mobile phone, an application will be installed on the primary caregiver\'s phone),
- Having a digital literacy scale score over 17,
Key exclusion criteria (2 listed)
- Patients diagnosed with acute renal failure
- Having vision problems
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 |
|---|---|---|
| Mobile appParticipants in the intervention group will be expected to watch the training video in the mobile application installed on their phones or tablets and then regularly enter all the food and liquid amounts they consume during the day into this application. In the mobile application data entry area, visuals that will be included in the application showing the amount and types of foods consumed by the participants during the day (1 soup bowl, 1 vegetable dish plate, 1 meat dish plate, 1 water glass, 1 tea glass, tablespoon, dessert spoon, teaspoon, ladle). etc.) will choose through. The mobile application will calculate the total amount of liquid consumed by the participants in 24 hours, and will give a yellow warning when the amount of liquid consumed is 2-2.5 liters, an orange warning when it is 2.5-3 liters, and a red warning when it is 3 liters and above. This will contribute to reducing the amount of fluid intake of participants between two dialysis sessions. | Other | Intervention group |
Primary outcome
Fluid intake compliance
Time frame: 4 months
Nutrition (for nutrition, Nutritional Behavior Scale in Hemodialysis Patients score) and fluid intake compliance (for fluid compliance, Nutritional Behavior Scale in Hemodialysis Patients score) of the patients included in the study will be evaluated. In addition, the entry kilogram information of the patients participating in the study will be taken from the patient files before the dialysis session. . Fluid Control Scale in Hemodialysis Patients: It consists of a total of 24 items and three sub-dimensions (knowledge, behavior and attitude), the lowest score from the scale is 24 and the highest score is 72. As the score increases, patients' compliance with fluid control also increases. Nutritional Behavior Scale of Hemodialysis Patients: It was developed to evaluate the nutritional behavior of patients receiving hemodialysis treatment. The scale score is between 13-65. The higher the score, the more "good behavior" is considered.
1 secondary outcome
Change of individual management
Time frame: 4 months
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 8 Aug 2025.
- Individual participant dataSharing planned: No. When the study is completed and published, other researchers who will need research data will be able to contact me in case of any request.
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 Mobile app in people with Cronich Kidney Disease, run by Ege 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 6 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 8 Aug 2025. 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?
Fluid intake compliance (time frame: 4 months). 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 8 Aug 2025.