End-Stage Renal Disease Requiring HaemodialysisNCT07211100
Evaluation of the Effectiveness of a Mobile Application Developed for Hemodialysis Patients.
A study testing Mobile Health Application in people with End-Stage Renal Disease Requiring Haemodialysis and Mobile Application, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of a mobile health application developed for adult patients undergoing hemodialysis treatment. The mobile application includes modules on adherence to medication, diet, and fluid restrictions, symptom management (fatigue, pain, itching), nutrition guidance, exercise… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease Requiring Haemodialysis, Mobile Application
- What is being tested?
- Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years.
- Diagnosed with end-stage renal disease (ESRD).
- Receiving maintenance hemodialysis treatment for at least 3 months.
- Able to use a smartphone and willing to install the mobile health application.
- Voluntarily agreeing to participate in the study and providing written informed consent.
Who cannot join
- Patients with cognitive impairment, severe psychiatric disorders, or communication barriers that may interfere with participation.
- Patients with visual or hearing impairments that prevent the use of the mobile application.
- Patients who have undergone kidney transplantation or are scheduled for transplantation within the study period.
- Patients with serious comorbid conditions requiring hospitalization (e.g., advanced cancer, severe heart failure).
- Participation in another interventional clinical trial within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gumushane State Hospital
Gümüşhane
İlknur Palaz, +905324511583, ilknurpalaz@gumushane.edu.tr
About this study
Official title: Evaluation of the Impact of a Mobile Application Developed for Hemodialysis Patients on Treatment Adherence, Symptom Management and Clinical Parameters.
This study aims to evaluate the effectiveness of a mobile health application developed for adult patients undergoing hemodialysis treatment. The mobile application includes modules on adherence to medication, diet, and fluid restrictions, symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, and motivational content. It also features reminder notifications, an "Ask the Expert" module, and personal symptom tracking.
The research will be conducted as a single-center, single-blind, randomized controlled experimental study. Participants will be assigned to intervention and control groups using block randomization. The intervention group will receive the mobile application, while the control group will receive standard care. Assessments will be carried out at baseline (T0), 1st month (T1), and 2nd month (T2).
Read more
The measurement tools to be used include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, clinical parameters such as serum potassium, phosphorus, and albumin will be evaluated.
A total of 72 patients (36 intervention, 36 control) will be included in the study. This study aims to assess the impact of a mobile health application on treatment adherence, symptom management, and clinical parameters among hemodialysis patients, and to develop a digital health model that can be integrated into nursing care.
Read the detailed description
Chronic kidney disease is a major global public health problem, and most patients with end-stage renal disease (ESRD) depend on hemodialysis to survive. Patients undergoing hemodialysis often experience difficulties with treatment adherence, challenges related to dietary and fluid restrictions, as well as common symptoms such as fatigue, pain, and itching. These problems negatively affect their quality of life. Previous studies have reported that more than half of hemodialysis patients demonstrate poor treatment adherence, which is associated with increased mortality. Therefore, innovative and technology-based approaches are needed to improve adherence and reduce symptom burden.
In recent years, mobile health (mHealth) applications have been increasingly used in the management of chronic diseases. Such applications enable patients to monitor their health more closely, improve medication and dietary adherence, and receive support for symptom management. However, most existing studies in the literature have focused on only one dimension of adherence (such as medication or diet) and have not comprehensively evaluated symptom management together with biochemical parameters.
This study aims to investigate the effect of a newly developed mobile health application, created by the research team, on treatment adherence, symptom management (fatigue, pain, itching), and clinical parameters (serum potassium, phosphorus, albumin) among hemodialysis patients. The study will be conducted as a single-center, single-blind, randomized controlled trial including a total of 72 patients (36 intervention, 36 control). Participants will be assigned to groups using block randomization. The intervention group will receive the mobile application, while the control group will continue with standard care.
The mobile application has been specifically designed and developed by the research team to meet the needs of hemodialysis patients. It consists of modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, itching, pain), nutrition guidance, exercise recommendations, reminder notifications, a question-answer section with experts, and personal monitoring. The aim is to improve patients' self-care abilities and reduce their symptom burden.
Data will be collected at baseline (T0), 1st month (T1), and 2nd month (T2). Measurement tools include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, laboratory parameters such as serum potassium, phosphorus, and albumin will be evaluated.
At the end of the study, scientific evidence will be obtained regarding whether the mobile health application developed by the research team is effective in improving treatment adherence, alleviating symptoms, and enhancing clinical outcomes in hemodialysis patients. The findings are expected to provide a model for integrating digital health applications into nursing care and to contribute to the healthcare system.
- Being tested
- Mobile Health Application
- Keywords
- hemodialiysis, mobile application, mobil health, pain, fatigue, itching, nursingcare, adaptation, esrd
- Medical subject headings
- Pain, Fatigue, Pruritus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health ApplicationBehavioural
A mobile health application developed by the research team to support hemodialysis patients. The application includes modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, reminder notifications, expert Q\&A, and personal tracking. The aim is to improve adherence to treatment, reduce symptom burden, and support patient self-care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Intervention Arm | Experimental | Participants assigned to this arm will receive the mobile health application developed by the research team. The application includes modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, reminder notifications, expert Q\&A, and personal tracking. Receives: Behavioral: Mobile Health Application |
| Arm 2 - Control Arm | No intervention | Participants in this group will receive standard hemodialysis care without the mobile application. Standard care includes routine clinical follow-up, medical treatment, and nursing care provided at the dialysis center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Adherence Score
Treatment adherence will be assessed using the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ). Higher scores indicate better adherence. The intervention group will use the mobile health application, while the control group will receive standard care.
Measured: Baseline (T0), 1 month (T1), and 2 months (T2).
Change in Symptom Burden
ymptom burden will be evaluated using the Edmonton Symptom Assessment Scale (ESAS), which covers multiple symptoms such as fatigue, itching, pain, sleep disturbance, and other common hemodialysis-related complaints. Higher scores reflect higher symptom severity.
Measured: Baseline (T0), 1st month (T1), and 2nd month (T2).
Secondary outcomes (1)
Mobile Application Usability
Measured by the Mobile Application Usability Scale among intervention group participants.
Measured: At the 2nd month and after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease Requiring HaemodialysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: an intervention group and a control group. The intervention group will use the mobile health application developed by the research team, while the control group will receive standard care without the application. Both groups will be followed simultaneously, and outcomes will be measured at baseline (T0), 1 month (T1), and 2 months (T2). Block randomization will be used to ensure balanced group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Gümüşhane Universıty
- Responsible party
- Principal investigator, İlknur Palaz, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211100
- Sponsor's protocol ID
- SBU-GHEM-IP-01
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study is a doctoral thesis project, and data use is restricted to the research team in accordance with ethics committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Mobile Application Developed for Hemodialysis Patients on Treatment Adherence, Symptom Management and Clinical Parameters.
- ClinicalTrials.gov ID
- NCT07211100
- Acronym / sponsor ID
- SBU-GHEM-IP-01
- Keywords
- hemodialiysis, mobile application, mobil health, pain, fatigue, itching, nursingcare, adaptation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Gümüşhane Universıty
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Oct 2025 (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.
This study aims to evaluate the effectiveness of a mobile health application developed for adult patients undergoing hemodialysis treatment. The mobile application includes modules on adherence to medication, diet, and fluid restrictions, symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, and motivational content. It also features reminder notifications, an "Ask the Expert" module, and personal symptom tracking.
The research will be conducted as a single-center, single-blind, randomized controlled experimental study. Participants will be assigned to intervention and control groups using block randomization. The intervention group will receive the mobile application, while the control group will receive standard care. Assessments will be carried out at baseline (T0), 1st month (T1), and 2nd month (T2).
The measurement tools to be used include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, clinical parameters such as serum potassium, phosphorus, and albumin will be evaluated.
A total of 72 patients (36 intervention, 36 control) will be included in the study. This study aims to assess the impact of a mobile health application on treatment adherence, symptom management, and clinical parameters among hemodialysis patients, and to develop a digital health model that can be integrated into nursing care.
Detailed description
Chronic kidney disease is a major global public health problem, and most patients with end-stage renal disease (ESRD) depend on hemodialysis to survive. Patients undergoing hemodialysis often experience difficulties with treatment adherence, challenges related to dietary and fluid restrictions, as well as common symptoms such as fatigue, pain, and itching. These problems negatively affect their quality of life. Previous studies have reported that more than half of hemodialysis patients demonstrate poor treatment adherence, which is associated with increased mortality. Therefore, innovative and technology-based approaches are needed to improve adherence and reduce symptom burden.
In recent years, mobile health (mHealth) applications have been increasingly used in the management of chronic diseases. Such applications enable patients to monitor their health more closely, improve medication and dietary adherence, and receive support for symptom management. However, most existing studies in the literature have focused on only one dimension of adherence (such as medication or diet) and have not comprehensively evaluated symptom management together with biochemical parameters.
This study aims to investigate the effect of a newly developed mobile health application, created by the research team, on treatment adherence, symptom management (fatigue, pain, itching), and clinical parameters (serum potassium, phosphorus, albumin) among hemodialysis patients. The study will be conducted as a single-center, single-blind, randomized controlled trial including a total of 72 patients (36 intervention, 36 control). Participants will be assigned to groups using block randomization. The intervention group will receive the mobile application, while the control group will continue with standard care.
The mobile application has been specifically designed and developed by the research team to meet the needs of hemodialysis patients. It consists of modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, itching, pain), nutrition guidance, exercise recommendations, reminder notifications, a question-answer section with experts, and personal monitoring. The aim is to improve patients' self-care abilities and reduce their symptom burden.
Data will be collected at baseline (T0), 1st month (T1), and 2nd month (T2). Measurement tools include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, laboratory parameters such as serum potassium, phosphorus, and albumin will be evaluated.
At the end of the study, scientific evidence will be obtained regarding whether the mobile health application developed by the research team is effective in improving treatment adherence, alleviating symptoms, and enhancing clinical outcomes in hemodialysis patients. The findings are expected to provide a model for integrating digital health applications into nursing care and to contribute to the healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: an intervention group and a control group. The intervention group will use the mobile health application developed by the research team, while the control group will receive standard care without the application. Both groups will be followed simultaneously, and outcomes will be measured at baseline (T0), 1 month (T1), and 2 months (T2). Block randomization will be used to ensure balanced group allocation.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Intervention Arm | Experimental | Behavioral: Mobile Health ApplicationParticipants assigned to this arm will receive the mobile health application developed by the research team. The application includes modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, reminder notifications, expert Q\&A, and personal tracking. |
| Arm 2 - Control Arm | No intervention | –Participants in this group will receive standard hemodialysis care without the mobile application. Standard care includes routine clinical follow-up, medical treatment, and nursing care provided at the dialysis center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosed with end-stage renal disease (ESRD).
- Receiving maintenance hemodialysis treatment for at least 3 months.
- Able to use a smartphone and willing to install the mobile health application.
- Voluntarily agreeing to participate in the study and providing written informed consent.
Key exclusion criteria (5 listed)
- Patients with cognitive impairment, severe psychiatric disorders, or communication barriers that may interfere with participation.
- Patients with visual or hearing impairments that prevent the use of the mobile application.
- Patients who have undergone kidney transplantation or are scheduled for transplantation within the study period.
- Patients with serious comorbid conditions requiring hospitalization (e.g., advanced cancer, severe heart failure).
- Participation in another interventional clinical trial within the past 3 months.
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 Health ApplicationA mobile health application developed by the research team to support hemodialysis patients. The application includes modules on treatment adherence (medication, diet, fluid restriction, dialysis attendance), symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, reminder notifications, expert Q\&A, and personal tracking. The aim is to improve adherence to treatment, reduce symptom burden, and support patient self-care. | Behavioural | Arm 1 - Intervention Arm |
Primary outcome
Change in Treatment Adherence Score
Time frame: Baseline (T0), 1 month (T1), and 2 months (T2).
Treatment adherence will be assessed using the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ). Higher scores indicate better adherence. The intervention group will use the mobile health application, while the control group will receive standard care.
Change in Symptom Burden
Time frame: Baseline (T0), 1st month (T1), and 2nd month (T2).
ymptom burden will be evaluated using the Edmonton Symptom Assessment Scale (ESAS), which covers multiple symptoms such as fatigue, itching, pain, sleep disturbance, and other common hemodialysis-related complaints. Higher scores reflect higher symptom severity.
1 secondary outcome
Mobile Application Usability
Time frame: At the 2nd month and after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is a doctoral thesis project, and data use is restricted to the research team in accordance with ethics committee approval.
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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.
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 Health Application in people with End-Stage Renal Disease Requiring Haemodialysis and Mobile Application, 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlknur PALAZ, PHD STUDENT (+905324511583, ilknurpalaz@gumushane.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Treatment Adherence Score (time frame: Baseline (T0), 1 month (T1), and 2 months (T2).). 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 7 Oct 2025.