Not Yet RecruitingNot Applicable

Evaluation of the Effectiveness of a Mobile Application Developed for Hemodialysis Patients.

Turkey (Türkiye)72 participantsStarted 2025-11

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Treatment Adherence Score

Timeframe: Baseline (T0), 1 month (T1), and 2 months (T2).

Change in Symptom Burden

Timeframe: Baseline (T0), 1st month (T1), and 2nd month (T2).

Trial details

NCT IDNCT07211100

SponsorSaglik Bilimleri Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

İlknur PALAZ, PHD STUDENT

+905324511583 ilknurpalaz@gumushane.edu.tr

View on ClinicalTrials.gov More End-Stage Renal Disease Requiring Haemodialysis trials