Evaluation of the Effectiveness of a Mobile Application Developed for Hemodialysis Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile Health Application
BehavioralA 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Intervention ArmExperimental treatment 1 intervention
Group B: Arm 2 - Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0), 1 month (T1), and 2 months (T2).2
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.
Time frame
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.
Time frame
At the 2nd month and after.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Saglik Bilimleri Universitesi
Lead sponsor
Gümüşhane Universıty
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: