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

NCT07211100 | Not Yet Recruiting

• 1 other identifier: SBU-GHEM-IP-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-Stage Renal Disease Requiring Haemodialysis; Mobile Application

Keywords

hemodialiysis; mobile application; mobil health; pain; fatigue; itching; nursingcare; adaptation; esrd

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (1)

• Mobile Application Usability

  At the 2nd month and after.

Study Arms (2)

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.

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.

Interventions

Mobile Health Application BEHAVIORAL

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.

Arm 1 - Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Gümüşhane Universıty: collaborator

Study Sites (1)

Gumushane State Hospital

Gümüşhane, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Fatigue; Pruritus; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Central Study Contacts

İlknur PALAZ, PHD STUDENT

CONTACT

+905324511583; ilknurpalaz@gumushane.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No additional parties are masked other than the outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student and lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)