NCT06293183

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

February 15, 2024

Last Update Submit

August 5, 2025

Conditions

Keywords

Hemodialysismobile learninghydrationnutritionnursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Secondary Outcomes (1)

  • Change of individual management

    4 months

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients diagnosed with acute renal failure
  • Having vision problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Daviva Buca Dialysis Centre

Izmir, Buca, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 5, 2024

Study Start

November 1, 2024

Primary Completion

February 20, 2025

Study Completion

April 28, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations