Clinical trial NCT06293183: The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management
Official title: The Effect of Artificial Intelligence Supported Mobile Learning Developed for Hemodialysis Patients on Nutrition/Fluid Intake Control and Individual Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cronich Kidney Disease
Keywords: Hemodialysis
mobile learning
hydration
nutrition
nursing
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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\&#39; 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.

Detailed description: Chronic kidney disease (CKD) in the late stage is defined as the progressive and irreversible loss of renal functions due to various reasons leading to a decrease in glomerular filtration rate (GFR). It is estimated that there are 37 million diagnosed cases of CKD worldwide, with CKD ranking ninth among the leading causes of death in the United States. Among the treatment options for end-stage renal failure are hemodialysis (HD), peritoneal dialysis (PD), and transplantation (TX), with HD being the most preferred method by patients. According to the 2022 registration data from the Turkish Society of Nephrology, there were a total of 86,665 CKD patients by the end of 2022, with 71.22% of these patients (n: 61,723) receiving HD treatment.

In patients undergoing HD treatment, the weight gained between two dialysis sessions is defined as interdialytic weight gain (IDWG). The development of hypervolemia due to excessive weight gain can lead to both systemic illnesses and problems during the treatment process. Particularly, cardiovascular problems rank first among systemic illnesses (43%), leading to complications related to excessive ultrafiltration (UF) during the treatment process (hypotension, muscle cramps, nausea-vomiting). Elevated IDWG generally leads to hypertension, left ventricular hypertrophy, pulmonary edema, congestive heart failure, and higher mortality rates due to all these cardiac problems. The ideal IDWG is expected to be in the range of 1-2 kg or 3-5%. In a study, it was reported that 85% of HD patients had an IDWG of \&gt;1.5 kg, especially young, male, and diabetic patients tend to have high IDWG, which leads to an increase in mortality rates due to cardiovascular diseases. Similar results have been reported in many other studies. According to estimates from the United States Renal Data System, cardiovascular events account for 40% of deaths. The 2022 data from the Turkish Society of Nephrology reports that cardiovascular diseases were the leading cause of death (46.3%) among HD patients in our country by the end of 2022. Similar results have been reported in many other studies.

The concept of individual management is defined as the ability of patients with a chronic disease to manage their illness, change their lifestyle, and therefore, live with a chronic disease. Individual management in HD patients requires various skills, including adherence to recommended treatment (e.g., weight gain, nutrition), effective symptom management, problem-solving ability, disease control, decision-making, and communication with the healthcare team. Therefore, increasing individual management in HD patients is known to be associated with increased treatment adherence and better clinical outcomes. In a study, it was found that a mobile application-based individual management program developed to determine the effects of HD patient role behaviors, basic psychological needs, and individual management was effective in increasing patients individual management.

Eligibility criteria: Inclusion Criteria:

* 18 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\&amp;#39;s phone),
* Having a digital literacy scale score over 17,
* Patients who agree to participate in the research will be included in the research.

Exclusion Criteria:

* Patients diagnosed with acute renal failure
* Having vision problems

Primary outcomes:
measure: Fluid intake compliance
timeFrame: 4 months
Secondary outcomes:
measure: Change of individual management
timeFrame: 4 months
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: Private Daviva Buca Dialysis Centre
state: Buca
Study officials:
References: