Clinical trial NCT05714358: The Effect Of Mobile Traınıng Applıcatıons On Chronıc Renal Faılure Progressıon
Official title: The Effect Of Mobile Traınıng Applıcatıons On Chronıc Renal Faılure Progressıon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases, Chronic
Keywords: Chronic renal failure; mobile application; patient education
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study, the experimental and control groups were determined as 110 individuals, 55 each.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of research that Mobile Education Application is to evaluate its effects on the progress of chronic renal failure . The sample of the study, which is conducted with a semi-experimental design, consisted of 100 patients (50 interventions and 50 controls) who applied to the nephrology outpatient clinic of a City Hospital affiliated to the Istanbul Provincial Health Directorate. Patient Diagnosis Form, Diet Information of Hemodialysis Patients, Dietary Behavior of Hemodialysis Patients, Cognitive Behavioral Physical Activity scale and mobile education application were used as data collection tools. In the analyses of data; descriptive analyses, parametric and non-parametric tests, generalized linear mixed model and linear regression analysis are used. Firstly, face-to-face training was given to the experimental and control groups. Subsequently, a mobile education application was installed on the phones of the experimental group. The patients in the experimental group were followed for six months with the mobile education application. The content of the mobile education application; education, nutritional contents, measurement values and ask me a question sections. With the reminder system in the application, notifications were sent to the patients 2 days a week. The characteristics of the participants in both groups of the study were similar.

Detailed description: This research; The limitations of mobile education applications to the progression of chronic renal failure were performed as a semi-treatment in order to ensure that the patients' management of their own disease was effective.Research; It was held between 01.06.2021 and 30.03.2022 in a City Hospital affiliated to Istanbul Provincial Health Directorate.The population of the study consisted of chronic renal failure stage 3 patients. Power analysis was performed using the G\*Power (v3.1.9) program to determine the size of the study. The power of the study is expressed as 1-β (β = probability of type II error) and in general studies should have 80% power. When a large (d=0.8) effect size was predicted in the comparisons between groups, it was calculated that at least 26 groups were required to obtain 80% power at α=0.05 diameter. However, considering that there may be cells that can be separated from the research of maintaining its reliability and continuing the study, the experimental and control groups were determined as 110 individuals, 55 each.

İnclusion Criteria for Research

* Being chronic renal failure stage (stage 3)
* Being between the ages of 18-65
* Knowing how to read and write
* Being able to use a smart phone
* Volunteering to participate in the study
* Not having a mental problem
* Not having a communication problem

Exclusion Criteria

* Being chronic renal failure stage 1-2-4-5
* Being illiterate
* Not using a smartphone

Dependent variables: Biochemical parameters, amounts of consumed food ingredients, dietary information, behavioral and cognitive behavioral physical activity scale scores, physical activity type and duration, measurement values, eGFR value Arguments: Mobile education app

İNTERVENTİONS GROUPS FIRST INTERVIEW

* Written informed consent was obtained from patients before data were collected.
* Data; Patient identification form was collected with Diet Information of Hemodialysis Patients, Dietary Behavior of Hemodialysis Patients, Cognitive Behavioral Physical Activity scale
* The results of the biochemical parameters requested by the physician were recorded.
* The patients were given face-to-face training on nutrition, physical activity and drug use in chronic renal failure
* After the training, the mobile training application, including the training, was installed on the patient's phone, and how to use it was explained.
* Our kidneys and their functions, chronic kidney failure and its stages, nutrition in chronic kidney failure, physical activity and drug use trainings, heart rate, physical activity, blood sugar, blood pressure measurement follow-ups, content values of foods and amount of fluid consumed in the mobile education application. There was a question section and reminder systems.
* The education of the patients was followed by the researcher through the mobile education application interface.
* The patients' biochemical parameters and use of mobile education applications were followed for 6 months.
* Reminders about their education, nutritional status, physical activities and drug use were made at regular intervals (2 times a week).
* Patients were able to reach the researcher whenever they wanted from the ask me a question section of the mobile application.

SECOND INTERVIEW

* The results of the biochemical parameters requested by the physician were recorded.
* Data collection forms were filled out again by interviewing the patients over the phone.

CONTROL GROUPS FIRST INTERVIEW

* Written informed consent was obtained from patients before data were collected.
* Data; Patient identification form was collected with Diet Information of Hemodialysis Patients, Dietary Behavior of Hemodialysis Patients, Cognitive Behavioral Physical Activity scale
* The results of the biochemical parameters requested by the physician were recorded.
* The patients were given face-to-face training on nutrition, physical activity and drug use in chronic renal failure .
* After the training, the biochemical parameters of the patients were followed for 6 months.
* In this process, the questions asked by the patients in order not to hinder their right to receive information were answered.

SECOND INTERVIEW

* The results of the biochemical parameters requested by the physician were recorded.
* Data collection forms were filled out again by interviewing the patients over the phone.

Eligibility criteria: Inclusion Criteria:

Being chronic renal failure (stage 3)

* Being between the ages of 18-65
* Knowing how to read and write
* Being able to use a smart phone
* Volunteering to participate in the study
* Not having a mental problem
* Not having a communication problem

Exclusion Criteria:

Being chronic renal failure stage 1-2-4-5

* Being illiterate
* Not using a smartphone

Primary outcomes:
measure: Patient Information Form:
timeFrame: Basaline
Secondary outcomes:
measure: Dietary Knowledge Scale of Hemodialysis Patients (HHDB):
timeFrame: Baseline
measure: Dietary Knowledge Scale of Hemodialysis Patients (HHDB):
timeFrame: 6 months later
Other outcomes:
measure: Dietary Behavior Scale of Hemodialysis Patients (HHDD):
timeFrame: Baseline
measure: Dietary Behavior Scale of Hemodialysis Patients (HHDD):
timeFrame: 6 months later
measure: Cognitive Behavioral Physical Activity Scale (BDFA):
timeFrame: Baseline
measure: Cognitive Behavioral Physical Activity Scale (BDFA):
timeFrame: 6 months later
measure: Mobile Education Application (Application)
timeFrame: for 6 months
Locations:
city: Istanbul
country: Turkey
facility: Arzu Kavala
Study officials:
References: