Kidney Diseases, ChronicNCT05714358
The Effect Of Mobile Traınıng Applıcatıons On Chronıc Renal Faılure Progressıon
A study testing Education in people with Kidney Diseases, Chronic, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, Chronic
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being chronic renal failure stage 1-2-4-5
- Being illiterate
- Not using a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Kidney Diseases, Chronic
- Being tested
- Education
- Keywords
- Chronic renal failure; mobile application; patient education
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | Face to face education programme and mobile app were used. Receives: Behavioral: Education |
| CONTROL GROUPS | No intervention | Only face to face education was used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form:
This form developed by the researcher; sociodemographic characteristics of the patient (age, gender, educational status), disease and treatment data (primary diagnosis, disease stage, other disease states), height, weight, Body Mass Index (BMI), daily amount of fluid consumed, amount of urine, medication using status and laboratory findings (urea, uric acid, creatinine, sodium, potassium, calcium, phosphorus, parathormone, albumin, iron, glucose, total cholesterol, HDL, LDL, triglyceride, urine amount, hemoglobin, hematocrit, eGFR and blood pressure value). ) consists of.
Measured: Basaline
Secondary outcomes (2)
Dietary Knowledge Scale of Hemodialysis Patients (HHDB):
It was developed by Bulantekin Düzalan and Çınar in 2014. The Cronbach's alpha reliability coefficient of the scale is 0.86 and 0.73, respectively. The scale is a 3-point Likert scale. For the knowledge scale, the participants were asked to answer each item as "True, False, I don't know". In the knowledge scale, correct is scored as "1", incorrectly as "0" and I do not know "0". The lowest is 0 and the highest is 18 points. The cut-off point of the scale was 7, and it was evaluated as "good knowledge level" over 7 points. There is no reverse scored item in the scale.
Measured: Baseline
Dietary Knowledge Scale of Hemodialysis Patients (HHDB):
It was developed by Bulantekin Düzalan and Çınar in 2014. The Cronbach's alpha reliability coefficient of the scale is 0.86 and 0.73, respectively. The scale is a 3-point Likert scale. For the knowledge scale, the participants were asked to answer each item as "True, False, I don't know". In the knowledge scale, correct is scored as "1", incorrectly as "0" and I do not know "0". The lowest is 0 and the highest is 18 points. The cut-off point of the scale was 7, and it was evaluated as "good knowledge level" over 7 points. There is no reverse scored item in the scale.
Measured: 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jun 2021
- Primary completion30 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Diseases, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study, the experimental and control groups were determined as 110 individuals, 55 each.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU KAVALA, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714358
- Sponsor's protocol ID
- Mobile Traınıng Applıcatıons
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Mobile Traınıng Applıcatıons On Chronıc Renal Faılure Progressıon
- ClinicalTrials.gov ID
- NCT05714358
- Acronym / sponsor ID
- Mobile Traınıng Applıcatıons
- Conditions
- Kidney Diseases, Chronic
- Keywords
- Chronic renal failure; mobile application; patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study, the experimental and control groups were determined as 110 individuals, 55 each.
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Behavioral: EducationFace to face education programme and mobile app were used. |
| CONTROL GROUPS | No intervention | –Only face to face education was used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Being chronic renal failure stage 1-2-4-5
- Being illiterate
- Not using a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education* 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. | Behavioural | INTERVENTION GROUP |
Primary outcome
Patient Information Form:
Time frame: Basaline
This form developed by the researcher; sociodemographic characteristics of the patient (age, gender, educational status), disease and treatment data (primary diagnosis, disease stage, other disease states), height, weight, Body Mass Index (BMI), daily amount of fluid consumed, amount of urine, medication using status and laboratory findings (urea, uric acid, creatinine, sodium, potassium, calcium, phosphorus, parathormone, albumin, iron, glucose, total cholesterol, HDL, LDL, triglyceride, urine amount, hemoglobin, hematocrit, eGFR and blood pressure value). ) consists of.
2 secondary outcomes
Dietary Knowledge Scale of Hemodialysis Patients (HHDB):
Time frame: Baseline
Dietary Knowledge Scale of Hemodialysis Patients (HHDB):
Time frame: 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Kidney Diseases, Chronic, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form: (time frame: Basaline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.