The Effect of the Mobile Application Developed for Hemodialysis Patients on Symptoms and Disease Compliance
Primary Purpose
Chronic Kidney Failure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobil Application
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Failure focused on measuring hemodialysis, Treatment Compliance, symptom managemen, mobile application, chronic kidney failure
Eligibility Criteria
Inclusion Criteria:
- Chronic kidney failure patient
- Agreeing to be a voluntary participant,
- Receiving dialysis treatment for at least 3 months,
- 18 years and over,
- Able to understand and speak Turkish
- At least primary school graduate,
- Using a smart phone for at least one year,
- Having internet access at home or at work.
- Able to use internet
Exclusion Criteria:
- Speech, hearing and visual impairment,
- Having any psychiatric diagnosis or treatment that may interfere with perception (Alzheimer, schizophrenia, major depression)
- rheumatological diseases, fracture, joint health problem, amputation
Sites / Locations
- Erzincan Binali Yıldırım University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
The developed mobile application will be installed on the phones of hemodialysis patients in the experimental group. Online consultancy and training will be provided with the application.
No intervention will be made. They will continue to receive routine care.
Outcomes
Primary Outcome Measures
Measure
The effect of mobile-based application and counseling on symptom management will be measured in patients receiving hemodialysis treatment. Patient Information Form and Dialysis Symptom Index will be used for measurement. The dialysis symptom scale includes 30 symptoms that describe physical or emotional symptoms. The patient responds to the symptoms he has experienced in the last week as yes-no, no, he/she answers that he/she has not experienced the symptom, and if yes, he/she has the symptom. If your answer is yes, the extent to which this symptom affects the patient is evaluated with a five-point Likert type scale. It is evaluated and scored as 1=none, 5=very much. After the obtained scores are summed, the total scale score is obtained. The scale point ranges from 0-150. The fact that the total score approaches 150 indicates that the effect of the symptom has increased.
Dialysis symptom
Reducing dialysis symptoms.
Secondary Outcome Measures
Measure
The effect of mobile-based application and counseling on treatment compliance will be measured in patients receiving hemodialysis treatment. Patient Information Form and End Stage Renal Failure Compliance Scale will be used.This 6-item scale, which questions participation in hemodialysis, drug use, fluid restriction and adherence to diet, constitutes the compliance behaviors sub-dimension. The weight system used in scoring these items was determined according to the degree of importance related to the clinical outcome of each section. Items 14, 17, 18, 26, 31 and 46, which evaluate the patient's compliance behaviors, and 15, 19 and 27, which affect the scoring of three of these items, were used in the scale. The total score that can be obtained from the scale is between 0 and 1200. The higher the score, the higher the level of adherence to treatment.
End Stage Renal Failure Compliance
End Stage Kidney Failure Improving compliance.
Full Information
NCT ID
NCT05322291
First Posted
January 31, 2022
Last Updated
December 8, 2022
Sponsor
Ozge AKBABA
Collaborators
Ataturk University
1. Study Identification
Unique Protocol Identification Number
NCT05322291
Brief Title
The Effect of the Mobile Application Developed for Hemodialysis Patients on Symptoms and Disease Compliance
Official Title
The Effect of Mobile-Based Training and Counseling Developed for Hemodialysis Patients on Adaptation to the Experienced Symptoms and Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ozge AKBABA
Collaborators
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine the effect of mobile-based education and counseling developed for hemodialysis patients on the symptoms experienced and the adaptation to the disease.
Detailed Description
Patients with end-stage renal disease are faced with many symptoms both during the disease and during the hemodialysis treatment process. Likewise, this process brings with it problems of adaptation to the disease. Experiencing intense symptoms negatively affects compliance with the disease and hemodialysis treatment, and compliance problems complicate symptom management. Therefore, patients need information support that can increase symptom management and compliance. Considering today's technology, this information can be provided by mobile phone, especially due to ease of use and fast transportation. In order for patients to access accurate information and receive consultancy from experts, appropriate software and sustainable mobile applications must be included in the disease management process. Today, mobile applications are an integral part of daily life for millions of users worldwide and are increasingly used to receive and communicate fast and interactive information about various chronic diseases. With the mobile-based training and counseling to be applied in this study, it is aimed to enable patients receiving hemodialysis treatment to access professional information support more easily, to better manage the symptoms they experience due to the disease, and to increase their adaptation to the disease. For this reason, the effect of mobile-based training and counseling developed for patients receiving hemodialysis treatment on the symptoms experienced by the patients and their adaptation to the disease will be evaluated in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
hemodialysis, Treatment Compliance, symptom managemen, mobile application, chronic kidney failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The mobile application developed will be installed on the phones of hemodialysis patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The developed mobile application will be installed on the phones of hemodialysis patients in the experimental group. Online consultancy and training will be provided with the application.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be made. They will continue to receive routine care.
Intervention Type
Behavioral
Intervention Name(s)
Mobil Application
Intervention Description
The mobile application developed will be installed on the phones of hemodialysis patients
Primary Outcome Measure Information:
Title
Measure
Description
The effect of mobile-based application and counseling on symptom management will be measured in patients receiving hemodialysis treatment. Patient Information Form and Dialysis Symptom Index will be used for measurement. The dialysis symptom scale includes 30 symptoms that describe physical or emotional symptoms. The patient responds to the symptoms he has experienced in the last week as yes-no, no, he/she answers that he/she has not experienced the symptom, and if yes, he/she has the symptom. If your answer is yes, the extent to which this symptom affects the patient is evaluated with a five-point Likert type scale. It is evaluated and scored as 1=none, 5=very much. After the obtained scores are summed, the total scale score is obtained. The scale point ranges from 0-150. The fact that the total score approaches 150 indicates that the effect of the symptom has increased.
Time Frame
0-3 months
Title
Dialysis symptom
Description
Reducing dialysis symptoms.
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
Measure
Description
The effect of mobile-based application and counseling on treatment compliance will be measured in patients receiving hemodialysis treatment. Patient Information Form and End Stage Renal Failure Compliance Scale will be used.This 6-item scale, which questions participation in hemodialysis, drug use, fluid restriction and adherence to diet, constitutes the compliance behaviors sub-dimension. The weight system used in scoring these items was determined according to the degree of importance related to the clinical outcome of each section. Items 14, 17, 18, 26, 31 and 46, which evaluate the patient's compliance behaviors, and 15, 19 and 27, which affect the scoring of three of these items, were used in the scale. The total score that can be obtained from the scale is between 0 and 1200. The higher the score, the higher the level of adherence to treatment.
Time Frame
3-6 months
Title
End Stage Renal Failure Compliance
Description
End Stage Kidney Failure Improving compliance.
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic kidney failure patient
Agreeing to be a voluntary participant,
Receiving dialysis treatment for at least 3 months,
18 years and over,
Able to understand and speak Turkish
At least primary school graduate,
Using a smart phone for at least one year,
Having internet access at home or at work.
Able to use internet
Exclusion Criteria:
Speech, hearing and visual impairment,
Having any psychiatric diagnosis or treatment that may interfere with perception (Alzheimer, schizophrenia, major depression)
rheumatological diseases, fracture, joint health problem, amputation
Facility Information:
Facility Name
Erzincan Binali Yıldırım University
City
Erzincan
State/Province
Merkez
ZIP/Postal Code
24800
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of the Mobile Application Developed for Hemodialysis Patients on Symptoms and Disease Compliance
We'll reach out to this number within 24 hrs