- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05322291
The Effect of the Mobile Application Developed for Hemodialysis Patients on Symptoms and Disease Compliance
December 8, 2022 updated by: Ozge AKBABA
The Effect of Mobile-Based Training and Counseling Developed for Hemodialysis Patients on Adaptation to the Experienced Symptoms and Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Erzincan, Merkez, Turkey, 24800
- Erzincan Binali Yıldırım University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
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.
|
The mobile application developed will be installed on the phones of hemodialysis patients
|
No Intervention: Control Group
No intervention will be made.
They will continue to receive routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure
Time Frame: 0-3 months
|
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.
|
0-3 months
|
Dialysis symptom
Time Frame: 0-3 months
|
Reducing dialysis symptoms.
|
0-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure
Time Frame: 3-6 months
|
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.
|
3-6 months
|
End Stage Renal Failure Compliance
Time Frame: 3-6 months
|
End Stage Kidney Failure Improving compliance.
|
3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2022
Primary Completion (Actual)
May 23, 2022
Study Completion (Actual)
July 25, 2022
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
April 3, 2022
First Posted (Actual)
April 11, 2022
Study Record Updates
Last Update Posted (Estimate)
December 9, 2022
Last Update Submitted That Met QC Criteria
December 8, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OAKBABA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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