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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05322291
Other study ID # OAKBABA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2022
Est. completion date July 25, 2022

Study information

Verified date December 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date July 25, 2022
Est. primary completion date May 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Mobil Application
The mobile application developed will be installed on the phones of hemodialysis patients

Locations

Country Name City State
Turkey Erzincan Binali Yildirim University Erzincan Merkez

Sponsors (2)

Lead Sponsor Collaborator
Ozge AKBABA Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 0-3 months
Primary Dialysis symptom Reducing dialysis symptoms. 0-3 months
Secondary 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. 3-6 months
Secondary End Stage Renal Failure Compliance End Stage Kidney Failure Improving compliance. 3-6 months
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