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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Mobil 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ozge AKBABA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ataturk University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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