Chronic Kidney FailureNCT05322291
The Effect of the Mobile Application Developed for Hemodialysis Patients on Symptoms and Disease Compliance
A study testing Mobil Application in people with Chronic Kidney Failure, run by Ozge AKBABA at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Mobil Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2022to 25 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Using a smart phone for at least one year,
- Having internet access at home or at work.
- Able to use internet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yıldırım University
Erzincan, Merkez, 24800
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Failure
- Being tested
- Mobil Application
- Keywords
- hemodialysis, Treatment Compliance, symptom managemen, mobile application, chronic kidney failure
- Medical subject headings
- Kidney Failure, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobil ApplicationBehavioural
The mobile application developed will be installed on the phones of hemodialysis patients
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Behavioral: Mobil Application |
| Control Group | No intervention | No intervention will be made. They will continue to receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-3 months
Dialysis symptom
Reducing dialysis symptoms.
Measured: 0-3 months
Secondary outcomes (2)
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.
Measured: 3-6 months
End Stage Renal Failure Compliance
End Stage Kidney Failure Improving compliance.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start28 Mar 2022
- Primary completion23 May 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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 mobile application developed will be installed on the phones of hemodialysis patients.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozge AKBABA
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Ozge AKBABA, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322291
- Sponsor's protocol ID
- OAKBABA
- Status last verified
- Dec 2022
- First submitted
- 31 Jan 2022
- Last updated
- 9 Dec 2022
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile-Based Training and Counseling Developed for Hemodialysis Patients on Adaptation to the Experienced Symptoms and Disease
- ClinicalTrials.gov ID
- NCT05322291
- Acronym / sponsor ID
- OAKBABA
- Conditions
- Chronic Kidney Failure
- Keywords
- hemodialysis, Treatment Compliance, symptom managemen, mobile application, chronic kidney failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ozge AKBABAUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 11 Apr 2022 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The mobile application developed will be installed on the phones of hemodialysis patients.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mobil ApplicationThe 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. |
| Control Group | No intervention | –No intervention will be made. They will continue to receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Mobil ApplicationThe mobile application developed will be installed on the phones of hemodialysis patients | Behavioural | Experimental Group |
Primary outcome
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.
Dialysis symptom
Time frame: 0-3 months
Reducing dialysis symptoms.
2 secondary outcomes
Measure
Time frame: 3-6 months
End Stage Renal Failure Compliance
Time frame: 3-6 months
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 9 Dec 2022.
- 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 Mobil Application in people with Chronic Kidney Failure, run by Ozge AKBABA 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 9 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 9 Dec 2022. 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?
Measure (time frame: 0-3 months). The study lists 2 primary outcomes in all. 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 9 Dec 2022.