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Liver TransplantationNCT05854472

Using Smartphone Application After Liver Transplantation

A study testing smartphone based application use in people with Liver Transplantation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this randomized controlled clinical study was a study that could facilitate the management of immunosuppressive therapy, including information specific to liver transplant patients, to increase immunosuppressive medication adherence and quality of life, and reduce anxiety in the early period in patients who… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Liver Transplantation
What is being tested?
smartphone based application use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Feb 2023to 26 Feb 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being over 18 years old
  • First time liver transplant and planning of discharge
  • Using at least one immunosuppressive drug
  • Ability to use immunosuppressive drugs independently
  • Absence of mental and auditory disabilities
  • Absence of a psychiatric disorder and not using drugs
Show all 11Show fewer
  • No problem in speaking and understanding Turkish
  • Using a smartphone for at least 6 months
  • Being an Android smartphone user
  • Having an internet connection
  • Agreeing to participate in the research voluntarily

Who cannot join

  • Failure to communicate with the patient before the data collection phases are over.
  • Leaving work voluntarily
  • Development of organ rejection during the data collection phase
  • The patient's death during the data collection phase

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir City Hospital

    Izmir, 35330

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of a Smartphone Application Developed for Patients With Liver Transplantation on Adherence to Immunosuppressive Drug Use, Anxiety and Quality of Life: Randomized Controlled Trial

The aim of this randomized controlled clinical study was a study that could facilitate the management of immunosuppressive therapy, including information specific to liver transplant patients, to increase immunosuppressive medication adherence and quality of life, and reduce anxiety in the early period in patients who have to use lifelong immunosuppressive medication to prevent organ rejection after liver transplantation. The aim of this study is to develop a smartphone application and evaluate the effectiveness of the application.

Research Question: What is the effect of smartphone application use on immunosuppressive medication adherence, anxiety and quality of life in patients undergoing liver transplant?

Read more

Research Hypotheses

H11: There is a difference between medication adherence in patients who use and do not use smartphone applications after liver transplantation at the 3rd month after discharge.

H21: There is a difference between the anxiety levels of the patients who used and did not use smart phone applications after liver transplantation in the first month after discharge.

H31: There is a difference between the anxiety levels of the patients using and not using smart phone applications after liver transplantation at the 3rd month after discharge.

H41: There is a difference between the quality of life of patients using and not using a smart phone application after liver transplantation, at the first month after discharge.

H51: There is a difference between the quality of life of patients who use and do not use smart phone applications after liver transplantation at the 3rd month after discharge.

H61: There is a difference between immunosuppressive blood drug levels in the 1st month after discharge in patients who use and do not use smart phone applications after liver transplantation.

H71: There is a difference between the immunosuppressive blood drug levels in the 3rd month after the discharge of the patients who used and did not use the smart phone application after liver transplantation.

H81: There is a difference between the rejection rates of patients who use and do not use smartphone applications after liver transplantation, within the 3 months after hospital discharge.

H91: There is a difference between the rates of readmission within the 3 months after hospital discharge in patients who use and do not use smart phone applications after liver transplantation.

Researchers will compare the experimental and control groups to see if there is a difference between patients' adherence to medication, quality of life, and anxiety levels. The experimental group is going to use the smartphone application developed specifically for patients with liver transplantation for 3 months.

Read the detailed description

During the lifelong immunosuppressive treatment after liver transplantation and in the process of adapting to this treatment, patients may experience difficulties in compliance with drug use. For this reason, the quality of life of patients is affected and psychiatric problems may occur. When studies on improving adherence to immunosuppressive therapy and improving quality of life after solid organ transplantation were examined, it was observed that interventional studies in the liver population were insufficient. The aim of this project, which is planned in this direction, is a smart phone application that contains information specific to liver transplantation patients in order to increase medication adherence and quality of life and reduce anxiety in the early period in patients who have to use lifelong immunosuppressive drugs to prevent organ rejection after liver transplantation. The aim of this study is to develop a smartphone application and evaluate the effectiveness of the application.

In the content of the smartphone application;

  • Time of drug use, reminder of the dose to be taken, drug information, drug-drug interactions and drug-food interactions information,
  • Patients' blood pressure, blood glucose values, immunosuppressive blood level
  • Patients can record and/or review the side effects, and take their own notes on the application, such as the subjects they want to convey to their doctor when they go to follow-up and controls,
  • Information about liver transplantation and life after it,
  • Reminding the appointment time,
  • Individual counseling (Patients leave questions to the researcher via the application on the subjects they need),
  • The interaction of the drugs used with the environmental factor (the effect of the air temperature in the city on the patient),
  • Notices encouraging a healthy lifestyle (drinking water, walking, exercising, not smoking, not drinking alcohol, etc.),

This study was planned as a single-center, randomized controlled clinical trial. Study sample; by taking 5% margin of error (α = 0.05) and 80% power (1-β = 0.80), the number of samples for each group was calculated as 23, a total of 46. Due to possible data loss, it is aimed to reach 60 patients, 30 in each group. In this project, a practical smartphone application will be developed that will meet the needs of patients undergoing liver transplantation and that they can easily carry with them.

In data collection, "Patient Description and Clinical Characteristics Form", "Immunosuppressive Treatment Adherence Scale", "Immunosuppressive Drug Adherence Scale", "Hospital Anxiety and Depression Scale", "SF-36 Quality of Life Scale", "Turkish-Computer System Usability Questionnaire Short Version Scale" and patients' immunosuppressive blood drug levels from hospital records will be used. Data were collected before patients were discharged, at 1 month postoperatively, and at 3 months postoperatively.

When parametric test prerequisites are met in the analysis of the data; It is envisaged to use Chi-Square Test, Mc Neamer test, Independent Sample T Test, Pearson Correlation Analysis, Analysis of Variance in Repeated Measurements, Bonferroni test as multiple comparison method. If the parametric test prerequisites are not met, it is predicted that Mann Whitney U test, Wilcoxon Test, Friedman Test and Spearman Correlation Analysis will be used.

The results of this study show that a new practical application, in which patients can follow the importance, effect, side effects and dose and hours of immunosuppressive drugs, in the difficult process that needs to be struggled with compliance with immunosuppressive drug hours after liver transplantation, fear of organ rejection and immunosuppressive treatment side effects, will help to improve drug compliance. It is predicted that it will reduce anxiety about drug treatment in the early period and increase the quality of life of the patient by increasing the patient's quality of life. In addition, it is thought that increasing drug compliance will reduce re-hospitalizations and organ rejection.

Being tested
smartphone based application use
Keywords
liver transplantation, drug adherence, quality of life, anxiety, smartphone application
Medical subject headings
Medication Adherence, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smartphone based application useOther

    A smartphone application content will be developed to facilitate the use of immunosuppressive drugs by individuals with liver transplantation and to provide guidance to patients. The effect of smartphone application usage on immunosuppressive drug compliance, anxiety and quality of life in liver transplant patients will be evaluated.

Study groups in NCT05854472
Study groupRoleWhat they receive
Use of smartphone applicationExperimentalA smartphone application content will be developed to facilitate the use of immunosuppressive drugs by individuals with liver transplantation and to provide guidance to patients. The effect of smartphone application usage on immunosuppressive drug compliance, anxiety and quality of life in liver transplant patients will be evaluated.
Receives: Other: smartphone based application use
not use a smart phone applicationNo interventionIn this group, patients who have liver transplantation and do not use a smart phone application for liver transplantation patients after discharge will be included.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication Adherence

    Two different scales called Immunosuppressive Treatment Adherence Scale (4 items) and Immunosuppressive Medication Adherence Scale (11 items) will be used to determine the medication adherence reported by the patients after 3 months of discharge. As a result of the Immunosuppressive Treatment Adherence Scale, the lowest 0 and the highest 12 points are obtained. 0 indicates very poor compliance and 12 indicates excellent compliance. On the Scale of Adherence to Drug Use, the lowest score is 11 and the highest score is 55. The increase in the score obtained from the scale indicates that the individual's compliance with the use of immunosuppressive drugs increases.

    Measured: 3 months

  2. the blood level of the immunosuppressive drug

    In order to determine the drug compliance of the patients, the blood level of the immunosuppressive drug will be checked in 1 month after discharge. Tacrolimus normal level will be evaluated according to the reference range of 5-15 mg/dl in the hospital protocol where the study will be conducted. The fact that the blood drug level is outside the reference range will be considered as an indicator of the patient's low compliance with the use of immunosuppressive drugs.

    Measured: 1month

  3. the blood level of the immunosuppressive drug

    In order to determine the drug compliance of the patients, the blood level of the immunosuppressive drug will be checked in 3 months after discharge. Tacrolimus normal level will be evaluated according to the reference range of 5-15 mg/dl in the hospital protocol where the study will be conducted. The fact that the blood drug level is outside the reference range will be considered as an indicator of the patient's low compliance with the use of immunosuppressive drugs.

    Measured: 3 months

Secondary outcomes (6)
  1. Anxiety Levels

    After 1 month after discharge, patients will complete the 14-item Hospital Anxiety and Depression Scale to determine the patients' anxiety status. The cut-off points for the Hospital Anxiety and Depression Scale are 10 for the anxiety subscale and 7 for the depression subscale. Patients with scores above these scores can be considered as a risk group.

    Measured: 1 month

  2. Anxiety Levels

    After 3 months after discharge, patients will complete the 14-item Hospital Anxiety and Depression Scale to determine the patients' anxiety status. The cut-off points for the Hospital Anxiety and Depression Scale are 10 for the anxiety subscale and 7 for the depression subscale. Patients with scores above these scores can be considered as a risk group.Odd-numbered items in the scale are anxiety, and even-numbered items are depression.In this study, the anxiety subscale of the scale will be used.

    Measured: 3 months

  3. Life Quality

    After spending 1 month after discharge, patients will complete the SF-36 Quality of Life Scale, which consists of 36 items, to evaluate the patients' quality of life levels. The scale with a positive score was scored so that the higher the score of each health area, the higher the health-related quality of life.

    Measured: 1 month

  4. Life Quality

    After spending 3 months after discharge, patients will complete the SF-36 Quality of Life Scale, which consists of 36 items, to evaluate the patients' quality of life levels. The scale with a positive score was scored so that the higher the score of each health area, the higher the health-related quality of life.

    Measured: 3 months

  5. Rejection rates

    Rejection rates are going to be collected from hospital records by the researchers. The high rates will be associated with the non-compliance of the patients to their drug use.

    Measured: 3 months

  6. Readmission Rates

    Readmission rates are going to be collected from hospital records by the researchers. The high rates will be associated with the non-compliance of the patients to their drug use.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start27 Feb 2023
  3. Primary completion26 Feb 2024
  4. Study completion26 Feb 2024

Resources

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
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854472
Sponsor's protocol ID
sbu-asavsar-hayhan-001
Status last verified
Feb 2023
First submitted
2 May 2023
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Faust A, Stine JG. Leveraging the Coronavirus Disease 2019 Pandemic: Is It Time to Consider Incorporating Mobile Applications Into Standard Clinical Management of the Liver Transplantation Patient? Liver Transpl. 2021 Apr;27(4):479-481. doi: 10.1002/lt.25991. Epub 2021 Mar 5. No abstract available.

    PubMed 33484229
  • Dobbels F, De Bleser L, Berben L, Kristanto P, Dupont L, Nevens F, Vanhaecke J, Verleden G, De Geest S. Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. J Heart Lung Transplant. 2017 May;36(5):499-508. doi: 10.1016/j.healun.2017.01.007. Epub 2017 Jan 6.

    PubMed 28162931
  • Harrison JJ, Badr S, Hamandi B, Kim SJ. Randomized Controlled Trial of a Computer-Based Education Program in the Home for Solid Organ Transplant Recipients: Impact on Medication Knowledge, Satisfaction, and Adherence. Transplantation. 2017 Jun;101(6):1336-1343. doi: 10.1097/TP.0000000000001279.

    PubMed 27367473

Questions about this trial

What is this clinical trial studying?

A study testing smartphone based application use in people with Liver Transplantation, run by Saglik Bilimleri Universitesi 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 11 inclusion and 4 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 2 Apr 2025. 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?

Medication Adherence (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854472, which also lists 3 linked publications.

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 2 Apr 2025.

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