Using Smartphone Application After Liver Transplantation

NCT05854472 | Completed

• 1 other identifier: sbu-asavsar-hayhan-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 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? 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.

Conditions

Liver Transplantation

Keywords

liver transplantation; drug adherence; quality of life; anxiety; smartphone application

Outcome Measures

Primary Outcomes (3)

• 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.

  3 months

• 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.

  1month

• 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.

  3 months

Secondary Outcomes (6)

• Anxiety Levels

  1 month

• Anxiety Levels

  3 months

• Life Quality

  1 month

• Life Quality

  3 months

• Rejection rates

  3 months

Study Arms (2)

Use of smartphone application

EXPERIMENTAL

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.

Other: smartphone based application use

not use a smart phone application

NO INTERVENTION

In this group, patients who have liver transplantation and do not use a smart phone application for liver transplantation patients after discharge will be included.

Interventions

smartphone based application use OTHER

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.

Use of smartphone application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Izmir City Hospital

Izmir, 35330, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33484229 BACKGROUND

• 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.

  PMID: 28162931 BACKGROUND

• 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.

  PMID: 27367473 BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Anxiety Disorders

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: there is no masking in the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: February 27, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 2, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)