Liver TransplantationNCT06424808
Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients
A study testing Consolidating content on a single website and providing access to it via QR codes in a brochure format in people with Liver Transplantation and Inpatients, run by Samsung Medical Center.
Trial summary
The investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Inpatients
- What is being tested?
- Consolidating content on a single website and providing access to it via QR codes in a brochure format
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2024to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Patients]
- Adults aged 18 and over
- Patients who are scheduled to undergo or have undergone liver transplant surgery
- Recruited through a call for research participants and have consented to participate in this study
- [Medical Staff]
- Adults aged 18 and over
- Medical staff at Samsung Medical Center involved in the post-liver transplant treatment process
Who cannot join
- [Patients]
- Individuals who have not consented to participate in this study
- Individuals whose health condition makes it difficult to participate in the intervention
- During the research period, the researcher will check if the brochure content has been shared during surveys or interviews with the research participants (information dissemination). If information dissemination is confirmed, the participant will be excluded from the study.
- [Medical Staff]
- Individuals who have not consented to participate in this study
- Medical staff not involved in the liver transplant treatment process
Trial locations and contacts
No sites are listed yet.
About this study
The investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format.
[Patients] Considering this as a pilot study, the investigators plan to recruit around 30 participants. Both the experimental and control groups will receive standard care and information, with the experimental group additionally receiving the brochure. Random assignment will be used for the experimental and control groups. Surveys and interviews will be conducted to assess changes in patient experience and usability before and after providing the brochure.
[Medical Staff] Among the medical staff involved in the liver transplant surgical process, researchers will select participants based on their degree of involvement with the intervention subjects. After obtaining their consent, interviews will be conducted concerning patient experiences and the brochure.
- Conditions
- Liver Transplantation, Inpatients
- Being tested
- Consolidating content on a single website and providing access to it via QR codes in a brochure format
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidating content on a single website and providing access to it via QR codes in a brochure formatOther
The group assigned to the experimental group will receive information in the same manner as current patients do, with the addition of receiving a brochure once when moving to a general ward after surgery. Afterward, they are free to use the brochure. The control group will receive information only in the manner currently provided to patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 1. The group assigned as the control group will receive information in the same manner as it is currently provided to patients. 2. A survey related to patient experience evaluation will be conducted before discharge. The survey will take about 10 minutes. 3. The control group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of. |
| Experimental Group | Experimental | 1. The group assigned as the experimental group will receive information in the same manner as it is currently provided to patients, with the addition of a brochure provided once when moving to a general ward after surgery. The brochure can then be used freely.
2. A survey related to patient experience evaluation will be conducted before discharge. For the experimental group, an additional survey regarding the provided brochure will be included. The survey will take about 15 minutes.
3. The experimental group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of. Receives: Other: Consolidating content on a single website and providing access to it via QR codes in a brochure format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient Experience 1
Inpatient Experience Evaluation Score, which ranges from a minimum of 0 to a maximum of 100 points, with higher scores indicating better patient experiences.
Measured: During the intervention
Inpatient Experience 2
Analysis of survey response trends and frequencies between the experimental and control groups
Measured: During the intervention
Inpatient Experience 3
Qualitative research through interviews
Measured: Patient: During the intervention and after intervention(Two times)/Medical staff: During the study period
Secondary outcomes (4)
Informational value of the intervention tool
Asking informational value of the intervention tool from survey and interview
Measured: During the intervention
Usability value of the intervention tool
Survey uses 'System Usability Scail' which ranges a minimum of 0 to a maximum of 100 points, with higher scores indicating better usability. Also related question will be asked by intervew.
Measured: During the intervention
Regarding utilization of the intervention tool
A survey and interview on the experience of utilization during hospitalization
Measured: During the intervention
Areas for improvement
A survey and interview on the advice for improvement
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start21 May 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taerim Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424808
- Sponsor's protocol ID
- 2024-04-078-001
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT06424808
- Acronym / sponsor ID
- 2024-04-078-001
- Conditions
- Liver Transplantation, Inpatients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 21 May 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 22 May 2024 (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 investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format.
[Patients] Considering this as a pilot study, the investigators plan to recruit around 30 participants. Both the experimental and control groups will receive standard care and information, with the experimental group additionally receiving the brochure. Random assignment will be used for the experimental and control groups. Surveys and interviews will be conducted to assess changes in patient experience and usability before and after providing the brochure.
[Medical Staff] Among the medical staff involved in the liver transplant surgical process, researchers will select participants based on their degree of involvement with the intervention subjects. After obtaining their consent, interviews will be conducted concerning patient experiences and the brochure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –1. The group assigned as the control group will receive information in the same manner as it is currently provided to patients. 2. A survey related to patient experience evaluation will be conducted before discharge. The survey will take about 10 minutes. 3. The control group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of. |
| Experimental Group | Experimental | Other: Consolidating content on a single website and providing access to it via QR codes in a brochure format1. The group assigned as the experimental group will receive information in the same manner as it is currently provided to patients, with the addition of a brochure provided once when moving to a general ward after surgery. The brochure can then be used freely. 2. A survey related to patient experience evaluation will be conducted before discharge. For the experimental group, an additional survey regarding the provided brochure will be included. The survey will take about 15 minutes. 3. The experimental group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- [Patients]
- Adults aged 18 and over
- Patients who are scheduled to undergo or have undergone liver transplant surgery
- Recruited through a call for research participants and have consented to participate in this study
- [Medical Staff]
Key exclusion criteria (7 listed)
- [Patients]
- Individuals who have not consented to participate in this study
- Individuals whose health condition makes it difficult to participate in the intervention
- During the research period, the researcher will check if the brochure content has been shared during surveys or interviews with the research participants (information dissemination). If information dissemination is confirmed, the participant will be excluded from the study.
- [Medical Staff]
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 |
|---|---|---|
| Consolidating content on a single website and providing access to it via QR codes in a brochure formatThe group assigned to the experimental group will receive information in the same manner as current patients do, with the addition of receiving a brochure once when moving to a general ward after surgery. Afterward, they are free to use the brochure. The control group will receive information only in the manner currently provided to patients. | Other | Experimental Group |
Primary outcome
Inpatient Experience 1
Time frame: During the intervention
Inpatient Experience Evaluation Score, which ranges from a minimum of 0 to a maximum of 100 points, with higher scores indicating better patient experiences.
Inpatient Experience 2
Time frame: During the intervention
Analysis of survey response trends and frequencies between the experimental and control groups
Inpatient Experience 3
Time frame: Patient: During the intervention and after intervention(Two times)/Medical staff: During the study period
Qualitative research through interviews
4 secondary outcomes
Informational value of the intervention tool
Time frame: During the intervention
Usability value of the intervention tool
Time frame: During the intervention
Regarding utilization of the intervention tool
Time frame: During the intervention
Areas for improvement
Time frame: During the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Consolidating content on a single website and providing access to it via QR codes in a brochure format in people with Liver Transplantation and Inpatients, run by Samsung Medical Center.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Min Kim, Ph.D (821020340550, flyhighsoom@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient Experience 1 (time frame: During the intervention). 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?
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 22 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.