Patient SatisfactionNCT06417294
Effects of a 3D-Printed Port-A Catheter Model Training Course
A study testing 3D health education model and traditional education in people with Patient Satisfaction and Cancer, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Satisfaction, Cancer
- What is being tested?
- 3D health education model and traditional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2024to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital
- Have Chinese communication skills
Who cannot join
- Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886-905-301-879, ck_qq@hotmail.com
Ke-Yun Chao, PhD
About this study
Official title: Effects of a 3D-Printed Port-A Catheter Model Training Course for Patient Discharge Instruction
The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.
Read the detailed description
Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.
Methods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.
Effect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.
- Conditions
- Patient Satisfaction, Cancer
- Being tested
- 3D health education model, traditional education
- Keywords
- 3D printed model, port-a catheter, discharge education
- Medical subject headings
- Patient Satisfaction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D health education modelOther
explanation combined with 3D printed health education model
traditional educationOther
Regular education
| Study group | Role | What they receive |
|---|---|---|
| 3D model group | Experimental | Received a explanation combined with 3D printed model Receives: Other: 3D health education model |
| traditional education group | Active comparator | Received a regular education Receives: Other: traditional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient education effectiveness questionnaire
higher scores mean a better outcome
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417294
- Sponsor's protocol ID
- FJUH112278
- Status last verified
- Jun 2024
- First submitted
- 12 May 2024
- Last updated
- 10 Jun 2024
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 3D-Printed Port-A Catheter Model Training Course for Patient Discharge Instruction
- ClinicalTrials.gov ID
- NCT06417294
- Acronym / sponsor ID
- FJUH112278
- Conditions
- Patient Satisfaction, Cancer
- Keywords
- 3D printed model, port-a catheter, discharge education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 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 aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.
Detailed description
Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.
Methods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.
Effect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D model group | Experimental | Other: 3D health education modelReceived a explanation combined with 3D printed model |
| traditional education group | Active comparator | Other: traditional educationReceived a regular education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital
- Have Chinese communication skills
Key exclusion criteria (1 listed)
- Refused to participate in the study.
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 |
|---|---|---|
| 3D health education modelexplanation combined with 3D printed health education model | Other | 3D model group |
| traditional educationRegular education | Other | traditional education group |
Primary outcome
Patient education effectiveness questionnaire
Time frame: immediately after the intervention
higher scores mean a better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- 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.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D health education model and traditional education in people with Patient Satisfaction and Cancer, run by Fu Jen Catholic University at 1 site in Taiwan.
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 2 inclusion and 1 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 10 Jun 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke-Yun Chao, PhD (+886905301879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient education effectiveness questionnaire (time frame: immediately after the intervention). 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 10 Jun 2024.