Liver TransplantNCT01380002
Home-Care Needs in Liver or Renal Transplantation Recipients and Their Spouses
An observational study of Liver Transplant and Renal Transplant, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Liver/renal transplantations are now tending to be the most important treatment for terminal liver and renal disease. Although transplantation can prevent recipients from suffering with critical and fatal symptoms, patients may experience the complication from surgery and immunosuppressive drugs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplant, Renal Transplant
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Dec 2011
- Phase
- Observational
- 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
Study population: * liver transplant recipients or renal transplant recipients with 18 to 80 years old who have regular follow up in organ transplant outpatient departments at National Taiwan University Hospital in Northern Taiwan. * We will also recuit spouses who live with recruited patients.
Who may be able to join
- about patients
- liver transplant recipients or renal transplant recipients who have regular follow up in organ transplant outpatient departments.
- conscious clear.
- above 18 years old.
- about spouse
- who live with patients.
- conscious clear.
- above 18 years old.
Who cannot join
- about patients
- who suffer form cancer now.
- have received transplantation twice.
- about spouse
- who liver apart from patients.
- whose spouse(patient) did not recruited in this research.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Hsuan Chang, master, 011-886-916-251-900, r98426009@ntu.edu.tw
About this study
- Liver/renal transplantations are now tending to be the most important treatment for terminal liver and renal disease. Although transplantation can prevent recipients from suffering with critical and fatal symptoms, patients may experience the complication from surgery and immunosuppressive drugs. Furthermore, they might have many unmet needs in daily life, and so as their spouses. The purpose of this study is to explore the home-care needs among the post liver or renal transplant recipients and their spouses, and identify the significant factors for care needs.
- A cross-sectional correlated design will be used and patients will be recruited by purposive sampling from an organ transplant outpatient department at a medical center in northern Taiwan. A set of structured questionnaires will be used to collect data.
- The result of this study will be helpful for clinical nurses to understand liver or renal recipients' physical and mental distress, also identify the potential risk of home-care needs and the degree of satisfaction as well.
- Conditions
- Liver Transplant, Renal Transplant
- Keywords
- care needs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shiow-Ching Shun, Doctor, Study chair, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380002
- Sponsor's protocol ID
- 201011063RC
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Care Needs in Liver or Renal Transplantation Recipients and Their Spouses
- ClinicalTrials.gov ID
- NCT01380002
- Acronym / sponsor ID
- 201011063RC
- Conditions
- Liver Transplant, Renal Transplant
- Keywords
- care needs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Jun 2011 (estimated)
- 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.
- Liver/renal transplantations are now tending to be the most important treatment for terminal liver and renal disease. Although transplantation can prevent recipients from suffering with critical and fatal symptoms, patients may experience the complication from surgery and immunosuppressive drugs. Furthermore, they might have many unmet needs in daily life, and so as their spouses. The purpose of this study is to explore the home-care needs among the post liver or renal transplant recipients and their spouses, and identify the significant factors for care needs.
- A cross-sectional correlated design will be used and patients will be recruited by purposive sampling from an organ transplant outpatient department at a medical center in northern Taiwan. A set of structured questionnaires will be used to collect data.
- The result of this study will be helpful for clinical nurses to understand liver or renal recipients' physical and mental distress, also identify the potential risk of home-care needs and the degree of satisfaction as well.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * liver transplant recipients or renal transplant recipients with 18 to 80 years old who have regular follow up in organ transplant outpatient departments at National Taiwan University Hospital in Northern Taiwan. * We will also recuit spouses who live with recruited patients.
Key inclusion criteria (8 listed)
- about patients
- about spouse
Key exclusion criteria (6 listed)
- about patients
- about spouse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Shiow-Ching Shun, Doctor study chair
Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant and Renal Transplant, run by National Taiwan University Hospital 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 8 inclusion and 6 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 23 Jun 2011. 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 Yu-Hsuan Chang, Master (0916-251-900, r98426009@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 23 Jun 2011.