Organ TransplantationNCT00792064
Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation
An observational study of Organ Transplantation and Anxiety, run by Hannover Medical School at 1 site in Germany.
Trial summary
A systematic evaluation of predictors of health related quality of life (HRQoL) leads to multiple level of data analysis. The aim of the herein described observational project is to create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally predictors of HRQoL after different types… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Organ Transplantation, Anxiety, Depression
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Jul 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients immediately after solid organ transplantation
Who may be able to join
- Follow-up at our outpatient clinics
- Written informed consent
- Sufficient German language skills to read and answer a battery of questionnaires
- Min 18 years
Who cannot join
- Illiteracy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery
Hanover, 30625
Christiane Kugler, 0049-511-5326586, kugler.christiane@mh-hannover.de
Christiane Kugler
About this study
Official title: Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study
A systematic evaluation of predictors of health related quality of life (HRQoL) leads to multiple level of data analysis. The aim of the herein described observational project is to create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally predictors of HRQoL after different types of solid organ transplantation in the long-term. A sample size of 700 participants consisting of all solid organ types is envisioned. Data will be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may guide development of tailored interventions to reduce complications and to further improve outcomes.
- Conditions
- Organ Transplantation, Anxiety, Depression
- Keywords
- quality of life, adverse effects
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Kidney-Tx-recipients | |
| 2 | Liver-Tx-recipients | |
| 3 | Heart-Tx-recipients | |
| 4 | Lung-Tx-recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL after transplantation
Measured: 5 yrs
Secondary outcomes (1)
Social re-integration
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Christiane Kugler, PhD, Principal investigator, Clinic for Cardiac, Thoracic, Transplantation and
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792064
- Sponsor's protocol ID
- IRB No_378
- Status last verified
- Aug 2009
- First submitted
- 14 Nov 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00792064
- Acronym / sponsor ID
- IRB No_378
- Conditions
- Organ Transplantation, Anxiety, Depression
- Keywords
- quality of life, adverse effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 17 Nov 2008 (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.
A systematic evaluation of predictors of health related quality of life (HRQoL) leads to multiple level of data analysis. The aim of the herein described observational project is to create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally predictors of HRQoL after different types of solid organ transplantation in the long-term. A sample size of 700 participants consisting of all solid organ types is envisioned. Data will be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may guide development of tailored interventions to reduce complications and to further improve outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Kidney-Tx-recipients |
| 2 | – | –Liver-Tx-recipients |
| 3 | – | –Heart-Tx-recipients |
| 4 | – | –Lung-Tx-recipients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients immediately after solid organ transplantation
Key inclusion criteria (4 listed)
- Follow-up at our outpatient clinics
- Written informed consent
- Sufficient German language skills to read and answer a battery of questionnaires
- Min 18 years
Key exclusion criteria (1 listed)
- Illiteracy
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
HRQoL after transplantation
Time frame: 5 yrs
1 secondary outcome
Social re-integration
Time frame: 5 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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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.
Christiane Kugler, PhD principal investigator
Clinic for Cardiac, Thoracic, Transplantation and
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 Organ Transplantation and Anxiety, run by Hannover Medical School at 1 site in Germany.
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 4 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 25 Aug 2009. 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 Germany. 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 Christiane Kugler, PhD (++49.511.532.6586, Kugler.Christiane@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL after transplantation (time frame: 5 yrs). 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 25 Aug 2009.