Hereditary HaemochromatosisNCT01991925
Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis
An observational study of Hereditary Haemochromatosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Haemochromatosis
- What is being tested?
- Interviews, questionaires, RAND-modified delphi method round
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Phase 1: RAND-modified Delphi Method: experts in the field of hereditary haemochromatosis Phase 2: Patients with hereditary haemochromatosis
Who may be able to join
- phase 1: experts in the field of haemochromatosis (hepatologists, hematologists, endocrinologists, general practitioner, nurses, ...)
- phase 2: patients with hereditary haemochromatosis, treatment with phlebotomy since 3 months, Dutch/English speaking
Who cannot join
- patients with secondary iron overload
- phlebotomy treatment less than 3 months
- language: no Dutch or English
Trial locations and contacts
1 site in 1 country.
About this study
Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital.
Read the detailed description
Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital during follow-up
- Conditions
- Hereditary Haemochromatosis
- Being tested
- Interviews, questionaires, RAND-modified delphi method round
- Medical subject headings
- Hemochromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews, questionaires, RAND-modified delphi method roundOther
phase 1: RAND-modified delphi method round with experts in hereditary haemochromatosis phase 2: patient interviews, questionnaires and focus group interviews
| Study group | Role | What they receive |
|---|---|---|
| quality of life, quality of care | hereditary haemochromatosis patients Receives: Other: Interviews, questionaires, RAND-modified delphi method round |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of quality of life
quality of life
Measured: after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startApr 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary HaemochromatosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annick Vanclooster, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Annick Vanclooster, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991925
- Sponsor's protocol ID
- UZL-INT-01
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2013
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis
- ClinicalTrials.gov ID
- NCT01991925
- Acronym / sponsor ID
- UZL-INT-01
- Conditions
- Hereditary Haemochromatosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Nov 2013 (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.
Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital.
Detailed description
Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital during follow-up
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality of life, quality of care | – | Other: Interviews, questionaires, RAND-modified delphi method roundhereditary haemochromatosis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1: RAND-modified Delphi Method: experts in the field of hereditary haemochromatosis Phase 2: Patients with hereditary haemochromatosis
Key inclusion criteria (2 listed)
- phase 1: experts in the field of haemochromatosis (hepatologists, hematologists, endocrinologists, general practitioner, nurses, ...)
- phase 2: patients with hereditary haemochromatosis, treatment with phlebotomy since 3 months, Dutch/English speaking
Key exclusion criteria (3 listed)
- patients with secondary iron overload
- phlebotomy treatment less than 3 months
- language: no Dutch or English
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 |
|---|---|---|
| Interviews, questionaires, RAND-modified delphi method roundphase 1: RAND-modified delphi method round with experts in hereditary haemochromatosis phase 2: patient interviews, questionnaires and focus group interviews | Other | quality of life, quality of care |
Primary outcome
evaluation of quality of life
Time frame: after 3 months of treatment
quality of life
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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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.
Annick Vanclooster principal investigator
UZ Leuven
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 Hereditary Haemochromatosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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: withdrawn, as of the sponsor's last update on 31 Mar 2023. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of quality of life (time frame: after 3 months of treatment). 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 31 Mar 2023.