NCT01991925

Brief Summary

Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2.4 years until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

November 18, 2013

Last Update Submit

March 28, 2023

Conditions

Hereditary Haemochromatosis

Outcome Measures

Primary Outcomes (1)

  • evaluation of quality of life

    quality of life

    after 3 months of treatment

Study Arms (1)

quality of life, quality of care

hereditary haemochromatosis patients

Other: Interviews, questionaires, RAND-modified delphi method round

Interventions

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

quality of life, quality of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Phase 1: RAND-modified Delphi Method: experts in the field of hereditary haemochromatosis Phase 2: Patients with hereditary haemochromatosis

You may qualify if:

  • 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

You may not qualify if:

  • patients with secondary iron overload
  • phlebotomy treatment less than 3 months
  • language: no Dutch or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Hemochromatosis

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Annick Vanclooster

    UZ Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

BE(1)