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Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01991925
Recruitment Status : Unknown
Verified November 2013 by Annick Vanclooster, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Annick Vanclooster, Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date November 18, 2013
First Posted Date November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date January 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2013)
evaluation of quality of life [ Time Frame: after 3 months of treatment ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis
Official Title Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis
Brief Summary Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Phase 1: RAND-modified Delphi Method: experts in the field of hereditary haemochromatosis Phase 2: Patients with hereditary haemochromatosis
Condition Hereditary Haemochromatosis
Intervention Other: Interviews, questionaires, RAND-modified delphi method round
phase 1: RAND-modified delphi method round with experts in hereditary haemochromatosis phase 2: patient interviews, questionaires and focusgroup interviews
Study Groups/Cohorts quality of life, quality of care
Intervention: Other: Interviews, questionaires, RAND-modified delphi method round
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 18, 2013)
130
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with secundary iron overload
  • phlebotomy treatment less than 3 months
  • language: no Dutch or English
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01991925
Other Study ID Numbers UZL-INT-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Annick Vanclooster, Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date November 2013