Implications for Quality of Life and Quality of Care in P... | NCT01991925

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

NCT01991925

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Withdrawn

Last Update Posted

Mar 31, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hereditary Haemochromatosis

Interventions

Interviews, questionaires, RAND-modified delphi method round

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Nov 18, 2013

First Submission Date that Met QC Criteria

Nov 18, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 31, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annick Vanclooster, Nurse, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
quality of life, quality of care		hereditary haemochromatosis patients	Other: Interviews, questionaires, RAND-modified delphi method round

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interviews, questionaires, RAND-modified delphi method round	Other	phase 1: RAND-modified delphi method round with experts in hereditary haemochromatosis phase 2: patient interviews, questionnaires and focus group interviews

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of quality of life	quality of life	after 3 months of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annick Vanclooster	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven	Vlaams-brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006432	Hemochromatosis

Ancestor Terms

ID	Term
D008664	Metal Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided