Actively Recruiting

Age: 8Years +
All Genders
ID06556615

Development and Validation of a Standardized Questionnaire for Health-related Quality of Life in Patients With Classical Homocystinuria

Led by University Children's Hospital, Zurich · Updated on 2025-04-10

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying health-related quality of life (HrQoL) in patients with Classical Homocystinuria, also called CBS deficiency. The study aims to develop and validate a standardized questionnaire that measures how this condition affects patients' daily lives. Participants include patients, parents of young or handicapped patients, and experts, who will provide information to create and test the questionnaire. The study involves interviews and the presentation of questionnaires to gather relevant content for the HrQoL assessment. After collecting this information, a draft questionnaire will be created and tested for clarity and understanding among patients and parents. A final version will then be evaluated for its validity and reliability as a useful tool. Participants will be involved in interviews and questionnaire testing over about six months. The researchers will assess the questionnaire’s quality and how well it measures health-related quality of life in this patient group. This observational study is led by the University Children's Hospital in Zurich and is expected to end in September 2025.

CONDITIONS

Brief Title

Health Related Quality of Life (HrQoL) in Classical Homocystinuria (CBS Deficiency)

Who Can Participate

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with CBS deficiency from age 8 years
  • Parents of patient(s) younger than 18 years with cognitive impairment
  • Parents of patients between age 4 and 7
  • Experts on CBS deficiency
  • Able to give informed consent as documented by signature
Not Eligible

You will not qualify if you...

  • Insufficient command of the German or the English language

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for consent and eligibility assessment

Interview

Duration - Approximately 6 months

Participants complete interviews and questionnaires to assess health-related quality of life.

1 or more visits depending on interview schedule

Trial Site Locations

Total: 1 location

1

Kinderspital Zürich

Zurich, Switzerland, 8008

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Research Team

H

Helene Werner, PD, Dr

M

Martina Huemer, Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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