Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059079) titled 'The Burden on Daily Life and Quality of Life for Patients with Mucopolysaccharidosis: An Interview Research' on Sept. 16.
Study Type:
Observational
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Mucopolysaccharidosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the daily burdens and actual state of quality of life experienced by patients with mucopolysaccharidosis and their families.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 16
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients
1) Patients aged 18 years or older diagnosed with a type of mucopolysaccharidosis without intellectual disability (diagnosed by developmental testing or genetic testing)
2) Patients aged 16 years or older but under 18 years of age diagnosed with a type of mucopolysaccharidosis without intellectual disability (diagnosed via developmental assessment or genetic testing), where both the patient and guardian have provided written consent for study participation (Since the patient is a minor, consent must be obtained from both the patient and guardian. If the guardian wishes to participate in the study, they may attend the interview).
3) No gender restrictions
4) Individuals who have received sufficient explanation regarding the purpose and content of this study and have provided written consent to participate
5) Individuals capable of communicating in Japanese
6) Individuals able to participate in online or in-person interviews
Guardian
1) Guardian of a patient diagnosed with mucopolysaccharidosis, regardless of the patient's age or presence of intellectual disability
2) No gender restrictions
3) Individuals who have received a thorough explanation of the purpose and content of this study and have provided written consent for research participation
4) Individuals capable of communicating in Japanese
5) Individuals able to participate in online or in-person interviews
Key exclusion criteria - Patients
1) Individuals deemed unable to participate in the interview survey due to severe physical complications
2) Other individuals deemed unsuitable as research subjects by the principal investigator (or co-investigator)
Guardian
1) Individuals whose patient is undergoing acute-phase treatment such as hospitalization due to severe physical complications and is deemed unable to participate in the interview survey
2) Other individuals deemed unsuitable as research subjects by the principal investigator (or co-investigator)
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 04 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 09 Month 16 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067438
Disclaimer: Curated by HT Syndication.