UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055144 |
|---|---|
| Receipt number | R000062926 |
| Scientific Title | Association between quality of life and changes in outdoor temperature in patients with Fabry disease: a longitudinal observational study |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/08/04 09:03:04 |
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Basic information
Public title
Association between quality of life and changes in outdoor temperature in patients with Fabry disease: a longitudinal observational study
Acronym
Fabry disease quality of life and changes in outside temperature
Scientific Title
Association between quality of life and changes in outdoor temperature in patients with Fabry disease: a longitudinal observational study
Scientific Title:Acronym
Fabry disease quality of life and changes in outside temperature
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between disease-specific quality of life and seasonal changes in outdoor temperature in adult patients with Fabry disease.
Basic objectives2
Others
Basic objectives -Others
To identify a baseline for disease-specific quality of life due to seasonal variation.
Examine the reliability of disease-specific quality of life measures based on correlations with general quality of life measures.
Calculate minimal clinically important difference in disease-specific quality of life measures.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factor scores on the adult Fabry disease-specific quality of life scale (AFQOL) every 3 months.
Key secondary outcomes
SF-8 score to be measured at the time of the initial survey
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age must be 18 years or older at the time consent is obtained.
2) 30 participants for each disease type (classic, late onset, and female heterozygous).
3) Participants with a diagnosis of Fabry's disease.
Key exclusion criteria
1) Those who are hospitalized for acute diseases
2) Persons with cognitive impairment or intellectual disability who do not have the ability to answer the questionnaire on their own, or who are suspected to have such impairment.
3) Other persons who are deemed inappropriate as research participants by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Koto |
Organization
Kansai Medical University
Division name
Faculty of Nursing
Zip code
573-1004
Address
2-2-2 Shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0095
kotoy@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Koto |
Organization
Kansai Medical University
Division name
Faculty of Nursing
Zip code
573-1004
Address
2-2-2 Shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0095
Homepage URL
kotoy@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Yuta Koto
Funding Source
Organization
Japanese Society for Inherited Metabolic Diseases
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Review Committee, Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata city, Osaka, Japan
Tel
072-804-0101
kotoy@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items
1) Background information (age, gender, disease type, age of diagnosis, current treatment, and prefecture of residence)
2) Conditions at the time of the survey (use of air conditioner, etc., outside temperature)
3)Adult Fabry Disease-Specific Quality of Life Scale (AFQOL)
4) Anchor questions to calculate meaningful clinically important differences (7-point method) (2nd survey only)
5) SF-8 general quality of life scale (1st survey only)
Management information
Registered date
| 2024 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062926
