UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045247 |
|---|---|
| Receipt number | R000051553 |
| Scientific Title | Development and Validation of a Measure to Assess Care-related Emotions of Family Members of Individuals with Mental Disorders |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/09/03 14:29:07 |
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Basic information
Public title
A Questionnaire Survey of the Care Burden of Family Members of People with Mental Illnesses
Acronym
A Survey of the Care Burden of Mental Illnesses
Scientific Title
Development and Validation of a Measure to Assess Care-related Emotions of Family Members of Individuals with Mental Disorders
Scientific Title:Acronym
Development and Validation of the CREAM
Region
| Japan |
Condition
Condition
Schizophrenia (SZ), schizoaffective disorder (SZA), bipolar disorder (BD),
and anorexia nervosa (AN)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the psychometric properties of CREAM.
Basic objectives2
Others
Basic objectives -Others
The study will also validate its screening performance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We will examine the CREAM's structural validity, reliability (internal consistency and test-retest reliability), and construct and criterion validities.
Key secondary outcomes
We will also examine its criterion validity.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for the survey are family members who (1) are aged between 18 and 74 years; (2) have relatives diagnosed with SZ, SZA, BD, or AN; (3) are ill individuals' parents, siblings, or spouses; and (4) have relatives being treated through regular visits, being admitted to medical facilities, or having had the last visit to medical facilities within the past year.
Key exclusion criteria
The exclusion criteria are family members who (1) are not ill individuals' parents, siblings, or spouses and (2) have relatives having had the last visit to medical facilities before the past year or not knowing the treatment condition.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Shiraishi |
Organization
Nagoya City University, Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81-52-853-8048
nao-shiraishi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Shiraishi |
Organization
Nagoya City University, Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81-52-853-8048
Homepage URL
nao-shiraishi@umin.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministry of Education, Science, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
+81-52-858-7215
clinical_research@med.nagoya-cu.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
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051553
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/pcn5.55
Number of participants that the trial has enrolled
611
Results
Our new measure demonstrated robust structural validity and excellent internal consistency. Moreover, we examined the role of caregiving burden and sense of coherence as mediating factors between the functional disabilities of patients with psychotic disorders and the negative and positive emotions of their siblings, using structural equation modeling (SEM). As the results, an approach that addresses caregiving both burden and sense of coherence could be effective in supporting siblings emotionally.
Results date posted
| 2024 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the SEM study, the sample included 237 siblings aged 42.3 years (mean) with a male-to-female ratio of 0.88 and 237 patients with schizophrenia (80.2%) or schizoaffective disorder (19.8%).
Participant flow
A nationwide online survey was used to screen and recruit family members, including siblings and spouses, of patients with psychotic disorders.
Adverse events
Not applicable
Outcome measures
Patients' disabilities in their work lives, socializing, and family communication, as well as the family members' care burden, sense of coherence, and positive and negative emotions, were assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registered people are invited to participate in the survey from the nationwide online survey panel that is managed by Rakuten Insight.
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051553
