UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056353 |
|---|---|
| Receipt number | R000064233 |
| Scientific Title | Study on evaluation of program to support middle-aged informal caregivers |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2025/12/05 09:05:10 |
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Basic information
Public title
Positive psychology-based online program for middle-aged informal caregivers
Acronym
Caring for oneself program
Scientific Title
Study on evaluation of program to support middle-aged informal caregivers
Scientific Title:Acronym
Positive psychology-based online program for middle-aged informal caregivers
Region
| Japan |
Condition
Condition
Informal caregivers in their 30s-50s of older adults with certified care needs
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the effectiveness of a positive psychology-based online support program for informal caregivers of older adults requiring long-term care at home. The program will improve the caregivers' well-being and quality of life by increasing their self-compassion, using their strengths, and being aware of their own authenticity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Well-being of informal caregivers
Key secondary outcomes
QOL
Self-compassion
Knowledge and use of own strengths
Authenticity
Resilience
Caregiver burden
Emotional exhaustion
Loneliness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will be provided an online self-study and psychoeducational program based on positive psychology for two months (8 sessions in total).
Interventions/Control_2
The control group will be presented a leaflet with an excerpt of the intervention content and the program after the intervention group has completed the eight sessions.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Informal caregiver for the older adults who need care at home among the monitored members of a web-based research company
Informal caregiver aged 30s to 50s
Older adult aged 65 years old and over
Older adult certified care needs (certification for support is acceptable)
Informal caregiver usually using the internet
Live together or separately is not relevant
Key exclusion criteria
Older adult is in an institution or in a hospital
Informal caregiver attending medical institutions such as psychiatry or psychosomatic medicine for mental illness
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | MORIYAMA |
Organization
National Institute of Public Health
Division name
Department of Health and Welfare Services
Zip code
351-0197
Address
2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan
TEL
048-458-6224
moriyama.y.aa@niph.go.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | MORIYAMA |
Organization
National Institute of Public Health
Division name
Department of Health and Welfare Services
Zip code
351-0197
Address
2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan
TEL
048-458-6224
Homepage URL
moriyama.y.aa@niph.go.jp
Sponsor or person
Institute
National Institute of Public Health
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
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
National Institute of Public Health
Address
2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan
Tel
048-458-6186
hagiwara.t.aa@niph.go.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 | 12 | Month | 06 | Day |
Related information
URL releasing protocol
https://pdf.sciencedirectassets.com/784987/1-s2.0-S2950307825X00023/1-s2.0-S295030782500044X/main.pd
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
500
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 | 11 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064233
