UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061848 |
|---|---|
| Receipt number | R000070760 |
| Scientific Title | Effects of Reading Others' Good Things Diaries of Caregiving on Psychological Well-Being, Caregiving Burden, Positive Aspects of Caregiving, and Perceived Stress Among Family Caregivers: An Exploratory Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/09 14:44:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of reading others' Good Things Diaries of Caregiving on psychological well-being, caregiving burden, positive aspects of caregiving, and perceived stress among family caregivers: an exploratory randomized controlled trial
Acronym
A study of the psychological effects of reading other caregivers' diaries among family caregivers
Scientific Title
Effects of Reading Others' Good Things Diaries of Caregiving on Psychological Well-Being, Caregiving Burden, Positive Aspects of Caregiving, and Perceived Stress Among Family Caregivers: An Exploratory Randomized Controlled Trial
Scientific Title:Acronym
Caregiving Diary Reading Study
Region
| Japan |
Condition
Condition
Caregiving burden among family caregivers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether reading others' Good Things Diaries of Caregiving or general caregiving diaries for 14 days affects caregiving burden among family caregivers. The study also exploratorily examines effects on psychological well-being, positive aspects of caregiving, and perceived stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in caregiving burden from baseline to 14 days, assessed using the total score of the Japanese short version of the Zarit Burden Interview (J-ZBI_8).
Key secondary outcomes
Changes from baseline to 14 days in psychological well-being measured by the Japanese version of the WHO-5 Well-Being Index, positive aspects of caregiving measured by the Japanese version of the Positive Aspects of Caregiving scale, and perceived stress measured by the Japanese version of the Perceived Stress Scale, as well as free-text responses after the diary-reading intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants read one Good Things Diary of Caregiving written by another caregiver per day for 14 days using a smartphone messaging application. The diaries describe positive caregiving-related events and associated feelings or thoughts. Each diary is anonymized and accompanied by brief demographic information about the diary writer and care recipient.
Interventions/Control_2
Participants read one general caregiving diary written by another caregiver per day for 14 days using a smartphone messaging application. The diaries describe caregiving-related events and associated feelings or thoughts. Each diary is anonymized and accompanied by brief demographic information about the diary writer and care recipient.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult family caregivers who currently live with and provide care for a parent or parent-in-law certified as requiring long-term care in Japan; are able to use a smartphone messaging application; and provided informed consent to participate.
Key exclusion criteria
No explicit exclusion criteria were prespecified. Participants whose intervention adherence could not be confirmed were excluded from the analysis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kurinobu |
Organization
Saitama Prefectural University
Division name
School of Health and Social Services
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama 343-8540, Japan
TEL
048-971-0500
kurinobu-takeshi@spu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kurinobu |
Organization
Saitama Prefectural University
Division name
School of Health and Social Services
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama 343-8540, Japan
TEL
048-971-0500
Homepage URL
kurinobu-takeshi@spu.ac.jp
Sponsor or person
Institute
Urawa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Urawa University and Urawa University Junior College
Address
3551 Osaki, Midori-ku, Saitama-shi, Saitama 336-0974, Japan
Tel
048-878-3741
soumu@urawa.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
浦和大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
40
Results
Forty participants were randomized; 38 were analyzed after excluding 2 for poor adherence. The primary outcome, total J-ZBI_8, showed no significant group effect or interaction. Secondary outcomes improved over time: WHO-5-J and J-PSS-10 improved after the intervention, and PAC-J total score improved significantly in the Good Things Diary group.
Results date posted
| 2026 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty family caregivers who lived with and cared for a parent or parent-in-law certified as requiring long-term care, and who agreed to participate in a smartphone messaging app-based study, were enrolled through a research company. The final analysis set included 38 participants: 19 in the Good Things Diary group (11 women; mean age 55.32 +/- 7.09 years) and 19 in the caregiving diary group (8 women; mean age 52.58 +/- 6.75 years).
Participant flow
Forty participants were randomized into two groups, with 20 participants in each group. In the Good Things Diary group, one participant was excluded for reading multiple diaries on the same day. In the caregiving diary group, one participant was excluded for never accessing the LINE official site. The final analysis set included 19 participants in each group, for a total of 38 participants.
Adverse events
No adverse events were reported.
Outcome measures
The primary outcome was the change in caregiving burden from baseline to 14 days, assessed using the total J-ZBI_8 score. Secondary outcomes were WHO-5-J, PAC-J, J-PSS-10, and free-text responses after reading the diaries.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This trial was retrospectively registered with UMIN-CTR after participant recruitment, intervention, and follow-up had been completed. The trial was not prospectively registered because it was initially planned as a small exploratory behavioral intervention study and the need for clinical trial registration was not fully recognized before recruitment. No changes were made to the study design, intervention, outcome measures, or analysis plan as a result of retrospective registration. Erikson's integrity scale was collected as an individual difference variable or exploratory moderator that might be associated with intervention effects.
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070760
