UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042326 |
|---|---|
| Receipt number | R000048296 |
| Scientific Title | A randomized controlled trial of the positive diary intervention for family caregivers of people with dementia |
| Date of disclosure of the study information | 2020/11/03 |
| Last modified on | 2021/12/24 20:29:53 |
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Basic information
Public title
The effects of the positive diary intervention for family caregivers of people with dementia
Acronym
The effects of the positive diary intervention for family caregivers of people with dementia
Scientific Title
A randomized controlled trial of the positive diary intervention for family caregivers of people with dementia
Scientific Title:Acronym
A randomized controlled trial of the positive diary intervention for family caregivers of people with dementia
Region
| Japan |
Condition
Condition
Family caregivers of people with dementia
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the effectiveness of the positive diary, in which family caregivers of people with dementia (PWD) can write down three good things that happened with reasons and compliment themselves on a daily basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuropsychiatric Inventory Caregiver Distress Scale (NPI-D)
Key secondary outcomes
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Center for Epidemiologic Studies Depression Scale (CES-D)
World Health Organization-Five Well-Being Index (WHO-5)
Short version of the Zarit Burden Interview (ZBI_8)
Caregiving Gratification Scale (CGS)
Dementia Caregiver Positive Feelings Scale 21-item version (DCPFS-21)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group was asked to use the positive diary for four weeks.
Interventions/Control_2
The control group was asked to keep a record of each meal (breakfast, lunch, and dinner) for four weeks.
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
The inclusion criteria specified that participants had to be family caregivers (primary caregivers) of PWD at home, could write a diary, and consented to participate.
Key exclusion criteria
Those who could not maintain diary or whose care recipients were in an unstable health condition were excluded from participating.
The discontinuance criteria specified that participants who could no longer continue writing a diary (for whatever reason), or whose care recipients experienced changes in dementia or psychotropic medications changed, or whose types of case services using changed had to withdraw from the research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Fuju |
Organization
Tokyo Center for Dementia Care Research and Practices
Division name
Research Department
Zip code
168-0071
Address
12-1-1 Takaido-Nishi, Suginami-Ku, Tokyo
TEL
03-6743-2181
m15711048@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Fuju |
Organization
Tokyo Center for Dementia Care Research and Practices
Division name
Research Department
Zip code
168-0071
Address
12-1-1 Takaido-Nishi, Suginami-Ku, Tokyo
TEL
03-6743-2181
Homepage URL
m15711048@gunma-u.ac.jp
Sponsor or person
Institute
Tokyo Center for Dementia Care Research and Practices
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Tokyo Center for Dementia Care Research and Practices
Address
12-1-1 Takaido-Nishi, Suginami-Ku, Tokyo
Tel
03-3334-2173
tokyo_dcrc@dcnet.gr.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
| 2020 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/ppc.13013
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/ppc.13013
Number of participants that the trial has enrolled
36
Results
The unpaired t-tests revealed significant improvements in the scores of the NPI-Q, CES-D, WHO-5, ZBI_8, and CGS in the intervention group.
A repeated-measures ANCOVA produced a significant interaction for the total score of the CES-D.
Results date posted
| 2021 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Family caregivers of people with dementia
Intervention group: mean age 61.1 years
Control group: mean age 63.8 years
Participant flow
Enrollment: 36
Intervention: 26 (intervention group: 13, control group: 13)
Analyzed: 22 (intervention group: 10, control group: 12)
Adverse events
No adverse effect reported
Outcome measures
Neuropsychiatric Inventory Caregiver Distress Scale (NPI-D) and NPI Questionnaire (NPI-Q)
Center for Epidemiologic Studies Depression Scale (CES-D)
World Health Organization-Five Well-Being Index (WHO-5)
Short version of the Zarit Burden Interview (ZBI_8)
Caregiving Gratification Scale (CGS)
Dementia Caregiver Positive Feelings Scale 21-item version (DCPFS-21)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registered as a retrospective
Management information
Registered date
| 2020 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048296
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
