UMIN-CTR Clinical Trial

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
Email	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
Email	m15711048@gunma-u.ac.jp

Sponsor
Institute	Tokyo Center for Dementia Care Research and Practices
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048296