UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038364 |
|---|---|
| Receipt number | R000043678 |
| Scientific Title | Effects of using a lost items finder on caregiving stress for family caregivers of patients with dementia: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/10/21 17:47:10 |
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Basic information
Public title
Effects of using a lost items finder on caregiving stress for family caregivers of patients with dementia
Acronym
Effects of using a lost items finder on caregiving stress for family caregivers of patients with dementia
Scientific Title
Effects of using a lost items finder on caregiving stress for family caregivers of patients with dementia: a pilot randomized controlled trial
Scientific Title:Acronym
Effects of using a lost items finder on caregiving stress for family caregivers of patients with dementia: a pilot randomized controlled trial
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to verify that the use of a lost items finder reduces the caregiving stress of family caregivers of patients with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Using the Japanese version of the Zarit Caregiver Burden Interview to assess the change of caregiving stress from baseline to two months after the intervention
Key secondary outcomes
Secondary outcome measures include the Japanese version for the Revised Scale for Caregiving Self-Efficacy, the Japanese version of the Burnout Measure, and reduction of finding time and finding frequency.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Lend a lost items finder to the intervention group, and the patient and caregiver will use it for two months.
Interventions/Control_2
The control group has no lost items finder and receive normal treatment.
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
Patient
1. People with dementia, mild cognitive impairment or subjective cognitive impairment who have losing problems, on average more than twice a month.
2. Patients who can understand the significance of this study.
Family caregiver
1. Family caregivers who live with the patient, accompany the patient and take care of them everyday.
2. Family caregivers who have no cognitive impairment
3. Family caregivers who can use the lost items finder correctly according to the instructions.
4. Family caregivers who agree to participate in this study and provide informed consent.
Key exclusion criteria
Patient
1. ADL is low and almost every day life is assisted.
Family caregiver
1. Family caregivers who are using the lost items finder at home already.
2. Family caregivers who have problems with vision or hearing.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ayae |
| Middle name | |
| Last name | Kinoshita |
Organization
Graduate School of Medicine Kyoto university
Division name
Human Health Sciences
Zip code
606-8397
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3969
kinoshita.ayae.6v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Zhouyuan |
| Middle name | |
| Last name | Peng |
Organization
Graduate School of Medicine Kyoto university
Division name
Human Health Sciences
Zip code
606-8397
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3969
Homepage URL
pengzhy9@mail2.sysu.edu.cn
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Toppan Printing Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
Yoshida-konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043678
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