UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054816 |
|---|---|
| Receipt number | R000062552 |
| Scientific Title | Intervention research NPI-Brief Questionnaire Form Dementia care positivity scare twenty-one item versin |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2024/06/28 23:11:28 |
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Basic information
Public title
Examining the effectiveness of a family suppot program for elderly people with dementia based on the philosophy of person-centerd care
Acronym
Examining the effectiveness of a family suppot program for elderly people with dementia based on the philosophy of person-centerd care
Scientific Title
Intervention research NPI-Brief Questionnaire Form Dementia care positivity scare twenty-one item versin
Scientific Title:Acronym
Intervention research NPI-Brief Questionnaire Form Dementia care positivity scare twenty-one item versin
Region
| Japan |
Condition
Condition
MCI
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study conducted a family support program based on the philosophy of person -centerd care for family caregivers of elderly people with dementia, and examined changes in family caregivers positive feelings about caregiving and sense of caregiving burden before and after the program. From the program effect. The purpose is to verify the results.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We checked the normality of the NPI-Q scores in the four counties at the program. at the end of the third program.on the last day.and two months after the last day, and if they were normally distributed. we conducted a repeated measures analysis of variance.implement. If the distribution is non-normal.perform a Friedman test to check whether there are differecences among the four groups.Afterwards,for those where differences were found,the Bonferroni method was used to clarify where the differences occurred between the four groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A program based on the concept of person-centered care will be implemented for family caregivers of elderly people with dementia, once every four weeks for a total of five sessions.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who meet the following criteria 1 to 4
1 Family members living with an elderly person diagnosed with dementia or MCI
2 Care recipient is 65 years of age or older
3 Family members living with an elderly person who is independent in ADL and requires care level 2 or lower
4 Subjects who can participate in all five programs implemented in this study
2. Subjects who have given consent to this study by signing a consent form
Key exclusion criteria
Subjects who meet any of the following criteria will not be included in this study.
1Those who have not given consent to participate in the study
2Those who are unable to communicate
3Those who are not feeling well on the day of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MIZUE |
| Middle name | |
| Last name | SUZUKI |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Nursing Course
Zip code
431-3192
Address
20-1, Handayama 1-chome, Higashi-ku, Hamamatsu City
TEL
0534352680
M22012@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | MITSUE |
| Middle name | |
| Last name | TANAKA |
Organization
Hamamatsu University School of Medicine
Division name
Graduate School of Medicine, Department of Nursing
Zip code
431-3192
Address
20-1, Handayama 1-chome, Higashi-ku, Hamamatsu City
TEL
0534352680
Homepage URL
M22012@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
20-1, Handayama 1-chome, Higashi-ku, Hamamatsu City
Tel
0534352680
M22012@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062552
