UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030271 |
|---|---|
| Receipt number | R000034563 |
| Scientific Title | A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2021/01/14 14:19:11 |
* 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
A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Acronym
A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Scientific Title
A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Scientific Title:Acronym
A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study of effective method of psychoeducation program for family caregivers of elderly with dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire survey on the contents of psychoeducational programs of high interest to family caregivers
Evaluate when psychoeducational education program is implemented for the first time and last time.
Key secondary outcomes
Zarit Care-Giver Burden Interview, NPI - Q (Neuropsychiatric Inventory - Questionnaire) Japanese version, Self-rating Depression Scale.
Evaluate when psychoeducational education program is implemented for the first time and last time.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Doctor, clinical psychologist, occupational therapist, physical therapist, nutritionist, social worker, nurse perform psychoeducational education program for family caregivers of elderly with dementia. The psychology education program is conducted twice a month, and it is carried out six times in total. It is 1 hour 30 minutes once.
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
Learners of psychoeducational programs for family caregivers of elderly people with dementia at Kitasato University East Hospital psychiatry department
Key exclusion criteria
Those who do not have adequate attendance rates for psychoeducational programs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Miyaoka |
Organization
Kitasato University of Medicine
Division name
psychiatry
Zip code
252-0380
Address
2-1-1 Asamizodai, Minami-ku, Sagamihara-City, Kanagawa Prefecture, Japan
TEL
042-748-9111
miyaoka@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kyou |
Organization
Kitasato University Graduate School
Division name
Medical Sciences
Zip code
252-0375
Address
1-15-1 Kitasato Minami-ku, Sagamihara-city, Kanagawa prefecture, Japan
TEL
042-778-9305
Homepage URL
kyouyoshitaka@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kitasato University Hospital Ethics Office
Address
1-15-1 Kitasato Minami-ku, Sagamihara-city, Kanagawa prefecture, Japan
Tel
042-778-8273
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
15
Results
There was no significant difference in each evaluation item before and after taking the psychological education program.
Results date posted
| 2020 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
15 participants, 8 male, 7 female.
The average age was 68 years.
The standard deviation was 9.8
Participant flow
We provided information on a psychoeducational program to patients with dementia and their families who are visiting the psychiatric outpatient department of Kitasato University East Hospital. This study was explained to the family members and patients who wished to participate in the psychoeducational program, and after obtaining consent, they were targeted for this study.
Adverse events
None.
Outcome measures
Self-rating Depression Scale
Neuropsychiatric Inventory-Questionnaire
Zarit Burden Interview
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
