UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033697 |
|---|---|
| Receipt number | R000038423 |
| Scientific Title | Measuring the effects of group education on families of people with dementia |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2022/08/13 10:25:39 |
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Basic information
Public title
Measuring the effects of group education on families of people with dementia
Acronym
Measuring the effects of group education on families of people with dementia
Scientific Title
Measuring the effects of group education on families of people with dementia
Scientific Title:Acronym
Measuring the effects of group education on families of people with dementia
Region
| Japan |
Condition
Condition
Family caregivers of people with dementia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and to put into practice disease education and psychotherapy program targeting caregivers of people with dementia. To collect basic data on the effect of the program on participants and lead to an improvement of the program and a new study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Depressive symptoms of family caregivers of people with dementia(PHQ-9)
Key secondary outcomes
Effectiveness Evaluation
1. care burden on the family caregivers(ZBI-J)
2. psychological variable of the family caregivers(QOL)
3. Behavioral and Psychological Symptoms of Dementia(BPSD) in patients with dementia(NPI-Q)
Feasibility Evaluation
1. Drop out rate
2. Adverse event rate
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
| Maneuver |
Interventions/Control_1
Group program(90 minutes, 5 sessions)
Contents of the program; psychoeducation about dementia, caregiver stress and the way of managing it, cognitive behavioral therapy, the way of utilizing social resources, the way of communicating with people with dementia.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those who aged between 20 and 89, inclusive.
2.Those who spend their time with families diagnosed with dementia more than ten hours a week.
3.Those who have no communication problem in Japanese(listening, speaking, writing, or reading).
Key exclusion criteria
1.Those who score 23 points or less of MMSE.
2.Those who are diagnosed with schizophrenia, substance use disorder, or organic mental disorder.
3.Those who are given less than one year to live due to cancer or other diseases.
4.Those who are deemed to have difficulty in participating by the researcher due to other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tajima |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL
042-341-2712
mtajima@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Tajima |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL
042-341-2712
Homepage URL
mtajima@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
intramural research grant for neurological and psychiatric disorders of NCNP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel
042-341-2712
mtajima@ncnp.go.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
| 2018 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://mol.medicalonline.jp/library/archive/search?jo=aj2rsizd&ye=2021&vo=32&issue=2&UserID=131.113
Publication of results
Published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/archive/search?jo=aj2rsizd&ye=2021&vo=32&issue=2&UserID=131.113
Number of participants that the trial has enrolled
23
Results
A total of 23 participants took part in the five session course, with the participants attending an average of 4.13 sessions.The participants'mean age was 65.74 years.Among the participants aged 75 years and younger, significant main effects were found with J-ZBI scores and the Personal Strain score. When compared to the pre-intervention group, the post-intervention group showed a moderate effect size on the J-ZBI total, Personal Strain, Role Strain, and Neuropsychiatric Inventory Questionnaire scores.
Results date posted
| 2022 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Key inclusion criteria
1.Those who aged between 20 and 89, inclusive.
2.Those who spend their time with families diagnosed with dementia more than ten hours a week.
3.Those who have no communication problem in Japanese(listening, speaking, writing, or reading)
Key exclusion criteria
1.Those who score 23 points or less of MMSE.
2.Those who are diagnosed with schizophrenia, substance use disorder, or organic mental disorder.
3.Those who are given less than one year to live due to cancer or other diseases.
4.Those who are deemed to have difficulty in participating by the researcher due to other reasons.
Participant flow
The physician gave the leaflet to the family caregivers. Family caregivers were interviewed by the study investigator to explain the study and confirm eligibility criteria. After obtaining research consent, a baseline survey was conducted to collect background information and psychological assessment.
Adverse events
No
Outcome measures
Primary outcomes
Depressive symptoms of family caregivers of people with dementia(PHQ-9)
Effectiveness Evaluation
1. care burden on the family caregivers(ZBI-J)
2. psychological variable of the family caregivers(QOL)
3. Behavioral and Psychological Symptoms of Dementia(BPSD) in patients with dementia(NPI-Q)
Feasibility Evaluation
1. Drop out rate
2. Adverse event rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038423
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
