UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042463 |
|---|---|
| Receipt number | R000048471 |
| Scientific Title | Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2022/11/18 11:00:52 |
* 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
Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: a cluster randomized controlled trial
Acronym
Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury
Scientific Title
Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: a cluster randomized controlled trial
Scientific Title:Acronym
Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury
Region
| Japan |
Condition
Condition
family caregivers of individuals with acquired brain injury
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to develop the web based program for life change adaptation in family caregivers of individuals with ABI and examine its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The life change adaptation scale(LCAS) (Shindo & Tadaka, 2020)
Key secondary outcomes
The Multidimensional Scale of Perceived Social Support (MSPSS)(Iwasa et al., 2007)
The Positive Appraisal of Care scale (PAC)(Yamamoto-Mitani et al., 2001; Yamamoto et al., 2002)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group was assigned the web-based program to promote the life change adaptation in addition to a routine family group activities.
Interventions/Control_2
The control group followed only routine family group activities.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study`s inclusion criteria for family associations as follows:
1.A family association aim at supporting the families of individuals with acquired brain injury (ABI) in the community, 2.The establishment of a family association is open to the public, 3.More than 15 members. 4.Understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.
The study`s inclusion criteria for family caregivers as follows:
1.older than 19 years, 2.having relatives of a family with an individual with ABI , 3.the individual with ABI have be evaluated from a doctor, and 4.It is judged by the family association manager that it is possible to participate in this study, 5.Understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.
Key exclusion criteria
The following exclusion criteria also had to be met for family associations: 1.A family association do not aim at supporting the families of individuals with acquired brain injury (ABI) in the community, 2.The establishment of a family association is not open to the public, 3.More than 15 members. 4.Do not understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.
The following exclusion criteria also had to be met for family caregivers:
1.younger than 19 years, 2.Not having relatives of a family with an individual with ABI , 3.the individual with ABI have not be evaluated from a doctor, and 4.It is not judged by the family association manager that it is possible to participate in this study, 5.Do not understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | IWATA |
Organization
School of Medicine, Yokohama City University
Division name
Department of Community Health Nursing
Zip code
236-0004
Address
3-9, Hukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872973
iwata.yuk.go@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | IWATA |
Organization
School of Medicine, Yokohama City University
Division name
Department of Community Health Nursing
Zip code
236-0004
Address
3-9, Hukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872973
Homepage URL
iwata.yuk.go@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Community Health Nursing, School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Department of Community Health Nursing, School of Medicine, Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Community Health Nursing, School of Medicine, Yokohama City University
Address
3-9, Hukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
0457872973
iwata.yuk.go@yokohama-cu.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
| 2020 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0273278
Number of participants that the trial has enrolled
240
Results
Results indicated that the LCAS improved significantly in the intervention group in the whole study period(P<0.001). Especially, at each measurement time, the intervention group had better performances in the life change adaptation than control group.
Results date posted
| 2021 | Year | 11 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 08 | Month | 18 | Day |
Baseline Characteristics
Participants were families of individuals with ABI of associations for families of individuals with ABI in Japan.
Participant flow
All the 82 associations for families of individuals with ABI in Japan invited in this study. Though, we excluded any association with fewer than 15 members (6 clusters) or unspecified members (43 clusters). Of the 18 eligible associations, studies conducted in 16 randomly selected associations were performed based on anticipation following: the required cluster size was 8 associations for each group.Before randomization assigned to two groups, a stratified randomization was adopted to reduce an unequal number of individuals which may be assigned to each arm of the study and performed based on the median cluster size 45 in eligible cluster. Then potential participants were randomly assigned to two groups (ratio=1:1): 8 associations in the intervention group (n= 120) and 8 associations in the control group (n=120). The associations mailed potential participants sequential invitation to express an interest in joining the study, of which 50 in each group expressed their participation in the study.
A total of 62 participants completed the study (retention rate: 25.8%): 9 participants withdrew by the three days interval (intervention group n = 9; control group n = 0) and 24 participants withdrew by the end of the month interval (intervention group n = 10; control group n = 14).
Adverse events
N/A
Outcome measures
Primary outcome: The Life change adaptation scale (LCAS) was used to measure the life change adaptation.
Secondary outcome: The Multidimensional Scale of Perceived Social Support (MSPSS) Japanese version to measure perceived social support.
The Positive Appraisal of Care scale (PAC) to measure positive appraisal of care.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048471
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
