| Eligibility |
| Age-lower limit |
|
| Age-upper limit |
|
| 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 |
| Email |
iwata.yuk.go@yokohama-cu.ac.jp |
| 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 |
|
UMIN-CTR Clinical Trial