UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043882 |
|---|---|
| Receipt number | R000050108 |
| Scientific Title | Ancillary Study on "Integrating specialist palliative care into residential care for older people: a stepped wedge trial (INSPIRED trial)": "Design and analysis of stepped wedge cluster randomized controlled trial using recurrent event data" |
| Date of disclosure of the study information | 2021/04/09 |
| Last modified on | 2025/07/14 17:10:32 |
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Basic information
Public title
Ancillary Study on "Integrating specialist palliative care into residential care for older people: a stepped wedge trial (INSPIRED trial)": "Design and analysis of stepped wedge cluster randomized controlled trial using recurrent event data"
Acronym
Ancillary Study on INSPIRED trial
Scientific Title
Ancillary Study on "Integrating specialist palliative care into residential care for older people: a stepped wedge trial (INSPIRED trial)": "Design and analysis of stepped wedge cluster randomized controlled trial using recurrent event data"
Scientific Title:Acronym
Ancillary Study on INSPIRED trial
Region
| Japan |
Condition
Condition
Residents in Australian care homes for older people
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Organize and evaluate the methodology of design and analysis of stepped wedge cluster randomized controlled trial using recurrent event data for "time to repeated hospitalization" collected in INSPIRED trial, through the application of existing analysis methods and Monte Carlo simulations, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to hospital admission
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of the subjects on the electronic data (anonymized) collected in "Integrating specialist palliative care into residential care for older people: a stepped wedge trial (INSPIRED trial)" (ANZCTR: ACTRN12617000080325), all subjects who were included in the statistical analysis in the results reporting paper are considered eligible.
Key exclusion criteria
According to INSPIRED trial.
Target sample size
1700
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Biostatistics
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Oyamada |
Organization
JORTC Data Center
Division name
Department of Biostatistics
Zip code
116-0013
Address
2-54-6-302 Nishi-Nippori, Arakawa-ku, Tokyo
TEL
03-5604-9850
Homepage URL
shunsuke.oyamada@jortc.jp
Sponsor or person
Institute
Division of Biostatistics, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
- Faculty of Social Sciences, University of Stirling
- College of Business & Economics, Australian National University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2021 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-022-01552-6
Number of participants that the trial has enrolled
1700
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 26 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since the co-sponsors have already completed the main trial of this ancillary study, "Anticipated trial start date" and "Last follow-up date" are entered as "Scheduled date of data provision from the co-sponsors" and "Scheduled date of this ancillary study completion," respectively.
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050108
