UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052982 |
|---|---|
| Receipt number | R000060443 |
| Scientific Title | Stepped-Wedge Cluster Randomized Control Trial Examining the Usefulness of Patient-Reported Outcomes in Hospice Housing setting |
| Date of disclosure of the study information | 2023/12/03 |
| Last modified on | 2025/12/04 10:45:38 |
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Basic information
Public title
Stepped-Wedge Cluster Randomized Control Trial Examining the Usefulness of Patient-Reported Outcomes in Hospice Housing setting
Acronym
Stepped-Wedge Cluster Randomized Control Trial Examining the Usefulness of Patient-Reported Outcomes in Hospice Housing setting
Scientific Title
Stepped-Wedge Cluster Randomized Control Trial Examining the Usefulness of Patient-Reported Outcomes in Hospice Housing setting
Scientific Title:Acronym
Stepped-Wedge Cluster Randomized Control Trial Examining the Usefulness of Patient-Reported Outcomes in Hospice Housing setting
Region
| Japan |
Condition
Condition
All diseases
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether the routine use of Patient Reported Outcomes in hospice housing setting is useful in improving the quality of patient-provider communication and patient quality of life in a Stepped-Wedge randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Feeling Heard and Understood scale
Key secondary outcomes
EORTC-QLQ-C15PAL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use the Integrated Palliative Care Outcome Scale as a Patient Reported Outcome Scale upon admission to the facility and at the time of change in condition.
Interventions/Control_2
Standard care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients 20 years of age or older admitted to a participating facility in the study
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Miyashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7924
miya@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Miyashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7924
Homepage URL
miya@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Mitsunori Miyashita
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@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
| 2023 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060443
