UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054489 |
|---|---|
| Receipt number | R000062241 |
| Scientific Title | Factors Predicting Clinical Outcomes in Older Adults Requiring Support and Care |
| Date of disclosure of the study information | 2024/05/27 |
| Last modified on | 2024/11/26 14:59:26 |
* 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
Factors Predicting Clinical Outcomes in Older Adults Requiring Support and Care
Acronym
Factors Predicting Clinical Outcomes in Older Adults Requiring Support and Care
Scientific Title
Factors Predicting Clinical Outcomes in Older Adults Requiring Support and Care
Scientific Title:Acronym
Factors Predicting Clinical Outcomes in Older Adults Requiring Support and Care
Region
| Japan |
Condition
Condition
Older adults requiring support or nursing care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine factors that predict exacerbating events such as hospitalization and ambulatory impairment in older adults who require support and nursing care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospitalization, walking disability, fall
Key secondary outcomes
Physical function: Short Physical Performance Battery, grip strength
Psychological state: Geriatric depression scale 5
Quality of life: EuroQol 5 dimensions 5-level
Activities of daily living: Barthel Index, Frenchay Activities Index
Physical activity: Accelerometer (sitting time, duration of light-, medium- and high-intensity physical activity, number of steps)
Cognitive function: Mini-Mental State Examination, Independence in daily living for older adults with dementia
Range of activities: Life space assessment
Social support: Social Support Scale, presence of physical activity-specific social support
Walkability: Walkscore
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Able to walk alone without walking aids.
Able to understand the content of the questionnaire.
Key exclusion criteria
Those who meet the Dohi-Anderson criteria for discontinuation of rehabilitation.
Those with a diagnosis of dementia or strong suspicion of dementia (Mini-Mental State Examination score of 23 or less).
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Takeda |
| Middle name | |
| Last name | Hiromichi |
Organization
Hokuriku University
Division name
Department of Physical Therapy, Faculty of Medical and Health Sciences
Zip code
920-1180
Address
1-1 Taiyougaoka, Kanazawa City, Ishikawa, Japn
TEL
076-229-6160
h-takeda@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeda |
| Middle name | |
| Last name | Hiromichi |
Organization
Hokuriku University
Division name
Department of Physical Therapy, Faculty of Medical and Health Sciences
Zip code
920-1180
Address
1-1 Taiyougaoka, Kanazawa City, Ishikawa, Japn
TEL
076-229-6160
Homepage URL
h-takeda@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokuriku University
Address
1-1 Taiyougaoka, Kanazawa City, Ishikawa, Japn
Tel
076-229-6160
h-takeda@hokuriku-u.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
医療法人田中外科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design:
Longitudinal study
method of recruitment of study participants:
Older adults requiring support and care who are using the cooperating facility will be recruited.
Assessment items will be measured once every 6 months, and the occurrence of events such as falls and hospitalization will be aggregated monthly.
Management information
Registered date
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062241
