UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062138 |
|---|---|
| Receipt number | R000071105 |
| Scientific Title | Longitudinal changes in home-based life-space, confidence in avoiding falls, activities of daily living, life satisfaction, patient global impression of change, and falls among users of home-visit rehabilitation: a single-center prospective practice-based registry study |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/04 12:41:50 |
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Basic information
Public title
Longitudinal changes in home-based life-space, confidence in avoiding falls, activities of daily living, life satisfaction, patient global impression of change, and falls among users of home-visit rehabilitation: a single-center prospective practice-based registry study
Acronym
A study of changes in daily life activities and falls among users of home-visit rehabilitation
Scientific Title
Longitudinal changes in home-based life-space, confidence in avoiding falls, activities of daily living, life satisfaction, patient global impression of change, and falls among users of home-visit rehabilitation: a single-center prospective practice-based registry study
Scientific Title:Acronym
Home-visit Rehabilitation Life-space Registry Study
Region
| Japan |
Condition
Condition
Community-dwelling users of home-visit rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to describe longitudinal changes in home-based life-space, activities of daily living, physical function, confidence in avoiding falls, life satisfaction, patient global impression of change, and falls among users of home-visit rehabilitation at our institution.
The primary outcome is the change in home-based life-space assessed by the Home-based Life-Space Assessment, Hb-LSA, from baseline to 6 months. We will also explore associations between changes in Hb-LSA and Barthel Index, grip strength, Functional Reach Test, single-item confidence in avoiding falls, single-item life satisfaction, Patient Global Impression of Change, and falls.
This prospective practice-based registry aims to provide fundamental data for improving assessment systems, goal setting, fall prevention, quality improvement of home-visit rehabilitation services, and future multicenter studies.
Basic objectives2
Others
Basic objectives -Others
Description and exploration of longitudinal changes and associated factors in life-related outcomes under usual home-visit rehabilitation practice
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the Home-based Life-Space Assessment, Hb-LSA, from baseline to 6 months.
The primary analysis will estimate longitudinal changes in Hb-LSA using repeated measurements at baseline, 3 months, and 6 months with a linear mixed-effects model.
Key secondary outcomes
Change in Hb-LSA from baseline to 12 months
Change in Barthel Index at 3, 6, 9, and 12 months
Change in grip strength at 3, 6, 9, and 12 months
Change in Functional Reach Test at 3, 6, 9, and 12 months
Change in single-item confidence in avoiding falls assessed using a 0-10 Numerical Rating Scale at 3, 6, 9, and 12 months
Change in single-item life satisfaction assessed using a 0-10 Numerical Rating Scale at 3, 6, 9, and 12 months
Patient Global Impression of Change at 3, 6, 9, and 12 months
Number of falls, proportion of fallers, proportion of recurrent fallers, and fall rate, falls per person-year, during 12 months
Injurious falls, medically attended falls, and fall-related hospitalizations during 12 months
All-cause hospitalizations, institutionalization, death, and termination of home-visit rehabilitation during 12 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Users of home-visit rehabilitation at the study institution, including those who newly start home-visit rehabilitation during the study period
Individuals living at home
Individuals for whom baseline assessment is partially or fully feasible
Individuals for whom neither the participant nor a proxy refuses the use of data for the study
Key exclusion criteria
Individuals for whom the participant or a proxy refuses the use of data for the study
Individuals for whom continued study assessment is considered clearly difficult due to terminal condition or similar reasons by the principal investigator or treating therapist
Individuals for whom study assessments are considered unsafe
Individuals judged by the principal investigator to be inappropriate for study inclusion
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Miyano |
Organization
Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
165-8906
Address
Egota 3-15-2, Nakano-ku, Tokyo
TEL
03-3387-5421
yu.kitaji@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kitaji |
Organization
Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
165-8906
Address
Egota 3-15-2, Nakano-ku, Tokyo
TEL
03-3387-5421
Homepage URL
https://www.tokyo-hospital.com/hospital/consent/
yu.kitaji@mt.strins.or.jp
Sponsor or person
Institute
Tokyo General Hospital
Institute
Department
Personal name
Yu Kitaji
Funding Source
Organization
Non
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
Tokyo General Hospital
Address
Egota 3-15-2, Nakano-ku, Tokyo
Tel
03-3387-5421
yu.kitaji@mt.strins.or.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
| 2026 | Year | 07 | Month | 06 | 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
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This is a single-center prospective longitudinal observational registry study of users of home-visit rehabilitation. The content, frequency, and duration of rehabilitation will not be assigned or modified for research purposes. Assessment data obtained under usual practice will be recorded prospectively.
Participants are community-dwelling users of home-visit rehabilitation at the study institution, including current users and new users during the study period. Data will not be used if the participant or a proxy refuses data use through the opt-out procedure.
Assessments will be conducted at baseline, 3, 6, 9, and 12 months. The primary outcome is change in Hb-LSA from baseline to 6 months. Secondary outcomes include Hb-LSA up to 12 months, Barthel Index, grip strength, Functional Reach Test, confidence in avoiding falls, life satisfaction, Patient Global Impression of Change, falls, fallers, injurious falls, medically attended falls, hospitalization, institutionalization, death, and termination of home-visit rehabilitation.
The primary analysis will estimate longitudinal change in Hb-LSA using a linear mixed-effects model. Falls will be recorded prospectively as much as possible using fall calendars and confirmation during home visits.
Management information
Registered date
| 2026 | Year | 07 | Month | 04 | Day |
Last modified on
| 2026 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071105
