UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031329 |
|---|---|
| Receipt number | R000035759 |
| Scientific Title | Evaluation of effectiveness of preventive rehabilitation programs for the frail elderly utilizing expertize of physical therapist in care prevention and daily life support local initiatives operated by Neyagawa city in Osaka, targeting (1) improving physical and oral functions, nutritive conditions, (2) regaining social roles and participation, and thus (3) continuing self-supported daily life without relying on public care insurance afterward. |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2019/07/12 20:20:18 |
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Basic information
Public title
Evaluation of effectiveness of preventive rehabilitation programs for the frail elderly utilizing expertize of physical therapist in care prevention and daily life support local initiatives operated by Neyagawa city in Osaka, targeting (1) improving physical and oral functions, nutritive conditions, (2) regaining social roles and participation, and thus (3) continuing self-supported daily life without relying on public care insurance afterward.
Acronym
Evaluation of effectiveness of preventive rehabilitation programs for the frail elderly by physical therapist
Scientific Title
Evaluation of effectiveness of preventive rehabilitation programs for the frail elderly utilizing expertize of physical therapist in care prevention and daily life support local initiatives operated by Neyagawa city in Osaka, targeting (1) improving physical and oral functions, nutritive conditions, (2) regaining social roles and participation, and thus (3) continuing self-supported daily life without relying on public care insurance afterward.
Scientific Title:Acronym
Evaluation of effectiveness of preventive rehabilitation programs for the frail elderly by physical therapist
Region
| Japan |
Condition
Condition
the frail elderly publicly certified for support need
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The shor-term(14 weeks) intensive rehabilitation program utilizing expertize of therapist in care prevention and daily life support local initiatives, introduced in FY2015 by the amendment of the care insurance system nationwide, is intended to serve as an effective approach for the frail elderly to continue self-supported daily life without relying on public care insurance.
In spite of its political intention, an effectiveness of the program has not been verified through scentific approach so far, and an essence and know-how of the program has not yet given a chance to be crystarized explicitly in the form that nation as a whole can benefit.
Therefore, this research, targeting the frail elderly publicly certified for support need in Neyagawa city (population: approx. 240,000 people, aging rate: 28%) in Osaka, will examine whether the difference of the conditions between those who get through the shor-term intensive rehabilitation program and those who only use care and support services as usual is statistically significant and can explain positive impact on continuing self-supported daily life without relying on public care insurance afterward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of not using public care and support services for the frail elderly for the period of 12 weeks after the end of intervention
Key secondary outcomes
Evaluate the following items in parallel with the primary outcomes;
- QOL of health conditions (EQ - 5D - 5L)
- IADL (the Tokyo Metropolitan Institute of Gerontology- TMIG Index of Competence; independence of instrumental activities, intellectual activities, social role)
- Depression symptoms (Geriatric depression scale-GDS)
- Physical function (Grip Strength, Time Up&Go Test, 5-Meter Walking Test, Berg Balance Scale-BBS) etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Implementation of short-term intensive rehabilitation program(17 sessions in total);
Preparatory period (until Mar 1st, 2018):
session 1 - assessment by visiting subject's house
session 2 - initial survey & measurement
session 3 - initial meeting to build consensus of care management policy
Intervention period (Start from May 7th 2018) :
session 4-15 - program executions (two hours each weekly for 3 months)
session 16 - review meeting to judge outcomes of program
session 17 - wrap-up & commencement for social paricipation
Overview of the program;
On-site programs
(1) Social participation program (including trial interactions with social resources in the real world)
(2) IADL and ADL program
(3) Education of care prevention
(4) Self-care-management program
(5) Mobility improvement program
(6) Oral function and nutritive condition improvement program
(7) Other programs beneficial for improving daily activities
Off-site(Visiting) supports
(1) Assessment of daily activities at the places and environments where subjects go around actually.
(2) Guidance on daily activities based on the assessments above.
(3) Advice on how to get the most out of social resources and tools including welfare equipments
Interventions/Control_2
Care and support services for the frail elderly other than short term intensive rehabilitation program
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Meeting all of the following criteria;
- Being 65 years and older
- Being certified for support need
- (1) Now using or (2) having intention to use any care and support services for the frail elderly
Key exclusion criteria
Meeting any of the following criteria:
- Patients with terminal cancer
- Patients with dementia(above a certain level)
- Patients with intractable diseases
- Those who are being judged that short-term intensive rehabilitation program is not suitable due to their physical and mental conditions based on the initial assessments by professional care managers
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Hattori |
Organization
Institute for Health Economics and Policy
Division name
Institute for Health Economics and Policy, Research Department
Zip code
Address
No.11 Toyo-kaiji Bldg, 1-5-11, Nishi-Shimbashi, Minato-ku, Tokyo,105-0003 Japan
TEL
03-3506-8529
shinji.hattori@ihep.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Hattori |
Organization
Institute for Health Economics and Policy
Division name
Institute for Health Economics and Policy, Research Department
Zip code
Address
No.11 Toyo-kaiji Bldg, 1-5-11, Nishi-Shimbashi, Minato-ku, Tokyo,105-0003 Japan
TEL
03-3506-8529
Homepage URL
shinji.hattori@ihep.jp
Sponsor or person
Institute
Institute for Health Economics and Policy
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Neyagawa City, Osaka
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪府寝屋川市
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 01 | 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
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035759
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
