UMIN-CTR Clinical Trial

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
Email	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
Email	shinji.hattori@ihep.jp

Sponsor
Institute	Institute for Health Economics and Policy
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035759