UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and effects of preventive home visit program among ambulatory frail older people living at home
Title of the study (Brief title)	Development and effects of preventive home visit program among frail older people living at home
Region	Japan

Condition
Condition	Support Level 1 or 2 certified by the Japanese Long-Term Care Insurance system
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop and examine the effects of a strucutured preventive home visit program.
Basic objectives2	Others
Basic objectives -Others	To examine the difference of the effects of the preventive home visit program according to ADLs
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	ADLs Functional Capacity Social activities-related daily life satisfaction Metamemory:capacity Depression Self-efficay of health promotion
Key secondary outcomes	Long-term care utilization

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Providing home visits once per 3-months for 2-years conducted by care managers or nurses in community-based comprehensive care centers, including structured comprehensive assessments and recommendations to participants
Interventions/Control_2	Providing usual 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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Living at home. Certified as Support Level 1 or 2 by the Long-Term Care Insurance System at baseline. Being Clients the community- based comprehensive care centers participated in the projects. Having informed consent.
Key exclusion criteria	Being at hospital or institutionalized at baseline.
Target sample size	360

Research contact person
Name of lead principal investigator	Ayumi Kono
Organization	Osaka City University
Division name	School of Nursing
Address	1-5-17 Asahi, Abeno, Osaka
TEL	06-6645-3540
Email

Public contact
Name of contact person	Ayumi Kono
Organization	Osaka City University
Division name	School of Nursing
Address	1-5-17 Asahi, Abeno, Osaka
TEL	06-6645-3540
Homepage URL
Email	ayukono@nurs.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science: Kiban-B
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Osaka Prefecture University Konan Women's University Oklahoma University
Name of secondary funｄer(s)

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	大阪府岬町・岬町地域包括支援センター 大阪府泉南市・泉南市地域包括支援センター 大阪府大東市・大東市地域包括支援センター

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 30 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2015 Year 01 Month 31 Day
Date of closure to data entry	2015 Year 01 Month 31 Day
Date trial data considered complete	2015 Year 01 Month 31 Day
Date analysis concluded	2016 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 10 Month 04 Day
Last modified on	2017 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007671