UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between social networks and social capital and physical frailty among community-dwelling older adults in a self management group: a cross-sectional study
Acronym	The relationship between social networks and social capital and physical frailty among community-dwelling older adults in a self management group: a cross-sectional study
Scientific Title	The relationship between social networks and social capital and physical frailty among community-dwelling older adults in a self management group: a cross-sectional study
Scientific Title:Acronym	The relationship between social networks and social capital and physical frailty among community-dwelling older adults in a self management group: a cross-sectional study
Region	Japan

Condition
Condition	Frail
Classification by specialty	Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The impact of different degrees of social networks and social capital in community-dwelling older people's commuting places on frailty has not been determined. For this reason, this study will examine the relationship between the prevalence of frailty and social networks and social capital among older adults living in the community who are socially involved in commuting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frail (J-CHS) is measured once at the time of measurement. Classify it as robust, pre-frail or frail.We also measure social networks and social capital as independent variables once at the time of measurement.
Key secondary outcomes

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	1) Seniors aged 65 years and older who are able to fill out a self-administered questionnaire 2) Those who are able to fill out the self-administered questionnaire 3) Those who are able to walk on their own
Key exclusion criteria	1) People with health problems such as Alzheimer's disease, Parkinson's disease and depression 2) Those with difficulty in understanding instructions 3) Those with missing data on exclusion criteria 4) Those who need assistance with the basic daily living level 5) A person who has not obtained consent from the patient or the patient's family
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Yasutada Middle name Last name Yamamoto
Organization	Graduate School of Kio University
Division name	Health Sciences Research Master Program
Zip code	635-0832
Address	4-2-2 Umaminaka, Hiroyo-cho, Kitakudajo-gun, Nara
TEL	0745-54-1601
Email	yasutada.yamamoto1210@gmai.com

Public contact
Name of contact person	1st name Yasutada Middle name Last name Yamamoto
Organization	Graduate School of Kio University
Division name	Health Sciences Research Master Program
Zip code	635-0832
Address	4-2-2 Umaminaka, Hiroyo-cho, Kitakudajo-gun, Nara
TEL	0745-54-1601
Homepage URL
Email	yasutada.yamamoto1210@gmai.com

Sponsor
Institute	Graduate School of Kio University Health Sciences Research Master Program
Institute
Department

Funding Source
Organization	Graduate School of Kio University Health Sciences Research Master Program
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Shouwakai Takarazuka Rehabilitation Hospital
Address	22-2 Tsurunoso, Takarazuka City, Hyogo
Tel	0797-81-2345
Email	yasutada.yamamoto1210@gmail.com

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	2020 Year 12 Month 10 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	2019 Year 12 Month 10 Day
Date of IRB	2020 Year 10 Month 15 Day
Anticipated trial start date	2020 Year 09 Month 15 Day
Last follow-up date	2022 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Inspection and measurement items Japanese CHS Criteria (J-CHS), Social Network (Sociometric Survey Methodology; (Opinion Leader (OL))), Social Capital (Health Related-Community Social Capital (HR-CSC)), Basic Attributes (Age, Gender, and (BMI), residential area (old village area, new residential area), number of people and years of living together, occupation, exercise adherence, Physical Activity Scale for the Elderly (PASE), Short Physical Performance Battery (SPPB), and sleep status The level of care required, history, A D L (Index of Ability to Engage in Activities of the Elderly, JST), number of years since the establishment of the commuting place, frequency of holding the meeting, and other number of social activities and the type of participation.

Management information
Registered date	2020 Year 12 Month 04 Day
Last modified on	2020 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048349