UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042648 |
|---|---|
| Receipt number | R000048349 |
| 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 |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2020/12/04 12:42:51 |
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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
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
yasutada.yamamoto1210@gmai.com
Sponsor or person
Institute
Graduate School of Kio University
Health Sciences Research Master Program
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048349
