UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057461 |
|---|---|
| Receipt number | R000065655 |
| Scientific Title | Investigation of the Relationship between Social Participation Self-Efficacy and Rest-Activity Rhythm in Elderly People with Social Frailty |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/31 15:11:15 |
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Basic information
Public title
The impact of social connectedness on health: perspectives on self-efficacy and life rhythm in the elderly.
Acronym
The impact of social connectedness on health: perspectives on self-efficacy and life rhythm in the elderly.
Scientific Title
Investigation of the Relationship between Social Participation Self-Efficacy and Rest-Activity Rhythm in Elderly People with Social Frailty
Scientific Title:Acronym
Investigation of the Relationship between Social Participation Self-Efficacy and Rest-Activity Rhythm in Elderly People with Social Frailty
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the relationship between socially frail older adults and the Rest-Activity Rhythm (RAR) construct, with social participation self-efficacy as an intermediate mediator.
Basic objectives2
Others
Basic objectives -Others
In this study, we utilize an intermediate mediation model to estimate how social participation self-efficacy affects the already reported model of rhythm stability and social frailty as an intermediate mediator.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social Self-Efficacy Scale for Socially Frail Elderly
Key secondary outcomes
(1) Basic information
Gender, age, medical history, comorbidities, medications, Body Mass Index (BMI), years of education, physical frailty measurements (weight loss, muscle weakness, fatigue, walking speed, and physical inactivity) using the Japanese version of the Cardiovascular Health Study criteria (J-CHS criteria), cognitive function measurements using the National Center for Geriatrics and Gerontology functional assessment tool (NCGG-FAT), and the Geriatric depression scale ), cognitive function measures using the National Center for Geriatrics and Gerontology functional assessment tool (NCGG-FAT), the Geriatric depression scale-15 (GDS-15), the Geriatric depression scale (GDS-15), the National Center for Geriatrics and Gerontology functional assessment tool (NCGG-FAT). (2) Rest-Activity (1) Cognitive function (2) Social frailty (3) Social depression (4) Social frailty (5) Social depression (6) Social depression (7) Social frailty (8) Social depression (9) Social frailty (10) Social depression (11) Social depression (12) Social depression (13) Social frailty (14)
(2) Measurement of Rest-Activity Rhythm (RAR) index
A wearable device, Motionwatch8 (CamNtech, UK), will be used to measure the number of steps taken in daily life and the amount of sleep at night. Each subject wears the wearable device on the non-dominant hand for 7 consecutive days, and Motionwatch8 is worn on the wrist of the non-dominant hand for 7 consecutive days. Body movements are detected by the device's built-in 3-axis acceleration sensor, and Activity Count (AC) is recorded for each minute of physical activity. The recorded data are then output using analysis software Motionware (CamNtech, UK) and Actiware (Philips, USA), and converted into RAR indices.
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) Subjects residing in the region who are publicly recruited between the date of approval by the head of the research institution and March 31, 2027
(2) Subjects who can obtain written consent from the individual to participate in the research of their own free will
(3) Subjects who are 65 years of age or older at the time consent is obtained
Key exclusion criteria
(1) Those with severe motor dysfunction, social frailty and difficulty in performing physical and mental function assessment
(2) Those with strong psychiatric symptoms and significant cognitive dysfunction
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kume |
Organization
Akita University
Division name
Graduate School of Medicine
Zip code
010-8543
Address
Hondo1-1-1, Akita city
TEL
0188846556
kume.yuu@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kume |
Organization
Akita university
Division name
Health Sciences
Zip code
010-8543
Address
Hondo 1-1-1, Akita city
TEL
0188846556
Homepage URL
kume.yuu@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Yu Kume
Funding Source
Organization
Akita University
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
Akita University
Address
Hondo 1-1-1, Akita city
Tel
0188846556
kume.yuu@hs.akita-u.ac.jp
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
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Self-efficacy for Social Participation scale (SOSA), a measure of self-efficacy for social participation among community-dwelling elderly reported in 2023, will be used as an assessment instrument in this study. The scale is classified into four categories: instrumental self-efficacy, economic self-efficacy, interpersonal self-efficacy, and cultural self-efficacy, and consists of three sub-items each, for a total of 12 items. Each item is self-rated on a scale of 0 to 3 (0: not at all confident, 3: very confident), for a total score ranging from 0 to 36. The higher the score, the higher the social participation self-efficacy is rated. Motionwatch8 is worn on the wrist of the subject's non-dominant hand for 7 consecutive days, and its built-in 3-axis acceleration sensor detects body movements and records Activity Count (AC) per minute as physical activity. The degree of social participation is also measured as an index of social participation. Regarding the relationship between social frailty and RAR, which is graded as one indicator of the degree of social participation, a previous study by Kume et al. (2023) showed a relationship between rhythm stability, one of the RAR indicators, and the maintenance and improvement of social frailty8). Therefore, this study will utilize an intermediate mediation model to estimate how social participation self-efficacy affects the already reported model between rhythm stability and social frailty as an intermediate mediator.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065655
