UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055326 |
|---|---|
| Receipt number | R000063223 |
| Scientific Title | Association between social prescribing and life functioning in community-dwelling older people on outpatient visits, originating from a nursing university |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/02/23 15:40:35 |
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Basic information
Public title
Implementation of social prescription starting from a nursing university to improve the life functions of elderly people living in the community during outpatient visits
Acronym
Implementation of social prescription starting from a nursing university to improve the life functions of elderly people living in the community during outpatient visits
Scientific Title
Association between social prescribing and life functioning in community-dwelling older people on outpatient visits, originating from a nursing university
Scientific Title:Acronym
Association between social prescribing and life functioning in community-dwelling older people on outpatient visits, originating from a nursing university
Region
| Japan |
Condition
Condition
Hypertension, Dyslipidemia, Type2 Diabetes, CKD, Ischemic heart disease, Osteoarthritis, Low back pain
Classification by specialty
| Medicine in general | Geriatrics | Orthopedics |
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this pilot study is to elucidate foundational information preceding a large-scale study aimed at verifying the hypothesis that the practice of social prescribing, which connects research collaborating medical institutions with citizen activities, improves physical functions in older adults at high risk of social isolation.
Basic objectives2
Others
Basic objectives -Others
Pilot study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes related to feasibility (successful rate of subject recruitment, study participation period, data collection compliance, acceptability of intervention method, blood test result acquisition rate, intraclass correlation in clusters)
Key secondary outcomes
Indicators related to evaluation of intervention effectiveness and safety (degree of loneliness, degree of frailty, degree of depression, walking speed, posture evaluation, general attributes, blood test results, adverse events, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Standard care plus 6 months of social prescribing
Interventions/Control_2
Standard 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
1. Persons with a current medical history of hypertension, dyslipidemia, type II diabetes, chronic renal dysfunction, ischemic heart disease, knee osteoarthritis, or orthopedic disease such as low back pain.
2. Persons who can participate in group walks.
3. Persons currently attending outpatient clinics at participating facilities.
4. Persons who have face-to-face or non-face-to-face interactions with people other than those living in their household less than once a week
Key exclusion criteria
1. Persons with a history of hospitalization due to an underlying disease within the past six months or whose underlying disease is poorly controlled.
2. Persons who need to limit their physical activity.
3. Persons who do not have cognitive decline that would limit their activities based on clinical judgment.
4. Any other person the research director judges as inappropriate as a research subject.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masumi |
| Middle name | |
| Last name | Takei |
Organization
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES.
Division name
Nursing Faculty
Zip code
247-0066
Address
1195-3 Yamasaki, Kamakura, Kanagawa
TEL
0467383101
m.takei@sku.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Takei |
Organization
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES.
Division name
Nursing Faculty
Zip code
247-0066
Address
1195-3 Yamasaki, Kamakura, Kanagawa
TEL
0467383101
Homepage URL
m.takei@sku.ac.jp
Sponsor or person
Institute
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES
Institute
Department
Personal name
Funding Source
Organization
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES
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
Shonan Kamakura University of Medical Sciences of Research Ethics Committee
Address
1195-3 Yamasaki, Kamakura, Kanagawa
Tel
0467383101
kenkyurinri@sku.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
| 2024 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063223
