UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047158 |
|---|---|
| Receipt number | R000053683 |
| Scientific Title | Social Prescribing for Elderly at High Risk for Social Isolation: A Cluster Non-Randomized Parallel Comparative Pilot Study |
| Date of disclosure of the study information | 2022/03/12 |
| Last modified on | 2024/10/08 16:22:45 |
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Basic information
Public title
Effectiveness, acceptability, and feasibility of a link worker-led social prescription to increase walking steps for community-dwelling older adults: A pilot Study
Acronym
Effectiveness, acceptability, and feasibility of a link worker-led social prescription to increase walking steps for community-dwelling older adults: A pilot Study
Scientific Title
Social Prescribing for Elderly at High Risk for Social Isolation: A Cluster Non-Randomized Parallel Comparative Pilot Study
Scientific Title:Acronym
Effectiveness, acceptability, and feasibility of a link worker-led social prescription to increase walking steps for community-dwelling older adults: A pilot Study
Region
| Japan |
Condition
Condition
Hypertension, Dyslipidemia, Type2 Diabetes, CKD, Ischemic heart disease, Osteoarthritis, Low back pain
Classification by specialty
| Medicine in general | Geriatrics | Orthopedics |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that social prescribing increases physical activity among elderly at high risk of social isolation, we plan a large cluster-randomized study in the future.
The aim of this pilot study is to measure variables for sample size calculation and to assess the feasibility of the cluster-randomized study.
Basic objectives2
Others
Basic objectives -Others
Pilot study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Items related to feasibility in a large-scale study (e.g. percentage of successful recruitment, compliance with data collection, etc.)
Key secondary outcomes
Indicators needed to assess the effectiveness and safety of the intervention (e.g. physical activity, degree of frailty, degree of social isolation, level of well-being, mediated community activities, adverse events, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Social prescribing for 6 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Over 65 years old
2) With one or more of the following medical conditions: hypertension, dyslipidemia, type 2 diabetes, chronic kidney disease, ischemic heart disease
osteoarthritis, and low back pain
3) Regular outpatient visits at the participating clinics
4) Less than once a week face-to-face or non-face-to-face interaction with someone other than the person living with them
Key exclusion criteria
1) With a history of hospitalization for an underlying medical condition within the past six months or with poor control of the underlying medical condition
2) Necessity to limit their physical activity
3) Have not been vaccinated for COVID-19
4) Due to cognitive dysfunction, difficult to assess the relationship between social prescriptions and physical activity
5) Due to underlying disease or dependency, judged as not-appropriate for their participations by primary physician or specialist based on the relevant academic society guidelines
6) Judged by the principal investigator as not-appropriate as the research subjects of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Sato |
Organization
Teikyo University
Division name
Faculty of Medical Technology
Zip code
192-0395
Address
359, Otsuka, IHachioji-shi, Tokyo
TEL
0120-508-739
shinjisato2005hawaii@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Sato |
Organization
Teikyo university
Division name
Faculty of Medical Technology
Zip code
173-8605
Address
359, Otsuka, IHachioji-shi, Tokyo
TEL
0120-508-739
Homepage URL
shinjisato2005hawaii@yahoo.co.jp
Sponsor or person
Institute
Teikyo university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo university Integrated Research Ethics Board
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
Tel
03-3964-1211
turb-office@teikyo-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
| 2022 | Year | 03 | Month | 12 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053683
