UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056460 |
|---|---|
| Receipt number | R000064456 |
| Scientific Title | A single-arm feasibility study to examine the effects of ICT-based social prescribing with wellbeing coordinators on improving wellbeing in isolated older adults |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2024/12/14 21:12:25 |
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Basic information
Public title
A single-arm feasibility study to examine the effects of ICT-based social prescribing with wellbeing coordinators on improving wellbeing in isolated older adults
Acronym
A single-arm feasibility study to examine the effects of ICT-based social prescribing with wellbeing coordinators on improving wellbeing in isolated older adults
Scientific Title
A single-arm feasibility study to examine the effects of ICT-based social prescribing with wellbeing coordinators on improving wellbeing in isolated older adults
Scientific Title:Acronym
A single-arm feasibility study to examine the effects of ICT-based social prescribing with wellbeing coordinators on improving wellbeing in isolated older adults
Region
| Japan |
Condition
Condition
Hypertension, Dyslipidemia, Type 2 Diabetes Mellitus, Chronic Kidney Disease, Ischemic Heart Disease, and other Internal Medicine Conditions,As well as orthopedic diseases such as knee osteoarthritis and 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 collect preliminary information for planning a study protocol and sample size calculation, and to assess the feasibility of a large-scale study, which will examine the effects of ICT-based social prescribing with well-being coordinators on improving the well-being of socially isolated older adults.
Basic objectives2
Others
Basic objectives -Others
Feasibility study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Items related to the feasibility of a large-scale study: recruitment success rate, data collection compliance, acceptability of intervention methods, success rate of link workers in facilitating activities, and rate of obtaining blood test results.
Key secondary outcomes
Indicators necessary to assess the effectiveness and safety of the intervention: subjective well-being, physical activity levels, degree of frailty, degree of social isolation, general blood test values, facilitated community activities, satisfaction with ICT tools, 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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Social describing for 6 months with standard treatment
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) Aged 65 years or older.
2) Individuals meeting any of the following criteria for social isolation:
(a) Less than one contact per week with a person other than cohabitants.
(b) Living alone.
(c) Any other case where a physician deems the individual to be at high risk of social isolation.
3) Individuals with chronic diseases: internal diseases such as hypertension, dyslipidemia, type 2 diabetes, chronic kidney disease, ischemic heart disease, as well as orthopedic diseases such as knee osteoarthritis and low back pain.
4) Individuals who own a smartphone.
Key exclusion criteria
1) Individuals deemed to have communication difficulties due to cognitive impairment or hearing loss.
2) Any other individual whom the principal investigator deems unsuitable for participation in the study.
Target sample size
30
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, Hachioji-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
192-0395
Address
359, Otsuka, Hachioji-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
| 2024 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064456
