UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062627 |
|---|---|
| Receipt number | R000071639 |
| Scientific Title | Development and Evaluation of an ICT-Based Support Model for Monitoring Older Adults: A Resident Co-creation Approach in Seiho District, Kurume City |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/19 23:27:54 |
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Basic information
Public title
A Study of Support for Older Adults Using ICT and Community Activities in Seiho District
Acronym
Seiho Support Study
Scientific Title
Development and Evaluation of an ICT-Based Support Model for Monitoring Older Adults: A Resident Co-creation Approach in Seiho District, Kurume City
Scientific Title:Acronym
Seiho ICT Support Study
Region
| Japan |
Condition
Condition
Loneliness, social isolation, and reduced social connectedness among community-dwelling older adults
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop an ICT-based support model that combines monitoring support with resident co-created community activities for community-dwelling older adults in Seiho District, Kurume City. It will evaluate the feasibility of the model and its effects on loneliness, mental well-being, and social networks. The study also aims to identify the characteristics of older adults at high risk of loneliness and social isolation and to explore effective social prescribing approaches according to individual characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the UCLA Loneliness Scale score from baseline to 6 months. Assessments will be conducted at baseline and at 1, 3, and 6 months, with 6 months designated as the primary assessment time point.
Key secondary outcomes
1. Changes in the WHO-5 Well-Being Index score from baseline to 1, 3, and 6 months.
2. Changes in the Lubben Social Network Scale-6 (LSNS-6) score from baseline to 1, 3, and 6 months.
3. Changes in the frequency of participation in community activities, conversations, and social interactions.
4. ICT use and the feasibility and acceptability of ICT-based monitoring support.
5. Change in the perceived burden score related to monitoring activities among community welfare commissioners from baseline to each assessment time point, assessed using study-specific questionnaire items.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A community-based intervention combining social prescribing and ICT-assisted monitoring support will be implemented for community residents, Minsei-iin community welfare volunteers, and individuals receiving monitoring support in the Seiho District of Kurume City.
Social prescribing activities will include health mahjong, social gatherings, health and daily-life consultations, smartphone consultations, and intergenerational community activities for children, adults, and older residents. Community residents will receive information and support to participate in these activities. For individuals receiving monitoring support, Minsei-iin community welfare volunteers and other community supporters will maintain communication through individual LINE messages, group-based information sharing, and voice or video calls as needed. The content and frequency of the intervention will be tailored to each participant's situation and preferences and will continue during the study period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Community residents aged 18 years or older who reside in the Seiho District of Kurume City, Minsei-iin community welfare volunteers or other community
supporters involved in monitoring activities in the district, or individuals receiving monitoring support
2.Individuals who have received information about the study and agreed to participate
3.Individuals who are able to complete questionnaires or participate in interviews
For the completely anonymous community resident survey, completion and submission of the questionnaire will be regarded as consent to participate.
Key exclusion criteria
Individuals meeting any of the following criteria will be excluded:
1.Individuals under 18 years of age
2.Individuals who are unable to understand the study or express their willingness to participate
3.Individuals who are unable to complete the questionnaire or participate in an interview because of their physical or psychological condition
4.Individuals who do not agree to participate in the study
5.Individuals considered unsuitable for participation by the principal investigator or a study investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | MICHIKO |
| Middle name | |
| Last name | NAITO |
Organization
Kurume University Medical Center
Division name
Primary and Community Health Care Centers
Zip code
839-0863
Address
155-1 Kokubu-machi, Kurume, Fukuoka 839-0863, Japan
TEL
0942-22-6111
hmichi@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | MICHIKO |
| Middle name | |
| Last name | NAITO |
Organization
Kurume University Medical Center
Division name
Primary and Community Health Care Centers
Zip code
839-0863
Address
155-1 Kokubu-machi, Kurume, Fukuoka 839-0863, Japan
TEL
0942-22-6111
Homepage URL
hmichi@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Medical Center
Institute
Department
Personal name
NAITO MICHIKO
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
NONE
Name of secondary funder(s)
NONE
IRB Contact (For public release)
Organization
Ethics Committee of Kurume University School of Medicine
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
Tel
0942-65-3749
i_rinri@kurume-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
久留米大学医療センター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 19 | 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 | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071639
