UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058798 |
|---|---|
| Receipt number | R000067233 |
| Scientific Title | Development and Evaluation of an Intergenerational Peer Support WEB (Gen-peer) Program for Working Carers of People with Dementia by Older Adults with Caregiving Experience: A Pilot Test |
| Date of disclosure of the study information | 2025/08/14 |
| Last modified on | 2025/08/13 18:42:23 |
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Basic information
Public title
A Pilot Test for GenPeer, an Online Exchange Program Connecting Working Family Carers of People with Dementia and Experienced Older Carers for Mutual Support
Acronym
GenPeer-Pilot test
Scientific Title
Development and Evaluation of an Intergenerational Peer Support WEB (Gen-peer) Program for Working Carers of People with Dementia by Older Adults with Caregiving Experience: A Pilot Test
Scientific Title:Acronym
GenPeer-Pilot Test
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a prototype of the Intergenerational Peer Support Web (GenPeer) Program, in which experienced older peer carers provide support to working carers of people with dementia, and to conduct a preliminary investigation to assess the program's validity and feasibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Care Burden (Assessment Points: Baseline, Post Intervention, and One Month Post-Intervention)
Key secondary outcomes
Self-efficacy, Social support, and Health-related Quality of Life (Assessment Points: Baseline, Post Intervention, and One Month Post-Intervention)
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
| Other |
Interventions/Control_1
Participants in the study will receive a two-week intervention through the GenPeer Program, which consists of the Good Things Diary and Peer Support. This program pairs working family carers - those balancing employment and caregiving responsibilities - with older peer carers who have experience caring for people with dementia, in a one-to-one format. It is a non-face-to-face, language-based exchange program that provides psychological support through diary-based records and responses grounded in caregiving experience. Before the intervention begins, participants will access a dedicated website explaining the purpose, methods, and key points of the Good Things Diary to ensure they understand how to complete it. They will then use the official LINE account's chat function to submit free-text entries describing things they felt good about while caregiving, moments they wanted to praise themselves for, or things that went well in caregiving. These submissions will be shared with their assigned older peer carer, who will respond with empathetic and positive messages based on their own caregiving experience. Responses will primarily include expressions that encourage awareness and positive emotions, and may also provide caregiving tips or words of encouragement as appropriate.
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged between 20 and 64 at the start of the study
Currently employed in a full-time position
Serving as the primary carer of the care recipient
The care recipient has been diagnosed with dementia
Has prior experience using the communication application LINE
Has provided written informed consent to participate in the study voluntarily after understanding its purpose
Key exclusion criteria
The care recipient is residing in a long-term care facility
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Tadaka |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Community and Public Health Nursing
Zip code
060-0812
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3695
e_tadaka@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Nanami |
| Middle name | |
| Last name | Oe |
Organization
Graduate School of Health Sciences, Hokkaido University
Division name
Department of Community and Public Health Nursing
Zip code
060-0812
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3695
Homepage URL
oe.nanami.s2@elms.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Tadaka Etsuko
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Health Sciences, Graduate School of Health Sciences, Hokkaido University
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-3316
shomu@hs.hokudai.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 | 08 | Month | 14 | 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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067233
