UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052667 |
|---|---|
| Receipt number | R000060099 |
| Scientific Title | Research on the development of Virtual Reality programs to reduce loneliness and social isolation among older people |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/11/01 11:14:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of Virtual Reality programs to reduce loneliness and social isolation among older people
Acronym
Impact of reducing loneliness with VR
Scientific Title
Research on the development of Virtual Reality programs to reduce loneliness and social isolation among older people
Scientific Title:Acronym
Impact of reducing loneliness with VR
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment, Subjective Cognitive Decline
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, we have experienced unprecedented levels of social isolation due to the spread of coronavirus infections. The health burden of social isolation and the loneliness that accompanies it is extensive; for example, it is known to increase the susceptibility to hypertension and immune system dysfunction, and to increase the risk of suicide. Loneliness is said to be as much or more of a health risk than obesity or smoking 15 cigarettes daily. Lonely people often have poor mental health and are reported to have an increased risk of dementia as well as depression and other mental illnesses, and elderly people who feel lonely are 1.64 times more likely to develop dementia than those who do not. The Japanese government has also indicated that it intends to address the issue of isolation and loneliness by establishing a "Minister of State for Isolation and Loneliness" in 2021. Therefore, this study aims to develop a VR program to reduce loneliness and social isolation. We will also investigate how reducing loneliness affects cognitive function, mental symptoms, and brain structure and function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Loneliness (UCLA Loneliness Scale (2nd Edition))
Key secondary outcomes
1. patient background: age, gender, educational history, dominant hand, and medical history are evaluated by interview.
2.Brain imaging: brain MRI images, SPECT scan
3.Cognitive function test: Mini Mental State Examination (MMSE)
4.Evaluation of psychiatric symptoms: Geriatric Depression Scale (GDS), Mild behavioral impairment-checklist (MBI-C)
5. Dementia severity: Clinical Dementia Rating (CDR)
6. Assessment of ADL: Instrumental activities of daily living (IADL), Physical Self-Maintenance Scale (PSMS)
7. Satisfaction and evaluation of the VR program
8. blood pressure and pulse rate before and after the program
9. evaluation of VR sickness: The Simulator Sickness Questionnaire (SSQ)
10. mood states before and after the program: Profile of Mood States (POMS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The first group will participate in the VR program once a month from 1-6 months after the start, and the observation period will be from 7-12 months. 6 times in total (once a month) will be scheduled for participation in the VR program. Before, 6 months, and 12 months after participation in the VR program, a loneliness scale, stress index, various cognitive function tests, and psychiatric symptom assessment will be conducted, respectively, to observe changes due to participation in the VR program.
Interventions/Control_2
The second group will participate in the VR program every month from 7 to 12 months, with an observation period from 1 to 6 months after the start of the program. Before, 6 months, and 12 months after participation in the VR program, a loneliness scale, stress index, various cognitive function tests, and psychiatric symptom assessment will be conducted to observe changes due to participation in the VR program.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients seen between the date of approval and March 31, 2024.
2. Patients who are able to obtain written consent for participation in the study of their own free will and whose cognitive function is not pathological (including SCD and MCI)
3. Patients who are 60 years of age or older at the time of obtaining consent
4. Gender: any gender
5. Inpatient/outpatient: Not applicable
6. Patients attending Kyoto Prefectural University of Medicine Hospital Medical Center for Dementia Diseases
Key exclusion criteria
(1) Patients with insufficient ability to speak and understand Japanese
(2) Other patients who are deemed inappropriate by the physician in charge.
(3) Those with a history of mental illness, head trauma, drug or alcohol abuse, those with significant visual or hearing impairment, and those who cannot use both hands.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Jin |
| Middle name | |
| Last name | Narumoto |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
6028566
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
TEL
0752515612
jnaru@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Imai |
| Middle name | |
| Last name | Ayu |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
6028566
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
TEL
0752515612
Homepage URL
imaiayu@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Ayu Imai
Funding Source
Organization
Nippon Life Insurance Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
Tel
0752515612
imaiayu@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-52
Org. issuing International ID_1
Osaka Institute of Technology
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060099
