UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052483 |
|---|---|
| Receipt number | R000059900 |
| Scientific Title | Family Relationship Focused ACP Programme Development and Practice Supporting the Elderly Using DX |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2023/10/13 12:05:52 |
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Basic information
Public title
ACP Programme Development and Practice Supporting the Elderly Using DX
Acronym
ACP Programme Development and Practice Supporting the Elderly Using DX
Scientific Title
Family Relationship Focused ACP Programme Development and Practice Supporting the Elderly Using DX
Scientific Title:Acronym
Family Relationship Focused ACP Programme Development and Practice Supporting the Elderly Using DX
Region
| Japan |
Condition
Condition
no
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a family-relationship-oriented Advance Care Planning (ACP) programme intervention that uses DX technology to share older people's hopes and wishes in old age, and to compare two groups of older people, family members and care support professionals, and older people-only VR viewing, to determine ACP readiness and family relationships. Clarification.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shortened version of the Older Adult Depression Scale.
Family Systems Assessment Scale, the Readiness for Advance Care Planning scale (RACP), which expresses self-worth and way of life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In this study, a family relationship-oriented ACP programme was developed using Virtual Reality (VR) 'virtual reality' (a virtual space that stimulates the five senses and provides a sense of realism close to reality) technology for mutual understanding and discussion among family members about the care and medical choices they want to receive in their final days, and training workshops were held using this programme The effects of the programme on the elderly, their families and the facilitators, such as care support specialists, will be verified.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly people
Target people who meet all of the following criteria: 1.
1. Elderly people aged 65 and over living in the district of Shodoshima. 2.
2. people who have not been certified as requiring long-term care
3. Persons who have agreed to participate in this study by signing a consent form in person. 4.
4. people who are not suffering from physical conditions such as dizziness on the day of the study.
Key exclusion criteria
Subjects who meet any of the following criteria will not be included in the study.
(i) Persons who could not give consent to participate in the study.
(ii) Persons with physical illnesses such as dizziness, lightheadedness, discomfort, eye fatigue, headache, sweating, nausea, etc.
(iii) Those who feel a sense of rejection regarding the ACP.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | mizue |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Nursing
Zip code
431-3192
Address
Handayama Hamamatsu
TEL
+81534352826
mizuesuzuki@gmail.com
Public contact
Name of contact person
| 1st name | mizue |
| Middle name | |
| Last name | suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Nursing
Zip code
431-3192
Address
Handayama 1-20-1
TEL
+81534352826
Homepage URL
mizuesuzuki@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nissay Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
Handayama 1-20-1
Tel
+81534352826
mizuesuzuki@gmail.com
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
| 2023 | Year | 10 | Month | 20 | 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
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 18 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059900
