UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057663 |
|---|---|
| Receipt number | R000065883 |
| Scientific Title | Evaluation of a care program involving resident volunteers in the care of elderly patients with delirium and dementia in an acute care hospital |
| Date of disclosure of the study information | 2025/04/20 |
| Last modified on | 2025/04/20 15:56:32 |
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Basic information
Public title
Development and validation of a delirium and dementia care program with resident volunteers for elderly patients in an acute care hospital.non-randomized controlled trial
Acronym
Development and validation of a delirium and dementia care program with resident volunteers for elderly patients in an acute care hospital
Scientific Title
Evaluation of a care program involving resident volunteers in the care of elderly patients with delirium and dementia in an acute care hospital
Scientific Title:Acronym
Development and validation of a delirium and dementia care program with resident volunteers for elderly patients in an acute care hospital.non-randomized controlled trial
Region
| Japan |
Condition
Condition
delirium dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of a care program involving resident volunteers in delirium and dementia care for elderly patients admitted to an acute care ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delirium Occurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Volunteers provide the following care
1) Environmental adjustment: creating an environment that is appropriate to the patient's daily life.
2) Care for visual and hearing impairments: checking for the use of hearing aids and glasses, and maintaining cleanliness.
3) Care for memory and disorientation: Reality orientation for anxiety.
Interventions/Control_2
Normal Care
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
| 70 | years-old | <= |
Age-upper limit
| 105 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly patients (70-105 years old) admitted to acute care wards will be evaluated for eligibility, and 1. those whose risk factors are determined to be Yes by 2 Delirium Risk Assessment based on the requirements for the additional care for high-risk patients with delirium, and 2. those whose consultation with the psychiatric liaison team falls under delirium care or dementia. Select patients with delirium care and dementia.
Key exclusion criteria
1. patients with difficulties in verbal communication (severe dementia or sensory aphasia).
2. patients with serious illness or critical illness.
3. terminally ill patients.
4. patients who have or are suspected to have an infectious disease such as new coronavirus or influenza.
5. patients who are deemed unfit for volunteer intervention by the attending physician or ward manager.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Hasegawa |
Organization
Public Interest Incorporated Associations Kyoto Hokenkai Kissyouin Hospital
Division name
nursing department
Zip code
601-8314
Address
43 Kichijoin Inokuchi-cho, Minami-ku, Kyoto
TEL
075-672-1331
kmch-2019@umin.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Hasegawa |
Organization
Public Interest Incorporated Associations Kyoto Hokenkai Kissyouin Hospital
Division name
nursing department
Zip code
6048823
Address
43 Kichijoin Inokuchi-cho, Minami-ku, Kyoto
TEL
09042752377
Homepage URL
kmch-2019@umin.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Kyoto Miniren Chuo Hospital Ethics Review Committee
Address
2-1, Ohata-Tsuchihonmachi, Ukyo-ku, Kyoto, Japan
Tel
075-861-2220
kmch-2019@umin.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 | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | 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
| 2025 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065883
