UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060601 |
|---|---|
| Receipt number | R000069313 |
| Scientific Title | Effect of a High-Quality Activity Program on Behavioral and Psychological Symptoms, Caregiver Burden, Quality of Life, and Emotional Function in Patients with Dementia |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/02/06 13:19:08 |
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Basic information
Public title
Impact of a High-Quality Activity Program on Behavioral and Psychological Symptoms, Caregiver Burden, Quality of Life, and Emotional Function in Patients with Dementia
Acronym
Effect of a High-Quality Activity Program on Patients with Dementia
Scientific Title
Effect of a High-Quality Activity Program on Behavioral and Psychological Symptoms, Caregiver Burden, Quality of Life, and Emotional Function in Patients with Dementia
Scientific Title:Acronym
Evaluation of the Effects of a High-Quality Activity Program on Patients with Dementia
Region
| Japan |
Condition
Condition
persons with cognitive impairment
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of a high-quality activity program on patients with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
behavioral and psychological symptoms, quality of life, and emotional function
Key secondary outcomes
cognitive function and caregiver burden
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group received a high-quality activity program during hospitalization.
Interventions/Control_2
The non-intervention group received usual occupational therapy during hospitalization.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of an orthopedic condition or disuse syndrome
2. Presence of cognitive impairment
3. Admission to a convalescent rehabilitation hospital
Key exclusion criteria
1. Individuals from whom informed consent to participate in the study could not be obtained from the participant or a legally authorized representative
2. Individuals judged to have difficulty participating in the study due to physical or mental conditions
3. Individuals for whom MMSE administration was not feasible and whose dementia severity could not be adequately assessed
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University of Human Sciences
Division name
Faculty of Health Sciences
Zip code
566-8501
Address
1-4-1 Shojaku, Settsu-shi, Osaka
TEL
+81663836441
yuki-nakagawa@kun.ohs.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University of Human Sciences, Japan
Division name
Faculty of Health Sciences
Zip code
566-8501
Address
1-4-1 Shojaku, Settsu-shi, Osaka
TEL
+81663836441
Homepage URL
yuki-nakagawa@kun.ohs.ac.jp
Sponsor or person
Institute
Osaka University of Human Sciences
Institute
Department
Personal name
Yuki Nakagawa
Funding Source
Organization
Osaka University of Human Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
multiple hospitals in Japan
Name of secondary funder(s)
Funding: Under application
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2026 | Year | 03 | Month | 31 | 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 | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069313
