UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051596 |
|---|---|
| Receipt number | R000057797 |
| Scientific Title | Establishment of an international method of Association Therapy for prevention of frailty in the older people at home and varification of its effectiveness. |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2024/08/01 13:11:41 |
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Basic information
Public title
Establishment of an international method of Association Therapy for prevention of frailty in the older people at home and varification of its effectiveness.
Acronym
Establishment of an international method of Association Therapy for prevention of frailty in the older people at home and varification of its effectiveness.
Scientific Title
Establishment of an international method of Association Therapy for prevention of frailty in the older people at home and varification of its effectiveness.
Scientific Title:Acronym
Establishment of an international method of Association Therapy for prevention of frailty in the older people at home and varification of its effectiveness.
Region
| Europe |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement the "Associative Method" in a foreign country (Finland) and clarify its effectiveness in preventing frailty, maintaining and improving quality of life, and preventing cognitive decline in the elderly, even in different lifestyles and cultural backgrounds.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EQ-5D-5L
Key secondary outcomes
1 Visual Analogue Scale
2 Mini Mental State Examination
3 Face Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention groups:To provide the " Association Therapy" program once a week for 20 minutes per session for 6 months.
Interventions/Control_2
Control Group: To provide the regular programs.
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
older people over 65 years of age.
Key exclusion criteria
Exclude persons under 65 years of age, incapable of writing or literacy in their native language, those with serious physical or mental illness, and those with severe audiovisual disabilities.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku Bunka Gakuen University
Division name
Department of Nursing, Faculty of Medical Sciences and Welfare
Zip code
981-8551
Address
6-45-1, Kunimi, Aoba-ku, Sendai, Japan
TEL
022-233-3683
sasaki.phn@ns.tbgu.ac.jp
Public contact
Name of contact person
| 1st name | Riki |
| Middle name | |
| Last name | Yamashita |
Organization
Tohoku Bunka Gakuen University
Division name
General Affairs Division
Zip code
981-8551
Address
6-45-1, Kunimi, Aoba-ku, Sendai, Japan
TEL
022-233-3310
Homepage URL
shomu-ka@office.tbgu.ac.jp
Sponsor or person
Institute
Tohoku Bunka Gakuen University
Institute
Department
Personal name
Akiko Sasaki
Funding Source
Organization
Japan Society for the Promotion of Science.
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
Tohoku Bunka Gakuen University Resaerch Ethics Review Board
Address
6-45-1,Kunimi,Aoba-ku, Sendai, Miyagi, Japan
Tel
022-233-3310
shomu-ka@office.tbgu.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
| 2023 | Year | 07 | Month | 12 | 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
114
Results
A total of 90 persons ,50 in the intervention group and 40 in the control group, who responded to the MMSE and other questionnaires were included in the analysis.
After 3 months and 6 months the mean of MMSE was no significant differences between the two groups.
Results date posted
| 2024 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
At Baseline, there were more women than men in both groups.
The mean age of all subjects was 82.8years, the intervention group was 81.5 years, and the mean age of the control group was 84.4 years.
The most common household composition was single person, with 45 in the intervention group and 31 in the control group.
In terms of the degree of independence in daily living of the disabled older people, the intervention group was the most independent, with 20 of the older people in the intervention group. In the control group, 16 were J1.
In terms of the degree of independence in daily living of the older people with dementia, Independence was the most common in both groups, 39 in the intervention group and 29 in the control group.
Participant flow
For the intervention group, care staff and volunteers facilitated and implement the "Association Therapy" in addition to the usual care prevention activities for 6 months. The control group received the usual care prevention program for 6 months.
Adverse events
Outcome measures
Subjective heath status, Face scale,EQ5D5L Index Value, VAS, MMSE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | 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 | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057797
