UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033573 |
|---|---|
| Receipt number | R000038272 |
| Scientific Title | Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care |
| Date of disclosure of the study information | 2018/08/03 |
| Last modified on | 2024/06/25 19:15:39 |
* 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
Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Acronym
Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Scientific Title
Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Scientific Title:Acronym
Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Region
| Japan |
Condition
Condition
People who live in community
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inquire into the effects of undertaking groupwork activities aimed at mental, psychological, and social aspects in a preventive care program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Activities of daily living and occupational functions
Key secondary outcomes
Cognitive functions, automatic thoughts, and physical functions
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 | Other |
Interventions/Control_1
Participants engaged in exercises and lectures about improving their nutritional condition and preventing diseases, for 60-90 minutes, and groupwork activities aimed at mental, psychological, and social aspects for 30-60 minutes.
Programs are carried out for about two hours each time, about 12 times, and for three months.
Interventions/Control_2
Participants engaged in exercises and lectures about improving their nutritional condition and preventing diseases, for 60-90 minutes, and games and chatting and so on for 30-60 minutes.
Programs are carried out for about two hours each time, about 12 times, and for three months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who participate in this program by getting to know about it through circular notices, leaflets, and bulletin boards in Atsubetsu-ku in Sapporo city, and agree with taking part in this study.
Key exclusion criteria
Not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Takashima |
Organization
Hokkaido University
Division name
Faculty of Health Sciences, Department of Functioning and Disability
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
TEL
011-706-3380
risa-t@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Takashima |
Organization
Hokkaido University
Division name
Faculty of Health Sciences, Department of Functioning and Disability
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
TEL
011-706-3380
Homepage URL
risa-t@hs.hokudai.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences, Department of Functioning and Disability, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Expert committee of faculty of health sciences of Hokkaido university
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
Tel
011-706-3316
shomu@hs.hokudai.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
| 2018 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
https://doi.org/10.1177/15691861211022986
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1177/15691861211022986
Number of participants that the trial has enrolled
91
Results
ANCOVA showed significant group and time interaction effects in the Five Times Sit-to-Stand Test (FTSST), the Timed Up & Go (TUG), occupational deprivation of the Classification and Assessment of Occupational Dysfunction Scale, and self-rated health. Simple main effect tests showed that the TUG decreased significantly in the PL group, while occupational deprivation and self-rated health scores improved significantly. In contrast, FTSST scores significantly improved in the FL group.
Results date posted
| 2024 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average ages were 76.64 years (SD 6.48) in the PL group (92.9% women) and 76.55 years (SD 5.75) in the FL group (75.9% women). The PL and FL groups were significantly different in total JST-IC score (t = -2.072, P = 0.045) and occupational deprivation (t = 2.075, P = 0.045). No statistically significant difference was observed for any other variable.
Participant flow
Ninety-one participants were recruited (29 PL and 62 FL). Nineteen participants dropped out after the first few sessions (eight PL and 11 FL), and 29 did not complete the post-evaluation because of emergent health problems, schedule conflicts, or inconvenient accessibility due to heavy snow (seven PL and 22 FL). Ultimately, 43 participants (14 PL and 29 FL, 47.3% of recruited participants) were included in the statistical analysis.
Adverse events
N/A
Outcome measures
Participants completed a demographic questionnaire (age, gender, and previous participation in a long-term preventive care class).
Physical functions were assessed with the Five Times Sit-to-Stand Test (FTSST) and Timed Up & Go (TUG). Automatic thoughts, a psychological function, were assessed by the Automatic Thoughts Questionnaire-Revised (ATQ-R).
The Classification and Assessment of Occupational Dysfunction Scale (CAOD), a self-reported questionnaire, assesses occupational dysfunction status, defined as having negative experiences during daily activities. The Japan Science and Technology Agency Index of Competence (JST-IC) assesses occupational dysfunctions in social occupations and includes four domains: technology usage, information practice, life management, and social engagement.
Self-rated health was measured by one item, "How do you feel about your health condition."
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038272
