UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021485 |
|---|---|
| Receipt number | R000024782 |
| Scientific Title | Study about effects of life goal setting technique in the care prevention program for elderly |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2016/03/15 21:49:27 |
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Basic information
Public title
Study about effects of life goal setting technique in the care prevention program for elderly
Acronym
The effects of a life goal-setting technique in a preventive care program for frail community-dwelling older people: a cluster nonrandomized controlled trial
Scientific Title
Study about effects of life goal setting technique in the care prevention program for elderly
Scientific Title:Acronym
The effects of a life goal-setting technique in a preventive care program for frail community-dwelling older people: a cluster nonrandomized controlled trial
Region
| Japan |
Condition
Condition
Frail older people
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of a life goal-setting technique (LGST) plus standard preventive care program for community-dwelling frail older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Health improvement according to the Japanese Ministry of Health, Labour and Welfare's "Kihon Checklists" for assessment of frailty
Assessed at baseline, 3, 6 and 9 months.
Key secondary outcomes
Quality of life (QOL), physical functions (grip strength, sit and reach and Timed Up-and-Go test) and assessment of life goals (degree of recognition, achievement and satisfaction).
QOL are assessed at baseline, 3, 6 and 9 months.
Physical functions are assessed at baseline and 3months.
Life goals are assessed at 3,6 and 9 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
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 group: Participants in the life goal-setting technique (LGST) group received life goal-setting supports from the occupational therapists, as well as standard care at the beginning and end of the classroom program.
Interventions/Control_2
Control group: Participants were encouraged to take regular exercise.
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
Those eligible were older people aged 65 or over living in the community in Izumi, Osaka, Japan, who were assessed as frail using the MHLW's "Kihon Checklist". They were invited to join a care prevention program between octpber 2010 and March 2014. And they decided to participate in a care prevention program for own intention.
Key exclusion criteria
1) receiving certification for long-term care; 2) having participated in a preventive care program within past 2 years; 3) missing more than five classes out of 12 (an overall attendance rate less than 66.6%); 4) absent on the day of life goal-setting; and 5) not returning the postal questionnaire.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Takabatake Yoshimi Yuri |
Organization
Osaka Prefecture University Graduate School
Division name
Comprehensive Rehabilitation
Zip code
Address
3-7-3, Habikino, Habikino-City, Osaka
TEL
072-950-2111
takabata@rehab.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimi Yuri |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code
Address
3-11-1, Asahigaoka, Kashiwara-City, Osaka
TEL
072-978-0088
Homepage URL
yuri@tamateyama.ac.jp
Sponsor or person
Institute
Osaka Prefecture University Graduate School of Comprehensive Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Occupational Therapists
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪府和泉市内3か所の施設（和泉シティープラザ、和泉市総合福祉会館、和泉市北部総合福祉会館）The programs were conducted in three places in Izumi Osaka.
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 15 | 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
Results
The improvement on the Kihon Checklist for the intervention group was approximately 60% from baseline to 9-months follow-up;the control group improved by approximately 40%. The difference between groups was significant at 3-month (p = 0.043) and 6-month (p = 0.015)follow-ups but not at 9-month (p = 0.098) follow-up. Analysis of QOL yielded a significant time group interaction effect (p = 0.022). The effect was significant at 3 months in the intervention group, but at no time in the control group.
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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024782
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