UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047109 |
|---|---|
| Receipt number | R000053739 |
| Scientific Title | Development of a multifactorial program for frail older adults: a feasibility study |
| Date of disclosure of the study information | 2022/03/08 |
| Last modified on | 2022/09/07 07:58:35 |
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Basic information
Public title
A feasibility study for a multifactorial Intervention in outpatients with frailty (pilot study)
Acronym
A feasibility study for a multifactorial Intervention in outpatients with frailty (pilot study)
Scientific Title
Development of a multifactorial program for frail older adults: a feasibility study
Scientific Title:Acronym
Development of a multifactorial program for frail older adults: a feasibility study
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the potential effects and feasibility of a multifactorial intervention in frail outpatients.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of participation in the program
Key secondary outcomes
Frailty phenotype
Revised J-CHS
Motor function
Short Physical Performance Battery
Cognitive function
1) MMSE-J
2) Word fluency
3) Logical Memory 1, 2
4) Digit Symbol Substitution Test
5) Trail Making Test Part A, B
6) Digit Span Test
7) Composite score calculated from MMSE, DSST, TMT, logical memory, number counting, and word recall tests
8) DASC-21
Nutrition and oral function
1) Dietary variety score
2) Council on Nutrition Appetite Questionnaire-J
3) Oral function
Body composition
Percent fat mass and fat-free mass measured by InBody770
Blood test
WBC, RBC, PLT, Hb, Ht, MCV, MCH, MCHC, differential count of leukocytes, TP, ALB, A/G, CRP, T-Bil, AST, ALT, LDH, gamma-GTP, CK, BUN, CRE, eGFR-CRE, UA, NA, K, Cl, TG, T-Chol, LDL-Chol, HDL-Chol, BG, Ft, Zn, HbA1c, GA, cystatin c, F-T3, F-T4, TSH
Urine analysis
Qualitative urine analysis, urinary sediment analysis, urinary microalbumin, U-CRE, U-Na, U-Cl, U-K
Mental Health
1) S-WHO-5-J
2) Japanese version of the UCLA Loneliness Scale
3) Subjective well-being
Social function and functional capacity
1) TMIG-IC
2) JST-IC
3) Japanese version of the Lubben Social Network Scale (LSNS-6)
4) Frequency of social interaction
5) Frequency of going out
6) Frequency of social participation
7) Smartphone use
8) Use of social networking services (SNS)
9) Willingness to continue using SNS
10) SNS use during the course
Impression of the programs/satisfaction level
Safety
Incidences of diseases or disorders developed during the intervention period will be checked.
Adherence
Withdrawal/dropout rates
Reasons for dropout
The reasons for dropouts, such as relocation, hospitalization, poor health, or busy schedule, will be clarified.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Multifactorial intervention composed of exercise, nutrition, oral health, and social interaction programs
Exercise program
Multifactorial exercise program (once a week, 60 min/session) + exercise diary
Nutrition program
Lectures by a registered dietitian (two sessions), healthy meal delivery/trying ready-to-eat meals + food diary
Oral health program
Lectures by a dentist (one session), oral care practice
Social interaction program
Face-to-face lectures (five sessions), interactions using SNS, face-to-face social events
Interventions/Control_2
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) Men and women aged 65 and older
2) Outpatients with frailty
3) Those who fall under the pre-frailty (4 - 7 points) or frailty (8 points or more) categories on the basic checklist
4) Smartphone users
Key exclusion criteria
Persons:
1) who have been diagnosed with dementia or prescribed anti-dementia medications
2) who have a disability affecting basic activities of daily living
3) who are prohibited from exercising (except for light exercise) by their family physician
4) who are on restricted protein diets for disease management and those with eGFR below 30
5) who have had angina, severe heart failure, terminal illness, myocardial infarction or cardiac surgery, or have been in palliative care within the past three months
6) who need to change their medications at the time of enrollment
7) who are participating in a specific rehabilitation program
8) who cannot walk more than 10 meters without assistance
9) who suffered a femoral neck fracture in the past
10) participating in other clinical research, and those participating-or who plan to participate-in a clinical trial
11) who have difficulty communicating in Japanese
12) who are deemed ineligible to be research participants at the discretion of the principal investigator and physician (co-investigator)
13) whose informed consent cannot be obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Araki |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Diabetes, Metabolism, and Endocrinology
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1141
aaraki@tmghig.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Motokawa |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1141
Homepage URL
kmoto@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
東京都健康長寿医療センター研究所
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 08 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053739
