UMIN-CTR Clinical Trial

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
Email	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
Email	kmoto@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053739