UMIN-CTR Clinical Trial

Public title

Identification of effective interventions for preventing the need for long-term care in older multi-morbid inpatients and outpatients

Acronym

Identification of effective interventions for preventing the need for long-term care in older patients

Scientific Title

Identifying intervention patterns that contribute to improving frailty in older multi-morbid patients using a patient registry containing multifaceted and longitudinal data.

Scientific Title:Acronym

Identification of intervention patterns contributing to the improvement of frailty in older multi-morbid patients

Region

Japan

Condition

Acute diseases (fractures, pneumonia, heart failure, etc.), lifestyle-related diseases

Classification by specialty

Medicine in general	Geriatrics	Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will establish a registry that accumulates longitudinal data on multifaceted changes based on geriatric medical interventions, including functional assessments along with their treatment content in frail older patients admitted to community-based care beds who have insufficient clinical evidence. This will contribute to identifying factors associated with recovery from frailty and establishing useful intervention patterns, thereby demonstrating the efficacy of community-based care beds or frailty outpatient clinics. Additionally, for older patients with comorbidities such as lifestyle-related diseases, musculoskeletal disorders, and cancer, we will examine the association between changes resulting from treatment for these conditions and geriatric medical interventions through subgroup studies.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Changes in FIM (Functional Independence Measure)

Key secondary outcomes

<Inpatients: From admission to discharge, Outpatients: From arrival to 12, 24 weeks after arrival>
Changes in CFS (Clinical Frailty Scale)
Comprehensive Geriatric Assessment (CGA)
1. Basic Activities of Daily Living: Barthel Index
2. Instrumental Activities of Daily Living: Lawton & Brody Scale
3. Motivation: Vitality Index
4. Cognitive Function: MMSE-J
5. Mood/Emotional State: GDS-15 (GDS-5)
6. Apathy: Motivation Score
Muscle Strength (Grip Strength), Physical Function (SPPB, TUG), Body Composition (Skeletal Muscle Mass, Body Fat Mass, Bone Mass, Phase Angle)
GLIM criteria
Mini Nutritional Assessment-Short Form: MNA-SF, MUST
Severity of geriatric syndromes (delirium, dysphagia, pain, falls, nocturia, insomnia, etc.)
Medications used (number, dosage, timing of administration)
Japanese version of the Anticholinergic Scale
Quality of Life (QOL) scale: EQ-5D
Patient Experience (PX): Inpatients (HCAHPS), Outpatients (CG-CAHPS)
Zarit Caregiver Burden Scale (inpatients)
Comorbidities (CCI)
Management status of lifestyle-related diseases
Dietary content and intake (inpatients)
Rehabilitation units (inpatients)
Dental-related items: Number of remaining teeth, occlusal support area, severity of periodontitis, presence of dentures or tooth pain (inpatients)

<Inpatients: Follow-up period (12 weeks post-discharge)>
QOL (EQ-5D), Zarit Caregiver Burden Scale, readmission status, change in care setting, mortality

<Temporal intervention effect assessment (selected cases)>
Inpatients: Wearable device (SOKAI RING)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

65

years-old

<

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who meet at least one of the J-CHS criteria
2. Patients aged 65 years or older
3. Outpatients or inpatients
4. Patients who have provided written consent

Key exclusion criteria

Patients deemed unsuitable for this trial by the principal investigator or sub-investigator

Target sample size

600

Name of lead principal investigator

1st name	KEN
Middle name
Last name	SUGIMOTO

Organization

Kawasaki Medical School

Division name

General Geriatric Medicine

Zip code

700-0821

Address

2-1-80, Nakasange, Kita-ku, Okayama, Okayama

TEL

086-225-2112

Email

ksugimoto@med.kawasaki-m.ac.jp

Name of contact person

1st name	KEN
Middle name
Last name	SUGIMOTO

Organization

Kawasaki Medical School

Division name

General Geriatric Medicine

Zip code

700-0821

Address

2-1-80, Nakasange, Kita-ku, Okayama, Okayama

TEL

086-225-2112

Homepage URL

Email

ksugimoto@med.kawasaki-m.ac.jp

Institute

Kawasaki Medical School

Institute

Department

Personal name

Organization

DAIICHI SANKYO, INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kawasaki Medical School Hospital Ethics Committee

Address

577, Matsushima. Kurashiki, Okayama

Tel

086-464-1076

Email

kmsrec@med.kawasaki-m.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

川崎医科大学高齢者医療センター、国立長寿医療研究センター

Date of disclosure of the study information

2025

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

07

Month

22

Day

Date of IRB

2025

Year

08

Month

26

Day

Anticipated trial start date

2025

Year

09

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

2028

Year

03

Month

31

Day

Date trial data considered complete

2028

Year

06

Month

30

Day

Date analysis concluded

2028

Year

09

Month

30

Day

Other related information

Outline of Research Methods
1) EDC (REDCap) will be used for case enrollment and data collection.
2) After obtaining written consent, the principal investigator or a research associate will enter the information of eligible patients into EDC during the enrollment period for case registration and data collection.
3) The investigator or research participant conducts the examinations and interviews specified in the protocol at the site and enters the necessary information in the EDC.
4) Conduct the prescribed examinations and interviews at the prescribed consultation, and store the data.
5) Subcohort studies (conducted only at Kawasaki Geriatric Medical School Medical Center) will be conducted in parallel with the present study for the subjects in each study.

This study does not aim to test any particular hypothesis, but rather to evaluate the effects of geriatric interventions implemented in patients admitted to community-based integrated care beds and frail older patients in a multifaceted and exploratory manner. Therefore, in addition to the a priori assumed analyses, we allow for additional exploratory analyses that may generate new hypotheses based on trends and characteristics of the actual data obtained.

Registered date

2025

Year

08

Month

26

Day

Last modified on

2025

Year

08

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067217