UMIN-ICDS Clinical Trial

Public title

Study on ADL Assessment and Rehabilitation for Individuals with Dementia using Photo Assessment and ZOOM

Acronym

Study on ADL Assessment and Rehabilitation for Individuals with Dementia using Photo Assessment and ZOOM

Scientific Title

A Study on Standardizing Non-Visit-Based ADL Assessment and Intervention Systems to Support the maintenance of living at home for Individuals with Dementia

Scientific Title:Acronym

A Study on Standardizing Non-Visit-Based ADL Assessment and Intervention Systems to Support the maintenance of living at home for Individuals with Dementia

Region

Japan

Condition

Dementia(Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia),Mild Cognitive Impairment(MCI)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In home visits for individuals with dementia living at home, a multidisciplinary team of healthcare professionals aims to maintain the patients' safe living conditions by conducting functional assessments and providing guidance. However, during the spread of the COVID-19 pandemic, we faced challenges in providing in-person support and guidance to patients due to the impact of movement restrictions. To address this issue, we developed non-contact methods for providing guidance to patients while avoiding direct contact between the patients and our support team. These methods include Photo Assessment (PA), which involves requesting caregivers to take photographs of the patients' living environment for evaluation, and Online Management (O-MGT), which utilizes web conferencing systems such as Zoom to conduct remote guidance sessions using the patients' personal computers. By utilizing existing devices, we have devised evaluation and support methods that enable us to provide assistance to patients while minimizing interpersonal contact. This study aims to conduct a multicenter verification study using the aforementioned methods of intervention, with the goal of establishing and standardizing a non-visit-based assessment and intervention system that enables appropriate home support for individuals with dementia even during infectious disease outbreaks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Activities of Daily Living;PADA-D (Process Analysis of Daily Activity for Dementia)

Key secondary outcomes

PSMS(Physical Self-Maintenance Scale),IADL (Lawton Instrumental Activities of Daily Living Scale),MMSE(Mini Mental State Examination), GDS(Geriatric Depression Scale), NPI(Neuropsychiatric Inventory), ZBI(Zarit Caregiver Burden Interview)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Other

Interventions/Control_1

Intervention Group (45 cases):
1.Conduct baseline assessments (PSMS, IADL, PADA-D, MMSE, NPI, GDS, ZBI) for the participants and their caregivers.
2. Provide caregivers with cameras to take home photographs, and perform home environment and ADL assessments based on the collected photos (PA).
3. Extract intervention needs from PA assessments and conduct rehabilitation sessions via ZOOM for patients and caregivers once a week, approximately for a duration of 3 months (O-MGT).
4.Conduct post-intervention reassessment.

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

40

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

#The etiology of dementia is limited to Alzheimer's disease, Lewy body dementia, and frontotemporal dementia(dementia defined as CDR of 1 or higher).
#For MCI, MMSE score should be 24 or higher, and CDR should be 0.5.
#Participants aged 40 or above but less than 90 at the time of obtaining consent.
#Participants who are living together with a caregiver who is well acquainted with the condition of the target individual in their own home. In the case of individuals living alone, there should be a supporting individual who is familiar with the condition of the target individual.
#Participants who can provide informed consent both in writing and orally based on their own free will, or participants for whom appropriate surrogate consent can be obtained to confirm their willingness.

Key exclusion criteria

#Patients with dementia or mild cognitive impairment due to medication or cerebrovascular disorders.
#Patients with severe medical conditions.
#Patients with coexisting psychiatric disorders such as schizophrenia, mood disorders, or substance abuse.
#Patients deemed unsuitable by the principal investigator or co-investigators.
#Patients deemed ineligible for participation by their attending physician.
#Individuals who require assistance in daily living activities primarily due to physical functional decline.
#Individuals who require constant caregiving due to cognitive decline.
#Other individuals deemed unsuitable by the principal investigator or co-investigators.

Target sample size

45

Name of lead principal investigator

1st name	Manabu
Middle name
Last name	Ikeda

Organization

Osaka University

Division name

Department of Psychiatry, Osaka University Graduate School of Medicine

Zip code

565-0871

Address

D3, 2-2 Yamadaoka, Suita City, Osaka

TEL

06-6879-3051

Email

mikeda@psy.med.osaka-u.ac.jp

Name of contact person

1st name	Maki
Middle name
Last name	Hotta

Organization

Osaka University

Division name

Department of Psychiatry, Osaka University Graduate School of Medicin

Zip code

565-0871

Address

D3, 2-2 Yamadaoka, Suita City, Osaka

TEL

06-6879-3051

Homepage URL

Email

komaki@psy.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Board Osaka University Hospital

Address

2-2 Yamadaoka, Suita City, Osaka 565-0871

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.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

Date of disclosure of the study information

2023

Year

08

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

2023

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2023

Year

08

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

07

Month

18

Day

Last modified on

2024

Year

01

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058899