UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025020
Receipt number R000028561
Scientific Title Rice-farming care for the elderly people with dementia
Date of disclosure of the study information 2017/04/01
Last modified on 2018/12/05 10:42:04

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Basic information

Public title

Rice-farming care for the elderly people with dementia

Acronym

RICE Study

Scientific Title

Rice-farming care for the elderly people with dementia

Scientific Title:Acronym

RICE Study

Region

Japan


Condition

Condition

cognitive impairment

Classification by specialty

Neurology Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to assess the effectiveness of rice farming care on the QOL and social participation of the peopl with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III


Assessment

Primary outcomes

QOL

Key secondary outcomes

cognitive impairment, clinical dementia rating, social participation, social network scale, social isolation, subjective health, blood examination, frailty


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

After dividing the participants into two groups, the intervention group start rice farming program every week.

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

50 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

to have cognitive impairment

Key exclusion criteria

to have severe physical illness

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chiaki Ura

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Promoting Independence of the Elderly

Zip code


Address

35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan

TEL

03-3964-3241

Email

ura@tmig.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chiaki Ura

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Promoting Independence of the Elderly

Zip code


Address

35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan

TEL

03-3964-3241

Homepage URL


Email

ura@tmig.or.jp


Sponsor or person

Institute

Tokyo Metropolitan Institute of Gerontology

Institute

Department

Personal name



Funding Source

Organization

Sompo Japan Nipponkoa Welfare Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kawamuro Memorial Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

医療法人常心会 川室記念病院(新潟県)


Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/geriatrics/55/1/55_55.106/_article/-char/ja

Number of participants that the trial has enrolled


Results

Aim: The aim of this study was to assess the feasibility of rice-farming care among elderly people with cognitive impairment as a tool for social inclusion.
Methods: Eight elderly individuals with cognitive impairment (7 men, 1 woman, mean age 68.3 years old) participated in the program over 25 weeks. The cognitive function, well-being, and depression were assessed before and after the program period. The degree of participants' independence during the program was also assessed. Semi-structured interviews with the participants and caregivers were held after the program period.
Results: The average participation rate was 93.0%. There were no unexpected events, and the subjects carried out farmwork almost independently. Regarding their well-being, two participants who scored below the cut-off criterion of mental health before the study scored above the cut-off after the study. Regarding depression, two participants who scored positive with a two-question case-finding instrument no longer scored positive after the study. Interviews with the participants showed that they enjoyed the program, especially because they had peers, a role, and gained positive emotions. Interviews with the caregivers showed that they had recognized for the first time what people can do with their skills.
Conclusion: The results of the present study indicate that rice-farming was a feasible method of care with a positive impact on the well-being and depression of elderly people with cognitive impairment and enhanced their social participation, drawing out their individual strengths.

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

Enrolling by invitation

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ura C, Okamura T, Yamazaki S, Ishiguro T, Ibe M, Miyazaki M, Torishima K, Kawamuro Y: The development of care farming for elderly people with cognitive impairment to enhance social inclusion: A feasibility study of rice-farming care for elderly people with cognitive impairment. Japanese Journal of Geriatrics, 55(1):106-116, 2018.
Ura C, Okamura T, Yamazaki S, Ishiguro T, Ibe M, Miyazaki M, Kawamuro Y: Rice-farming care for the elderly people with cognitive impairment in Japan: A case series. International Journal of Geriatric Psychiatry, 33:435-437, 2018.


Management information

Registered date

2016 Year 11 Month 28 Day

Last modified on

2018 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028561


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name