UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012994
Receipt number R000014739
Scientific Title Effect and cost-effectiveness analysis of occupational based occupational therapy for elderly people in geriatric facility:randmized controlled trial
Date of disclosure of the study information 2014/01/28
Last modified on 2014/09/10 15:12:22

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Basic information

Public title

Effect and cost-effectiveness analysis of occupational based occupational therapy for elderly people in geriatric facility:randmized controlled trial

Acronym

Effect and cost-effectiveness analysis of occupational based occupational therapy for elderly people in geriatric facility:randmized controlled trial

Scientific Title

Effect and cost-effectiveness analysis of occupational based occupational therapy for elderly people in geriatric facility:randmized controlled trial

Scientific Title:Acronym

Effect and cost-effectiveness analysis of occupational based occupational therapy for elderly people in geriatric facility:randmized controlled trial

Region

Japan


Condition

Condition

eldely people in geriatric facility

Classification by specialty

Geriatrics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is investigated effect and cost-effectiveness of coccupational based occupational therapy for elderly people in geriatric facility:a cluster randmized controled trial

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MOS 36-Item Short-Form Health Survey(japanes version)

Key secondary outcomes

Barthel index(Activities of daliy living:ADL)
Occupational performance Autonomy:OPA
Total medical cost or total care cost


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In the intervention group, clients and occupational therapists begins to share and identifiy meaningful occupations for the client by using Aid for Decision-making in Occupation Choice (ADOC). Then, occupational therapist observed the meaningful occupation and analyzed occupational performance. Interventions focused on enabling the occupation. During the care facility stay, majority interventions (had to be more than 2/3) was "Real-occupationnal practice (P-ADL)" and "Real-occupational practice (except for P-ADL)", and as appropriate, intervention in TOP group was allowed the "Basic function exercise" and "Simulated occupation practice" within the range of 1/3.

Interventions/Control_2

In the control group, occupational therapist focus evaluations on the patient's generic abilities (i.e., boby functions and structures according to the ICF) and personal activities of daily living (P-ADL). During the care facility stay, majority interventions (had to be more than 2/3) was "Basic function exercise" and "Simulated occupation practice", and as appropriate, intervention in BOT group was allowed the "Real-occupationnal practice (P-ADL)" and "Real-occupational practice (except for P-ADL)" within the range of 1/3. This intervention was usual practice in all occupational therapist participated in this study (data not shown).

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Participants don't have progressive disease, constitutional symptoms are stable, communication and a cognitive function not having the major problem.
They conducted individual training twice a week.

Key exclusion criteria

MMSE<10
Participants have difficulty in communication.
We will stop studying that the participant could not carry on occupational therapy as judged by a primary doctor or participant and their family hope for a cancellation.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirofumi Nagayama

Organization

Kanagawa University of Human Services

Division name

Department of occupational therapy

Zip code


Address

1-10-1 Heiseityou,Yokosuka

TEL

0468282805

Email

nagayama-ktr@kuhs.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirofumi Nagayama

Organization

Kanagawa University of Human Services

Division name

Department of occupational therapy

Zip code


Address

1-10-1 Heiseityou,Yokosuka

TEL

0468282805

Homepage URL


Email

nagayama-ktr@kuhs.ac.jp


Sponsor or person

Institute

Kanagawa University of Human Services

Institute

Department

Personal name



Funding Source

Organization

Japanese Assosiation of Occupational Therapists

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 28 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

2013 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2014 Year 02 Month 28 Day

Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 06 Month 01 Day

Date analysis concluded

2014 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 28 Day

Last modified on

2014 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014739


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name