Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/08/2008
Date assigned
29/08/2008
Last edited
11/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hiroyuki Shimada

ORCID ID

Contact details

Tokyo Metropolitan Institute of Gerontology
35-2 Sakae-cho
Itabashi
Tokyo
173-0015
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Implementation of an assessment-based multifactorial intervention on fall prevention in disabled elderly will decrease the number of fallers and the number of falls.

Ethics approval

The Ethics Committee of the Tokyo Metropolitan Institute of Gerontology. Date of approval: 26/09/2006 (ref: 16)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Falls/ high risk population with falls

Intervention

Intervention group: Falls prevention programme, consisting of the following:
1. Fall-risk assessment
2. Falls prevention education for both the participating care service providers and the elderly participants

Control group: Usual care

Total duration of interventions: 3 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Fall rates and number of falls. Duration of follow-up: 1 year.

Secondary outcome measures

Fall-related fractures. Duration of follow-up: 1 year.

Overall trial start date

01/09/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women who are 65 years of age or older who utilised day-care services.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

5,000

Participant exclusion criteria

Acute health conditions.

Recruitment start date

01/09/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Japan

Trial participating centre

Tokyo Metropolitan Institute of Gerontology
Tokyo
173-0015
Japan

Sponsor information

Organisation

Tokyo Metropolitan Institute of Gerontology (Japan)

Sponsor details

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

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Tsukui Co (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes