Prevention of Falls and Injurious Falls Among Elderly People | NCT00247546

Studies
Prevention of Falls and Injurious Falls Among Elderly People

NCT00247546

Sponsor

The Hospital District of Satakunta

Status

Completed

Last Update Posted

Oct 18, 2006Estimated

Enrollment

592

Phase

Not Applicable

Conditions

Falls
Accidental Falls

Interventions

Multifactorial prevention

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005

First Submitted Date

Nov 1, 2005

First Submission Date that Met QC Criteria

Nov 1, 2005

First Posted Date

Nov 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2006

Last Update Posted Date

Oct 18, 2006Estimated

Description Module

Brief Summary

The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged.

Detailed Description

The aims of the study:

To implement a program for the prevention of falls and injurious falls.
To describe the structure and activities of the fall prevention program implemented among the aged who are living in their own home, have at least moderate cognitive abilities, have fallen during previous 12 months and are 65 years of age or older. A further aim is to describe the frequency of participation according to age, gender, residence, health and physical condition.
To describe the effects of prevention on primary risk factors of falling such as muscle strength, balance, eye sight, medications, depression and home hazards in relation to age, gender, health and physical condition.
To describe and assess the effects of prevention on the incidence of falls and injurious falls.
To assess the effects of prevention on physical, cognitive and psychosocial functional abilities, quality of life and use of health and social services and deaths.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

592

Name	Type	Description	Arm Group Labels	Other Names
Multifactorial prevention	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of falls and injurious falls

Secondary Outcomes

Measure	Description	Time Frame
Risk factors of falling
Functional abilities
Quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years of age or older
home-dweller
having fallen at least once during the previous 12 months
at least moderate cognitive abilities (MMSE over 17)
able to walk 10 metres independently

Exclusion Criteria:

MMSE under 17

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sirkka-Liisa Kivelä, Professor	The Hospital District of Satakunta	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital District of Satakunta		Pori			Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19958918	Derived	Salminen M, Vahlberg T, Kivela SL. The long-term effect of a multifactorial fall prevention programme on the incidence of falls requiring medical treatment. Public Health. 2009 Dec;123(12):809-13. doi: 10.1016/j.puhe.2009.10.018.