Intervention to Reduce Falls Incidence | NCT01279525

Studies
Intervention to Reduce Falls Incidence

NCT01279525

Sponsor

Andalusian Regional Ministry of Health

Status

Completed

Last Update Posted

Jan 19, 2011Estimated

Enrollment

404Actual

Phase

Not Applicable

Conditions

Patient Fall

Interventions

multifactorial

Countries

Spain

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

ID	Type	Description	Link
PI-279/03	Other Identifier	Health Department of the Andalusian Region Government

Status Module

Record Verification Date

Jan 2011

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

Jan 2005

Primary Completion Date

Not provided

Completion Date

Jan 2011Actual

First Submitted Date

Jan 18, 2011

First Submission Date that Met QC Criteria

Jan 18, 2011

First Posted Date

Jan 19, 2011Estimated

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

Jan 18, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Andalusian Regional Ministry of HealthOTHER_GOV

Collaborators

Name	Class
Andalusian Society of Family Medicine	UNKNOWN
Spanish Society of Family and Community Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.

Detailed Description

The objective of this research is to verify if a simple multifactorial intervention program that is applicable in PC settings is more effective to decrease fall incidence than a brief advice for community-living people aged 70 or older.

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

404Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multifactorial intervention	Experimental	Multifactorial intervention to prevent falls	Device: multifactorial

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multifactorial	Device	individual advice, information leaflet, physical exercise workshop and home visits	Multifactorial intervention

Measure	Description	Time Frame
fall incidence rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients residing in the community

Exclusion Criteria:

to be institutionalized
Immobilized or bedridden
Present a terminal disease or severe psychiatric illness
Have contraindications to physical exercise

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luis A Pérula, Ph D	Andalusian Health Service	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad Docente de Medicina Familiar y Comunitaria		Córdoba	Cordoba	14011	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22609117	Derived	Perula LA, Varas-Fabra F, Rodriguez V, Ruiz-Moral R, Fernandez JA, Gonzalez J, Perula CJ, Roldan AM, de Dios C; EPICA Study Collaborative Group. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Oct;93(10):1677-84. doi: 10.1016/j.apmr.2012.03.035. Epub 2012 May 15.