Public Health Concerns of Elderly Fallers and Non-fallers... | NCT02177968

Studies
Public Health Concerns of Elderly Fallers and Non-fallers in a Community

NCT02177968

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Jun 30, 2014Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Accidental Falls
Aging

Interventions

descriptive analysis of characteristics

Countries

Brazil

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

Jun 2014

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

Aug 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 23, 2014

First Submission Date that Met QC Criteria

Jun 27, 2014

First Posted Date

Jun 30, 2014Estimated

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

Jun 27, 2014

Last Update Posted Date

Jun 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luciana Paludetti Zubieta Traldi, Department Social Medicine's Master, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 identify the prevalence and the characterization of health of elderly fallers and non-fallers in the southeastern community of Brazil in the state of São Paulo.

Detailed Description

The population consisted of 638 elderly individuals enrolled and attended by the teams of the Family Health Strategy in the city of Araraquara, São Paulo state. The sample was selected in a systematic way, considering the order of micro-areas, 1-7, which 10% sampling error, 15% rate answer. To this, instruments were used based SABE Study, Health Wellbeing and Aging modified, and the International Physical Activity Questionnaire (IPAQ), short version.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly fallers or non-fallers		characteristics of these groups	Other: descriptive analysis of characteristics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
descriptive analysis of characteristics	Other	comparison between elderly fallers and non-fallers	Elderly fallers or non-fallers

Measure	Description	Time Frame
Healthy, Well-being and Aging questionnaire		5 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People aged 60 years and over

Exclusion Criteria:

Vestibular alteration
Postoperative requiring continuous home
Low vision or complete blind
Bedridden
Empty house
Subjects without registration at the health family unity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciana PZ Traldi, research		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Educação Permanente, Prefeitura Municipal de Araraquara		Araraquara	São Paulo		Brazil