The Characteristics of Falls and Its Potential Predictors | NCT03879902

Studies
The Characteristics of Falls and Its Potential Predictors

NCT03879902

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jun 7, 2021Actual

Enrollment

2,101Actual

Phase

Not provided

Conditions

Fall Patients

Interventions

Not provided

Countries

Hong Kong

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 2021

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

Jul 20, 2017Actual

Primary Completion Date

Nov 10, 2020Actual

Completion Date

Nov 10, 2020Actual

First Submitted Date

Feb 24, 2019

First Submission Date that Met QC Criteria

Mar 14, 2019

First Posted Date

Mar 19, 2019Actual

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 4, 2021

Last Update Posted Date

Jun 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

A prospective study to examine the fall characteristics among elderly faller in Hong Kong and the potential predictors of falls incidence.

Detailed Description

This will be a prospective study. One thousand and five hundred older fallers would be recruited. Baseline assessments would be conducted to examine potential fall risk factors and the fall history. The subjects would be followed up for 1 year for fall incidence. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

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

2,101Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of falls	Prospective fall data will be collected through telephone follow-up for 1 year. The number of fall during the follow-up period and the circumstances while the falls occur would be recorded.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 60 or older
able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
able to walk for ≥ 10 meters
history of falls in the past 12 months
living in the community
able to understand Chinese

Exclusion Criteria:

blindness

Accepts Healthy Volunteers

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-dwelling older adults with fall history

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Kwok, MD	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control		Hong Kong			Hong Kong