NCT04301713

Brief Summary

HYPOTHESIS: The incidence of risk of falls is related to the living conditions of elderly people in the community. OBJECTIVES:

  • To study the relationship between living conditions and the incidence of risk of falls in older adults in the community. SPECIFIC OBJECTIVES:
  • Describe the socio-characteristics of the elderly group in the community.
  • Identify the pathologies or health problems that they present.
  • Evaluate their functional and dependency degree.
  • Evaluate the risk of falls that each person may have.
  • Identify the risk factors involved in falls.
  • Analyze the prevalence of falls that they present. STUDY DESIGN: Descriptive and analytical-statistical study. Administration of the Barthel Index. Administration of the Downton fall risk assessment scale and the Falls Efficacy Scale-International (FES-I). Administration of the Tinetti assessment tool and the Short Physical Performance Battery (SPPB). Evaluation of socio-demographic characteristics, clinical and functional assessment, consumption of drugs, as well as characteristics of the falls of each elderly person in the community. The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

February 4, 2020

Last Update Submit

March 5, 2020

Conditions

Keywords

older adultscale, testrisk of fallslife conditionsnursing role

Outcome Measures

Primary Outcomes (1)

  • Risk of falls

    Psychometric characteristics of the scale, the following criteria will be analyzed: * Reproducibility: reliability study (homogeneity of measurements). * Validity: content (the items of the instrument adequately represent the construct that it intends to measure) and criteria (degree of similarity in scale scores compared to a standard or reference standard).

    26/5000 January 2017 - up to 24 weeks

Interventions

An evaluation of the risk of falls will be carried out in the elderly in the province of Salamanca. This will attempt to identify the risk of falling as well as to be able to establish protocols for action of a preventive and rehabilitative nature.

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People over 75 years of the province of Salamanca who are not institutionalized.

You may qualify if:

  • Men and women, aged 75 or older.
  • Citizens of Salamanca city, in Spain.
  • People who are attached to the National Health System.
  • Potential candidates who express consent to participate in the study.

You may not qualify if:

  • People bedridden for illness in the last three months.
  • Terminal patients or with diagnosis of severe cognitive impairment.
  • Living in nursing homes or homes for the elderly.
  • Potential candidates who do not express consent to participate in the study.
  • Withdrawal Criteria:
  • Participants who decide to leave the study in any of its phases.
  • People who leave the National Health System in Salamanca to go to another community.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irene Escosura Alegre

Salamanca, Spain

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Eduardo José IP Fernandez, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2020

First Posted

March 10, 2020

Study Start

October 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

A specific database will be created to which any external researcher can access after contacting by email with the PI (mail: ire.escosura@usal.es)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations