Multifactorial Study of the Relationship Between the Conditions of Life and the Incidence of Risk of Falling
1 other identifier
observational
400
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
February 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 10, 2020
March 1, 2020
1.2 years
February 4, 2020
March 5, 2020
Conditions
Keywords
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
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)