Multifactorial Study of the Relationship Between the Conditions of Life and the Incidence of Risk of Falling

March 5, 2020 updated by: Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca

Multifactorial Study of the Relationship Between the Conditions of Life and the Incidence of Risk of Falling, From the Nursing Perspective, in Elderly Adults of the Community

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Detailed Description: OBJECTIVES:

To study the relationship between living conditions and the incidence of risk of falls in the elderly group 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:

Observational, cross-sectional 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.

Analyze statistically the results obtained and interpret them. The study was carried out over three years. This research study was approved by the Bioethics Committee of the University of Salamanca.

SITE - SAMPLE SELECTION:

The study will include men and women, aged 75 or older, citizens of Salamanca city, who voluntarily participate in the study, during the years 2018-2020, and are attached to the National Health System.

SAMPLE SIZE:

The sample size of the study will be calculated through the estimate of the population of inhabitants of the city of Salamanca in the last year.

The sample technique is intentional. Participants who have met the previously established inclusion criteria and who did not present any exclusion criteria are recruited, as long as they expressed their consent in the participation of the study, voluntarily and altruistically, when they are asked by the nurse. If so, they will be cited later to conduct a separate personal interview.

INDEPENDENT VARIABLES:

• Demographic data of the subject: age, sex, marital status, profession, lifestyle (lives alone: yes/no and housework help: yes/no), weight, height, body mass index, pathological antecedents, pharmacological treatment and history of falls.

DEPENDENT VARIABLES:

• Habitual physical activity, characteristics of falls, risk of falls and fear of falling.

DESCRIPTION OF THE INTERVENTION: Process description

  1. Subjects interested in participating in the study will receive a Participant Information Sheet, explaining the objectives and procedures of the research study. It also refers to the principles of non-maleficence, autonomy and participation and voluntary withdrawal, data protection and confidentiality.
  2. All the participants included in the study will be identified with a unique number (the selection number) to guarantee anonymity. The code that identifies them will appear in each source of the study.

  3. Socio-demographic data of the subjects, pathological history, falls and habitual medication are collected.

    The subjects are evaluated on the risk of falls, the basic activities of daily life and walking and balance, fragility and fear of falling, through the administration of the scales: the Barthel Index, the Downton fall risk assessment scale, the Falls Efficacy Scale-International (FES-I) and the Tinetti assessment tool and the Short Physical Performance Battery (SPPB).

  4. The final phase consists on analyze statistically the results obtained and interpret them.

ETHICAL-LEGAL ASPECTS OF THE PROJECT: The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain
        • Recruiting
        • Irene Escosura Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. People bedridden for illness in the last three months.
  2. Terminal patients or with diagnosis of severe cognitive impairment.
  3. Living in nursing homes or homes for the elderly.
  4. Potential candidates who do not express consent to participate in the study.

Withdrawal Criteria:

  1. Participants who decide to leave the study in any of its phases.
  2. People who leave the National Health System in Salamanca to go to another community.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of falls
Time Frame: 26/5000 January 2017 - up to 24 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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)

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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