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

Nursing Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04301713
• Other study ID #: 0000281
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2020
• Source: University of Salamanca
• Contact: Eduardo José IP Fernandez, PhD
• Phone: 699244390
• Email: edujfr[@]usal.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging Disorder
• Disease
• Nursing Caries
• Old Age; Debility

Intervention

Other:
• Evaluation of rik of falls
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.

Locations

Country	Name	City	State
Spain	Irene Escosura Alegre	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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