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
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.
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
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