Nursing CariesNCT04301713
Multifactorial Study of the Relationship Between the Conditions of Life and the Incidence of Risk of Falling
An observational study of Nursing Caries and Old Age; Debility, run by University of Salamanca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Old Age; Debility, Aging Disorder
- What is being tested?
- Evaluation of rik of falls
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: People over 75 years of the province of Salamanca who are not institutionalized.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Irene Escosura Alegre
Salamanca
Irene IP Escosura Alegre, Nursing, 630228796, ire.escosura@usal.es
About this study
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.
Read more
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.
Read the 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
- 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.
- 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.
- 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).
- 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
- Conditions
- Nursing Caries, Old Age; Debility, Aging Disorder
- Being tested
- Evaluation of rik of falls
- Keywords
- older adult, scale, test, risk of falls, life conditions, nursing role
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of rik of fallsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 26/5000 January 2017 - up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Oct 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301713
- Sponsor's protocol ID
- 0000281
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04301713
- Acronym / sponsor ID
- 0000281
- Conditions
- Nursing Caries, Old Age; Debility, Aging Disorder
- Keywords
- older adult, scale, test, risk of falls, life conditions, nursing role
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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.
- 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.
- 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).
- 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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- People over 75 years of the province of Salamanca who are not institutionalized.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Participants who decide to leave the study in any of its phases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of rik of fallsAn 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. | Other | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nursing Caries and Old Age; Debility, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo José IP Fernandez, PhD (699244390, edujfr@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of falls (time frame: 26/5000 January 2017 - up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.