Accidental FallPREFALLNCT03608709
Development of a Multivariable Prognostic PREdiction Model for 1-year Risk of FALLing in Community-dwelling Older Adults in a Non-clinical Setting
An observational study of Accidental Fall and Fall, run by Aalborg University Hospital at 5 sites in Denmark.
Trial summary
Falls in community-dwelling older adults is a frequent problem with an incidence of 30 % in over-65s and 50 % in over-80s. Incidences are expected to increase significantly in the future due to population aging. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Fall
- How many people
- 241 participants
- Where
- 5 sitesDenmark
- Study dates
- 14 Jun 2018to 18 Jul 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: The target group of PHVs is community-dwelling older adults primarily +75 years old. PHVs are not offered to citizens already receiving local authority home help except for those receiving help with cleaning. As of 2017, the target group of PHVs in the municipality of Hjørring consisted of approximately 4,800 community-dwelling older adults of which 2,053 received a PHV. We expect to include 400 participants from PHVs. Data collection will be performed by trained nurses. - The target group of SACs is primarily retirees (+65 years old), but also early retirees (+60 years old) with reduced physical, psychological or social functional capacity. As of 2018, 318 citizens of the target group attend SACs in the municipality of Hjørring weekly. We expect to include 100 participants from SACs. However, in case of economical, administrative or timing problems, this may alter in both PHV and SACs. The activity centres are staffed with health care workers collecting data for this study.
Who may be able to join
- Community-dwelling older adults
- 75 years old or above
Who cannot join
- Presence of acute illness defined by the presence of a participant-reported experience of illness arisen within 7 days prior to inclusion impairing their everyday functioning in such a way that they opt out of social activities outside their homes while this state is present.
- Unable to understand Danish evaluated by the data collectors.
- Diagnosed with dementia.
- Unable to stand up for 60 seconds without support and visually fixate on an object at the same time. Support is defined by any assistive devices or help from another person.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aktivitetscenter Lynggården
Hirtshals, 9850
Aktivitetscenter Vesterlund
Hjørring, 9800
Forsamlingsbygningen
Hjørring, 9800
Sundhedscenter Hjørring
Hjørring, 9800
Sindal Aktivitetscenter
Sindal, 9870
About this study
Falls in community-dwelling older adults is a frequent problem with an incidence of 30 % in over-65s and 50 % in over-80s. Incidences are expected to increase significantly in the future due to population aging. For instance, as of 2017, the global population older than 65 years is estimated to be 962 million and will increase to 1.4 and 2.1 billion in 2030 and 2050 respectively. In Denmark, falls are the most common accidents among older adults with around 36,000 fall accidents seen annually by the Danish health services and approximately 680 deaths yearly. This high frequency of fall accidents may also support the fact that falls in Denmark are the fourth most common reason for years lived with disability, thereby giving rise to reduced quality of life. Also, falls are associated with elevated morbidity, mortality, poorer physical functioning and early admission to long-term care facilities. Thus, this frequent and escalating problem of fall accidents is of major concern.
Fall prevention is therefore highly relevant. It is recognised that fall-preventive strategies should take on a multifaceted approach due the multifactorial aetiology of falls. This is substantiated by more than 400 risk factors of falling that have now been identified. These spread across different domains including socio-demographics, medical conditions (e.g. atrial fibrillation), medication, physical performance (e.g. reduced lower extremity strength or reaction time), psychology (e.g. depression or fear of falling) and cognition (e.g. global cognitive impairment or reduced executive functioning).
Read more
In order to aid health care professionals in targeting fall-preventive interventions, individual assessments of fall risk are imperative. In Denmark, municipalities are obliged to perform preventive initiatives to preserve the physical, mental and social health along with the functional capacity and quality of life of their older adults. The aim of these initiatives is to enable the older adults to live an independent and meaningful life for as long as possible. Recently, The Danish Health Authority released an updated manual to support this work. This emphasised the need for development of a validated prediction model to be used in a municipally environment to identify older adults at risk of falling. This is due to the abovementioned consequences of falls. To the knowledge of the authors, this is in line with literature being sparse on prognostic prediction models on falls in community-dwelling older adults with data collected outside a clinical environment (i.e. hospitals, GPs and screening or assessment centres).
Objectives:
Primary:
To develop and internally validate a multifactorial prognostic prediction model on fall risk in community-dwelling older adults in a non-clinical setting. The intended use of the model is, for municipalities, to identify and refer citizens with high risk of falls to fall-preventive interventions.
Secondary:
- To estimate time-consumption for the final prediction model.
- To describe the prevalence of arrhythmias in community-dwelling older adults.
Read the detailed description
Study design and sample size:
A prospective cohort study with 1-year follow-up will be performed in collaboration with the municipality of Hjørring, Denmark. A total sample size of 500 participants is expected. This was chosen due to economical and administrative reasons of the municipality contributing with personnel to include participants and collect data on predictors. Data for the development and internal validation of the model will originate from the same cohort.
Study setting, participants, data collectors, process of recruitment and data collection:
According to Danish legislation on health and social services, Danish municipalities are responsible for developing and initiating prophylactic and health-promoting initiatives for their senior citizens. This is done through different authorities in the municipality (e.g. preventive-home-visits, senior activity centres). Also, the municipality of Hjørring administers a local hall for citizens together with general- and patient associations. Therefore, data collection will be performed in participants' own homes through preventive-home-visits, at senior activity centres and at the local hall in the municipality of Hjørring, Denmark.
Predictors:
Data collection of predictors will be performed at baseline. The following predictors were chosen by an expert panel. Reasons are stated at each predictor. First, a brief summary on the process of how predictors were selected will be given followed by a short description of each predictor.
- Predictor selection process: A feasibility study. This model is intended for health care professionals in a non-clinical setting, in this case the municipality of Hjørring with a setting consisting of homes and activity centres. Therefore, it needs to be time-efficient, low-cost and practicable. In order to ease implementation if the model is successful in accuracy, the predictors for data collection was chosen by an expert panel on the basis of scientific value and experiences from a feasibility study performed as a precursor for this study.
The feasibility study investigated the feasibility of measuring a set of predictors, selected by the expert panel, with regards to time-consumption and user experiences both from participants and data collectors in order to ensure participant and public involvement. These predictors constituted the basis from which final selection for the prospective cohort study was performed.
In order to collect data on predictors in a time-efficient way. It was decided to collect these both by tests performed by data collectors and questionnaires filled out by study participants. All results from tests and questionnaire will be typed into REDCap (Research Electronic Data Capture, Vanderbilt University, Nashville, USA) electronic data capture tool hosted at Region Nordjylland, Denmark.
Tests:
- Arrhythmias: The investigator's study will be the first to investigate the prevalence of arrhythmias in a Danish population of older adults (+75 years old) by performing data collection in participants' own environments (i.e. own homes and activity centres). All participants will receive 5 days of 2-lead continuous heart rhythm monitoring (E-patch system, BioTelemetry Inc, Denmark).
- Lower limb reaction time: This was chosen since a slow reaction time was found in earlier studies to increase the risk of falling.12 Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).
- Unilateral lower extremity strength: This was chosen since a poor lower strength in lower extremities was found in earlier studies to increase the risk of falling. Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).
- Grip strength: This was chosen since a poor grip strength was found in earlier studies to increase the risk of frailty, which is associated to increased fall risk. Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).
- Balance with dual-tasking: This was chosen since a poor dual-tasking ability was found in earlier studies to an increased fall risk. Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).31 Simultaneously, participants will be instructed mention as many things one can buy in a supermarket, while attempting to stand still on the board.
- Walking speed: This was chosen since a poor gait speed was found in earlier studies to an increased fall risk. Participants will be instructed to do a 4-meter walk at regular speed. Time spent will be noted using a stop watch. The fastest of the two measurements will be selected for further analysis.
- Physical activity: This will be measured using an accelerometer incorporated in the hearth rhythm monitoring device.
Questionnaire:
The following list specifies predictors of falls and participant characteristics that will be included in the questionnaire.
- Age.
- Gender.
- Comorbidities.
- Medication.
- Educational level.
- Status of living.
- Prior falls.
- Walking aids.
- Alcohol consumption.
- Using multifocal lenses.
- Having dogs or cats in the household.
- Health-related quality of life using EQ-5D-3L by the EuroQol group
- Nutrition status.
- Symptoms of urinary incontinence, pain when walking and dizziness.
- Patient self-assessment as a measure of self-awareness of fall risk: Do you think that you could fall during the next year?
- Fear of falling using Short FES-I 7 item.
- Depression using Geriatric Depression Scale 4 item.
- Frailty using Tilburg Frailty Indicator.
- Activities of Daily Living using Vulnerable Elders Survey
- Orientation-Memory-Concentration test performed over the telephone
Blinding: Due to nature of the study design, all assessments of predictors for the outcome to be predicted, future falls, will be blinded.
- Conditions
- Accidental Fall, Fall
- Keywords
- Accidental falls, Prediction model
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls
Falls will be monitored using monthly prepaid fall calendars and validated by a phone call if a fall is registered. Also, circumstances of the fall will be asked about in the phone call.
Blinding:
Assessors of the outcome will be naturally blinded towards the predictors due to test results not being available before end of follow-up. Also, assessors of the outcome will be blinded to the questionnaire results by not having access to these in REDCap
Measured: 1 year follow up
Secondary outcomes (2)
Time consumption for the final prediction model
Time consumption for both the tests and questionnaire
Measured: After 6 months
Arrhythmias
Prevalence of arrhythmias will be calculated as the proportion of participants having arrhythmias in the study population at the time of the baseline measurements.
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start14 Jun 2018
- Primary completion18 Jul 2020
- Study completion18 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Valentin Blichfeldt Sørensen, Aalborg University Hospital
- Investigators
- Stig Andersen, MD, PhD, Study director, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608709
- Sponsor's protocol ID
- 2018-82
- Acronym
- PREFALL
- Status last verified
- Jan 2021
- First submitted
- 14 Jun 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gade GV, Jorgensen MG, Ryg J, Masud T, Jakobsen LH, Andersen S. Development of a multivariable prognostic PREdiction model for 1-year risk of FALLing in a cohort of community-dwelling older adults aged 75 years and above (PREFALL). BMC Geriatr. 2021 Jun 30;21(1):402. doi: 10.1186/s12877-021-02346-z.
PubMed 34193084
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multivariable Prognostic PREdiction Model for 1-year Risk of FALLing in Community-dwelling Older Adults in a Non-clinical Setting
- ClinicalTrials.gov ID
- NCT03608709
- Acronym / sponsor ID
- PREFALL / 2018-82
- Conditions
- Accidental Fall, Fall
- Keywords
- Accidental falls, Prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 1 Aug 2018 (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.
Falls in community-dwelling older adults is a frequent problem with an incidence of 30 % in over-65s and 50 % in over-80s. Incidences are expected to increase significantly in the future due to population aging. For instance, as of 2017, the global population older than 65 years is estimated to be 962 million and will increase to 1.4 and 2.1 billion in 2030 and 2050 respectively. In Denmark, falls are the most common accidents among older adults with around 36,000 fall accidents seen annually by the Danish health services and approximately 680 deaths yearly. This high frequency of fall accidents may also support the fact that falls in Denmark are the fourth most common reason for years lived with disability, thereby giving rise to reduced quality of life. Also, falls are associated with elevated morbidity, mortality, poorer physical functioning and early admission to long-term care facilities. Thus, this frequent and escalating problem of fall accidents is of major concern.
Fall prevention is therefore highly relevant. It is recognised that fall-preventive strategies should take on a multifaceted approach due the multifactorial aetiology of falls. This is substantiated by more than 400 risk factors of falling that have now been identified. These spread across different domains including socio-demographics, medical conditions (e.g. atrial fibrillation), medication, physical performance (e.g. reduced lower extremity strength or reaction time), psychology (e.g. depression or fear of falling) and cognition (e.g. global cognitive impairment or reduced executive functioning).
In order to aid health care professionals in targeting fall-preventive interventions, individual assessments of fall risk are imperative. In Denmark, municipalities are obliged to perform preventive initiatives to preserve the physical, mental and social health along with the functional capacity and quality of life of their older adults. The aim of these initiatives is to enable the older adults to live an independent and meaningful life for as long as possible. Recently, The Danish Health Authority released an updated manual to support this work. This emphasised the need for development of a validated prediction model to be used in a municipally environment to identify older adults at risk of falling. This is due to the abovementioned consequences of falls. To the knowledge of the authors, this is in line with literature being sparse on prognostic prediction models on falls in community-dwelling older adults with data collected outside a clinical environment (i.e. hospitals, GPs and screening or assessment centres).
Objectives:
Primary:
To develop and internally validate a multifactorial prognostic prediction model on fall risk in community-dwelling older adults in a non-clinical setting. The intended use of the model is, for municipalities, to identify and refer citizens with high risk of falls to fall-preventive interventions.
Secondary:
- To estimate time-consumption for the final prediction model.
- To describe the prevalence of arrhythmias in community-dwelling older adults.
Detailed description
Study design and sample size:
A prospective cohort study with 1-year follow-up will be performed in collaboration with the municipality of Hjørring, Denmark. A total sample size of 500 participants is expected. This was chosen due to economical and administrative reasons of the municipality contributing with personnel to include participants and collect data on predictors. Data for the development and internal validation of the model will originate from the same cohort.
Study setting, participants, data collectors, process of recruitment and data collection:
According to Danish legislation on health and social services, Danish municipalities are responsible for developing and initiating prophylactic and health-promoting initiatives for their senior citizens. This is done through different authorities in the municipality (e.g. preventive-home-visits, senior activity centres). Also, the municipality of Hjørring administers a local hall for citizens together with general- and patient associations. Therefore, data collection will be performed in participants' own homes through preventive-home-visits, at senior activity centres and at the local hall in the municipality of Hjørring, Denmark.
Predictors:
Data collection of predictors will be performed at baseline. The following predictors were chosen by an expert panel. Reasons are stated at each predictor. First, a brief summary on the process of how predictors were selected will be given followed by a short description of each predictor.
- Predictor selection process: A feasibility study. This model is intended for health care professionals in a non-clinical setting, in this case the municipality of Hjørring with a setting consisting of homes and activity centres. Therefore, it needs to be time-efficient, low-cost and practicable. In order to ease implementation if the model is successful in accuracy, the predictors for data collection was chosen by an expert panel on the basis of scientific value and experiences from a feasibility study performed as a precursor for this study.
The feasibility study investigated the feasibility of measuring a set of predictors, selected by the expert panel, with regards to time-consumption and user experiences both from participants and data collectors in order to ensure participant and public involvement. These predictors constituted the basis from which final selection for the prospective cohort study was performed.
In order to collect data on predictors in a time-efficient way. It was decided to collect these both by tests performed by data collectors and questionnaires filled out by study participants. All results from tests and questionnaire will be typed into REDCap (Research Electronic Data Capture, Vanderbilt University, Nashville, USA) electronic data capture tool hosted at Region Nordjylland, Denmark.
Tests:
- Arrhythmias: The investigator's study will be the first to investigate the prevalence of arrhythmias in a Danish population of older adults (+75 years old) by performing data collection in participants' own environments (i.e. own homes and activity centres). All participants will receive 5 days of 2-lead continuous heart rhythm monitoring (E-patch system, BioTelemetry Inc, Denmark).
- Lower limb reaction time: This was chosen since a slow reaction time was found in earlier studies to increase the risk of falling.12 Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).
- Unilateral lower extremity strength: This was chosen since a poor lower strength in lower extremities was found in earlier studies to increase the risk of falling. Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).
- Grip strength: This was chosen since a poor grip strength was found in earlier studies to increase the risk of frailty, which is associated to increased fall risk. Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).
- Balance with dual-tasking: This was chosen since a poor dual-tasking ability was found in earlier studies to an increased fall risk. Measurements will be performed using a Nintendo Wii Balance Board with appropriate software Fysiometer (Bronderslev, Denmark).31 Simultaneously, participants will be instructed mention as many things one can buy in a supermarket, while attempting to stand still on the board.
- Walking speed: This was chosen since a poor gait speed was found in earlier studies to an increased fall risk. Participants will be instructed to do a 4-meter walk at regular speed. Time spent will be noted using a stop watch. The fastest of the two measurements will be selected for further analysis.
- Physical activity: This will be measured using an accelerometer incorporated in the hearth rhythm monitoring device.
Questionnaire:
The following list specifies predictors of falls and participant characteristics that will be included in the questionnaire.
- Age.
- Gender.
- Comorbidities.
- Medication.
- Educational level.
- Status of living.
- Prior falls.
- Walking aids.
- Alcohol consumption.
- Using multifocal lenses.
- Having dogs or cats in the household.
- Health-related quality of life using EQ-5D-3L by the EuroQol group
- Nutrition status.
- Symptoms of urinary incontinence, pain when walking and dizziness.
- Patient self-assessment as a measure of self-awareness of fall risk: Do you think that you could fall during the next year?
- Fear of falling using Short FES-I 7 item.
- Depression using Geriatric Depression Scale 4 item.
- Frailty using Tilburg Frailty Indicator.
- Activities of Daily Living using Vulnerable Elders Survey
- Orientation-Memory-Concentration test performed over the telephone
Blinding: Due to nature of the study design, all assessments of predictors for the outcome to be predicted, future falls, will be blinded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The target group of PHVs is community-dwelling older adults primarily +75 years old. PHVs are not offered to citizens already receiving local authority home help except for those receiving help with cleaning. As of 2017, the target group of PHVs in the municipality of Hjørring consisted of approximately 4,800 community-dwelling older adults of which 2,053 received a PHV. We expect to include 400 participants from PHVs. Data collection will be performed by trained nurses. - The target group of SACs is primarily retirees (+65 years old), but also early retirees (+60 years old) with reduced physical, psychological or social functional capacity. As of 2018, 318 citizens of the target group attend SACs in the municipality of Hjørring weekly. We expect to include 100 participants from SACs. However, in case of economical, administrative or timing problems, this may alter in both PHV and SACs. The activity centres are staffed with health care workers collecting data for this study.
Key inclusion criteria (2 listed)
- Community-dwelling older adults
- 75 years old or above
Key exclusion criteria (4 listed)
- Presence of acute illness defined by the presence of a participant-reported experience of illness arisen within 7 days prior to inclusion impairing their everyday functioning in such a way that they opt out of social activities outside their homes while this state is present.
- Unable to understand Danish evaluated by the data collectors.
- Diagnosed with dementia.
- Unable to stand up for 60 seconds without support and visually fixate on an object at the same time. Support is defined by any assistive devices or help from another person.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of falls
Time frame: 1 year follow up
Falls will be monitored using monthly prepaid fall calendars and validated by a phone call if a fall is registered. Also, circumstances of the fall will be asked about in the phone call. Blinding: Assessors of the outcome will be naturally blinded towards the predictors due to test results not being available before end of follow-up. Also, assessors of the outcome will be blinded to the questionnaire results by not having access to these in REDCap
2 secondary outcomes
Time consumption for the final prediction model
Time frame: After 6 months
Arrhythmias
Time frame: After 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 34193084Gade GV, Jorgensen MG, Ryg J, Masud T, Jakobsen LH, Andersen S. Development of a multivariable prognostic PREdiction model for 1-year risk of FALLing in a cohort of community-dwelling older adults aged 75 years and above (PREFALL). BMC Geriatr. 2021 Jun 30;21(1):402. doi: 10.1186/s12877-021-02346-z.
- Individual participant dataSharing planned: No
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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.
Stig Andersen, MD, PhD study director
Aalborg University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Fall and Fall, run by Aalborg University Hospital at 5 sites in Denmark.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls (time frame: 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608709, which also lists 1 linked publication.
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 13 Jan 2021.