FallPRECISANCT03592420
PRE.C.I.S.A - Fall Prevention and Promotion of Active and Healthy Aging
A study testing Interdisciplinary multicomponent interventions in people with Fall and Aging, run by Azienda Unita' Sanitaria Locale Di Modena at 2 sites in Italy.
Trial summary
Randomized Controlled Trial (RCT) aiming at assessing the efficacy of an interdisciplinary multi-component and personalized multi-factorial intervention for reducing falls at one year post-enrolment in comparison to the usual care in a sample of community dwelling elderly (age ≥65 years), with or without Parkinson's… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Aging, Parkinson Disease
- What is being tested?
- Interdisciplinary multicomponent interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 2 sitesItaly
- Study dates
- 31 Dec 2014to 30 Jun 2017
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling elderly (aged ≥65 years)
- Moderate to high fall risk, either associated to aging or to neurological diseases as Parkinson's Disease and stroke.
- Ability to walk 10 meters without assistance (walking aid permitted)
- Informed consent to participation
Who cannot join
- Whatever concurrent medical condition which may constitutes a contraindication to physical exercise
- Known cognitive decline or an established diagnosis of dementia (mini mental score >24) or an evident cognitive decline on pre-enrolment which would be likely to impair the ability of comprehension of simple instructions and / or of collaborating
- Severe hearing impairment, so that a subject will not understand less than 80% of ordinary conversation with/or without hearing aids.
- Severe hypovision, not counteracted by lenses, which will limit the patient in executing at least one activity of daily living (for instance, necessity of assistance for walking because of visual deficit).
- Severe aphasia or visuo-spatial deficits, to the extent that these impairments will limit significantly the ability to comprehend (orally or visually) simple instructions.
- Acute vertigo or dizziness lasting less than 3 months
- Regular participation to other exercise program that it is likely to challenge balance, including physical therapy.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Nuovo Ospedale Civile Sant'Agostino Estense
Modena, 41121
Arcispedale "Santa Maria Nuova" di Reggio Emilia
Reggio Emilia, 42121
About this study
Official title: Efficacy of a Multifactorial and Personalized Program for Fall Prevention in Community-dwelling Elderly in Comparison to the Usual Care: a Randomized Controlled Trial
Randomized Controlled Trial (RCT) aiming at assessing the efficacy of an interdisciplinary multi-component and personalized multi-factorial intervention for reducing falls at one year post-enrolment in comparison to the usual care in a sample of community dwelling elderly (age ≥65 years), with or without Parkinson's Disease and/or previous Stroke.
Read the detailed description
BACKGROUND: Current literature on fall prevention for community-dwelling elderly who are at risk of falling suggests that: 1) either single, multicomponent or multifactorial interventions are effective at preventing falls; 2) elderly at risk of falling with Parkinson's Disease (PD) and previous Stroke, although having an even greater risk of falling, are often excluded by these interventions; 3) often, present screening methods for risk of falling do not allow the early identification of subjects at risk before the first fall.
AIMS
- To compare the efficacy of an interdisciplinary multicomponent and personalized multifactorial intervention aiming at reducing falls in comparison to the usual care, in a sample of community dwelling elderly, with or without Parkinson's Disease and/or previous Stroke, within the context of an RCT.
- To improve the accuracy of screening tests for risk of falling by using wearable inertial sensors.
- To develop a reduced set of clinical and instrumental indicators, to be utilized as a quick and reliable screening tests in outpatients clinics.
METHODS: multicenter, randomized controller trial, with blind assessments on pretest, postest and on one-year follow-up.
POPULATION: community-dwelling elderly (aged ≥65 years) with age-related or neurological condition-related (Parkinson's Disease and/or Stroke) risk of falling.
INTERVENTION: interdisciplinary multi-component (group-based exercise; home-based exercise; increasing knowledge/education; home safety interventions) and personalized multi-factorial interventions (assessment and treatment of individual fall risk factors) CONTROL: structured information about participant's own personal risk factors given to the family doctor.
OUTCOMES: The primary endpoint is the fall rate at one year in both groups. The secondary endpoint is the fall risk at one year.
EXPECTED RESULTS: in the intervention group, a significant reduction in the number of total fall is expected, together with decreases indicators of utilization of acute health services because of falls. At three months, it is expected a significant improvement of functioning (motor functions, activity and participation) and health quality indicators.
- Conditions
- Fall, Aging, Parkinson Disease, Stroke
- Being tested
- Interdisciplinary multicomponent interventions, Usual care
- Keywords
- Accidental falls, Clinical trial, Aged, Parkinson's Disease, Stroke, Exercise, Education
- Medical subject headings
- Parkinson Disease, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary multicomponent interventionsBehavioural
Usual careBehavioural
standard care
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary interventions | Experimental | Multicomponent interventions
* On-site supervised group exercise program (11 weeks)
* Educational / behavioral sessions addressing specific behavioral and environmental risk factors for falls delivered by trained health professionals (11 sessions in total)
* Home visits for suggestion and implementations of safety interventions aiming at reducing environmental hazards
* Home-based exercise program: Personalized multi-factorial interventions: patients will have geriatric, neurology and physiatrist outpatient referrals to assess and treat individual risk factors.
Personalized multi-factorial interventions. Patients will have geriatric, neurology and physiatrist outpatient referrals to assess and treat individual risk factors Receives: Behavioral: Interdisciplinary multicomponent interventions |
| Usual care | Active comparator | Usual care: after pre-test assessment and randomization, participants in the control group will be given a structured booklet with detailed information about participant's own personal risk factors (fall risk profile) to be given to the family doctor, together with an information booklet on fall risk factors and their prevention. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rate at 12 months from enrolment
The primary endpoint will be the total number of falls (fall rate) occurred in each arm within 12 months from enrolment. This endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Secondary outcomes (8)
Risk of falling at 12 months from enrolment
This secondary endpoint will be calculated as the number of patients with at least one falls within 12 months from enrolment. This endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Percentage of falls associated to hospital admission at 12 months from enrolment
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Severity of the fall
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Mortality attributable to fall
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Fall-free interval time
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Total number of A&E accesses attributable to falls
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Risk of A&E access attributable to falls
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Length of stay as inpatient attributable to falls
This secondary endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
Measured: Months 1 - Months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start31 Dec 2014
- Primary completion31 Dec 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unita' Sanitaria Locale Di Modena
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Modena, Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Sponsor
- Investigators
- Fabio La Porta, MD, Principal investigator, AZIENDA USL DI MODENA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592420
- Sponsor's protocol ID
- PRUA2-2013-00002056
- Acronym
- PRECISA
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
PubMed 22972103Weiss A, Herman T, Plotnik M, Brozgol M, Giladi N, Hausdorff JM. An instrumented timed up and go: the added value of an accelerometer for identifying fall risk in idiopathic fallers. Physiol Meas. 2011 Dec;32(12):2003-18. doi: 10.1088/0967-3334/32/12/009. Epub 2011 Nov 17.
PubMed 22094550Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.
PubMed 23350947La Porta F, Lullini G, Caselli S, Valzania F, Mussi C, Tedeschi C, Pioli G, Bondavalli M, Bertolotti M, Banchelli F, D'Amico R, Vicini R, Puglisi S, Clerici PV, Chiari L; PRECISA Group. Efficacy of a multiple-component and multifactorial personalized fall prevention program in a mixed population of community-dwelling older adults with stroke, Parkinson's Disease, or frailty compared to usual care: The PRE.C.I.S.A. randomized controlled trial. Front Neurol. 2022 Sep 1;13:943918. doi: 10.3389/fneur.2022.943918. eCollection 2022.
PubMed 36119666
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multifactorial and Personalized Program for Fall Prevention in Community-dwelling Elderly in Comparison to the Usual Care: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03592420
- Acronym / sponsor ID
- PRECISA / PRUA2-2013-00002056
- Conditions
- Fall, Aging, Parkinson Disease, Stroke
- Keywords
- Accidental falls, Clinical trial, Aged, Parkinson's Disease, Stroke, Exercise, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Azienda Unita' Sanitaria Locale Di ModenaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Modena, Azienda USL Reggio Emilia - IRCCS
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 19 Jul 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.
Randomized Controlled Trial (RCT) aiming at assessing the efficacy of an interdisciplinary multi-component and personalized multi-factorial intervention for reducing falls at one year post-enrolment in comparison to the usual care in a sample of community dwelling elderly (age ≥65 years), with or without Parkinson's Disease and/or previous Stroke.
Detailed description
BACKGROUND: Current literature on fall prevention for community-dwelling elderly who are at risk of falling suggests that: 1) either single, multicomponent or multifactorial interventions are effective at preventing falls; 2) elderly at risk of falling with Parkinson's Disease (PD) and previous Stroke, although having an even greater risk of falling, are often excluded by these interventions; 3) often, present screening methods for risk of falling do not allow the early identification of subjects at risk before the first fall.
AIMS
- To compare the efficacy of an interdisciplinary multicomponent and personalized multifactorial intervention aiming at reducing falls in comparison to the usual care, in a sample of community dwelling elderly, with or without Parkinson's Disease and/or previous Stroke, within the context of an RCT.
- To improve the accuracy of screening tests for risk of falling by using wearable inertial sensors.
- To develop a reduced set of clinical and instrumental indicators, to be utilized as a quick and reliable screening tests in outpatients clinics.
METHODS: multicenter, randomized controller trial, with blind assessments on pretest, postest and on one-year follow-up.
POPULATION: community-dwelling elderly (aged ≥65 years) with age-related or neurological condition-related (Parkinson's Disease and/or Stroke) risk of falling.
INTERVENTION: interdisciplinary multi-component (group-based exercise; home-based exercise; increasing knowledge/education; home safety interventions) and personalized multi-factorial interventions (assessment and treatment of individual fall risk factors) CONTROL: structured information about participant's own personal risk factors given to the family doctor.
OUTCOMES: The primary endpoint is the fall rate at one year in both groups. The secondary endpoint is the fall risk at one year.
EXPECTED RESULTS: in the intervention group, a significant reduction in the number of total fall is expected, together with decreases indicators of utilization of acute health services because of falls. At three months, it is expected a significant improvement of functioning (motor functions, activity and participation) and health quality indicators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary interventions | Experimental | Behavioral: Interdisciplinary multicomponent interventionsMulticomponent interventions * On-site supervised group exercise program (11 weeks) * Educational / behavioral sessions addressing specific behavioral and environmental risk factors for falls delivered by trained health professionals (11 sessions in total) * Home visits for suggestion and implementations of safety interventions aiming at reducing environmental hazards * Home-based exercise program: Personalized multi-factorial interventions: patients will have geriatric, neurology and physiatrist outpatient referrals to assess and treat individual risk factors. Personalized multi-factorial interventions. Patients will have geriatric, neurology and physiatrist outpatient referrals to assess and treat individual risk factors |
| Usual care | Active comparator | Behavioral: Usual careUsual care: after pre-test assessment and randomization, participants in the control group will be given a structured booklet with detailed information about participant's own personal risk factors (fall risk profile) to be given to the family doctor, together with an information booklet on fall risk factors and their prevention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-dwelling elderly (aged ≥65 years)
- Moderate to high fall risk, either associated to aging or to neurological diseases as Parkinson's Disease and stroke.
- Ability to walk 10 meters without assistance (walking aid permitted)
- Informed consent to participation
Key exclusion criteria (7 listed)
- Whatever concurrent medical condition which may constitutes a contraindication to physical exercise
- Known cognitive decline or an established diagnosis of dementia (mini mental score >24) or an evident cognitive decline on pre-enrolment which would be likely to impair the ability of comprehension of simple instructions and / or of collaborating
- Severe hearing impairment, so that a subject will not understand less than 80% of ordinary conversation with/or without hearing aids.
- Severe hypovision, not counteracted by lenses, which will limit the patient in executing at least one activity of daily living (for instance, necessity of assistance for walking because of visual deficit).
- Severe aphasia or visuo-spatial deficits, to the extent that these impairments will limit significantly the ability to comprehend (orally or visually) simple instructions.
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 |
|---|---|---|
| Interdisciplinary multicomponent interventions | Behavioural | Interdisciplinary interventions |
| Usual carestandard care | Behavioural | Usual care |
Primary outcome
Fall rate at 12 months from enrolment
Time frame: Months 1 - Months 12
The primary endpoint will be the total number of falls (fall rate) occurred in each arm within 12 months from enrolment. This endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
8 secondary outcomes
Risk of falling at 12 months from enrolment
Time frame: Months 1 - Months 12
Percentage of falls associated to hospital admission at 12 months from enrolment
Time frame: Months 1 - Months 12
Severity of the fall
Time frame: Months 1 - Months 12
Mortality attributable to fall
Time frame: Months 1 - Months 12
Fall-free interval time
Time frame: Months 1 - Months 12
Total number of A&E accesses attributable to falls
Time frame: Months 1 - Months 12
Risk of A&E access attributable to falls
Time frame: Months 1 - Months 12
Length of stay as inpatient attributable to falls
Time frame: Months 1 - Months 12
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 19 Jul 2018.
- Results publication: PubMed 22972103Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
- Results publication: PubMed 22094550Weiss A, Herman T, Plotnik M, Brozgol M, Giladi N, Hausdorff JM. An instrumented timed up and go: the added value of an accelerometer for identifying fall risk in idiopathic fallers. Physiol Meas. 2011 Dec;32(12):2003-18. doi: 10.1088/0967-3334/32/12/009. Epub 2011 Nov 17.
- Results publication: PubMed 23350947Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.
- Derived from this study: PubMed 36119666La Porta F, Lullini G, Caselli S, Valzania F, Mussi C, Tedeschi C, Pioli G, Bondavalli M, Bertolotti M, Banchelli F, D'Amico R, Vicini R, Puglisi S, Clerici PV, Chiari L; PRECISA Group. Efficacy of a multiple-component and multifactorial personalized fall prevention program in a mixed population of community-dwelling older adults with stroke, Parkinson's Disease, or frailty compared to usual care: The PRE.C.I.S.A. randomized controlled trial. Front Neurol. 2022 Sep 1;13:943918. doi: 10.3389/fneur.2022.943918. eCollection 2022.
- 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.
Fabio La Porta, MD principal investigator
AZIENDA USL DI MODENA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary multicomponent interventions in people with Fall and Aging, run by Azienda Unita' Sanitaria Locale Di Modena at 2 sites in Italy.
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: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Fall rate at 12 months from enrolment (time frame: Months 1 - Months 12). 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 NCT03592420, which also lists 4 linked publications.
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 19 Jul 2018.