PRE.C.I.S.A - Fall Prevention and Promotion of Active and Healthy Aging
PRECISA
Efficacy of a Multifactorial and Personalized Program for Fall Prevention in Community-dwelling Elderly in Comparison to the Usual Care: a Randomized Controlled Trial
1 other identifier
interventional
366
1 country
2
Brief 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 Disease and/or previous Stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedFirst Submitted
Initial submission to the registry
June 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedJuly 19, 2018
July 1, 2018
2 years
June 25, 2018
July 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Months 1 - Months 12
Secondary Outcomes (8)
Risk of falling at 12 months from enrolment
Months 1 - Months 12
Percentage of falls associated to hospital admission at 12 months from enrolment
Months 1 - Months 12
Severity of the fall
Months 1 - Months 12
Mortality attributable to fall
Months 1 - Months 12
Fall-free interval time
Months 1 - Months 12
- +3 more secondary outcomes
Study Arms (2)
Interdisciplinary interventions
EXPERIMENTALMulticomponent 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 COMPARATORUsual 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nuovo Ospedale Civile Sant'Agostino Estense
Modena, 41121, Italy
Arcispedale "Santa Maria Nuova" di Reggio Emilia
Reggio Emilia, 42121, Italy
Related Publications (4)
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.
PMID: 22972103RESULTWeiss 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.
PMID: 22094550RESULTSchoene 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.
PMID: 23350947RESULTLa 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.
PMID: 36119666DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio La Porta, MD
AZIENDA USL DI MODENA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2018
First Posted
July 19, 2018
Study Start
December 31, 2014
Primary Completion
December 31, 2016
Study Completion
June 30, 2017
Last Updated
July 19, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share