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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Parkinson Disease; Aging; Fall
• Intervention / Treatment: Behavioral: Interdisciplinary multicomponent interventions; Behavioral: Usual care

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 Type: Interventional
• Enrollment (Actual): 366
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41121
    • Nuovo Ospedale Civile Sant'Agostino Estense
  • Reggio Emilia, Italy, 42121
    • Arcispedale "Santa Maria Nuova" di Reggio Emilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Community-dwelling elderly (aged ≥65 years)
2. Moderate to high fall risk, either associated to aging or to neurological diseases as Parkinson's Disease and stroke.
3. Ability to walk 10 meters without assistance (walking aid permitted)
4. Informed consent to participation

Exclusion Criteria:

1. Whatever concurrent medical condition which may constitutes a contraindication to physical exercise
2. 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
3. Severe hearing impairment, so that a subject will not understand less than 80% of ordinary conversation with/or without hearing aids.
4. 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).
5. Severe aphasia or visuo-spatial deficits, to the extent that these impairments will limit significantly the ability to comprehend (orally or visually) simple instructions.
6. Acute vertigo or dizziness lasting less than 3 months
7. Regular participation to other exercise program that it is likely to challenge balance, including physical therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interdisciplinary interventions; 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	Behavioral: Interdisciplinary multicomponent interventions
Active Comparator: Usual care; 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.	Behavioral: Usual care; standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	Months 1 - Months 12

Collaborators and Investigators

• Sponsor: Azienda Unita' Sanitaria Locale Di Modena
• Collaborators: Azienda Ospedaliero-Universitaria di Modena; Azienda Unita Sanitaria Locale Reggio Emilia; Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: Fabio La Porta, MD, Azienda USL di Modena

Publications and helpful links

General 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.
• Weiss 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.
• Schoene 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.
• La 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Stroke; Parkinson's Disease; Clinical trial; Education; Aged; Accidental falls
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PRUA2-2013-00002056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No