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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Italy

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.

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 groups in NCT03592420
Study groupRoleWhat they receive
Interdisciplinary interventionsExperimentalMulticomponent 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 careActive 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.
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Months 1 - Months 12

Secondary outcomes (8)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted19 Jul 2018
  2. Study start31 Dec 2014
  3. Primary completion31 Dec 2016
  4. Study completion30 Jun 2017

Resources

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)
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 22972103

  • 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.

    PubMed 22094550

  • 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.

    PubMed 23350947

  • 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.

    PubMed 36119666

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.

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