PRE.C.I.S.A - Fall Prevention and Promotion of Active and Healthy Aging

Stroke Clinical Trial

— PRECISA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592420
• Other study ID #: PRUA2-2013-00002056
• Status: Completed
• Phase: N/A
• Start date: December 31, 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2018
• Source: Azienda Unita' Sanitaria Locale Di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Disease and/or previous Stroke.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: June 30, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Fall
• Parkinson Disease
• Stroke

Intervention

Behavioral:
• Interdisciplinary multicomponent interventions

• Usual care
standard care

Locations

Country	Name	City	State
Italy	Nuovo Ospedale Civile Sant'Agostino Estense	Modena
Italy	Arcispedale "Santa Maria Nuova" di Reggio Emilia	Reggio Emilia

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Unita' Sanitaria Locale Di Modena	Arcispedale Santa Maria Nuova-IRCCS, Azienda Ospedaliero-Universitaria di Modena, Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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;(9):CD007146. doi: 10.1002/14651858.CD007146.pub3. R — View Citation

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( — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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