An interventional study of Interdisciplinary multicomponent interventions and Usual care in Fall, Aging and Parkinson Disease, sponsored by Azienda Unita' Sanitaria Locale Di Modena. Completed at 2 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by Azienda Unita' Sanitaria Locale Di Modena · Not applicable, Interventional, and Prevention
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.
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
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 366 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Azienda Unita' Sanitaria Locale Di Modena is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Time frame: Months 1 - Months 12
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Months 1 - Months 12
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Azienda Unita' Sanitaria Locale Di Modena