Steady Stride Fall Prevention Protocol vs Standard of Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSteady Strides: Fall Prevention and Stroke Rehabilitation Medical Institute
About this trial
Falls are the leading cause of preventable morbidity and mortality in community dwelling older US adults (65 years old and older) . This is a research study to evaluate the comparative effectiveness of the structured physiatry-based Steady Strides Fall Prevention Protocol compared to the standard of care treatment provided by primary care providers in preventing falls in community-dwelling older adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Steady Strides
Other interventionParticipants in the control arm will receive a one-time assessment by a trained research assistant at baseline and once more at 2 month follow up. Research assistant will measure and document the specified demographic and clinical variables to be compared between the control and intervention groups. Participants in the intervention arm will receive a multifactorial intervention, including: Medical Intervention: Provided by physician(s) and/or nurse practitioners (NPs) or physician assistants (PAs) trained in the Steady Strides fall prevention protocol via the hybrid online and in person course on the Steady Strides fall prevention protocol . Rehabilitation Intervention: Provided by occupational therapists (OTs) and physical therapists (PTs) trained through a hybrid online and in person course on the Steady Strides fall prevention protocol
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Steady StridesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Falls
The primary outcome is self-reported total number of falls during the 6 months of the follow up period after the 2 month intervention. Values 0-100. Lower number are better functioning. Falls were defined as "unintentionally coming to the ground or some lower level and other than as a consequence of sustaining a violent blow, loss of consciousness, sudden onset of paralysis as in stroke or an epileptic seizure."
Time frame
Total falls reported after completion of the intervention 6 months after the intervention.Secondary outcomes
1
Fall-Related Morbidity-number of hospitalizations or ED visits
number of hospitalizations or ED visits. Possible values 0-100, lower number better function.
Time frame
assessed monthly at months 1-82
Fall Risk
Assessed using Single Leg Stance. Seconds, 0-100. Higher numbers are better
Time frame
Assessed at the completion of the intervention (2 months after the first visit)3
Fall-Related Healthcare Utilization
Self reported number of Days in Hospital or in Nursing Home/Subacute Rehab Facility due to falls in the past month. values 0-100, less is better functioning.
Time frame
baseline and monthly for 8 months4
Fear of Falls
FES-I (Falls Efficacy Scale - International): Measures fear of falling during daily activities. Values 16-64, lower numbers are better functioning
Time frame
Assessed at the completion of the intervention (2 months after the first visit)Sponsors and contacts
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Source ClinicalTrials.gov