- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895021
"Stepping On" to Pisando Fuerte: Adapting an Evidence-Based Falls Prevention Program for Latino Seniors
Study Overview
Detailed Description
Stepping On is an evidence-based falls prevention program for community-dwelling persons 65+. It uses principles of self-efficacy in 2-hour sessions held once a week for 7 weeks + one home visit to review principles learned in class and one booster class after 3 months.
The program, developed and researched in Australia, was found to reduce falls by 30%. It was brought to the U.S. in 2006 by the Kenosha County Aging Division in collaboration with Dr. Jane Mahoney, U.W. Madison and other Wisconsin partners using foundation and state funding. Funding from the CDC provided the opportunity to adapt the program for widespread dissemination in the United States. In addition preliminary work was done on translating and culturally adapting Stepping On for the Latino community. The adapted program, known as Pisando, was offered as a pilot class at the United Community Center in Milwaukee in 2012. Further revisions were made to the program based on the experience at the pilot classes and advice from the advisory board, but questions remained about some key areas of workshop format.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53704
- North/Eastside Senior Coalition (NewBridge Madison)
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Milwaukee, Wisconsin, United States, 53204
- Centro Hispano
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have fallen in the past year
Exclusion Criteria:
- Living arrangement does not include a kitchen of their own (i.e., independent living)
- Unable to walk without help from another person, ambulate independently
- Reliant on a walker to get around inside of home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Intervention
This multifaceted, adapted program focuses preventing falls through balance and strength exercises, teachings from guest experts (e.g., PT, Pharmacist, vision) and at-home safety education.
Participants attended weekly 2-hour group sessions (8 -12 persons) over the course of 8 weeks delivered in Spanish by trained Hispanic/Latino personnel in two communities in Wisconsin.
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"Pisando Fuerte", a linguistically and culturally appropriate version for Spanish speakers of an evidence-based fall prevention program ("Stepping On" [SO]).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Falls per person
Time Frame: 6 months
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To help test effectiveness; direct empirical evidence.
Results will be reported as an average number.
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6 months
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Falls Behavioral Scale (FaB)
Time Frame: 6 months
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To help test implementation; direct empirical evidence.
Shortened Fall Behavioral Scale (FaB) scale, a 24-item validated tool that assesses the presence of protective behaviors for falls in older adults using a scale between 0 (not at all) and 4 (very much).
High scores indicate the safest behaviors and low scores indicate risky behaviors.
Total averaged scores range from 1-4.
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6 months
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Fidelity of Enactment
Time Frame: 1 week and 6 months
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To help test implementation; proxy empirical evidence.
This is an assessment of fidelity of participants' whom engaged in intermediary falls prevention behaviors after Pisando Fuerte ended (two time-points: at 1-week post-intervention and 6 months post-intervention), expressed as a percentage.
Falls prevention behavior measures include: exercise adherence, elimination of at-home falls hazards, and adjustments to walking form and standing posture.
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1 week and 6 months
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Fidelity of delivery
Time Frame: 6 months
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To help test implementation; direct empirical evidence.
This is an assessment of fidelity of trained Pisando Fuerte leaders' delivery of the program's key elements (as determined in the original Stepping On program), expressed as a percentage for each component/element.
Elements measured for fidelity of delivery include: Adult Learning, Program Aspects, Exercise Element, Upgrading Exercise, Background & Training of Group Leader, Group Leader's Role, Elements of Peer Co-leader Role, and Cultural Adaption (specific to Pisando Fuerte, not included in Stepping On).
The benchmark to be considered sufficient fidelity of delivery is 80%.
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6 months
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Reach
Time Frame: 6 months
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Number of individuals screened, enrolled, completed program; direct empirical evidence
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6 months
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Timed Up and Go (TUG)
Time Frame: Up to 8 weeks
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Assess mobility, balance, walking ability and fall risk in older adults.
Assessors used the following instruction: "Levantese de la silla, camine 10 pies a un paso cómodo, gire, y regrese a la silla a sentarse otra vez", which translates to: "Stand up from the chair, walk 10 feet using a comfortable pace, turn around, and walk back and sit down."
An older adult who takes 12+ seconds to complete is considered at risk for falling.
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Up to 8 weeks
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Collaborators and Investigators
Publications and helpful links
General Publications
- Aarons GA, Sklar M, Mustanski B, Benbow N, Brown CH. "Scaling-out" evidence-based interventions to new populations or new health care delivery systems. Implement Sci. 2017 Sep 6;12(1):111. doi: 10.1186/s13012-017-0640-6.
- Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
- Ford JH 2nd, Abramson B, Wise M, Dattalo M, Mahoney JE. Bringing Healthy Aging to Scale: A Randomized Trial of a Quality Improvement Intervention to Increase Adoption of Evidence-Based Health Promotion Programs by Community Partners. J Public Health Manag Pract. 2017 Sep/Oct;23(5):e17-e24. doi: 10.1097/PHH.0000000000000503.
- Mahoney JE, Clemson L, Schlotthauer A, Mack KA, Shea T, Gobel V, Cech S. Modified Delphi Consensus to Suggest Key Elements of Stepping On Falls Prevention Program. Front Public Health. 2017 Feb 20;5:21. doi: 10.3389/fpubh.2017.00021. eCollection 2017.
- Mora Pinzon M, Myers S, Jacobs EA, Ohly S, Bonet-Vazquez M, Villa M, Castro A, Mahoney J. "Pisando Fuerte": an evidence-based falls prevention program for Hispanic/Latinos older adults: results of an implementation trial. BMC Geriatr. 2019 Sep 18;19(1):258. doi: 10.1186/s12877-019-1273-1.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-1311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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