"Stepping On" to Pisando Fuerte: Adapting an Evidence-Based Falls Prevention Program for Latino Seniors

Falls Prevention Clinical Trial

Official title:

"Stepping On" to Pisando Fuerte: Adapting an Evidence-Based Falls Prevention Program for Latino Seniors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895021
• Other study ID #: 2013-1311
• Status: Completed
• Phase: N/A
• Start date: June 25, 2013
• Est. completion date: December 15, 2015

Study information

• Verified date: July 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are no evidence-based fall prevention programs for Hispanic/Latinos even though their age-adjusted death rate from unintentional falls is climbing in the US. "Pisando Fuerte", a linguistically and culturally appropriate version of an evidence-based fall prevention program for Spanish speakers ("Stepping On" [SO]) is evaluated. "Pisando Fuerte" consists of 2-hour group sessions over the course of 8 weeks delivered in Spanish by trained Hispanic/Latino personnel in two communities in Wisconsin. Implementation and intervention fidelity were evaluated by an independent assessor on three sessions using a-priori criteria based on key elements of SO. Uptake, proximal and distal outcomes were assessed through interviews 6 months after the program.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 15, 2015
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Falls Prevention

Intervention

Behavioral:
• Pisando Fuerte
"Pisando Fuerte", a linguistically and culturally appropriate version for Spanish speakers of an evidence-based fall prevention program ("Stepping On" [SO]).

Locations

Country	Name	City	State
United States	North/Eastside Senior Coalition (NewBridge Madison)	Madison	Wisconsin
United States	Centro Hispano	Milwaukee	Wisconsin

Sponsors (7)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Centro Hispano, Community-Academic Aging Research Network, Greater Wisconsin Agency on Aging Resources, Latino Health Council, North/Eastside Senior Coalition, United Community Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls per person	To help test effectiveness; direct empirical evidence. Results will be reported as an average number.	6 months
Primary	Falls Behavioral Scale (FaB)	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.	6 months
Primary	Fidelity of Enactment	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.	1 week and 6 months
Primary	Fidelity of delivery	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%.	6 months
Primary	Reach	Number of individuals screened, enrolled, completed program; direct empirical evidence	6 months
Primary	Timed Up and Go (TUG)	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.	Up to 8 weeks