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

NCT03895021 | Completed

• 1 other identifier: 2013-1311
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Falls Prevention

Keywords

falls prevention; Latino; Hispanic; Stepping On

Outcome Measures

Primary Outcomes (6)

• Falls per person

  To help test effectiveness; direct empirical evidence. Results will be reported as an average number.

  6 months

• 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

• 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

• 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

• Reach

  Number of individuals screened, enrolled, completed program; direct empirical evidence

  6 months

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Pisando Fuerte

Interventions

Pisando Fuerte BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Have fallen in the past year

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• United Community Center: collaborator
• Centro Hispano: collaborator
• North/Eastside Senior Coalition: collaborator
• Latino Health Council: collaborator
• Greater Wisconsin Agency on Aging Resources: collaborator
• Community-Academic Aging Research Network: collaborator

Study Sites (2)

North/Eastside Senior Coalition (NewBridge Madison)

Madison, Wisconsin, 53704, United States

Location

Centro Hispano

Milwaukee, Wisconsin, 53204, United States

Location

Related Publications (5)

• 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.

  PMID: 28877746 BACKGROUND

• 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.

  PMID: 15367063 BACKGROUND

• 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.

  PMID: 27997482 BACKGROUND

• 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.

  PMID: 28265557 BACKGROUND

• 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.

  PMID: 31533636 DERIVED

Study Officials

• Jane E Mahoney, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: June 25, 2013
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)