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Falls PreventionNCT03895021

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

A study testing Pisando Fuerte in people with Falls Prevention, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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"… Read more about this study

Who is it for?
Any age
Conditions the study is for
Falls Prevention
What is being tested?
Pisando Fuerte
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
25 Jun 2013to 15 Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Have fallen in the past year

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • North/Eastside Senior Coalition (NewBridge Madison)

    Madison, Wisconsin, 53704

  • Centro Hispano

    Milwaukee, Wisconsin, 53204

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pisando Fuerte
Keywords
falls prevention, Latino, Hispanic, Stepping On

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pisando FuerteBehavioural

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

Study groups in NCT03895021
Study groupRoleWhat they receive
InterventionExperimentalThis 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.
Receives: Behavioral: Pisando Fuerte

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Falls per person

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

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 1 week and 6 months

  4. 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%.

    Measured: 6 months

  5. Reach

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

    Measured: 6 months

  6. 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.

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start25 Jun 2013
  3. Primary completion15 Dec 2015
  4. Study completion15 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895021
Sponsor's protocol ID
2013-1311
Status last verified
Jul 2019
First submitted
27 Mar 2019
Last updated
22 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28877746

  • 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.

    PubMed 15367063

  • 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.

    PubMed 27997482

  • 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.

    PubMed 28265557

  • 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.

    PubMed 31533636

Questions about this trial

What is this clinical trial studying?

A study testing Pisando Fuerte in people with Falls Prevention, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Falls per person (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895021, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.

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