Implementation of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons (BE-EMPOWERed)

BE-EMPOWERed Study: Belgian Study Enhancing the Uptake and the Effectiveness of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons

Approximately 24 to 40% community-dwelling older persons fall annually, of which 21 to 45% fall recurrently. Many factors contribute to the risk of falling, such as mobility impairment, medication use, environmental issues and risk behavior. Falls are associated with an increased risk of morbidity and mortality and often lead to physical and psychosocial consequences. Falls and related injuries have a huge economic impact on society. Given its proven efficacy as shown by controlled trials, multifactorial falls prevention interventions are recommended as primary strategy. However, poor implementation in daily clinical practice leads to inconclusive results on clinical outcomes. Several studies show that implementation, effectiveness and context are linked. Context is a critical concept to understand variation in implementation and clinical outcomes. Therefore, it is necessary to comprehensively understand the context prior to implementation.To date, the context and tailored implementation are neglected in the majority of falls prevention research. Given this, this Belgian study aims to Enhance the uptake and the Effectiveness of a Multifactorial falls Prevention intervention in Older community-dWElling peRsons (BE-EMPOWERed).

Study Overview

• Status: Completed
• Conditions: Older People; Implementation; Falls Prevention
• Intervention / Treatment: Other: BE-EMPOWERed program

Detailed Description

The overall objective is to comprehensively evaluate the BE-EMPOWERed program on clinical and implementation outcomes and assess the implementation processes.The BE-EMPOWERed program consists of a multifactorial falls prevention intervention in older persons and strategies to implement the intervention, both tailored to the community setting in Belgium (Flanders).

Aim: To implement the BE-EMPOWERed program in 4 primary care areas in Belgium (Flanders) and to explore the effectiveness on clinical outcomes and to assess the implementation process and outcomes in a mixed methods study with a convergent parallel design.

i. To explore the effectiveness of the BE-EMPOWERed program on fear of falling.

ii. To assess the implementation outcomes for the BE-EMPOWERed program such as: reach, fidelity, feasibility, acceptability, sustainability and implementation costs.

iii. To understand the implementation process of the BE-EMPOWERed program from the perspective of the older persons, healthcare professionals, local service centers and local policy makers.

Overall methodology: We use Intervention Mapping in line with the Medical Research Council (MRC) framework for developing and evaluating the BE-EMPOWERed program.

A stakeholder group is installed and meets twice each year during the development, implementation and evaluation (October 2020 - December 2025). It includes 21 participants: two physiotherapists, an occupational therapist, a geriatrician and a pharmacist; a representative of the local service centers in Flanders, of the Flemish council of older persons and of Flanders Institute of Healthy Living and two representatives of 'Lokaal Gezondheids Overleg' (LOGO); a researcher in occupational therapy; a researcher in physiotherapy and a researcher with expertise in implementation science; a staff member of a home care nursing organization, of an organization of home health aides, of an organization that represents family caregivers and home care districts in Flanders, of an organization that represents general practitioners, of a Belgian sickness funds and of the Center of Expertise for Falls and Fracture Prevention Flanders; a policy maker of the Flemish Government and a coach for older persons.

Setting: Flanders has 6.7 million inhabitants, has five provinces and consists of 59 primary care areas. A primary care area is developed by the Flemish Government and is network of primary care providers in a geographically defined area; with the objective to exchange knowledge and information and to coordinate their activities. The study takes place in 4 primary care areas.

Evaluation: A mixed methods study with a convergent parallel design in 4 primary care areas. A variety of methods are being used to collect data on implementation outcomes and process such as self-reported implementation costs, surveys, interviews and focus groups.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria group program:

• Community-dwelling
• 65 years and over
• Independent with or without walking aid
• Understanding and speaking of the Dutch language
• Experienced one or more of the following events in the past year? (1) one or more falls; or (2) mobility or balance problems; or (3) concerns about falling

Exclusion Criteria group program:

- Neurological and cognitive problems (Parkinson, CVA, dementia, delirium)

Inclusion Criteria workshops:

• Healthcare professionals
• Working in the primary care area
• Understanding and speaking of the Dutch language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: BE-EMPOWERed program; The BE-EMPOWERed program entails a group program for older people, workshops for healthcare professionals and a 6-steps implementation plan for primary care areas. The group program for older people is based on the main principles of the Australian multifactorial falls prevention program 'Stepping On'. The workshops for healthcare professionals focus on the multifactorial falls prevention approach, reimbursement of healthcare costs, referrals to other healthcare professionals and motivational interviewing. The Implementation plan consists of 6-steps: 1. enable support, 2. map baseline situation, 3. define objectives and priorities, 4. plan implementation, 5. implementation and 6. evaluation, adjust and work towards sustainability. Last, to support the primary care areas, implementation facilitators were trained.

Other: BE-EMPOWERed program; The BE-EMPOWERed program entails a group program for older people, workshops for healthcare professionals and a 6-steps implementation plan for primary care areas. The group program for older people is based on the main principles of the Australian multifactorial falls prevention program 'Stepping On'. The workshops for healthcare professionals focus on the multifactorial falls prevention approach, reimbursement of healthcare costs, referrals to other healthcare professionals and motivational interviewing. The Implementation plan consists of 6-steps: 1. enable support, 2. map baseline situation, 3. define objectives and priorities, 4. plan implementation, 5. implementation and 6. evaluation, adjust and work towards sustainability. Last, to support the primary care areas, implementation facilitators were trained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity of the group program	Fidelity is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. Based on the key elements of the group program a questionnaire was developed (fidelity checklist). After every group program the group leader will fill in this questionnaire. The researcher will also observe one out of seven sessions and give feedback to the group leader based on the key elements of this questionnaire (fidelity checklist). The percentage of key elements that were complied or not complied to by the group leader will be measured.	Immediately after every session and follow-up session (up to 8 months).
Fidelity of the workshops	Fidelity is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. Fidelity checklist by the trainer. Based on the key elements of the workshops a questionnaire was developed (fidelity checklist). After every workshop the trainer will fill in this questionnaire (self reporting) The percentage of key elements that were complied or not complied to by the trainer will be measured.	Immediately after every workshop (up to 1 month).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach older people	Reach is defined as the absolute number, proportion, and representativeness of individuals who are willing to participate in a given initiative, intervention, or program, and reasons why or why not. Reach of the older people. Participant list group program by the group leader.	Immediately after every session and follow-up session (up to 8 months).
Implementation cost	Is defined as the cost impact of an implementation effort. Self-report of costs group program and workshop.	2 years
Falls Behaviour of the older person	Falls Behavioural Scale for the Older Person (FaB). The FaB scale consists of 30 items. Ten behavioral dimensions were identified including Cognitive Adaptations, Protective Mobility, Avoidance, Awareness, Pace, Practical Strategies, Displacing Activities, Being Observant, Changes in Level, and Getting to the Phone. Respondents are asked to rate 30 behavioral factors related to the prevention of falling on a 4-point rating scale (1-4) with 0 for does not apply. High scores equal the safest behaviours and low scores the riskiest behaviours (min. 0 - max: 120). The total FaB mean scores for items at baseline will be compared to the FaB mean score for items after 6 months.	Baseline and after 6 months
Experiences with the BE-EMPOWERed program	Focus group and interviews with older people, healthcare professionals, policy makers	The last 6 months of the study.
Feasibility of the BE-EMPOWERed program by experiences of the participants	Is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Focus group and interviews with older people, healthcare professionals, policy makers. A topic guide and interview guide will be used to guide the interviews and focus groups. The feasbility of the program will be questioned.	The last 6 months of the study.
Acceptability of the BE-EMPOWERed program by experiences of the participants	Is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Focus group and interviews with older people, healthcare professionals, policy makers. Focus group and interviews with older people, healthcare professionals, policy makers. A topic guide and interview guide will be used to guide the interviews and focus groups. The acceptability of the program will be questioned.	The last 6 months of the study.
Concerns about falling	Falls Efficacy Scale International (16 items) older person (min. 16 - max. 64). Score 16-22: People no concern about falling. Score 23-64: People are severe concerned about falling.	Baseline and after 6 months
Reach of healthcare professionals	Reach is defined as the absolute number, proportion, and representativeness of individuals who are willing to participate in a given initiative, intervention, or program, and reasons why or why not. Reach of healthcare professionals. Participant list workshops by the trainer.	Immediately after every workshop (up to 1 month).
Physical activity	Incidental and planned activity questionnaire (IPEQ) for older people. The IPEQ is a self-reported questionnaire and consists of 10 questions on physical activity. It measures type and amount of physical activity. Provides estimates of the frequency and duration of planned exercise and more casual day-to-day activities Outcome: hours of planned exercise per week Total time spent will be summed across all components and expressed as hours per week. The score will be derived from multiplying frequency score and duration score to create a total duration for the week score. The total hours of planned exercise per week will be measured at baseline and compared to the total hours of planned exercise per week after 6 months.	Baseline and after 6 months

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Flemish Agency for Care and Health

Publications and helpful links

General Publications

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
• Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P; STRIDE Trial Investigators. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183.
• Hopewell S, Adedire O, Copsey BJ, Boniface GJ, Sherrington C, Clemson L, Close JC, Lamb SE. Multifactorial and multiple component interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD012221. doi: 10.1002/14651858.CD012221.pub2.
• Clemson L, Cumming RG, Kendig H, Swann M, Heard R, Taylor K. The effectiveness of a community-based program for reducing the incidence of falls in the elderly: a randomized trial. J Am Geriatr Soc. 2004 Sep;52(9):1487-94. doi: 10.1111/j.1532-5415.2004.52411.x.
• Vandervelde S, Vlaeyen E, de Casterle BD, Flamaing J, Valy S, Meurrens J, Poels J, Himpe M, Belaen G, Milisen K. Strategies to implement multifactorial falls prevention interventions in community-dwelling older persons: a systematic review. Implement Sci. 2023 Feb 6;18(1):4. doi: 10.1186/s13012-022-01257-w.
• Hopewell S, Copsey B, Nicolson P, Adedire B, Boniface G, Lamb S. Multifactorial interventions for preventing falls in older people living in the community: a systematic review and meta-analysis of 41 trials and almost 20 000 participants. Br J Sports Med. 2020 Nov;54(22):1340-1350. doi: 10.1136/bjsports-2019-100732. Epub 2019 Aug 21.
• Lamb SE, Bruce J, Hossain A, Ji C, Longo R, Lall R, Bojke C, Hulme C, Withers E, Finnegan S, Sheridan R, Willett K, Underwood M; Prevention of Fall Injury Trial Study Group. Screening and Intervention to Prevent Falls and Fractures in Older People. N Engl J Med. 2020 Nov 5;383(19):1848-1859. doi: 10.1056/NEJMoa2001500.
• Carpenter CR, Malone ML. Avoiding Therapeutic Nihilism from Complex Geriatric Intervention "Negative" Trials: STRIDE Lessons. J Am Geriatr Soc. 2020 Dec;68(12):2752-2756. doi: 10.1111/jgs.16887. Epub 2020 Oct 20. No abstract available.
• Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.
• Clemson L, Cumming RG, Heard R. The development of an assessment to evaluate behavioral factors associated with falling. Am J Occup Ther. 2003 Jul-Aug;57(4):380-8. doi: 10.5014/ajot.57.4.380.
• Delbaere K, Hauer K, Lord SR. Evaluation of the incidental and planned activity questionnaire (IPEQ) for older people. Br J Sports Med. 2010 Nov;44(14):1029-34. doi: 10.1136/bjsm.2009.060350. Epub 2009 May 26.
• Kempen GI, Todd CJ, Van Haastregt JC, Zijlstra GA, Beyer N, Freiberger E, Hauer KA, Piot-Ziegler C, Yardley L. Cross-cultural validation of the Falls Efficacy Scale International (FES-I) in older people: results from Germany, the Netherlands and the UK were satisfactory. Disabil Rehabil. 2007 Jan 30;29(2):155-62. doi: 10.1080/09638280600747637.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Implementation; Aged; Community setting; Falls prevention
• Other Study ID Numbers: BE-EMPOWERed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. As far as requests are in line with the scope and research objectives of the Be-Empowered study.
• IPD Sharing Time Frame: On reasonable request
• IPD Sharing Access Criteria: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. As far as requests are in line with the scope and research objectives of the Be-Empowered study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No