NCT06105437

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

October 12, 2023

Last Update Submit

March 17, 2026

Conditions

Falls PreventionImplementationOlder People

Keywords

Community settingImplementationFalls preventionAged

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Reach older people

    Immediately after every session and follow-up session (up to 8 months).

  • Implementation cost

    2 years

  • Falls Behaviour of the older person

    Baseline and after 6 months

  • Experiences with the BE-EMPOWERed program

    The last 6 months of the study.

  • Feasibility of the BE-EMPOWERed program by experiences of the participants

    The last 6 months of the study.

  • +4 more secondary outcomes

Study Arms (1)

BE-EMPOWERed program

OTHER

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

Interventions

BE-EMPOWERed programOTHER

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.

BE-EMPOWERed program

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling
  • 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

You may not qualify if:

  • \- Neurological and cognitive problems (Parkinson, CVA, dementia, delirium)
  • Healthcare professionals
  • Working in the primary care area
  • Understanding and speaking of the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (12)

  • 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.

    PMID: 36747293BACKGROUND

  • 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.

    PMID: 30035305BACKGROUND

  • 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.

    PMID: 31434659BACKGROUND

  • 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.

    PMID: 32640131BACKGROUND

  • 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.

    PMID: 33211928BACKGROUND

  • 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.

    PMID: 33079398BACKGROUND

  • 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.

    PMID: 15341550BACKGROUND

  • 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.

    PMID: 20957426BACKGROUND

  • 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.

    PMID: 34367671BACKGROUND

  • 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.

    PMID: 12911079BACKGROUND

  • 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.

    PMID: 19474003BACKGROUND

  • 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.

    PMID: 17364765BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A mixed methods study with a convergent parallel design will be carried out in four primary care areas in Flanders (Belgium). Within this mixed methods study, the researchers gather information on and experiences with the implementation process of the BE-EMPOWERed program from the perspective of the older people, healthcare professionals, implementation facilitators, the working group of the primary care area and local policy makers. To evaluate the implementation process and outcomes, the following data are being collected: reach, fidelity, feasibility, acceptability, sustainability and cost of implementation. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 27, 2023

Study Start

January 1, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
On reasonable request
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.

Locations

BE(1)