Falls PreventionBE-EMPOWERedNCT06105437
Implementation of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons
A study testing BE-EMPOWERed program in people with Falls Prevention and Implementation, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls Prevention, Implementation, Older People
- What is being tested?
- BE-EMPOWERed program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2023to 31 May 2025
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
- Healthcare professionals
- Working in the primary care area
- Understanding and speaking of the Dutch language
Who cannot join
- Neurological and cognitive problems (Parkinson, CVA, dementia, delirium)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- 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.
- Conditions
- Falls Prevention, Implementation, Older People
- Being tested
- BE-EMPOWERed program
- Keywords
- Community setting, Implementation, Falls prevention, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: BE-EMPOWERed program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Immediately after every workshop (up to 1 month).
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 6 months
Experiences with the BE-EMPOWERed program
Focus group and interviews with older people, healthcare professionals, policy makers
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jan 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Falls PreventionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Agency for Care and Health
- Responsible party
- Principal investigator, prof. dr. Koen Milisen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105437
- Sponsor's protocol ID
- BE-EMPOWERed
- Acronym
- BE-EMPOWERed
- Status last verified
- Mar 2026
- First submitted
- 12 Oct 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36747293Hopewell 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.
PubMed 30035305Hopewell 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.
PubMed 31434659Bhasin 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.
PubMed 32640131Lamb 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.
PubMed 33211928Carpenter 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.
PubMed 33079398Clemson 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.
PubMed 15341550Proctor 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.
PubMed 20957426Holtrop 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.
PubMed 34367671Clemson 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.
PubMed 12911079Delbaere 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.
PubMed 19474003Kempen 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.
PubMed 17364765Vandervelde S, Belaen G, Dierckx de Casterle B, Vlaeyen E, Flamaing J, Delbaere K, Bohyn A, Milisen K. Belgium program Enhancing the uptake and Effectiveness of a Multifactorial falls Prevention intervention in Older community-dWElling peRsons (BE-EMPOWERed): A study protocol. BMC Geriatr. 2025 Sep 24;25(1):692. doi: 10.1186/s12877-025-06190-3.
PubMed 40993544
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE-EMPOWERed Study: Belgian Study Enhancing the Uptake and the Effectiveness of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons
- ClinicalTrials.gov ID
- NCT06105437
- Acronym / sponsor ID
- BE-EMPOWERed / BE-EMPOWERed
- Conditions
- Falls Prevention, Implementation, Older People
- Keywords
- Community setting, Implementation, Falls prevention, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Flemish Agency for Care and Health
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BE-EMPOWERed program | Other | Other: BE-EMPOWERed programThe 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Neurological and cognitive problems (Parkinson, CVA, dementia, delirium)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BE-EMPOWERed programThe 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 |
Primary outcome
Fidelity of the group program
Time frame: Immediately after every session and follow-up session (up to 8 months).
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.
Fidelity of the workshops
Time frame: Immediately after every workshop (up to 1 month).
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.
9 secondary outcomes
Reach older people
Time frame: Immediately after every session and follow-up session (up to 8 months).
Implementation cost
Time frame: 2 years
Falls Behaviour of the older person
Time frame: Baseline and after 6 months
Experiences with the BE-EMPOWERed program
Time frame: The last 6 months of the study.
Feasibility of the BE-EMPOWERed program by experiences of the participants
Time frame: The last 6 months of the study.
Acceptability of the BE-EMPOWERed program by experiences of the participants
Time frame: The last 6 months of the study.
Concerns about falling
Time frame: Baseline and after 6 months
Reach of healthcare professionals
Time frame: Immediately after every workshop (up to 1 month).
Physical activity
Time frame: Baseline and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 36747293Vandervelde 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.
- Background: PubMed 30035305Hopewell 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.
- Background: PubMed 31434659Hopewell 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.
- Background: PubMed 32640131Bhasin 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.
- Background: PubMed 33211928Lamb 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.
- Background: PubMed 33079398Carpenter 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.
- Background: PubMed 15341550Clemson 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.
- Background: PubMed 20957426Proctor 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.
- Background: PubMed 34367671Holtrop 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.
- Background: PubMed 12911079Clemson 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.
- Background: PubMed 19474003Delbaere 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.
- Background: PubMed 17364765Kempen 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BE-EMPOWERed program in people with Falls Prevention and Implementation, run by KU Leuven at 1 site in Belgium.
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 8 inclusion and 1 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Fidelity of the group program (time frame: Immediately after every session and follow-up session (up to 8 months).). The study lists 2 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 NCT06105437, which also lists 13 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 18 Mar 2026.