Implementation of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons

Older People Clinical Trial

— BE-EMPOWERed  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105437
• Other study ID #: BE-EMPOWERed
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: KU Leuven
• Contact: Koen Milisen, PhD
• Phone: +3216377979
• Email: koen.milisen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Falls Prevention
• Implementation
• Older People

Intervention

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.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Flemish Agency for Care and Health

Country where clinical trial is conducted

Belgium, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	Implementation cost	Is defined as the cost impact of an implementation effort. Self-report of costs group program and workshop.	2 years
Secondary	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
Secondary	Experiences with the BE-EMPOWERed program	Focus group and interviews with older people, healthcare professionals, policy makers	The last 6 months of the study.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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).
Secondary	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