Clinical trial NCT06105437: Implementation of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons
Official title: BE-EMPOWERed Study: Belgian Study Enhancing the Uptake and the Effectiveness of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Falls Prevention
Implementation
Older People
Keywords: Community setting
Implementation
Falls prevention
Aged
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Flemish Agency for Care and Health
First posted: 2023-10-27
Enrollment: 550
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fidelity of the group program
timeFrame: Immediately after every session and follow-up session (up to 8 months).
measure: Fidelity of the workshops
timeFrame: Immediately after every workshop (up to 1 month).
Secondary outcomes:
measure: Reach older people
timeFrame: Immediately after every session and follow-up session (up to 8 months).
measure: Implementation cost
timeFrame: 2 years
measure: Falls Behaviour of the older person
timeFrame: Baseline and after 6 months
measure: Experiences with the BE-EMPOWERed program
timeFrame: The last 6 months of the study.
measure: Feasibility of the BE-EMPOWERed program by experiences of the participants
timeFrame: The last 6 months of the study.
measure: Acceptability of the BE-EMPOWERed program by experiences of the participants
timeFrame: The last 6 months of the study.
measure: Concerns about falling
timeFrame: Baseline and after 6 months
measure: Reach of healthcare professionals
timeFrame: Immediately after every workshop (up to 1 month).
measure: Physical activity
timeFrame: Baseline and after 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams Brabant
Study officials:
References:
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