Falls Management Exercise programme: Improving reach, effectiveness, value and sustainability in Ireland. Case studies for learning (acronym: FaME Ireland): protocol of an observational evaluation study

The intervention: Falls Management Programme (FaME)

The Falls Management Programme (FaME) is a tailored group exercise programme shown to reduce falls by up to 54% and increase physical activity to recommended levels (Iliffe et al., 2015; Orton et al., 2021; Skelton & Dinan, 1999; Skelton et al., 2005). It involves 24 weekly 1-hour group sessions (10–12 participants) led by PSIs, supplemented by individual home exercises. Essential components include progressive strength, balance, endurance, flexibility training, and adapted Tai Chi. Equipment includes weights, resistance bands, and mats. Sessions conclude with social time, and exercise preferences are explored midway to support sustained activity.

Currently in Ireland, FaME is delivered by Physiotherapist PSIs (for six weeks) and then continued by the Exercise Professional PSIs, in community venues, with the aim to fast track people away from clinical care to exercising beneficially in the community.

Location and setting

The programme is implemented at three primary care/community sites. FaME is Initially delivered in healthcare settings by physiotherapist-PSIs for the first six weeks, transitioning to exercise professional-PSIs for the remaining 18 weeks

Risk assessments and supervision are prioritized across all sites.

Eligibility criteria for participants

FaME is suitable for people with a history of falls and those deemed to be at high risk of falling. In this study, we will use the existing eligibility criteria for the service. In the early adopter sites, people must be referred from their healthcare provider (mostly primary care physiotherapists). This will be further explored in the co-DESIGN phase (see later) when we will explore the feasibility of other HCPs, social care providers and self-referral options into FaME to widen reach.

Participants must be aged 65+, at risk of falls, living at home, medically stable, and physically capable of group exercise. Exclusion criteria include uncontrolled medical conditions, significant exercise-related BP changes, psychiatric conditions, or dependence on one-to-one therapy.

We anticipate that we will recruit 80–100 participants over the three sites. This study will not aim to determine effectiveness; the sample size aims to get a strong representation of FaME participants, across the sexes, within the lifetime of the project.

Ethical considerations. In line with the Declaration of Helsinki, local ethical approval has been granted for each site. Ethical approval for the study was provided by the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC) [Ref Number EMC 4 (u) 14/05/2024 & ECM 3 (aaaa) 02/07/2024] and Sligo Research Ethics Committee [Ref 1019, 13/09/2024, 16/12/2024]. The HSE Research and Development office granted permission to proceed with the study in the Dublin site based on documents submitted, in line with the terms and conditions of CREC and in lieu of no HSE research ethics committee coverage in the Dublin primary care area.

Written informed consent will be obtained from participants, including commissioners, instructors, and service-users. All participants must provide informed consent. The PSIs will inform the FaME participants of the study and provide the information packs. All the research team will be available to ask any questions and will gather written informed consent. Copies of the forms will be available on request.

Participating in FaME exercise sessions is safe, thanks to the PSIs' skilled training and ability to tailor exercises to reduce fall risk. All research assessments are non-invasive and are low-risk. While adverse events are unlikely, any that occur will be recorded and categorized. If an adverse event happens, appropriate care will be provided following HSE guidelines. Potential risks will be discussed during the informed consent process. To prevent fatigue, breaks will be included between assessments. Family members are welcome to support participants throughout the project.

Data protection information is detailed in Section 6: Data Protection Information.

Implementation evaluation research design

The FaME-Ireland evaluation design, developed in collaboration with health service professionals, previous FaME participants, and policymakers, follows the AFFINITY National Falls and Bone Health Project framework (CES, 2019). Please see Figure 1 study flow-chart.

Figure 1. Define, Design, Deliver: Change Activities.

The project follows the HSE Health Services Change Guide (Health Services Executive, 2018) is divided into three work packages (DEFINE, coDESIGN, DELIVER) (Figure 2) utilizing a multi-method approach to assess the FaME programme’s process, outcomes, impact, and value.

1.   In DEFINE, the current practices will be explored and examined to determine good practice and areas for improvement.

2.   In co-DESIGN, a local co-DESIGN workshop involving local stakeholders will work together to find local practical solutions.

3.   In DELIVER, the adapted practice will be explored using the same methods as DEFINE, to identify the impact of the adaptations.

Figure 2. FaME Ireland Flow Diagram for DEFINE and DELIVER phases.

Finally, we will “Disseminate” through public meetings, workshops, and short video production to inform people about falls prevention and exercise. The UK FaME Implementation Toolkit will be adapted for the Irish context. Reports and presentations will be generated for the ethics boards and will be published open access to increase clinical, medical and public awareness.

Work package 1 and 3: DEFINE and DELIVER

DEFINE aims to examine current practices, and DELIVER will examine adapted practices, after the local co-DESIGN workshops. Firstly, the only activity not to be repeated in DELIVER is a national survey conducted exploring all trained PSIs’ experience of setting up and maintaining a FaME programme. Secondly, at three early adopter sites (Kerry, Dublin, Leitrim), a mixed methods local evaluation will be conducted. These three sites represent both urban and rural settings, and less and more established programmes. The work package will continue for the 32 weeks, ie., the full length of the programme with a follow-up period. Four key themes will be examined:

Reach and equity

Through examination of referral pathways, participant type, we aim to identify gaps of knowledge and access equity for participants.

4.   Analyse referral patterns and participant types including differences between sexes

5.   Interview referring physiotherapists about the reach of FaME to potentially underserved communities.

Indicators of Reach include gaps in referral pathway, and participant types who fail to reach the classes.

Efficiency, appropriateness, effectiveness, cost and sustainability of FaME

Through PSI national survey and local interviews, observation of the programme, and analysis of participant outcomes, we will aim to describe the threats to sustaining the service, measure its effects and efficiency in the Irish context, and identify the necessary supports for treatment fidelity. Through participant interviews and programme observations, we aim to describe levels of participant readiness, satisfaction, perceived appropriateness.

1.   Survey trained PSIs to assess threats and opportunities to FaME delivery.

2.   Observe one class at each site to evaluate time resources, exercise progression, individualization, and participant numbers.

3.   Interview PSIs about venue suitability, time/resource allocation, safety issues, participant numbers, fidelity challenges, and financial viability.

4.   Interview FaME participants to assess readiness, venue suitability, required participant numbers, dropout and re-entry, safety, satisfaction, perceived gains, and enjoyment.

5.   Measure attendance, drop-outs, referrals, waiting lists, and effects.

6.   Complete a cost analysis of the intervention (including training, time, venue, equipment, refreshments, and travel costs)

7.   Complete a sensitivity analysis to compare differing local methods of delivery and patient presentation

Indicators of Efficiency, Appropriateness, Effectiveness, and Sustainability include threats to sustained delivery, levels of effectiveness and efficiency, appropriate support for fidelity, participant readiness, satisfaction, and perceived appropriateness. People routinely miss classes over the 26 weeks of the programme; PSIs are trained to contact non-attenders to encourage them back to the class. A 20% attrition rate can be anticipated. Indicators of current cost will include the expenses of implementing FaME using different delivery methods.

Sustaining physical activity and independence after FaME

Through interviews and three-month follow-up assessments, we will aim to identify suitable options to remain physically active, indicators of sustained PA and independence, and perceived acceptability and satisfaction of physical activity options.

1.   Profile participants’ exercise preference, examining for differences between the sexes.

2.   Explore options to keep active after FaME for all participants.

3.   Measure falls rate, self-efficacy, and physical activity after the programme.

4.   Conduct focus groups at completion to assess the acceptability of options, reasons for choices, satisfaction, and perceived self-efficacy (in their classes)

5.   Conduct three-month brief follow-up phone interviews (20% purposive sample) to measure physical activity, falls, self-efficacy, and qualitative indicators of self-efficacy, independence, and exercise.

Indicators of keeping physical active and independent after FaME will include preferred options for exercise and perceived confidence to progress to a different exercise programme/activity, measures of PA up to three months after the programme.

Data collection procedures

See Table 1 for an overview of data collection. Data collection will include interviews with referrers, PSIs, and participants to identify knowledge gaps and perceived sustainability threats. All interviews will be completed by the research team, unknown by the FaME participants to encourage open dialogue. Training will be provided by the principal investigator, experienced in conducting and supervising qualitative research. Topic guides will be refined prior to the interviews and will be iteratively adapted through regular discussion of emerging themes. Field notes will support self-reflexivity, which will be considered in the analysis. Early interviews will explore local referral practices, and PSIs’ experience of running the programme. Interviews with participants will be conducted half-way, at completion and at 6 weeks follow-up. All data collection will happen locally, in-person or through MS Teams, if preferred.

Baseline and outcome data will be used to assess the effects of FaME (see Table 2) and will primarily be collected by the PSIs. Every attempt will be made to collect complete data sets from consented participants. The PSI training ensures competency in conducting these measurements. Supplemental files available at https://osf.io/m2ds7/ provide a complete description of the instruments.

Data analysis

All quantitative process measures, baseline functional assessments and outcomes will be described using frequencies, percentages, means and standard deviations, medians and interquartile ranges and rates as appropriate. Because this study is not powered to show effect in falls or physical function, effectiveness on physical function and change in falls status will be considered using change from baseline scores. Missing data will not be imputed. The proportions of patients reaching the recommended government target of at least >150 mins moderate or vigorous physical activity per week will be compared using chi-square tests. The data will inform the effects of FaME, characteristics of FaME participants, differences between the sexes, class uptake, adherence and adverse events.

Evaluation of the implementation (structure/process/outcome) measures will be completed qualitatively through in-depth semi-structured interviews and focus groups. Data will be transcribed verbatim and checked for verification. Thematic analysis using Braun and Clarke reflexive thematic analysis with two independent researchers will be utilised (Braun & Clarke, 2019). An economic evaluation will be completed to determine the cost of the service provision. The qualitative analysis will inform us of access, acceptability, satisfaction, and perceived impact on physical activity, function and social engagement. Good practice and areas to consider for change will be brought to the local co-DESIGN event.

Questions to be discussed

The data collected in DEFINE will guide the questions for co-DESIGN discussions. Emerging data highlight key issues at both the local level (e.g., access, facilities, delivery) and broader national level (e.g., resources, interagency collaboration, cost). Therefore, we propose inviting both local stakeholders and national representatives of key authorities to the co-DESIGN process (Table 3).

Participants

Participants will include the following and will be adapted in response to the emergent themes of the DEFINE data at each early adopter site. We will aim to limit the number to less than 20 people to foster a deeper conversation on the questions poised, aiming to get balance between the sexes.

The core team will select suitable participants for each local café and invite them through the appropriate team member. Participants will be informed about the Café’s purpose, commitment, and expectations. The context, goals, and discussion questions will be clearly outlined, along with procedures for recording, analysing, and publishing the data. Participants will have the opportunity to ask questions before giving consent.

Procedure

The Café will be held in a convenient location with good parking and access. To create a welcoming, open environment, small tables with paper for writing will be set up for group discussions. The session will begin with a presentation to set the context, covering FaME evidence, participant journeys, and emergent questions from DEFINE. The process, facilitators, and Café Etiquette will be introduced.

Groups will be prearranged to foster openness and effectively address the questions. Hosts will guide discussions towards identifying local solutions, with verbal summaries captured at each table. Notes and doodles will be collected for analysis. Participants will be encouraged to add their thoughts, enriching the conversations.

Groups will rotate between tables to build on ideas, with time to reflect on emerging themes. After all rounds, the group will reconvene to share insights, patterns, and recommendations. A more detailed report will be sent to all participants after the workshop.

The data will be analysed for strategic planning. Actionable items will be prepared for the DELIVER phase, while other important strategic actions will be compiled into a report for future planning.

Data analysis ensuring trustworthiness

After the session, all materials, including flipcharts notes and doodles, will be collected. The data will be organized by the questions discussed during the rounds and note-keeping data to emerging themes.

Thematic analysis will identify recurring patterns or ideas, with key phrases or concepts being coded. Connections or unique insights will be highlighted, using visual methods like mind maps or thematic networks to display relationships.

The codes will be grouped into broader categories, which will be further refined into themes, supported by illustrative quotes for credibility. Findings will undergo member checking by a core group of participants to ensure accuracy.

The core research team, along with PPI representatives, will translate the findings into actionable outcomes. Outcomes will inform the DELIVER phase. Some will be actionable, while other actions will guide future planning and innovation opportunities. The research process will be recorded, and the protocol pre-registered to ensure confirmability. This approach ensures data effectively guides decision-making and future research.

DEFINE and DELIVER phases

Data will include qualitative, survey and quantitative data.

Qualitative data

Most data will be qualitative, collected through interviews with participants, instructors, and commissioners, conducted via MS Teams or in-person. MS Teams interviews will be recorded and saved on UCC’s cloud storage, while in-person interviews will be audio-recorded using a Dictaphone. These recordings will be transcribed and stored on UCC’s cloud storage platform for analysis. Once transcripts are verified, the original recordings will be deleted. All transcripts will be pseudo-anonymized before sharing with the research team, with a separate key stored securely to link data.

After each interview, recordings will be transferred to an encrypted laptop and deleted from the recording device. Identifying information will be removed from transcripts and be pseudo-anonymized. Only the anonymized transcript will remain, stored on UCC’s OneDrive for ten years. The key linking participant data to study numbers will be securely kept in a locked cupboard in a restricted access room. All data will be stored for ten years.

Survey data

A survey will be conducted via UCC Qualtrics during the DEFINE phase. All information will remain confidential and anonymized. No personal information will be collected, but participants will be asked for their location and profession to aid in data interpretation. Responses cannot be traced back to individuals. The anonymous data will be stored on University College Cork’s OneDrive platform for ten years and shared with the research team.

Outcome data

The outcome measures routinely collected by instructors will be analysed to assess the effects and efficiency. These measures are taken at the beginning and on completion of the program during both the DEFINE and DELIVER phases and do not require additional procedures from participants. The data will be pseudo-anonymized before being shared with the research team, meaning only the instructor who took the measurements will be able to identify them as belonging to a specific participant.

Permission to re-use anonymised data

For all data, we will also ask permission to use the anonymised data in future studies, noting that any future studies will be approved by a research ethics committee.

Procedures to minimise data breach

To minimize the risk of a data breach, the following procedures will ensure the safety, confidentiality, and anonymity of participant information:

Note keeping material

All note-keeping materials will be collected at the end of the Café. These notes will be converted into PDF documents and stored on the University College Cork OneDrive platform for ten years. The documents will be accessible only to the research team.

Permission to re-use anonymised data

For all data, we will also ask permission to use the anonymised data in future studies, noting that any future studies will be approved by a research ethics committee.

Procedures to minimise data breach

To minimize the risk of data breach, the following procedures will be implemented to ensure information remains safe, confidential, and unidentifiable: