Evaluation of the early adoption of the Falls Management Exercise Programme in Ireland
| ISRCTN | ISRCTN85505403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85505403 |
- Submission date
- 29/08/2024
- Registration date
- 09/09/2024
- Last edited
- 18/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Falls are common, with over a third of those aged 65 years and older falling each year. Falls can lead to injuries and admission to hospital or care homes. Many falls are preventable. Research shows that exercise, including strength and balance training, is key to reducing falls. For maximum results, people need to exercise three times per week and train balance and strength progressively and safely. FaME is a community-based falls management exercise programme. It is 6 months long, led by specialist trained physiotherapists and exercise instructors. It has been shown to reduce falls and improve physical activity levels and wellbeing. FaME was first introduced in Ireland in 2021, and there will be over 100 specialist instructors trained to deliver FaME by the end of this year. This study aims to find the best way to get FaME up and running well in Ireland, linked to the Irish healthcare system. Specifically, the aims are to explore access, acceptability, efficiency and cost of the programme through interviews, and observations with the service providers and users.
Who can participate?
Those who are attending a FaME programme in Ireland at any of the three early adopter sites can participate in the study. People who live in the community, are aged 65 years and over and have fallen, or fear falling are eligible to join the FaME programme. Those delivering the programme at those three sites will also participate in the study.
What does the study involve?
The study will involve interviewing the FaME service users about halfway through the programme, at the end of the programme, and completing a brief survey about three months after the programme. The service providers will also be interviewed mid-way and at the end of the programme.
What are the possible benefits and risks of participating?
There are no real benefits or risks to the participants taking part in this study. However, the information will help future scaling up of the programme in Ireland.
Where is the study run from?
Three early adopter sites in Ireland: Health Service Executive Community Organisations at Leitrim, Kerry and Dublin. All are community-based centres.
When is the study starting and how long is it expected to run for?
March 2024 to March 2026
Who is funding the study?
The Health Research Board, with co-funding from the Health Service Executive (Ireland)
Who is the main contact?
Dr Ruth McCullagh, r.mccullagh@ucc.ie
Contact information
Public, Scientific, Principal Investigator
Discipline of Physiotherapy
School of Clinical Therapies
UCC@ Nano Nagle Place, Douglas St.
Cork
T12 X70A
Ireland
 ORCID ID |
0000-0002-6489-183X |
|---|---|
| Phone | +353 (0)21 4904902 |
| r.mccullagh@ucc.ie |
Public
Discipline of Physiotherapy
School of Clinical Therapies
UCC@ Nano Nagle Place, Douglas St.
Cork
T12 X70A
Ireland
| Phone | +353 (0)214904902 |
|---|---|
| Katherine.thackeray@ucc.ie |
Public
Discipline of Physiotherapy
School of Clinical Therapies
UCC@ Nano Nagle Place, Douglas St.
Cork
T12 X70A
Ireland
| Phone | +353 (0)214904902 |
|---|---|
| celdridge@ucc.ie |
Study information
| Study design | Multicentre observational evaluation study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Evaluation study |
| Study setting(s) | Community |
| Study type | Other, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Falls Management Exercise Programme: Improving Reach, Effectiveness, VaLue and SustAiNability in IrelanD. Case studies for learning (FaME Ireland) |
| Study acronym | FaME Ireland |
| Study objectives | Establishing the Falls Management Exercise Programme is complex, involving many key agencies and stakeholders, and must be adapted to the local needs and availability while remaining effective. We aim to examine the early adoption of FaME to learn lessons about delivering FaME in the Irish Healthcare landscape, to learn lessons about its future scaling. |
| Ethics approval(s) |
1. Approved 01/10/2024, Clinical Research Ethics Committee of the Cork Teaching Hospitals (6, Lancaster Hall, Little Hanover St, Cork, T12 W778, Ireland; +353 (0)21 4901901; crec@ucc.ie), ref: ECM 3 (aaaa) 02/07/2024 2. Approved 13/09/2024, Sligo Research Ethics Committee (Research & Education Foundation CLG, ETC Building, Sligo University Hospital, Sligo, F91H684, Ireland; +353 (0) 7191 80305; office@ref-sligo.ie), ref: 1019 |
| Health condition(s) or problem(s) studied | Older adult falls prevention |
| Intervention | Observational data of the falls prevention programme will include interviews and observational data. data will help identify key local issues. These issues will be addressed at a co-design workshop, and local practical solutions will be agreed by key stakeholders. The programme will be observed again to identify the impact of the changes. An implementation toolkit will be drawn up for the Irish context. |
| Intervention type | Mixed |
| Primary outcome measure | Participants will be interviewed twice and will complete two surveys: Interview 1: Participants experience and perception of the exercise programme early in the programme (within the first 13 weeks) Interview 2: Participants experience and perception of the exercise programme later in the programme (within 6 weeks of the end of the programme) Survey 1: Participants preferences in exercises beyond the programme (midway through the programme [weeks 10-16]) Survey 2: Exercise practice after the FaME programme (follow-up, at 6-12 weeks) Trained Instructors will be interviewed once about their perception and experience of delivering the programme midway through the programme (week 10-16) Referrers to the exercise programme will be interviewed once about their experience and perception of falls prevention exercise programmes (before week 24). All the qualitative data will be analysed using thematic analysis. Routinely collected outcome data will be analysed to determine effects from baseline. Data will be analysed to determine its distribution, and the appropriate tests will be used to determine differences from baseline. Percentage or average mean differences will be compared to the minimal clinically important difference, or indicators of independent community ambulation, when appropriate. Results will be compared to previous implementation studies for indicators of effectiveness. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 03/03/2024 |
| Completion date | 03/03/2026 |
Eligibility
| Participant type(s) | Health professional, Service user, Other |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | Health professional: All health professionals providing the falls prevention programme at the early adopter sites Service users: All service users at the early adopter sites are eligible to participate. People who are eligible to use the FaME programme are: 1. Aged 65 years and over who are at risk of falling 2. Currently living at home (i.e. not in residential care) 3. Medically stable 4. Capable of walking independently indoors and outdoors (with or without walking aids or help from another person) 5. Physically able to take part in a group exercise class as assessed by the referrer. Other (service commissioner): All commissioners of the service at the three early adopter sites |
| Key exclusion criteria | Service users: 1. Uncontrolled high blood pressure or tachycardia 2. Experienced a significant drop in BP during exercise 3. Psychiatric conditions which would prevent participation in an exercise class 4. Uncontrolled medical problems, which the GP considered would exclude patients from 5. Undertaking the exercise programme (e.g. acute systemic illness such as rheumatoid arthritis) conditions requiring one-to-one or therapy-led exercise programme (e.g. unable to maintain a seated upright position) 6. Not living independently (e.g. living in residential or nursing homes) 7. Cognitive impairment preventing the ability to follow simple instructions |
| Date of first enrolment | 10/09/2024 |
| Date of final enrolment | 01/03/2026 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Tralee, Co Kerry
V92 YA25
Ireland
Sligo
F91 Y992
Ireland
161-171 Vernon Ave Health Centre
Dublin
D03 WT26
Ireland
Sponsor information
University/education
First Floor, East Wing
Main Quadrangle
University College Cork
Western Rd
Cork
T12 YN60
Ireland
| Phone | +353 (0)21 490 3411 |
|---|---|
| nora.geary@ucc.ie | |
| Website | http://www.ucc.ie/en/ocla |
"ROR" |
https://ror.org/03265fv13 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
- Location
- Ireland
No information available
Results and Publications
| Intention to publish date | 01/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. The public The aim of our dissemination to the public is to inform them that most falls are avoidable and that strength and balance exercises can improve independence, physical activity and quality of life. How to reach FaME classes, what to expect, how it has impacted others and how to remain healthy, independent and active as they age. With advice from our International Advisory Committee, PPI group and local steering committee, we aim to produce infographics with a visual representation of our data and results, which can be presented in local GP and healthcare clinics. We will produce short audio and video recordings, showing them what to expect from a FaME program and the impact it has had on people. We will produce press releases and articles for newspapers, magazines and to the news media. We will provide a short video which could be played at pre-retirement sessions, clubs and libraries educating people about the benefits of strength and balance activities to many aspects of life and health but also the importance of seeking support if they are avoiding activity through fear or have experienced falls. We will speak at public meetings such as during Positive Aging Week, and other local initiatives. We will use Fiverr.com or CANVA.com to produce flyers, posters, infographics and storyboards for different visual learners and audiences. This format has been well received by PPI contributors on previous projects. We will also encourage participants to “spread the word” amongst their peers, social networks, and health providers. 2. Health providers The aim of our dissemination to health providers is the same public health message, but also to inform them of ways to refer people to FaME, to influence organisational cultures as well as individuals. The aim is to improve reach and accessibility for all at risk of falling. We hope at the end of this study to have improved reach through technology and online provision, for people unable or unwilling to attend community-based classes. Health providers in the HSE, exercise professionals, sports partnerships etc. will be our target audience. Building trust between therapists and Exercise Professionals is supported through shared training to become PSIs. It is also important to ensure high-risk fallers are supported to continue to exercise from the hospital setting or therapy provision to the community or self-management home setting with motivation support from Exercise Professionals or effective dose will not be reached and the person may stop exercising, decondition and become a faller again. Exercise only works if you continue to do it. With advice from all stakeholders and the international advisory committee, we will produce referral infographics and clear referral systems embedded into the existing referral system in the HSE. Presentations and workshops will be held at the national level, including the Annual Irish Gerontological Meeting and the International Association of Gerontology and Geriatrics conference, (August 2025). Information will be provided locally through local primary healthcare meetings and webinars. 3. Service providers The aim of our dissemination is to inform service providers of the support mechanisms and training available. The outputs of the project will include an Irish FaME Implementation Toolkit, freely available to download in an interactive PDF format (with embedded URLs to forms, videos, infographics, referral forms, business cases etc.), to support commissioners and providers of FaME. Champions will be identified locally to help early adoption of FaME, and we will aim to support additional new FaME providers or individual PSIs. Workshops and presentations will be made available to Local Special Interest Groups. Short videos showing practical techniques will be made available. Brief announcements will be made on applications to share information such as Twitter etc. A Community of Practice for PSIs exists in the UK and hosts multiple resources, FAQs, short explainer videos, case studies to share best practice, a discussion board and regular online live chats to discuss challenges and potential solutions. The provider of this Community of Practice, Later Life Training, is willing to host (for free and without a time limit) an Irish FaME Community of Practice, but also facilitate engagement with experienced PSIs in the UK, many of which have been delivering FaME for over 10 years. Skelton (Co-I) is a Director of Later Life Training, a not-for-profit training organisation. 4. Service Management and Policy Formation The aim of our dissemination to service management is to report the impact FaME can have on independence and wellbeing, and the necessary requirements to sustain FaME delivery for effective outcomes. Dwyer, our Primary Investigator-Knowledge User, will be instrumental in this part of our dissemination. She is in the key position to apply our findings to clinical practice and service delivery. We will produce information that is relevant and useful for policy formation and business planning. These will also be embedded in the Toolkit. Findings will be presented to Social Care and Enhanced Community Care services, and the National Clinical Program for Older People, and Sport Partnership Ireland to drive the sustainability of this program. Growth planning for the Exercise Professional Workforce may also be necessary. 5. Academics We will publish our protocol/methods and our findings in peer-reviewed scientific journals and present at notable national and international conferences. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
18/10/2024: Ethics approval by the Sligo Research Ethics Committee was added.
30/08/2024: Study's existence confirmed by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.
