FP-00020

Section 1 - Basic information about you and your application:

Title of research project
Development and feasibility of a digital health intervention to encourage exercise maintenance after falls prevention exercise programmes end.

Grant Type
The ORUK Early-career Research Fellowship

Research area
Treatment

Duration
24

Start date
May 1, 2024

Have you previously received funding from ORUK?
No.

Profession
Academic scientist

Your current job title/position
Assistant Professor in Physiotherapy

Are you an early-career researcher (ECR)? (definition of ECR)
yes

Section 2 - Lay summary

Lay summary:

Falls and broken bones are a common health problem faced by older adults. Worldwide, one third of adults aged over 65 years old, and half of adults aged over 80 years, fall each year. One in five falls in older adults result in hospitalisation and one in twenty cause broken bones. Each year, 300,000 older adults break a bone following a fall which costs the UK £4.4billion in healthcare costs.  Broken hip bones are the most serious outcome of a fall. One in twenty older adults will die and one in five need care assisted living following a hip fracture.

Muscles and bones become weaker after 50 years of age which increases an older adults’ risk of falling and breaking a bone. Falls prevention programmes that include muscle strength and balance exercise improves physical function and helps to prevent falls and broken bones in older adults. However, many older adults stop doing exercise and become less physically active after falls prevention programmes end. Gains in balance and muscle strength are lost and falls risk increase if people don’t keep exercising. More people are reaching older ages and becoming less active.  Therefore, this problem will worsen unless healthcare practices become better at preventing falls and broken bones in older adults.

My ambition is to create a technology supported home exercise programme that encourages older adults to keep exercising after falls prevention programmes end.  This will help to prevent future falls and broken bones which will allow more older adults to continue living independently. The home exercise programme will benefit older adults everyday lives by helping them to maintain good physical health and improve their ability to perform daily tasks without the fear of falling.

Older people at risk of falls, clinicians, and public members from different cultures and backgrounds will be invited to form a research advisory group. The group will work with the research team to create the home exercise programme and research plan and advise how best to communicate the research to the public. Diversity within the research advisory group will be important to help shape the research to meet the diverse views and needs of the many different people affected by falls and broken bones.  We will target the research to help older adults with the greatest health needs. Older adults living in deprived neighbourhoods have the greatest risk of falling and dying following a broken bone. The home exercise programme will be researched in older adults attending falls prevention programmes in the most deprived regions of England. This will help us to explore whether the programme could encourage the continuation of exercise in older adults who need it most.

Section 3 - Purpose of research

Purpose of research:

STUDY AIM:  To design and investigate the feasibility, acceptability and safety of a digitally supported exercise maintenance intervention to Falls Management Exercise (FaME) programme service-users.

 

STUDY OBJECTIVES:

1. Co-design a digitally supported exercise maintenance intervention with a Community of Practice Group (COPG) and Patient and Public Involvement (PPI) group.
2. Investigate the acceptability of the digitally supported exercise maintenance intervention to FaME programme service-users.
3. Assess the feasibility of the research methods and key parameters needed to conduct future clinical trials.

 

PROJECT DELIVERABLES:   Accessible project deliverables will be co-produced with the COPG and PPI group and will include the following:

Academic outputs:  The project will result in two research publications (i.e., intervention development  and feasibility study publications) and the research will be presented at a minimum of two national and/or international conferences (e.g., Falls Prevention Summit, World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Disease).

Summary briefs, newsletters, infographics, animation podcasts: We will work in collaboration with the Higher Education Institutions (HEI) Technology Enhanced Learning team to create infographics and animation podcasts. Infographics/podcasts will be posted on YouTube and social media and links sent to relevant stakeholders.  Study findings will be shared via newsletter with external organisations with an interest in ageing musculoskeletal health, such as Versus-Arthritis, Royal Osteoporosis Society, British Orthopaedic Association, Age UK, healthcare service-providers, National FaME Implementation Team.

Clinical education: Our clinical academics will work with clinical communities to produce education materials around digital and ageing musculoskeletal health. These will inform the clinical curriculums across our HEIs and within the training provider of FaME. 

Future bidding capacity:  If shown to be feasible, we will have developed an exercise maintenance intervention that is acceptable for service-users to receive. We will also have the feasibility data needed to bid for further funding to conduct a larger scale clinical trial.

Section 4 - Background to investigation

Background to investigation:

Background:   One third of adults aged over 65 years old, and half of adults aged over 80 years, fall each year^{[1, 2]}.  The human cost of falls includes reduced confidence, painful injuries, disability, loss of independence and premature mortality^{[3, 4]}. Approximately, 20% of older adult falls result in hospitalisation and 5% lead to bone fractures^{[3, 5, 6]}. Annually, 300,000 older adults suffer a falls related fracture, which costs the UK economy £4.4billion; £2billion being spent on hip fractures alone.   Hip fractures are the most serious consequence of falls in older adults. Each month, 1,150 older UK citizens die and 20% are admitted into care homes following a hip fracture^[7]. Persistent health inequalities mean that people from low-income households are disproportionately affected by falls, as have a 25% higher risk of sustaining a falls related fracture and greater mortality rates following hip fractures^{[8, 9]}.  The proportion of people reaching older ages is increasing and health inequalities remain largely unchanged.  Therefore, this problem is predicted to worsen unless healthcare practices improve to prevent falls and fractures across all older adult groups.

Multiple factors increase an older adult’s risk of falling, including environmental hazards, polypharmacy, poor neurological and cardiovascular health, multimorbidity and impairments in vision, continence and cognition^[10].  However, age-related declines in muscle strength and balance are among the strongest risk factors for falls and severe injury in older adults^{[10, 11]}.  Thus, clinical guidelines recognise falls prevention exercise programmes as primary treatments^{[6, 12, 13]}.

Completion of group-based, in-person, Falls Management Exercise (FaME) programmes lasting 24 weeks or more, significantly improves muscle strength and balance^[14], functional status^[14-17] and reduces falls rates^[15] and injury incidence^[18] in older adults.  Physical activity (PA) engagement needs to continue after FaME programmes end to maintain the health benefits gained, but often wanes between 6 to 24-months after programmes end^{[15, 17]}. The demand for in-person FaME programmes vastly outweighs clinical capacity, meaning that patients cannot attend programmes indefinitely. Therefore, a widely available and scalable solution is needed to maintain exercise participation and improve the long-term clinical effectiveness after FaME programmes end.

The NHS Long-Term Plan endorses Telehealth interventions^[19] and lessons learnt from the COVID-19 pandemic demonstrate that well designed digital health interventions improve healthcare service efficiency^[20-22]. Systematic review evidence demonstrates that home-based exercise delivered via digital means is effective at improving strength, balance and functional status and significantly reduces falls incidence in older adults^[23]. This presents an opportunity for healthcare researchers to develop digital health interventions to support the discharge planning from falls prevention services.

To date, no research has investigated whether digital health interventions are acceptable to encourage exercise maintenance after FaME programmes end.  This research aims to design and investigate the feasibility and acceptability of a digitally supported exercise maintenance intervention. Once developed and investigated, the intervention could be readily implemented into falls prevention pathways to help empower patients to self-manage their health and live-well for longer.

Track-record: I am an advanced musculoskeletal physiotherapist and early career clinical academic who aspires to become a leader within the MSK field. During the fellowship I will develop my research independence by leading on a team of well-established researchers. Strengthening my research collaborations and producing internationally recognised research during the fellowship will help me to develop a strong and internationally visible research profile to support my trajectory towards becoming a MSK leader.

I was awarded an NIHR funded PhD in 2019. My PhD gave me the subject knowledge, experience, leadership and research skills needed to manage this project to time and target. During my PhD, I developed and investigated a complex face-to-face intervention that aimed to maintain increases in moderate-to-vigorous PA (MVPA) in people exiting commissioned FaME programmes. An intervention mapping approach and stakeholder engagement underpinned the intervention development process^[24]. The intervention was later investigated in a two-arm, randomised multisite feasibility trial^[25].  My research led to numerous measures of esteem including being invited to deliver presentations at local, national and international conferences and disseminating my work to clinical teams.

I was a research team member on another two NIHR funded falls prevention studies. The first, was a qualitative study that investigated the factors associated with PA maintenance after FaME’s completion.  Three publications arose from this study and ResearchGate metrics show they have been cited 67 times, suggesting they are influencing future research.  The second study investigated the large-scale implementation of FaME programmes in local authority services. This study was highly impactful as it led to the generation of new FaME programme provisions regionally. National impact was achieved through publishing a FaME implementation toolkit that provides service-providers with a suite of resources to help plan, implement, and monitor FaME programmes. The study received global recognition after being published as a case-study within the World Health Organisation “Step Safely” report.  Working on this project expanded my knowledge around producing various research deliverables and impact generation activities which I will transfer into this project.

Preliminary data:  Qualitative data arising from my PhD^[25] and a falls prevention study I co-authored^[26], demonstrates that home exercise plans, peer support and tracking PA on smart phones motivates older adults to maintain MVPA increases after FaME programmes end. The feasibility study in my PhD, achieved a 74.6% recruitment, 92.3% retention and 94.2% attendance rates and participants reported the intervention was acceptable.  This provides insight that older adults are receptive to receiving exercise maintenance interventions.  However, intervention delivery methods are important as we received a mixed reception to the printed materials supporting the intervention.

Co-applicants on this bid, have produced research showing that older adults find digital health interventions to be acceptable in helping them to engage in falls prevention exercise^{[27, 28].}  They have designed and investigated an NHS approved digital health App that engages older adults in safe, evidence-based falls prevention exercise. When tested,  older adults reported the falls prevention App was acceptable and easy to use and they expressed good intentions towards using the App^[28]. Therefore, a digital exercise maintenance intervention may offer a promising solution to help encourage older adults to continue exercising after FaME ends.

 

Section 5 - Plan of investigation

Plan of investigation:

STUDY DESIGN: The project will be conducted in two separate phases as interdependency exists between the research objectives:

• Phase 1. Intervention Development.
• Phase 2. Feasibility Study.

 

METHODS:

Phase 1.  Intervention Development will be informed by the Normalisation Process Theory and Theoretical Framework of Acceptability^{[29, 30]}.  In consultations, the research team will work with a group of diverse PPI members and key stakeholders to define a digitally supported exercise maintenance intervention and procedures. Digital intervention components may include self-monitoring PA via wearables, digital peer support and home exercise delivered via an evidence-based Falls Prevention App^[28].

To explore early intervention acceptability, n=10 FaME class users will be invited to test the exercise maintenance intervention for 1 month. Intervention acceptability feedback will be collected via technology acceptance questionnaires^{[31, 32]}, analysed and triangulated into a report.  After initial testing, research participants will be invited to attend a COPG workshop, containing researchers, PPI members and service providers, to provide further qualitative feedback regarding the interventions acceptability.  During the workshop, the collective group will use the participants feedback and the information in the report to optimise the intervention for progression into phase 2. Workshops will be audio-recorded, transcribed, and analysed thematically.

 

Phase 2.  Feasibility Study:  A mixed methods single-arm multi-site feasibility study will be conducted to investigate the feasibility, acceptability and safety of the exercise maintenance intervention (optimised in phase 1) and the feasibility of the research methods. We will recruit and deliver the exercise maintenance intervention for up to 6 months in 30 FaME class attendees.

Feasibility data will be collected and measured over 6 months via:

• Recruitment and retention rates. Recruitment rates will be recorded as the number of participants invited and the percentage consenting to enter the study.  Retention rates will be calculated as the number and percentage of participants providing post intervention follow up data.
• Feasibility of collecting self-reported quality of life, falls incidence, and confidence data via the Falls Prevention App will be determined by the percentage of participants completing the inbuilt questionnaires.
• Adverse event data will be collected by the research team (via email/telephone) and assessed for causality.
• Intervention adherence will be ascertained via; i) frequency and duration of technology use and exercise progressions (collected via the Falls Prevention App metrics), ii) Weekly minutes of MVPA and strength and balance exercise minutes will be collected via self-reported PA questionnaires (PASE)^[33]. Exercise minutes will be reported as mean (Standard deviation) or median (interquartile range) and the effect size analysed using Cohen’s d^[21].

A priori progression criteria will be set on feasibility outcomes to help determine future progression to a larger-scale clinical trial^[34].

Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n=20 participants. Semi-structured interviews will be conducted by a researcher in the participants preferred venue or online. Interviews will be audio recorded, transcribed, and handled using NVIVO10-software.  Two researchers will code the transcripts via framework analysis^[35].

Participant data is routinely collected by the Community Charity for service purposes.  Under information sharing agreements, the following routine data will be shared with the researchers:  Age, gender, ethnicity, postcode/IMD, height, body weight, medical history, medication, falls history, functional ability (i.e. 30-s chair stand, Timed-Up-and-Go), balance measures (i.e. four-stage balance test).  This routine data will be collected at three time-points (T1-before FaME, T2-after FaME, T3-after the maintenance intervention) and will be analysed and reported via descriptive statistics.

 

SAMPLE & SETTING:  We are working in collaboration with a Community Health Charity that delivers FaME classes to people living in deprived areas of Newcastle. To ensure people experiencing health inequalities are represented in the study, we will recruit a sample of culturally diverse older adults from four Community Charity hubs and deliver the intervention in these venues.

ELIGABILITY CRITERIA:

• Community dwelling older adults
• Independently mobile
• Enrolled on a FaME programme delivered by a Community Health Charity hub.
• Able to provide written informed consent.

EXCLUSION CRITERIA:

• Has been advised by a GP or consultant not to exercise or has a medical, cognitive or physical condition that prevents safe engagement with unsupervised exercise.

 

SAMPLE SIZE: During the intervention development phase, a phenomenological approach will be adopted to investigate the participants views on their experience of engaging with the intervention.  Creswell and Creswell^[36] advise between 3-10 participants should be included in phenomenological research. We will recruit 10 participants to test and make recommendations to optimise the exercise maintenance intervention in phase 1.

Lancaster et al., advise 30 participants are needed to provide methodological rigour in feasibility studies^[37].  There is an average of 20 people per class and four classes (with waiting lists) across the four community charity hubs.  Previously, we achieved a 74.6% recruitment rate when inviting older adults from community-based falls prevention programmes into a feasibility study^[25].  Therefore, we are confident in our aim to recruit 30 participants across all four community charity hubs.

 

COMMERCIAL EXPLOITATION & CLINICAL ADOPTION.

We are not generating new technology or Intellectual Property around the technology used in this project; therefore, a commercial exploitation strategy is not required.  All technology used in this project is commercially available to public members and the Falls prevention App is NHS approved and available for free download on Android and Apple devices which provides good opportunities for clinical adoption.

The research team has undertaken preliminary PPI work via discussions with the Community Health Charity and a local NIHR patient and carer panel.  The charity believes a digital intervention is feasible to deliver and has good potential to support exercise maintenance after FaME programmes end.  Feedback from the patient and carer panel on the Falls Prevention App was positive. Panel members felt the App was easy to use and exercises valuable. All panel members reported having computer or tablet access but were unsure whether others would have similar digital access.  Digital poverty may add risk to clinical adoption.   Supported by the COPG, we will investigate the intervention in a sample of people facing health inequalities to help us better understand and address the opportunities and risks around digital poverty and inclusion.

Section 6 - Research environment and resources

Research environment and resources:

The applicant will have their own office space within the department and access to the full IT infrastructure and library and support facilities. The host university provides a vibrant working environment, research and leadership training opportunities and academic mentorship to support career progression and pastural care to early career researchers. The applicant will receive direction and guidance for the research project, training opportunities and career progression activities during monthly meetings with the fellowship supervisor and quarterly meetings with an academic mentor.

Promoting healthy ageing and preserving musculoskeletal health is a key research priority within the host university.  The host university operates a research strategy that focuses on generating high quality research outputs and facilitating a collaborative research culture. A collaborative research culture will be facilitated by working in partnership with internationally recognised academics from two external universities, an award-winning local Community Health Charity and a Community of Practice Group (COPG) consisting of service-users, practitioners and PPI members. The fellowship will strengthen these partnerships by providing an opportunity for the COPG, Community Health Charity and researchers to work towards a joint goal of producing research that will directly benefit people at risk of falls and fractures.  Establishing these partnerships will support the production of future collaborative research bids that will seek funding to progress the research to a larger scale clinical trial.  The research team have local, national and international collaborations with research institutions, charities and healthcare providers which will support impact generation activities and assist the project in becoming internationally recognised.

The Community Health Charity supporting the project have won multiple national awards in patient experience and networking.  They received a Kings Fund award to recognise the outstanding community-based work they have done to tackle health inequalities within local communities.  The charity has a track record of supporting health innovation practices by working with patients, academics, and NHS partners to develop and pilot interventions in their services.  The charity is supporting the research project by helping to form the COPG by recruiting their established PPI members into the study.  The intervention will be embedded into the falls management exercise programmes delivered across four local Community Health Charity hubs.  Intervention delivery will be facilitated by staff members and FaME instructors working for the charity.  The charity will also provide a venue to host the COPG meetings and provide a space to conduct semi-structured interviews. Funding to conduct the research in these community charity hubs, including staff/ instructor costs and venue hire, and for the digital equipment needed to deliver the intervention (e.g. smart watches, android tablets) have been fully costed into the research bid.

Section 7: Research impact

Who will benefit from this research?

Falls and fractures are a common and serious health issue faced by older adults. Older adults and their families/carers will benefit from the intervention as it will provide ongoing exercise support to improve long-term patient outcomes and lessen the human cost of falls. This research will reduce the burden falls and fractures have on multiple NHS departments by providing a scalable and widely available solution to reduce falls incidence. Research findings will add to the academic and NHS evidence-base supporting falls prevention services to improve the long-term clinical and cost effectiveness of services delivered. The work will feed into the HEIs clinical curriculums to benefit learning across our clinical communities.  Lastly, understanding the views of older adults on the use of digital health technology will feed into research external to this bid. This includes our co-applicants research that focuses on exploring digital health technologies to prevent falls in different populations.

How can your research be translated in real-life?

The research is underpinned by the Normalisation Process Theory (NPT).  NPT is a methodological approach which guides the development, optimisation and evaluation of complex interventions.  Implementation potential is central in NPT, as the process guides researchers to problem-solve any implementation issues from the initial stages of testing intervention concepts to the latter stages of intervention implementation. NTP is best applied in research when interventions are developed with key-stakeholders and considered legitimate by potential users^{[38, 39]}.  The project places stakeholders and service-users central in the intervention design and evaluation process and will be investigated in a real-world setting. The digital intervention components are widely available to the public and are NHS approved (i.e.  Falls Prevention App) or NHS endorsed (i.e. physical activity trackers).  These research foundations will help ensure that the intervention developed has good potential to be translated directly into real-world practice

How will your research be beneficial for ORUK and its purpose?

This project supports ORUK strategy by helping to reduce the burden that falls and fractures have on individuals and the healthcare system. Investing in the development of this innovative research will help to pioneer a new form of treatment that aims to improve patient outcomes and empower older adults to self-manage their physical health and live well for longer. A digital intervention offers a low-cost scalable solution to help promote the continuation of falls prevention exercise, so to prevent future falls and injuries and reduce the burden these have on the NHS. The production of high-quality project deliverables and public engagement and outreach activities will champion our research and mobilise falls prevention and exercise maintenance knowledge to professionals, patients, and academics.  Lastly, this fellowship provides ORUK with an opportunity to nurture the applicant’s development into an independent researcher and a recognised ORUK advocate within the Musculoskeletal community.

Section 8: Outreach and engagement

Continued stakeholder engagement will support evolution and monitoring of the below public engagement and outreach plan to ensure it continually meets public needs and expectations.

AIM: To communicate research knowledge, ideas and results to target audiences and the wider public using their preferred communication mediums.

OBJECTIVES:
1. Identify and raise awareness of the project to target audiences with an interest in, or affected by, falls and fragility fractures.
2. Create local and national collaborative partnerships to raise project awareness to the wider public.
3. To use suitable communication mediums and accessible project deliverables to reach non-academic communities.

METHODS:

1. Reaching target audiences.

Community of Practice Group (COPG). Project awareness will be raised to key stakeholders during the formation of a COPG consisting of patients, carers, clinicians and service-providers. Research knowledge, ideas and results will be communicated via presentations, written materials, and open discussions during three COPG events. Event agendas will include creating and reviewing accessible key messages, summaries and project deliverables.

External Organisations with an interest in ageing, musculoskeletal health and falls will be reached through various communication modes (e.g., emails, meetings, project deliverables). We will form external organisation partnerships to support a downstream approach to help reach target groups and the wider public.

Organisations will include, but will not be limited to:
– Healthcare providers (e.g. primary care networks, orthopaedic and rehabilitation departments, local-authority services).
– Charities (e.g. Age UK, Versus-Arthritis, Royal Osteoporosis Society).
– Training providers (e.g. Later-Life Training)
– Professional societies (e.g. Chartered Society of Physiotherapy).

Professional groups with an interest in ageing, musculoskeletal health and falls will be reached via:
– Producing and promoting project deliverables via our external organisation partners and their established communication modes (e.g. websites, event/ seminar talks, email channels).
– Presenting research at professional conferences (e.g. Physiotherapy UK conference).
– Co-producing and sharing educational materials with organisations who deliver professional and clinical education.
– Publishing research in open access journals to inform evidence-based-practice.
– Posting research deliverables on YouTube and social-media.

People affected by falls and fractures will be reached by:
– Promoting research in the public domain (e.g. external organisation websites, public event talks, social-media posts).
– Word of mouth from professional groups.

2. Raising public awareness.

We will work with our COPG and external partners to create key public messages, tailor project deliverables and identify the most effective communication modes to raise public awareness. We will specifically seek the help of organisations that strive to reach public members via campaigns, news stories, public talks and by delivering health and wellbeing services (e.g. Age UK).

We will strive to maximise impact by working with our COPG to ensure all project deliverables are accessible and translated as required to support inclusion.

Section 9: Research budget

Requested funding from ORUK

University fees (if any)
£0

Salary
£97234.76

Consumables
£12385.84

Publications
£0

Conference attendance
£0

Other items
£

Total 'requested fund'
£109620.6



Other items




Other secured funds

Internal funding
£0

Partner (University)
£0

Partner (Commercial)
£0

Partner (Charity)
£0

Other sources
£0

Total 'other funds)
£0

Section 10: Intellectual property and testing on animal

Is there an IP linked to this research?
Yes

Who owns and maintains this patent?

This is a collaborative project between the host HEI and KOKU Health.   The intention is to include the KOKU App as a component within the digital exercise maintenance intervention developed.  The KOKU platform is supplied to users and clients via KOKU Health which is established as a not-for-profit Community Interest Company (CIC). Prior to project initiation, a collaboration agreement between the host HEI and KOKU Health CIC will be drafted which will include arrangements for Intellectual Property (IP) management. The Technology Transfer Officers of both the host HEI and KOKU Health are aware of this collaboration and will assist with drafting the collaboration agreement and subsequent licensing of the KOKU App to the host HEI for use within the proposed study. Any new IP generated specifically relating to the KOKU program will be licensed to KOKU Health CIC.

Does your research include procedures to be carried out on animals in the UK under the Animals (Scientific Procedures) Act?
No

If yes, have the following necessary approvals been given by:

The Home office(in relation to personal, project and establishment licences)?


Animal Welfare and Ethical Review Body?


Does your research involve the use of animals or animal tissue outside the UK?
No

Does the proposed research involve a protected species? (If yes, state which)



Does the proposed research involve genetically modified animals?


Include details of sample size calculations and statistical advice sought. Please use the ARRIVE guidelines when designing and describing your experiments.


There should be sufficient information to allow for a robust review of any applications involving animals. Further guidance is available from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), including an online experimental design assistant to guide researchers through the design of animal experiments.

Please provide details of any moderate or severe procedures


Why is animal use necessary, are there any other possible approaches?


Why is the species/model to be used the most appropriate?