RecruitingACTRN12621001215819

Telehealth for Falls and Fracture Prevention Implementation Trial (TeleFFIT)

TeleFFIT - A personalized, telehealth exercise and lifestyle risk factor management program to reduce falls and fracture risk in older adults: A 12-month hybrid effectiveness-implementation trial

Sponsor

Deakin University

Enrollment

386 participants

Start Date

May 16, 2022

Study Type

Interventional

Conditions

Fracture risk Osteoporosis Osteopenia

Summary

Falls and fragility fractures cause more days of hospitalization than most other diseases and account for over half of all injury-related healthcare costs. Current models of care for osteoporosis and fracture prevention focus on pharmaceuticals which reduce fracture risk by 20-50%, missing 50-60% of fracture cases in those with osteopenia (low bone density), and fail to reduce falls, a key contributor to fractures. Best practice clinical guidelines endorse the use of exercise and nutrition interventions with lifestyle risk factor management to reduce falls/fracture risk, but few evidence-based interventions have been translated into practice and long-term adherence to most effective centre/community exercise-nutrition programs is often poor. This suggests that current delivery models do not meet the needs of many individuals. Digital health technologies such as iPad/tablets and smartphones offer an equitable opportunity to increase the scope, utilization and effectiveness of best practice models of service delivery and care for falls/fracture prevention by delivering personalized programs and information, and supporting timely patient-practitioner communication. Therefore, the aim of this 12-month trial is evaluate the clinical and cost effectiveness of a multifaceted, person-centred, telehealth falls/fracture prevention program in people at increased falls/fracture risk. Key features of TeleFFIT are that it incorporates a home-based exercise program tailored to each individual's needs/preferences and is delivered through an exercise training app with ongoing exercise and nutritional support (health coaching) from qualified exercise professionals and dietitians, tailored health messages and access to evidence-based, online educational material to encourage self-care, and healthy lifestyle behaviour change strategies to optimize musculoskeletal health and mobility for older people with or at risk of osteoporosis, falls or fractures.

Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Falls and broken bones are a major health concern for older Australians — they cause more hospital days than almost any other condition. Osteoporosis (brittle bones) and low bone density (osteopenia) significantly increase fracture risk, and most current treatments only address the bone side of the problem, not the risk of falling itself. This trial is testing a comprehensive telehealth program called TeleFFIT, which delivers personalised home exercise programs, nutrition coaching from dietitians, and educational resources — all via a tablet or smartphone app — to help people strengthen their bones, improve their balance, and reduce their risk of falls and fractures over 12 months. Researchers are comparing the TeleFFIT program against usual care to see if the digital approach is effective and cost-efficient. The program is designed to meet people where they are — at home — removing barriers like transport and gym access. You may be eligible if you are aged 60 or over, have osteoporosis or low bone density, have had a fracture after age 50, or have fallen at least once in the past year. You must also have access to a smart device with internet and be able to exercise. People with a hip fracture in the past year, terminal illness, active cancer, progressive neurological conditions like Parkinson's disease, or a BMI below 18 or above 40 are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

TeleFFIT is a multifaceted, telehealth-based exercise and lifestyle risk factor management program that is designed to reduce the risk of falls and fracture in older people with or at risk of osteoporosis, falls and fractures. Following an initial health/medical/lifestyle assessment that includes identifying barriers/facilitators to exercise training and goal setting during a one-on-one consultation (~75-90 min) with an exercise practitioner (EP: exercise physiologist/physiotherapist), participants will be asked to exercise at home (or at a training facility if they prefer) thrice weekly for 12 months (~30 min sessions). Participants will be provided with exercise equipment (resistance bands, foam mat, stepping box or weights). The EP will prescribe each participant their own personalized exercise program via an exercise app (TeleHab) that includes narrated videos and instructions. The EP will determine an appropriate exercise program for each participant based on their medical history, previous exercise experience, previous/current musculoskeletal injuries or other co-morbidities and their baseline physical and functional test performance. All exercise programs (and sessions) will be remotely monitored by the EP via the app and with 12 (over 12 months) follow-up video consultations (~15-20 min) to provide support, advice and motivation. The exercise program will focus on three key components: "Strong" including resistance and weight-bearing exercises to strengthen bones and muscles; "Steady" including challenging balance, mobility and stepping activities to reduce the risk of falls and "Straight" including postural exercises to protect the spine and strengthen the back muscles. Participants will complete an initial 4-week familiarization phase of training after which they will be prescribed 4 x 12 week programs designed to be progressively more challenging. Participants will also be instructed to incorporate short bouts of daily stepping/weight-bearing 'activity snacking' exercises (~5 min/d) into their daily routine to further target bone strength and mobility. Participant adherence (and training dose, rating of perceived exertion and any pain) will be monitored directly via the exercise app and self-reported exercise calendars. Participants will also receive nutritional advice (4 sessions: 1 x 60 min plus 3 x ~30 min remotely via Zoom) throughout the study from a trained dietitian to encourage healthy eating behaviours related to adequate calcium and protein intake, fruits and vegetables and limiting alcohol intake. They will also be provided with evidence-based, online learning modules/educational videos related to musculoskeletal health and function designed specifically for this study to promote self-management and mitigate the future risk of falls/fractures. To provide further support to adopt long-term healthy lifestyle behaviour changes, participants will receive regular health (text) messages and tips on simple strategies to improve self-management behaviours to optimize their bone and muscle health and mobility. The text messages will be personalized based on participants falls history and functional performance (i.e. risk of future falls), and presence of osteopenia or osteoporosis. Participants will receive 4-5 text messages per week in the first 8 weeks of the study and first 4 weeks of each new exercise program, and 2-3 messages per week for the remaining intervention. Adherence to, and perceived usefulness of, online learning modules/educational videos, nutritional advice and text messages for the adoption of healthy lifestyle behaviours will be assessed via questionnaire. Upon completion of the intervention, all EPs and dietitians delivering the intervention and a subset of approximately 24 participants will be purposively sampled (based on age, gender, program adherence and individual program effectiveness to ensure a range of views are obtained) to participate in semi-structured interviews to explore intervention implementation barriers and facilitators and factors related to future scalability. All participants in the intervention group will be asked to complete an evaluation survey upon completion of the study. A workshop will also be held with key stakeholders and consumers prior to the intervention to discuss potential scalability.