Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001215819
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
10/09/2021
Date last updated
29/02/2024
Date data sharing statement initially provided
10/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth for Falls and Fracture Prevention Implementation Trial (TeleFFIT)
Scientific title
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
Secondary ID [1] 303753 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 321230 0
Osteopenia 321231 0
Falls risk 321232 0
Fracture risk 322741 0
Condition category
Condition code
Musculoskeletal 319023 319023 0 0
Osteoporosis
Physical Medicine / Rehabilitation 320529 320529 0 0
Other physical medicine / rehabilitation
Musculoskeletal 320530 320530 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320109 0
Prevention
Intervention code [2] 320110 0
Treatment: Other
Intervention code [3] 320111 0
Lifestyle
Comparator / control treatment
Participants in the usual-care group will receive usual care from their clinician, i.e. they will not receive any component of the study intervention, however they will have access to generic exercise/nutrition/falls/fracture prevention information, advice and education sheets via our study website.
Control group
Active

Outcomes
Primary outcome [1] 326988 0
Falls rate monitored via falls calendars completed by participants daily
Timepoint [1] 326988 0
12 months post start of intervention
Primary outcome [2] 326989 0
Femoral neck areal bone mineral density (aBMD) measured by DXA
Timepoint [2] 326989 0
Baseline and 12 months
Secondary outcome [1] 397712 0
Total hip and lumbar spine aBMD measured by DXA
Timepoint [1] 397712 0
Baseline and 12 months
Secondary outcome [2] 397713 0
Thoracic kyphosis measured by inclinometer
Timepoint [2] 397713 0
Baseline, 6 and 12 months
Secondary outcome [3] 397714 0
Lean tissue mass measured by DXA
Timepoint [3] 397714 0
Baseline and 12 months
Secondary outcome [4] 397715 0
Isometric maximal muscle strength of quadriceps measured using the Lord’s strap assembly with a strain gauge and the knee at 90 degrees of flexion
Timepoint [4] 397715 0
Baseline, 6 and 12 months
Secondary outcome [5] 397716 0
Short Physical Performance Battery (SPPB) score which is a composite outcome based on an assessment of balance, gait speed and sit-to-stand performance.
Timepoint [5] 397716 0
Baseline, 6 and 12 months
Secondary outcome [6] 397717 0
Functional muscle power assessed by 5 times sit to stand test
Timepoint [6] 397717 0
Baseline, 6 and 12 months
Secondary outcome [7] 397718 0
Dynamic balance/movement speed assessed by the four square step test
Timepoint [7] 397718 0
Baseline, 6 and 12 months
Secondary outcome [8] 397719 0
Proportion of participants that fall, assessed via falls calendars completed by participants daily.
Timepoint [8] 397719 0
12 months post start of intervention
Secondary outcome [9] 397720 0
Fear of falling assessed by the Falls Efficacy Scale - International (FES-I)
Timepoint [9] 397720 0
Baseline, 6 and 12 months
Secondary outcome [10] 397721 0
Functional limitations/disability assessed by the Late-Life Function and Disability Instrument (LLFDI)
Timepoint [10] 397721 0
Baseline, 6 and 12 months
Secondary outcome [11] 397723 0
Quality of Life assessed by the AQoL-8D
Timepoint [11] 397723 0
Baseline, 6 and 12 months
Secondary outcome [12] 397727 0
Rate of fall-related injuries assessed via falls calendars completed by participants daily.
Timepoint [12] 397727 0
12 months post start of intervention
Secondary outcome [13] 397731 0
Self-efficacy for healthy lifestyle behaviours for musculoskeletal health (assessment via questionnaire designed for study)
Timepoint [13] 397731 0
Baseline, 3, 6, 9 and 12 months
Secondary outcome [14] 397735 0
Adverse events reported ad hoc and via 4-weekly online questionnaire designed specifically for this study.
Timepoint [14] 397735 0
Continuous over 12-month intervention
Secondary outcome [15] 397987 0
Health economic evaluation (health care usage and costs) to assess the cost-effectiveness of the intervention from a health care system perspective (incremental cost effectiveness ratio (ICER) and cost utility ratio) assessed by questionnaire designed specifically for this study and using Medicare and Pharmaceutical Benefits Scheme database extractions.
Timepoint [15] 397987 0
Via questionnaire every 4 weeks and at the end of 12 months
Secondary outcome [16] 397989 0
Implementation outcomes: Adoption - Recruitment of EPs/dietitians. Monitored via study database
Timepoint [16] 397989 0
At completion of study
Secondary outcome [17] 398694 0
Isometric maximal back extensor muscle strength measured using the Lafayette handheld dynamometer in a standing position,
Timepoint [17] 398694 0
Baseline, 6 and 12 months
Secondary outcome [18] 398695 0
Grip strength measured using a Jamar hand-held dynamometer.
Timepoint [18] 398695 0
Baseline, 6 and 12 months
Secondary outcome [19] 398696 0
Dynamic balance/movement speed assessed by the 15-Second Step Test
Timepoint [19] 398696 0
Baseline, 6 and 12 months
Secondary outcome [20] 398722 0
Implementation outcomes: Reach - recruitment. Monitored via screening questionnaire developed for study and study database.
Timepoint [20] 398722 0
At completion of study
Secondary outcome [21] 398723 0
Implementation outcome: exercise dose delivered to participants. Monitored via exercise app/online platform and study database.
Timepoint [21] 398723 0
Baseline, 3, 6, 9 and 12 months
Secondary outcome [22] 398724 0
Implementation outcome: exercise dose received. Monitored via exercise app/online platform or study database.
Timepoint [22] 398724 0
Baseline, 3, 6, 9 and 12 months
Secondary outcome [23] 398725 0
Implementation outcomes: fidelity, Monitored via exercise app/online platform, study database and/or qualitative (semi-structured) interviews with the exercise practitioners and dietitians.
Timepoint [23] 398725 0
Baseline, 3, 6, 9 and 12 months
Secondary outcome [24] 398726 0
Implementation outcome: Appropriateness. Monitored via questionnaire (Likert scale) and qualitative interview data (subset of participants only).
Timepoint [24] 398726 0
At end of intervention
Secondary outcome [25] 398740 0
Implementation outcomes: Acceptability. Monitored via questionnaire (Likert scale) and qualitative interview data (subset of participants only).
Timepoint [25] 398740 0
At end of intervention
Secondary outcome [26] 398741 0
Implementation outcomes: usability. Monitored via questionnaire (Likert scale) and qualitative interview data (subset of participants only).
Timepoint [26] 398741 0
At end of intervention
Secondary outcome [27] 398742 0
Implementation outcomes: usefulness. Monitored via questionnaire (Likert scale) and qualitative interview data (subset of participants only).
Timepoint [27] 398742 0
At end of intervention
Secondary outcome [28] 398745 0
Implementation outcomes: sustainability. Monitored via questionnaire designed for study and qualitative interview data (subset of participants only).
Timepoint [28] 398745 0
At end of intervention
Secondary outcome [29] 398746 0
Implementation outcomes: potential scalability. Monitored via responses from a workshop with key stakeholders, consumers and study staff (prior to intervention) and questionnaire (Likert scale) developed for study and qualitative interview data (subset of participants only) at end of intervention.
Timepoint [29] 398746 0
Pre-intervention and at end of intervention
Secondary outcome [30] 398918 0
Functional muscle power assessed by the 5-step stair climb test
Timepoint [30] 398918 0
Baseline, 6 and 12 months
Secondary outcome [31] 399889 0
Implementation outcomes: Reach - attrition. Monitored via study database.
Timepoint [31] 399889 0
At end of intervention
Secondary outcome [32] 399890 0
Implementation outcomes: Reach - participation. Monitored via study database.
Timepoint [32] 399890 0
At end of intervention
Secondary outcome [33] 399964 0
Timed load stance as a measure of back muscle endurance
Timepoint [33] 399964 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Participants must be aged 60 years and over and classified at increased risk for falls/fracture defined as: 1) the presence of osteoporosis (as diagnosed by a doctor) or confirmed by a DXA scan during screening at Deakin University (proximal femur scan T-score equal to or less than -2.5 SD); 2) currently (or previously) treated for osteoporosis by medication, or 3) a previous history of a minimal trauma fracture (defined as a fracture resulting from trauma equal to (or less than) a fall from standing height) since the age of 50 years or at least 1 fall in the past 12 months, or at increased falls risk (score 3 or more) based on our Falls/Fracture risk questionnaire in combination with the presence of low BMD (osteopenia or osteoporosis) at the proximal femur (T-score <-1.0) as determine by DXA. To be included in the study, participants must also have access to a smart device/computer (including wi-fi/internet) and capable of making and receiving telephone and/or video conferencing calls and messaging (text/SMS), be willing to be randomized to either the TeleFFIT intervention (and undertake exercise for 12 months) or the usual care group and understand all the study requirements.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study based on the following:
1) history of a hip fracture in the past year;
2) acute/terminal illness, medical disorder or recent surgery likely to limit training or regular use of a walking frame;
3) currently being treated for cancer (or if treatment ceased in the past 3 months);
4) any progressive neurological condition (eg Parkinson’s disease, dementia/Alzheimer’s disease) or palliative condition;
5) currently involved in a regular structured exercise training program (resistance training, weight bearing exercises) or falls prevention program more than once a week;
6) BMI <18 or >40;
7) non-English speaking;
8) current and ongoing use of glucocorticoids, if >7.5 mg/d and for >3 months; aromatase inhibitors or anti-androgen therapy;
9) no access to a smart device/phone;
10) recent (last 3 months) or considering gastric bypass surgery in the next 12 months;
11) impaired capacity or unable to provide informed consent (inability to understand – reiterate – the purpose of the study and its requirements);
12) For those who do not pass the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool, their GP does not provide consent for them to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to the intervention or control group will be performed by an independent person not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation prepared by our study biostatistician, stratified by gender, with a 3:2 allocation to the TeleFFIT and usual care group, respectively.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be randomised into either the TeleFFIT intervention or usual-care group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 386 participants will be recruited and randomized in a 3:2 allocation (favoring TeleFFIT) to detect clinically meaningful differences in either of the two primary outcomes with success based on a positive outcome for fall rate or femoral neck BMD. Assuming 15% attrition, we aim to collect complete data on 328 participants (197 to TeleFFIT; 131 to usual care group). Clustering (8 EPs delivering the intervention to 232 participants) was accounted for correcting for the design effect (DE). Power estimates are conservative as the main analysis will adjust for factors used in the stratified randomization. Primary outcomes after 12 months (correcting for two primary outcomes; a 0.025): 1) Fall rate: we expect a fall rate of 0.85 falls per person-year in the usual care group. Using data from two previous exercise meta-analyses which reported a 39% and 50% reduction in fall rate, the target sample size (197 to TeleFFIT; 131 to usual care group) achieves 80% power to detect a conservative 35% reduction in fall rate in the intervention group (Poisson distribution, ICC 0.001, DE 1.024). 2) Change in FN aBMD: the target sample size achieves >90% power to detect a net 1.2% mean difference for the change over 12 months (SD= 2.8%, ICC 0.004, DE 1.095).

Statistical analysis will be conducted on an intention-to-treat basis using SPSS and Stata statistical software. Prior to analysis, all data will be checked for outliers and/or data errors. Non-normal data will be transformed to meet normality assumptions of parametric methods, or non-parametric methods will be used where appropriate. All models will include the stratification factors (sex/anti-osteoporotic therapy) as fixed effects. Intervention effects on fall rate will be assessed using generalised estimation equations, log link and Poisson distribution. Overdispersion will be tested and corrected if necessary. Intervention effects at 6 and 12 months on femoral neck BMD and secondary outcomes will be estimated using linear mixed models with group and baseline value of the outcome as fixed effects and EP as random effect. All data will be first analysed unadjusted, and relevant confounders (eg. age, changes in weight or habitual physical activity) will be considered as covariates in subsequent analyses, including accounting for baseline value for outcomes. Sensitivity analysis will be undertaken including: 1) those that adhere to the Telehealth exercise intervention (at least 60% adherence) and 2) those not treated with osteoporosis medication. Missing data. Reasons for dropout will be collected for any withdrawals. Multiple imputation will be used to handle missing data. For all analyses, a P-value of <0.05 will be considered statistically significant. For the qualitative data, all interviews will be transcribed verbatim and imported into NVivo12 for coding and thematic analysis.

A health economic analysis will be conducted to assess the cost-effectiveness of the intervention from a health care system perspective. The two primary outcomes (fall rate and femoral neck BMD) and secondary outcome (AQoL-8D: health-related QoL) will be used to determine the incremental cost effectiveness ratio (ICER). The ICER around the primary outcomes will be calculated as the difference in total program and health service costs per mean difference in falls rate and 1.2% group difference in FN BMD. A cost utility ratio will be calculated based on AQoL-8D as the change in total program and health service cost per change in quality adjusted life year saved in the intervention and control groups. One-way sensitivity analyses will investigate the robustness of the ICER to a range of cost and effect estimates. On the cost side, this may include alternative delivery arrangements, scaling up the intervention, salaries and program length; and on the effect side health-related QoL, falls rate, change in BMD and time spent in exercise.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
16/05/2022
Date of last participant enrolment
Anticipated
19/04/2024
Actual
Date of last data collection
Anticipated
16/05/2025
Actual
Sample size
Target
386
Accrual to date
340
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308161 0
Government body
Name [1] 308161 0
Medical Research Future Fund, Department of Health
Country [1] 308161 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood
Melbourne, Australia 3125
Country
Australia
Secondary sponsor category [1] 308929 0
None
Name [1] 308929 0
Address [1] 308929 0
Country [1] 308929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308147 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308147 0
Ethics committee country [1] 308147 0
Australia
Date submitted for ethics approval [1] 308147 0
09/02/2021
Approval date [1] 308147 0
10/03/2021
Ethics approval number [1] 308147 0
2021-052

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109694 0
Prof Robin Daly
Address 109694 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood,
Melbourne, VIC, Australia 3125
Country 109694 0
Australia
Phone 109694 0
+61 03 92446040
Fax 109694 0
Email 109694 0
[email protected]
Contact person for public queries
Name 109695 0
Jenny Gianoudis
Address 109695 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood
Melbourne, VIC, Australia 3125
Country 109695 0
Australia
Phone 109695 0
+61 03 92446668
Fax 109695 0
Email 109695 0
[email protected]
Contact person for scientific queries
Name 109696 0
Robin Daly
Address 109696 0
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences,
221 Burwood Highway, Burwood
Melbourne, VIC, Australia 3125
Country 109696 0
Australia
Phone 109696 0
+61 03 92446040
Fax 109696 0
Email 109696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, except the qualitative data from the process evaluation.
When will data be available (start and end dates)?
Data will be available after the main findings from the study are published; no end date determined
Available to whom?
Researchers requesting data only.
Available for what types of analyses?
For individual patient data meta-analysis or to address secondary related (or unrelated) research questions associated with the approval aims/study design.
How or where can data be obtained?
By emailing the Principal Investigator Prof Robin Daly ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.