ABSTRACT
OBJECTIVE: To investigate the trial-based cost-effectiveness of the addition of a tailored digitally enabled exercise intervention to usual care shown to be clinically effective in improving mobility in the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial compared to usual care alone. DESIGN: Economic evaluation alongside a pragmatic randomized controlled trial. PARTICIPANTS: 300 people receiving inpatient aged and neurological rehabilitation were randomized to the intervention (n = 149) or usual care control group (n = 151). MAIN MEASURES: Incremental cost effectiveness ratios were calculated for the additional costs per additional person demonstrating a meaningful improvement in mobility (3-point in Short Physical Performance Battery) and quality-adjusted life years gained at 6 months (primary analysis). The joint probability distribution of costs and outcomes was examined using bootstrapping. RESULTS: The mean cost saving for the intervention group at 6 months was AU$2286 (95% Bootstrapped cost CI: -$11,190 to $6410) per participant; 68% and 67% of bootstraps showed the intervention to be dominant (i.e. more effective and cost saving) for mobility and quality-adjusted life years, respectively. The probability of the intervention being cost-effective considering a willingness to pay threshold of AU$50,000 per additional person with a meaningful improvement in mobility or quality-adjusted life year gained was 93% and 77%, respectively. CONCLUSIONS: The AMOUNT intervention had a high probability of being cost-effective if decision makers are willing to pay AU$50,000 per meaningful improvement in mobility or per quality-adjusted life year gained, and a moderate probability of being cost-saving and effective considering both outcomes at 6 months post randomization.
Subject(s)
Neurological Rehabilitation , Humans , Aged , Cost-Benefit Analysis , Exercise , Quality-Adjusted Life Years , Quality of LifeABSTRACT
BACKGROUND: There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. METHODS: A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. DISCUSSION: This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ( ANZCTR ) Registration date: 10/12/2018.
Subject(s)
Exercise , Walking , Australia , Focus Groups , Humans , Prospective Studies , Randomized Controlled Trials as TopicABSTRACT
PURPOSE: To describe device use and physiotherapy support in the post-hospital phase of the AMOUNT rehabilitation trial. METHODS: We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase (n = 144). Intervention, additional to standard rehabilitation, utilised eight digital devices (virtual reality videogames, activity monitors and handheld computer devices) to improve mobility and increase physical activity. Participants were taught to use devices during inpatient rehabilitation and were then discharged home to use the devices for the remainder of the 6-month trial. Physiotherapist-participant contact occurred every 1-2 weeks using a health coaching approach, including technology support when required. Intervention datasheets were audited, and descriptive statistics used to report device use and support required. RESULTS: Participants (mean (SD) age 70 (18) years; 49% neurological health conditions) used an average of 2 (SD 1) devices (98% used an activity monitor). Eight percent of physiotherapy contact included technology support with 30% provided remotely. Support addressed 845 issues categorised under initial set-up and instruction (27%), education and training (31%), maintenance (23%) and trouble-shooting (19%). CONCLUSION: Digital devices can be used for home-based rehabilitation, but ongoing technology support is essential. Clinical Trials Registry: ACTRN12614000936628IMPLICATIONS FOR REHABILITATIONDigital device use at home to support long-term management of health conditions is likely to become increasingly important as the need for rehabilitation increases and rehabilitation resources become more limited.Technology support for set-up and ongoing device use is a critical enabler of home-based digital interventions.Health professionals delivering home-based digital interventions require sufficient training and equipment and may need to vary the mode (e.g., home visit vs. telephone or video conference) depending on the technology support required.
Subject(s)
Physical Therapy Modalities , Virtual Reality , Aged , Exercise , Hospitals , Humans , TechnologyABSTRACT
INTRODUCTION: Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists. METHODS AND ANALYSIS: This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other. ETHICS AND DISSEMINATION: Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers. TRIAL REGISTRATION NUMBER: ACTRN12618001983291.
Subject(s)
Accidental Falls , Exercise , Mentoring , Fear , Humans , Quality of LifeABSTRACT
BACKGROUND: Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation. METHODS AND FINDINGS: We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes. CONCLUSIONS: In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.
Subject(s)
Computers, Handheld , Exercise , Fitness Trackers , Mobility Limitation , Neurological Rehabilitation/methods , Physical Therapy Modalities , Smartphone , Video Games , Aged , Aged, 80 and over , Australia , Female , Humans , Male , Middle Aged , Mobile Applications , Virtual RealityABSTRACT
OBJECTIVES: To determine what is the use of time and physical activity in people undertaking inpatient rehabilitation in a specialised brain injury unit. To determine participants' level of independence related to the use of time and physical activity. METHODS: Design: Cross-sectional observation study. PARTICIPANTS: Fourteen people [mean (SD) age 40 (15) years] with brain injuries undertaking inpatient rehabilitation. PROCEDURE: Participants were observed every 12 minutes over 5 days (Monday to Friday from 7:30 am until 7:30 pm) using a behaviour mapping tool. OUTCOME MEASURES: Observation of location, people present, body position and activity engaged in (both therapeutic and nontherapeutic). Functional Independence Measure (FIM) scores were determined for each participant. RESULTS: Participants spent a large part of their time alone (34%) in sedentary positions (83%) and in their bedrooms (48%) doing non-therapeutic activities (78%). There was a positive relationship between a higher level of independence (higher FIM score) and being observed in active body positions (r=0.60; p=0.03) and participating in physically active therapeutic activities (r=0.53; p=0.05). CONCLUSION: Similar to stroke units, inpatients in a specialised brain injury unit spend large parts of the day sedentary, alone and doing non-therapeutic activities. Strategies need to be evaluated to address this problem, particularly for people with greater physical dependence.
Subject(s)
Brain Injuries/physiopathology , Brain Injuries/rehabilitation , Exercise/physiology , Physical Therapy Modalities , Adult , Australia , Cross-Sectional Studies , Female , Humans , Inpatients , Male , Middle Aged , Rehabilitation Centers , Time Factors , Treatment OutcomeABSTRACT
INTRODUCTION: People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. METHODS AND ANALYSIS: A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6â months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6â months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an intention-to-treat approach. ETHICS AND DISSEMINATION: The protocol has been approved by the relevant Human Research Ethics Committees and the results will be disseminated widely through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12614000936628. Pre-results.
