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BackgroundChanging population demographics and technology developments have resulted in growing interest in the potential of consumer-facing digital health. In the United Kingdom, a £37 million (US $49 million) national digital health program delivering assisted living lifestyles at scale (dallas) aimed to deploy such technologies at scale. However, little is known about how consumers value such digital health opportunities. ObjectiveThis study explored consumers’ perspectives on the potential value of digital health technologies, particularly mobile health (mHealth), to promote well-being by examining their willingness-to-pay (WTP) for such health solutions. MethodsA contingent valuation study involving a UK-wide survey that asked participants to report open-ended absolute and marginal WTP or willingness-to-accept for the gain or loss of a hypothetical mHealth app, Healthy Connections. ResultsA UK-representative cohort (n=1697) and a dallas-like (representative of dallas intervention communities) cohort (n=305) were surveyed. Positive absolute and marginal WTP valuations of the app were identified across both cohorts (absolute WTP: UK-representative cohort £196 or US $258 and dallas-like cohort £162 or US $214; marginal WTP: UK-representative cohort £160 or US $211 and dallas-like cohort £151 or US $199). Among both cohorts, there was a high prevalence of zeros for both the absolute WTP (UK-representative cohort: 467/1697, 27.52% and dallas-like cohort: 95/305, 31.15%) and marginal WTP (UK-representative cohort: 487/1697, 28.70% and dallas-like cohort: 99/305, 32.5%). In both cohorts, better general health, previous amount spent on health apps (UK-representative cohort 0.64, 95% CI 0.27 to 1.01; dallas-like cohort: 1.27, 95% CI 0.32 to 2.23), and age had a significant (P>.00) association with WTP (UK-representative cohort: −0.1, 95% CI −0.02 to −0.01; dallas-like cohort: −0.02, 95% CI −0.03 to −0.01), with younger participants willing to pay more for the app. In the UK-representative cohort, as expected, higher WTP was positively associated with income up to £30,000 or US $39,642 (0.21, 95% CI 0.14 to 0.4) and increased spending on existing phone and internet services (0.52, 95% CI 0.30 to 0.74). The amount spent on existing health apps was shown to be a positive indicator of WTP across cohorts, although the effect was marginal (UK-representative cohort 0.01, 95% CI 0.01 to 0.01; dallas-like cohort 0.01, 95% CI 0.01 to 0.02). ConclusionsThis study demonstrates that consumers value mHealth solutions that promote well-being, social connectivity, and health care control, but it is not universally embraced. For mHealth to achieve its potential, apps need to be tailored to user accessibility and health needs, and more understanding of what hinders frequent users of digital technologies and those with long-term conditions is required. This novel application of WTP in a digital health context demonstrates an economic argument for investing in upskilling the population to promote access and expedite uptake and utilization of such digital health and well-being apps.

The main aim of this study was to assess the criterion validity of the Sedentary Behavior Questionnaire (SBQ) to measure SB in community-dwelling older adults using thigh-measured accelerometry as the criterion method. 801 participants (75.6 ± 6.1 years old, 57.6% females) provided valid thigh-based accelerometer data (activPAL/Axivity) and completed the SBQ. Criterion validity was assessed using Spearman's Rho coefficients. Bland--Altman plots, including 95% limits of agreement and Intraclass Correlation Coefficient (ICC), were used to assess the agreement between self-report and device-measured daily SB time. Strength of the association was examined using multiple linear regression. There was a weak correlation (Rho = 0.25, p < 0.001) between self-reported and device-based SB measures. The SBQ under-estimated daily SB time compared to accelerometry. Our results highlighted an overall weak-to-moderate correlation between measures, with significant differences between each country's version. Researchers should be cautious when using the SBQ to provide an estimation of SB time in older adults.

Background: In countries where malaria is endemic, the use of rapid diagnostic tests(RDTs) has become routine, especially in rural settings. Such regions are characterised by often having other co-endemic infectious diseases, at high levels of prevalence. Aim: To illustrate the potential added-value of "sentinel" screening for patients presenting for a routine diagnostic test for malaria, at healthcare facilities in Uganda. Methods: We developed an economic model by combining two decision trees, one for malaria and a second for the co-endemic disease schistosomiasis. The integrated model was designed to inform policy strategies for the co-endemic disease in addition to malaria (i.e., whether to test opportunistically for schistosomiasis or use mass drug administration(MDA) as per usual practice).We performed the analysis on three comparators varying testing accuracy and costs. Results: Sentinel screening can provide added value to the testing of patients compared with the status quo: when schistosomiasis prevalence is high then MDA is preferential; if low prevalence, treating no one is preferred. If the disease has average levels of prevalence, then a strategy involving testing is preferred. Prevalence thresholds driving the dominant strategy are dependent upon the model parameters, which are highly context specific. At average levels of prevalence for schistosomiasis and malaria for Uganda, adding a sentinel screening was cost-effective when the accuracy of test was higher than current diagnostics and when economies of scope were generated(Expected value clinical Information = 0.65$ per DALY averted, 137.91$ per correct diagnoses).Protocols using diagnostics with current accuracy levels were preferred only for levels of MDA coverage below 75%. Conclusion: The importance of the epidemiological setting is crucial in determining the best cost-effective strategy for detecting endemic disease. Economies of scope can make sentinel screenings cost-effective strategies in specific contexts. Blanket thresholds recommended for MDA may not always be the preferred option for endemic diseases. Author summary: Malaria tests are commonly the default assessment when febrile patients arrive at clinics in low- and middle-income countries. This is due to the high prevalence of the disease coupled with the increased reliability and affordability of rapid diagnostic tests. While malaria and other prevalent diseases have received great attention in terms of international investments and local efforts over the years, other endemic diseases do not receive the same consideration in terms of testing capacity and, consequently, correct treatment. This study aims to provide a model to inform policymakers on the costs and benefits of carrying out an opportunistic screening for one (or potentially more) of these neglected tropical diseases (NTD), performed at the same time as a malaria diagnosis for febrile patients presenting at clinics. To achieve this, we developed a model to evaluate different healthcare protocols detecting malaria and schistosomiasis simultaneously, with input values referring to Uganda, as a case study. Schistosomiasis is an NTD and the main treatment strategy in endemic populations is mass drug administration (MDA). This study shows the added value of sentinel screening during a malaria diagnosis varying the level of prevalence of both malaria and schistosomiasis. [ABSTRACT FROM AUTHOR]

Background Health-related quality of life metrics evaluate treatments in ways that matter to patients, so are often included in randomised clinical trials (hereafter trials). Multimorbidity, where individuals have 2 or more conditions, is negatively associated with quality of life. However, whether multimorbidity predicts change over time or modifies treatment effects for quality of life is unknown. Therefore, clinicians and guideline developers are uncertain about the applicability of trial findings to people with multimorbidity. We examined whether comorbidity count (higher counts indicating greater multimorbidity) (i) is associated with quality of life at baseline; (ii) predicts change in quality of life over time; and/or (iii) modifies treatment effects on quality of life. Methods and findings Included trials were registered on the United States trials registry for selected index medical conditions and drug classes, phase 2/3, 3 or 4, had [greater than or equal to]300 participants, a nonrestrictive upper age limit, and were available on 1 of 2 trial repositories on 21 November 2016 and 18 May 2018, respectively. Of 124 meeting these criteria, 56 trials (33,421 participants, 16 index conditions, and 23 drug classes) collected a generic quality of life outcome measure (35 EuroQol-5 dimension (EQ-5D), 31 36-item short form survey (SF-36) with 10 collecting both). Blinding and completeness of follow up were examined for each trial. Using trials where individual participant data (IPD) was available from 2 repositories, a comorbidity count was calculated from medical history and/or prescriptions data. Linear regressions were fitted for the association between comorbidity count and (i) quality of life at baseline; (ii) change in quality of life during trial follow up; and (iii) treatment effects on quality of life. These results were then combined in Bayesian linear models. Posterior samples were summarised via the mean, 2.5th and 97.5th percentiles as credible intervals (95% CI) and via the proportion with values less than 0 as the probability (P.sub.Bayes) of a negative association. All results are in standardised units (obtained by dividing the EQ-5D/SF-36 estimates by published population standard deviations). Per additional comorbidity, adjusting for age and sex, across all index conditions and treatment comparisons, comorbidity count was associated with lower quality of life at baseline and with a decline in quality of life over time (EQ-5D -0.02 [95% CI -0.03 to -0.01], P.sub.Bayes > 0.999). Associations were similar, but with wider 95% CIs crossing the null for SF-36-PCS and SF-36-MCS (-0.05 [-0.10 to 0.01], P.sub.Bayes = 0.956 and -0.05 [-0.10 to 0.01], P.sub.Bayes = 0.966, respectively). Importantly, there was no evidence of any interaction between comorbidity count and treatment efficacy for either EQ-5D or SF-36 (EQ-5D -0.0035 [95% CI -0.0153 to -0.0065], P.sub.Bayes = 0.746; SF-36-MCS (-0.0111 [95% CI -0.0647 to 0.0416], P.sub.Bayes = 0.70 and SF-36-PCS -0.0092 [95% CI -0.0758 to 0.0476], P.sub.Bayes = 0.631. Conclusions Treatment effects on quality of life did not differ by multimorbidity (measured via a comorbidity count) at baseline-for the medical conditions studied, types and severity of comorbidities and level of quality of life at baseline, suggesting that evidence from clinical trials is likely to be applicable to settings with (at least modestly) higher levels of comorbidity. Trial registration A prespecified protocol was registered on PROSPERO (CRD42018048202)., Author(s): Elaine W. Butterly 1, Peter Hanlon 1, Anoop S. V. Shah 2, Laurie J. Hannigan 3,4,5, Emma McIntosh 1, Jim Lewsey 1, Sarah H. Wild 6, Bruce Guthrie 6, [...]

The WHO aims to eliminate schistosomiasis as a public health problem by 2030. However, standard morbidity measures poorly correlate to infection intensities, hindering disease monitoring and evaluation. This is exacerbated by insufficient evidence on Schistosoma's impact on health-related quality of life (HRQoL). We conducted community-based cross-sectional surveys and parasitological examinations in moderate-to-high Schistosoma mansoni endemic communities in Uganda. We calculated parasitic infections and used EQ-5D instruments to estimate and compare HRQoL utilities in these populations. We further employed Tobit/linear regression models to predict HRQoL determinants. Two-thirds of the 560 participants were diagnosed with parasitic infection(s), 49% having S. mansoni. No significant negative association was observed between HRQoL and S. mansoni infection status/intensity. However, severity of pain urinating (β = −0.106; s.e. = 0.043) and body swelling (β = −0.326; s.e. = 0.005), increasing age (β = −0.016; s.e. = 0.033), reduced socio-economic status (β = 0.128; s.e. = 0.032), and being unemployed predicted lower HRQoL. Symptom severity and socio-economic status were better predictors of short-term HRQoL than current S. mansoni infection status/intensity. This is key to disentangling the link between infection(s) and short-term health outcomes, and highlights the complexity of correlating current infection(s) with long-term morbidity. Further evidence is needed on long-term schistosomiasis-associated HRQoL, health and economic outcomes to inform the case for upfront investments in schistosomiasis interventions. [ABSTRACT FROM AUTHOR]

Background: Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective: The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils' social and emotional well-being. Design: This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting: The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants: A total of 2639 pupils in Scotland. Intervention: The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure: The primary outcome was pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results: The primary outcome, pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk −1.30 (95% confidence interval −1.87 to −0.73), standardised effect size −0.27 (95% confidence interval −0.39 to −0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk −2.36 (95% confidence interval −3.62 to −1.11), standardised effect size −0.42 (95% confidence interval −0.64 to −0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations: It was a challenge to retain schools over five waves of data collection. Conclusions: This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work: Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration: This trial is registered as ISRCTN51707384. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information. Plain language summary: We studied the Social and Emotional Education and Development (SEED) primary school intervention to see if it could improve the social and emotional well-being of pupils in Scotland. The SEED intervention is a process with several elements. We collected information from school pupils, staff and parents, and assessed if the schools involved were happy, safe and caring environments. We sought to highlight any strengths or weaknesses in how each school approaches social and emotional well-being. The SEED intervention also measures the social and emotional well-being of pupils. This includes pupils' strengths and difficulties, confidence, understanding of emotions and quality of relationships. We gave the information back to each school to help them decide what they can do to improve the social and emotional well-being of their pupils. We gave schools a guide to available resources, reviewed according to how well they are known to work elsewhere. The same social and emotional well-being measurements were repeated every 1 or 2 years, to see if any improvements had been made, and to guide any further adaptions of activities. The study ran in 38 schools over 7 years; half of the schools were randomly selected to receive the SEED intervention and half carried on as normal. Two age groups of pupils were recruited; the younger group was aged 4 or 5 years and the older group was aged 8 or 9 years at the start of the study. We found that the SEED intervention did slightly improve social and emotional well-being. Improvements were greater for older pupils, in particular for boys, and lasted beyond their transition from primary to secondary school. We also found that it was cost-effective for schools to run the SEED intervention. Schools valued the structure and shared ownership associated with the process. We concluded that the SEED intervention is an acceptable way to modestly improve pupil well-being and school ethos. Scientific summary: Background: Improved social and emotional well-being (SEW) during primary school years has been shown to have an impact on health and academic performance and protect against risk behaviours in later years. However, there is little evidence on which school-based programmes are most effective, particularly in the UK. This trial rigorously evaluated one such innovative programme in Scotland. The Social and Emotional Education and Development (SEED) intervention was designed to promote SEW in primary schools in Scotland. Rather than adopting a one-size-fits-all approach whereby SEW packages are delivered in schools to all pupils regardless of need, the SEED intervention was designed to draw on principles of co-production to tailor activities in response to school need. It has three components: (1) an assessment of school needs through staff, pupil and parent questionnaires; (2) feedback of needs assessment data to all school staff and reflective discussion (RD), facilitated by the schools' educational psychologists (EPs), to select and co-produce school-appropriate, evidence-based actions and initiatives at both class and whole-school levels; and (3) implementation and maintenance of initiatives. Objectives: The overarching aim of this study was to rigorously evaluate the impact of the SEED intervention on improving pupils' SEW via a stratified cluster randomised controlled trial (RCT). The main research questions were addressed by the complementary outcome, process evaluations and economic evaluations. The pupil-related research questions were as follows: Does the SEED intervention improve pupils' SEW? If so, is the impact different for specific subgroups of pupils (e.g. gender, deprivation)? Is the SEED intervention more effective if started with younger children [ SEED trial younger cohort (YC) vs. older cohort (OC)]? What is the duration of the SEED intervention effect? Does the SEED intervention improve the social and emotional experience of transition from primary to secondary school? What is the impact on health behaviours of the SEED intervention during early secondary school years? What are pupils' experiences of the SEED intervention? The teacher-related research questions were as follows: Are there changes in teachers' knowledge, attitudes and behaviour relating to developing pupils' SEW? Were teachers involved, and, if so, how were they involved, in selecting initiatives to respond to the pupils' needs assessment? What contextual factors facilitate or inhibit the delivery of the SEED intervention? What contextual factors support or hinder the ability of the SEED intervention to improve pupils' SEW? Which teachers engage best with the SEED intervention? What are teachers' experiences of the SEED intervention? The parent-related research questions were as follows: Do parents report a difference in their child(ren)'s emotional and social development? If applicable, what are parents' experiences of the SEED intervention? The economic research question was as follows: is SEED cost-effective? Methods: A stratified cluster RCT was undertaken across 38 schools in the central Scotland area between 2013 and 2019. We invited state-funded denominational and non-denominational schools from three Scottish local authorities; we did not include independently funded schools. The intervention was delivered in primary schools, but the evaluation took place in primary and secondary schools. Baseline questionnaire data were collected from two cohorts of pupils in primary school, one in year 1 (aged 4–6 years) and the other in year 5 (aged 8–10 years), their parents and school staff. After a 1-year gap, to enable commencement of action plans, three waves of follow-up data were collected annually, then a further final follow-up wave was carried out 2 years after that with the OC of pupils only. Main trial outcomes: The primary outcome was the Strengths and Difficulties Questionnaire-Total Difficulties Score (SDQ-TDS) at time 3 (T3) (follow-up 3), when the younger pupils were aged 8–10 years and the older pupils were aged 12–14 years. Secondary outcomes included all five subscales of the Strengths and Difficulties Questionnaire (SDQ); additional measures included pupil and staff well-being, school ethos and relationships. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in the statistical package R (The R Foundation for Statistical Computing, Vienna, Austria). Missing data were handled using repeated measures. Process evaluation: The process evaluation design was guided by the UK Medical Research Council framework for the evaluation of complex interventions. Mixed methods included semistructured interviews with head teachers/depute head teachers and EPs, ethnographic notes from RD sessions and focus groups with pupils. An initial analysis was carried out on data collected from case study schools prior to knowing the main trial outcomes using an agreed coding framework. Further thematic analysis was conducted using NVivo (QSR International, Warrington, UK) to interpret trial outcomes and understand mechanisms of change. Economic evaluation: The economic evaluation was conducted from a public sector perspective, including the NHS, Personal Social Services and local government. A validated child-specific preference-based measure, the Child Health Utility-9 Dimensions, was used to obtain utility values, which, together with costs, were used to conduct a cost–utility analysis. In addition, a within-trial cost-effectiveness analysis was conducted using the SDQ-TDS , the primary outcome measure for the trial. Data on the costs include costs associated with the provision of the intervention, including staff time, travel and consumables at each stage of the intervention, as well as the resource use cost collected at time 1 (T1) (follow-up 1) and T3 in the public sector, such as general practitioner visits and police visits. Resource use data were collected via the self-completed questionnaires, and the unit costs were obtained from standard UK sources. All analyses were undertaken according to the principle of intention-to-treat and in Stata®/SE 14.0 (StataCorp LP, College Station, TX, USA). Results (research findings): We recruited 38 primary schools with > 2600 pupils. The primary outcome, pupils' SDQ-TDSs at T3 , showed statistically significant improvements for pupils in the intervention arm, compared with those in the control arm [relative risk −1.30, 95% confidence interval (CI) −1.87 to −0.73]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. A subgroup analysis showed that all effect sizes were larger for the OC , particularly older boys (relative risk −2.36, 95% CI −3.62 to −1.11). All five SDQ subscales also showed beneficial and statistically significant results. A secondary analysis showed that the intervention had a range of positive effects on social and emotional skills, and school ethos and relationships. Only boys showed significant results for conduct problems and prosocial behaviour; all the other subscales showed effects for both genders. The intervention effect appeared to be diminished at the longer-term, final follow-up, 6 years post baseline. The economic evaluation concluded that the SEED intervention was likely to be cost-effective, but more so for the OC than the YC. Among the YC , the intervention was associated with a £166 increase in the cost and a 0.19 decrease in the SDQ-TDS , leading to a result of £856 per decrease in SDQ-TDS. Costs were lower in the OC because of the smaller incremental cost and much larger treatment effect, with an incremental cost-effectiveness ratio of £1.22 per 1-unit decrease in the SDQ-TDS. The probability of the SEED intervention being cost-effective at £20,000 per quality-adjusted life-year was > 80%. The process evaluation showed that there was an appreciation for the timing of the SEED intervention in terms of its alignment with the Scottish curriculum. The intervention was perceived as complementary to, rather than competing against, other established initiatives and priorities. Although there was variability in fidelity to the SEED intervention process, the data collection and the process of feeding back data at whole-school staff sessions were the most consistently implemented aspects. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss SEW and its contribution to a culture of evaluating practice. Limitations: It was a challenge to retain schools over five waves of data collection. At two waves of data collection (T2 and T4), we lost three schools; however, we did have good school participation at the other three waves of data collection. We caution readers that there is more uncertainty about our results for these two waves. Low parental participation in our survey meant that parent data were unlikely to be a fair basis for influencing school-level decision-making, and this was communicated to schools. Conclusions: The SEED cluster RCT provides robust evidence about the effects of the SEED intervention, a school-based intervention to promote SEWamong children. We have demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older pupils and, among the older pupils, particularly for boys and those with greater levels of psychological difficulties of both genders. There is no evidence of the intervention being more beneficial for advantaged pupils, so it should not widen the inequalities gap. It was beneficial during the transition from primary to secondary school, but longer-term analysis suggests that the effect is diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other intervention initiatives. Future work: Our recommendations for future implications in relation to action, in numbered order, are to: conduct data linkage to SEED pupils' external examination results (aggregated linkage rather than individual-pupil level), to assess whether or not the SEED intervention had any beneficial impact on academic attainment explore the transferability of the SEED intervention to other countries within the UK and beyond investigate the impact of adding core training elements (e.g. teacher training on young people's mental health and well-being) to the intervention process extend the SEED intervention-style process to secondary schools understand the gender differences illustrated by the SEED outcomes develop and evaluate the SEED intervention concept in different settings across the life course further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration: This trial is registered as ISRCTN51707384. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information. [ABSTRACT FROM AUTHOR]

Background Venous leg ulcers (VLUs) heal slowly, are painful for patients and are costly for healthcare systems; they also affect patients’ quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However, a large population of people with VLUs are unable to access such an intervention due to frailty and age. Objectives To assess the feasibility of ‘FISCU Home’ (a co-designed, 12-week home-based self-managed lifestyle programme based on exercise and behaviour support) as an adjunct therapy to compression in people with VLUs. Methods Forty people with VLUs, receiving treatment at home, were recruited from community nursing and tissue viability teams, and via a newspaper advertisement. Participants were randomized 1 : 1 either to exercise with behaviour support (three times per week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events (AEs). Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e. ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated. Results The study recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed compression therapy. No serious AEs or exercise-related AEs were reported. Median (interquartile range) ulcer healing time was shorter in the exercise group [29 (7–108) vs. 42 (6–116) weeks]. Conclusions The feasibility and acceptability of both a home- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported. [ABSTRACT FROM AUTHOR]