Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).

BackgroundMultimorbidity is common in deprived communities and reduces quality of life. Our aim was to evaluate a whole-system primary care-based complex intervention, called CARE Plus, to improve quality of life in multimorbid patients living in areas of very high deprivation.MethodsWe used a phase 2 exploratory cluster randomised controlled trial with eight general practices in Glasgow in very deprived areas that involved multimorbid patients aged 30–65 years. The intervention comprised structured longer consultations, relationship continuity, practitioner support, and self-management support. Control practices continued treatment as usual. Primary outcomes were quality of life (EQ-5D-5L utility scores) and well-being (W-BQ12; 3 domains). Cost-effectiveness from a health service perspective, engagement, and retention were assessed. Recruitment and baseline measurements occurred prior to randomisation. Blinding post-randomisation was not possible but outcome measurement and analysis were masked. Analyses were by intention to treat.ResultsOf 76 eligible practices contacted, 12 accepted, and eight were selected, randomised and participated for the duration of the trial. Of 225 eligible patients, 152 (68 %) participated and 67/76 (88 %) in each arm completed the 12-month assessment. Two patients died in the control group. CARE Plus significantly improved one domain of well-being (negative well-being), with an effect size of 0.33 (95 % confidence interval [CI] 0.11–0.55) at 12 months (p = 0.0036). Positive well-being, energy, and general well-being (the combined score of the three components) were not significantly influenced by the intervention at 12 months. EQ-5D-5L area under the curve over the 12 months was higher in the CARE Plus group (p = 0.002). The incremental cost in the CARE Plus group was £929 (95 % CI: £86–£1788) per participant with a gain in quality-adjusted life years of 0.076 (95 % CI: 0.028–0.124) over the 12 months of the trial, resulting in a cost-effectiveness ratio of £12,224 per quality-adjusted life year gained. Modelling suggested that cost-effectiveness would continue.ConclusionsIt is feasible to conduct a high-quality cluster randomised control trial of a complex intervention with multimorbid patients in primary care in areas of very high deprivation. Enhancing primary care through a whole-system approach may be a cost-effective way to protect quality of life for multimorbid patients in deprived areas.Trial registrationTrial registration: ISRCTN 34092919, assigned 14/1/2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0634-2) contains supplementary material, which is available to authorized users.

BackgroundDigital health has the potential to support care delivery for chronic illness. Despite positive evidence from localized implementations, new technologies have proven slow to become accepted, integrated, and routinized at scale.ObjectiveThe aim of our study was to examine barriers and facilitators to implementation of digital health at scale through the evaluation of a £37m national digital health program: ‟Delivering Assisted Living Lifestyles at Scale” (dallas) from 2012-2015.MethodsThe study was a longitudinal qualitative, multi-stakeholder, implementation study. The methods included interviews (n=125) with key implementers, focus groups with consumers and patients (n=7), project meetings (n=12), field work or observation in the communities (n=16), health professional survey responses (n=48), and cross program documentary evidence on implementation (n=215). We used a sociological theory called normalization process theory (NPT) and a longitudinal (3 years) qualitative framework analysis approach. This work did not study a single intervention or population. Instead, we evaluated the processes (of designing and delivering digital health), and our outcomes were the identified barriers and facilitators to delivering and mainstreaming services and products within the mixed sector digital health ecosystem.ResultsWe identified three main levels of issues influencing readiness for digital health: macro (market, infrastructure, policy), meso (organizational), and micro (professional or public). Factors hindering implementation included: lack of information technology (IT) infrastructure, uncertainty around information governance, lack of incentives to prioritize interoperability, lack of precedence on accountability within the commercial sector, and a market perceived as difficult to navigate. Factors enabling implementation were: clinical endorsement, champions who promoted digital health, and public and professional willingness.ConclusionsAlthough there is receptiveness to digital health, barriers to mainstreaming remain. Our findings suggest greater investment in national and local infrastructure, implementation of guidelines for the safe and transparent use and assessment of digital health, incentivization of interoperability, and investment in upskilling of professionals and the public would help support the normalization of digital health. These findings will enable researchers, health care practitioners, and policy makers to understand the current landscape and the actions required in order to prepare the market and accelerate uptake, and use of digital health and wellness services in context and at scale.

BackgroundThe prevalence of male obesity is increasing alongside low uptake of existing weight management programmes by men. Football Fans in Training (FFIT) is a group-based, weight management and healthy living programme delivered by community coaches.ObjectivesTo assess (1) the effectiveness and cost-effectiveness of FFIT, (2) fidelity of delivery and (3) coach and participant experiences of FFIT.DesignA two-arm, pragmatic, randomised controlled trial; associated cost-effectiveness [in terms of incremental cost per quality-adjusted life-year (QALY) within trial and over individuals’ lifetimes]; and process evaluation. Participants were block randomised in a 1 : 1 ratio, stratified by club; the intervention group started FFIT within 3 weeks and the comparison group were put on a 12-month waiting list.SettingThirteen professional football clubs in Scotland, UK.ParticipantsA total of 747 men aged 35–65 years with an objectively measured body mass index (BMI) of ≥ 28 kg/m2.InterventionsFFIT was gender sensitised in context, content and style of delivery. A total of 12 weekly sessions delivered at club stadia combined effective behaviour change techniques with dietary information and physical activity sessions. Men carried out a pedometer-based walking programme. A light-touch maintenance programme included six e-mails and a reunion session at 9 months. At baseline, both groups received a weight management booklet, feedback on their BMI and advice to consult their general practitioner if blood pressure was high.Primary outcomeMean difference in weight loss between groups at 12 months expressed as absolute weight and a percentage. Intention-to-treat analyses used all available data.Data sourcesObjective measurements, questionnaires, observations, focus groups and coach interviews.ResultsA total of 374 men were allocated to the intervention and 333 (89%) completed 12-month assessments; a total of 374 were allocated to the comparator and 355 (95%) completed 12-month assessments. At 12 months, the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4.94 kg [95% confidence interval (CI) 3.95 kg to 5.94 kg]; percentage weight loss, similarly adjusted, was 4.36% (95% CI 3.64% to 5.08%), in favour of the intervention (p < 0.0001). Sensitivity analyses gave similar results. Pre-specified subgroup analyses found no significant predictors of primary outcome. Highly significant differences in favour of the intervention were observed for objectively measured waist, percentage body fat, systolic and diastolic blood pressure, and self-reported physical activity, diet and indicators of well-being and physical aspects of quality of life. Eight serious adverse events were reported, of which two were reported as related to FFIT participation. From the within-trial analysis, FFIT was estimated to cost £862 per additional man maintaining a 5% weight reduction at 12 months and £13,847 per additional QALY, both compared with no intervention. For a cost-effectiveness threshold of £20,000/QALY, the probability that FFIT is cost-effective, compared with no active intervention, is 0.72. This probability rises to 0.89 for a cost-effectiveness threshold of £30,000/QALY. From the longer-term analysis, FFIT was estimated to cost £2535 per life-year gained and £2810 per QALY gained. FFIT was largely delivered as intended. The process evaluation demonstrated the powerful draw of football to attract men at high risk of ill health. FFIT was popular and analyses suggest that it enabled lifestyle change in ways that were congruent with participants’ identities.ConclusionsParticipation in FFIT led to significant reductions in weight at 12 months. It was cost-effective at standard levels employed in the UK, attracted men at high risk of future ill health and was enjoyable. Further research should investigate whether or not participants retained weight loss in the long term, how the programme could be optimised in relation to effectiveness and intensity of delivery and how group-based programmes may operate to enhance weight loss in comparison with individualised approaches.Study registrationCurrent Controlled Trials ISRCTN32677491.FundingScottish Government and The Football Pools funded the delivery of FFIT. National Institute for Health Research Public Health Research programme funded the evaluation and will be published in full inPublic Health Research; Vol. 3, No. 2. See the NIHR Journals Library website for further project information.

BackgroundThere is no established primary care solution for the rapidly increasing numbers of severely obese people with body mass index (BMI) >40 kg/m 2 . AimThis programme aimed to generate weight losses of ≥15 kg at 12 months, within routine primary care. Design and settingFeasibility study in primary care. MethodPatients with a BMI ≥40 kg/m 2 commenced a micronutrient-replete 810-833 kcal/day lowenergy liquid diet (LELD), delivered in primary care, for a planned 12 weeks or 20 kg weight loss (whichever was the sooner), with structured food reintroduction and then weight-loss maintenance, with optional orlistat to 12 months. ResultsOf 91 patients (74 females) entering the programme (baseline: weight 131 kg, BMI 48 kg/ m 2 , age 46 years), 58/91(64%) completed the LELD stage, with a mean duration of 14.4 weeks (standard deviation [SD] = 6.0 weeks), and a mean weight loss of 16.9 kg (SD = 6.0 kg). Four patients commenced weight-loss maintenance omitting the food-reintroduction stage. Of the remaining 54, 37(68%) started and completed food reintroduction over a mean duration of 9.3 weeks (SD = 5.7 weeks), with a further mean weight loss of 2.1 kg (SD = 3.7 kg), before starting a long-term low-fat-diet weight-loss maintenance plan. A total of 44/91 (48%) received orlistat at some stage. At 12 months, weight was recorded for 68/91 (75%) patients, with a mean loss of 12.4 kg (SD = 11.4 kg). Of these, 30 (33% of all 91 patients starting the programme) had a documented maintained weight loss of ≥15 kg at 12 months, six (7%) had a 10-15 kg loss, and 11 (12%) had a 5-10 kg loss. The indicative cost of providing this entire programme for wider implementation would be £861 per patient entered, or £2611 per documented 15 kg loss achieved. ConclusionA care package within routine primary care for severe obesity, including LELD, food reintroduction, and weight-loss maintenance, was well accepted and achieved a 12-monthmaintained weight loss of ≥15 kg for one-third of all patients entering the programme.