A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial.

INTRODUCTION: Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting. METHODS AND ANALYSIS: General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45-65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia. ETHICS AND DISSEMINATION: Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time. TRIAL REGISTRATION NUMBER: ACTRN12621001168842.

Effects of customer relationship management (CRM) strategies and socio-cognitive constructs on the physical activity of individuals with arthritis over time.

BACKGROUND: Regular physical activity is important for arthritis self-management and could be promoted through tailoring community leisure and fitness centers' customer-relationship management (CRM) strategies. OBJECTIVES: This study investigates the influence of two CRM strategies on individuals with arthritis reaching or maintaining two moderate-to-vigorous physical activity (MVPA) thresholds (≥150 and ≥45 minutes/week) from baseline-to-12 months and 12-to-24 months as well as mean changes in total minutes/week of MVPA. It also explores time-dependent variations in the influence of socio-cognitive variables on MVPA outcomes. METHODS: Survey data from 374 participants with arthritis in a two-year randomized controlled trial (control versus two CRM strategies: IncentiveOnly and Incentive+Support) were used. Participants reported measures of physical activity participation, socio-cognitive decision-making, mental and physical wellbeing, friendship, community connectedness, sense of trust in others, and demographics. FINDINGS/DISCUSSION: Receiving the Incentive+Support CRM strategy (versus control) increased participants' likelihood of reaching/maintaining both physical activity thresholds from 12-to-24 months (≥150 MVPA minutes/week, p < .001; ≥45 MVPA minutes/week, p < .032) but not from baseline-to-12 months. However, receiving the IncentiveOnly CRM strategy (versus control) did not predict reaching/maintaining these thresholds. Importantly, socio-cognitive decision-making variables' influence on reaching/maintaining these MVPA thresholds varied over time, suggesting CRM strategies may require further tailoring based on time-specific profiles. Perhaps because of new facility induced excitement, the mean change in total MVPA minutes/week for the control group significantly increased (26.8 minute/week, p = .014, 95% CI [5.5, 48.0]) from baseline-to-12 months, but subsequently declined by 11.4 minute/week from 12-to-24 months (p = .296, 95% CI [-32.7, 9.9]). Mean changes in total MVPA minutes/week were non-significant for those receiving IncentiveOnly content but significant for those receiving Incentive+Support content: baseline-to-12 months (38.2 minute/week increase, p = .023, 95% CI [4.9, 71.4]) and baseline-to-24-months (45.9 minute/week increase, p = .007, 95% CI [12.7, 79.1]).

How social norms and values shape household healthcare expenditures and resource allocation: Insights from India.

We present a novel perspective on thinking about and studying healthcare spending in contexts where few health-related financial risk protection mechanisms exist and where out-of-pocket spending by households is the norm. Drawing on interviews conducted across 20 villages in two states of India, we illustrate and problematize how a complex interplay of social norms and cultural factors underpin spending decisions within households in such contexts. While our analysis draws on the fieldwork at large, we present our findings through selected narratives - stories of patients suffering from chronic breathlessness. We engage with and reveal the various ways in which social norms dynamically drive this household economy, and shape resource allocation-related decisions. We conclude that in health system contexts where out-of-pocket spending by households is the norm, it is essential to recognise the pragmatic and calculative nature of intra-household allocation of resources, and how it involves bargaining and negotiations at the intersection of social norms, economic class, caste, gender, age, and productive status. And at the same time, how all of this occurs within the economy of the family, and how it plays out differently for different members of a family is also important to recognise. Such recognition can not only help one better appreciate how this household level economy may sometimes maintain and perpetuate entrenched hierarchies and gender inequities, crucially, it can help target health related social protection policies and strategies and make them more responsive to the needs of the most vulnerable in the society and within households.

Different Case Finding Approaches to Optimise COPD Diagnosis: Evidence from the RADICALS Trial.

Aim: Diagnosis of COPD in primary care is hindered by underuse of spirometry. Case finding using validated symptom and health status questionnaires, and simple handheld devices in high-risk populations may improve diagnosis. This study aimed to determine the best combination of measures to optimise COPD diagnosis in the primary care setting. Methods: We recruited 335 current or ex-smokers, including those with an established diagnosis of COPD from general practices. Participants' FEV1 and FEV6 were measured using a handheld spirometry device (COPD-6®). Each completed the COPD assessment test (CAT), a modified Medical Research Council (mMRC) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ) and smoking history questionnaire. From these data we calculated the predictive validity for spirometry-confirmed diagnosis of COPD. Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive and negative predictive values (PPV, NPV) were calculated for each. Kappa coefficient was used to measure the agreement between the Fixed-Ratio (FR) and Lower Limit of Normal (LLN) spirometric criteria in diagnosing COPD. Results: FEV1/FEV6 <0.70 alone showed significant association (p<0.0001) with COPD diagnosis and good predictive accuracy (AUROC=0.725). However, no further improvement was found after combining SGRQ, CAT and mMRC with FEV1/FEV6. FEV1/FEV6 <0.70 using the COPD-6® handheld device had moderate sensitivity (65.7%) and high PPV (90.1%), high specificity (79.3%) and NPV (44.8%). There was good agreement between FR and LLN definitions (κ=0.70). Conclusion: Handheld micro-spirometers can facilitate case finding of COPD in smokers and ex-smokers attending general practice. The fixed ratio criterion currently recommended by COPD-X guidelines offers the simplest method for diagnosing COPD in Australian primary care.

Combining general and central measures of adiposity to identify risk of hypertension: a cross-sectional survey in rural India.

AIM: In three socioeconomically diverse regions of rural India, we determined the optimal cut-offs for definition of overweight, the prevalence of overweight, and the relationships between measures of overweight and risk of hypertension. SUBJECTS AND METHODS: Villages were randomly sampled within rural Trivandrum, West Godavari, and Rishi Valley. Sampling of individuals was stratified by age group and sex. Cut-offs for measures of adiposity were compared using area under the receiver operating characteristic curve. Associations between hypertension and definitions of overweight were assessed by logistic regression. RESULTS: Of 11 657 participants (50 % male; median age 45 years), 29.8 % had hypertension. Large proportions were overweight as defined by body mass index (BMI) ≥ 23 kg/m2 (47.7 %), waist circumference (WC) ≥ 90 cm for men or ≥ 80 cm for women (39.6 %), waist-hip ratio (WHR) ≥ 0.9 for men or ≥ 0.8 for women (65.6 %), waist-height ratio (WHtR) ≥ 0.5 (62.5 %), or by BMI plus either WHR, WC or WHtR (45.0 %). All definitions of overweight were associated with hypertension, with optimal cut-offs being at, or close to, the World Health Organization (WHO) Asia-Pacific standards. Having overweight according to both BMI and a measure of central adiposity was associated with approximately twice the risk of hypertension than overweight defined by only one measure. CONCLUSIONS: Overweight, as assessed by both general and central measures, is prevalent in rural southern India. WHO standard cut-offs are appropriate in this setting for assessing risk of hypertension. However, combining BMI with a measure of central adiposity identifies risk of hypertension better than any single measure. The risk of hypertension is significantly greater in those centrally and generally overweight than those overweight by a single measure.

Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial.

BACKGROUND: Pulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people's homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial. METHODS: A mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up. DISCUSSION: The process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

The role of hospitals in strengthening primary health care in the Western Pacific.

Despite the imperative to strengthen primary health care (PHC) to respond to demographic and epistemological transitions, and meet commitments to achieve universal health coverage, health systems remain hospital-centric with health resources largely concentrated in urban centres. This paper examines islands of innovation that demonstrate the role hospitals can play in influencing the provision of PHC. Drawing on the literature and country case studies from the Western Pacific region, we illustrate mechanisms used to unlock hospital resources to improve PHC, with the transition towards "systems-focused hospitals". This paper identifies four "ideal types" of roles hospitals perform to strengthen PHC in different contexts. This provides a framework to inform health systems policy by examining existing and potential roles of hospitals to support the provision of frontline services and reorient health systems towards PHC.

The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol.

INTRODUCTION: India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. OBJECTIVES: The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. METHODS: The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. DISCUSSION: Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry-(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191.

Morbidity and utilisation of healthcare services among people with cardiometabolic disease in three diverse regions of rural India.

OBJECTIVES: To assess the prevalence and determinants of cardiometabolic disease (CMD), and the factors associated with healthcare utilisation, among people with CMD. METHODS: Using a cross-sectional design, 11,657 participants were recruited from randomly selected villages in 3 regions located in Kerala and Andhra Pradesh from 2014 to 2016. Multivariable logistic regression was used to identify factors independently associated with CMD and healthcare utilisation (public or private). RESULTS: Thirty-four per cent (n = 3629) of participants reported having ≥1 CMD, including hypertension (21.6%), diabetes (11.6%), heart disease (5.0%) or chronic kidney disease (CKD) (1.6%). The prevalence of CMD was progressively greater in regions of greater socio-economic position (SEP), ranging from 19.1% to 40.9%. Among those with CMD 41% had sought any medical advice in the last month, with only 19% utilising public health facilities. Among people with CMD, those with health insurance utilised more healthcare (age-gender adjusted odds ratio (AOR) (95% confidence interval (CI)): 1.31 (1.13, 1.51)) as did those who reported accessing private rather than public health services (1.43 (1.23, 1.66)). DISCUSSION: The prevalence of CMD is high in these regions of rural India and is positively associated with indices of SEP. The utilisation of outpatient health services, particularly public services, among those with CMD is low.

Perceived Autonomy Support in Telerehabilitation by People With Chronic Respiratory Disease: A Mixed Methods Study.

BACKGROUND: Autonomy-supportive health environments can assist patients in achieving behavior change and can influence adherence positively. Telerehabilitation may increase access to rehabilitation services, but creating an autonomy-supportive environment may be challenging. RESEARCH QUESTION: To what degree does telerehabilitation provide an autonomy-supportive environment? What is the patient experience of an 8-week telerehabilitation program? STUDY DESIGN AND METHODS: Individuals undertaking telerehabilitation or center-based pulmonary rehabilitation within a larger randomized controlled equivalence trial completed the Health Care Climate Questionnaire (HCCQ; short form) to assess perceived autonomy support. Telerehabilitation participants were invited 1:1 to undertake semistructured interviews. Interviews were transcribed verbatim and coded thematically to identify major themes and subthemes. RESULTS: One hundred thirty-six participants (n = 69 telerehabilitation) completed the HCCQ and 30 telerehabilitation participants (42%) undertook interviews. HCCQ summary scores indicated that participants strongly agreed that the telerehabilitation environment was autonomy supportive, which was similar to center-based participants (HCCQ summary score, P = .6; individual HCCQ items, P ≥ .3). Telerehabilitation interview data supported quantitative findings identifying five major themes, with subthemes, as follows: (1) making it easier to participate in pulmonary rehabilitation, because telerehabilitation was convenient, saved time and money, and offered flexibility; (2) receiving support in a variety of ways, including opportunities for peer support and receiving an individualized program guided by expert staff; (3) internal and external motivation to exercise as a consequence of being in a supervised group, seeing results for effort, and being inspired by others; (4) achieving success through provision of equipment and processes to prepare and support operation of equipment and technology; and (5) after the rehabilitation program, continuing to exercise, but dealing with feelings of loss. INTERPRETATION: Telerehabilitation was perceived as an autonomy-supportive environment, in part by making it easier to undertake pulmonary rehabilitation. Support for behavior change, understanding, and motivation were derived from clinicians and patient-peers. The extent to which autonomy support translates into ongoing self-management and behavior change is not clear. TRIAL REGISTRY: Australian and New Zealand Clinical Trials Registry; No.: ACTRN12616000360415; URL: https://anzctr.org.au/.

'We are the bridge': an implementation research study of SEWA Shakti Kendras to improve community engagement in publicly funded health insurance in Gujarat, India.

INTRODUCTION: India's efforts towards universal health coverage include a national health insurance scheme that aims to protect the most vulnerable from catastrophic health expenditure. However, emerging evidence on publicly funded health insurance, as well as experience from community-based schemes, indicates that women face specific barriers to access and utilisation. Community engagement interventions have been shown to improve equitable utilisation of public health services, but there is limited research specific to health insurance. We examined how existing community-based resource centres implemented by a women's organisation could improve women's access to, and utilisation of, health insurance. METHODS: We conducted an implementation research study in Gujarat, India to examine how SEWA Shakti Kendras, established by the Self-Employed Women's Association, worked to improve community engagement in health insurance. SEWA organises women in the informal sector and provides social protection through health, insurance and childcare services. We examined administrative data, programme reports and conducted 30 in-depth qualitative interviews with users and staff. Data were analysed thematically to examine intervention content, context, and implementation processes and to identify enablers and barriers to improving women's access to health insurance through SEWA's community engagement approach. RESULTS: The centres worked through multiple channels-doorstep services, centre-based support and health system navigation-to strengthen women's capability to access health insurance. Each centre's approach varied by contextual factors, such as women's digital literacy levels and rural-urban settings. Effective community engagement required local leadership, strong government partnerships and the flexibility to address a range of public services, with implementation by trusted local health workers. CONCLUSION: SEWA Shakti Kendras demonstrate how a local, flexible and community-based model can serve as a bridge to improve utilisation of health insurance, by engaging women and their households through multiple channels. Scaling up this approach will require investing in partnerships with community-based organisations as part of strategies towards universal health coverage.

People's care seeking journey for a chronic illness in rural India: Implications for policy and practice.

Drawing on interviews conducted in 2019-2020, across twenty villages in India, this paper unpacks how people with chronic illness navigate complex care-seeking terrain. We show how the act of seeking care involves navigating through personal, family, social, economic, cultural, and most importantly, difficult health systems spaces-and entails making difficult social, moral, and financial choices. We show how the absence of reliable and accessible points of first contact for primary care results in people running from pillar to post, taking wrong turns, and becoming disappointed, frustrated, and, sometimes, impoverished. We reveal the complex individual and social dynamics of hope and misplaced and misguided expectations, as well as social obligations and their performance that animate the act of navigating care in rural India. We shine light on how a health system with weak primary care and poor regulation amplifies the medical, social, and financial consequences of an otherwise manageable chronic illness, and how these consequences are the worst for those with the least social, network and economic capital. Crucially we highlight the problematic normalisation of the absence of reliable primary care services for chronic illness in India, in rural India specifically. We signpost implications for research, and for policy and practice in India and similar health system contexts, i.e. those with weak primary care and poor regulation of the private sector. We argue that in India, having in place accessible, good quality, and trustworthy sources of advice and care for chronic illness at the first point of call, for all, is critical. We contend that this first point of call should be quality, public primary care services. We conclude that if such arrangements are in place in public services, people will use them.

Travel time to health facilities in Papua New Guinea: Implications for coverage and equity in child vaccinations.

With infant and child mortality rates that are among the highest in the Pacific region, and basic vaccination coverage rates that are 39% among children 12-23 months, increased coverage of vaccines is a high priority investment for Papua New Guinea (PNG). Using recently gathered household survey data for PNG, this paper contributes to the evidence-base for enhancing investments in frontline facilities by examining the implications of travel time to health facilities for basic vaccination coverage among children in PNG. We find that vaccination coverage rates among children 12-23 months old in PNG are decreasing in distance to healthcare facilities; and this holds whether the outcome is receipt of basic vaccinations (BCG; 3 dose pentavalent; OPV3; Measles), or basic vaccinations-plus (basic vaccinations + Hepatitis B + PCV3). We also find that travel time to health facilities lowers vaccination rates among children 12-23 months old in poor households to a greater extent than for children from richer households. Thus, enhanced geographical access to and resourcing of frontline facilities is likely to expand not only immunization coverage, lower mortality and increase aggregate economic gains, but also improve the distribution of immunization coverage in PNG across socioeconomic groups.

Implementing a choice of pulmonary rehabilitation models in chronic obstructive pulmonary disease (HomeBase2 trial): protocol for a cluster randomised controlled trial.

INTRODUCTION: There is compelling evidence that either centre-based or home-based pulmonary rehabilitation improves clinical outcomes in chronic obstructive pulmonary disease (COPD). There are known health service and personal barriers which prevent potentially eligible patients from accessing the benefits of pulmonary rehabilitation. The aim of this hybrid effectiveness-implementation trial is to examine the effects of offering patients a choice of pulmonary rehabilitation locations (home or centre) compared with offering only the traditional centre-based model. METHOD AND ANALYSIS: This is a two-arm cluster randomised, controlled, assessor-blinded trial of 14 centre-based pulmonary rehabilitation services allocated to intervention (offering choice of home-based or centre-based pulmonary rehabilitation) or control (continuing to offer centre-based pulmonary rehabilitation only), stratified by centre-based programme setting (hospital vs non-hospital). 490 participants with COPD will be recruited. Centre-based pulmonary rehabilitation will be delivered according to best practice guidelines including supervised exercise training for 8 weeks. At intervention sites, the home-based pulmonary rehabilitation will be delivered according to an established 8-week model, comprising of one home visit, unsupervised exercise training and telephone calls that build motivation for exercise participation and facilitate self-management. The primary outcome is all-cause, unplanned hospitalisations in the 12 months following rehabilitation. Secondary outcomes include programme completion rates and measurements of 6-minute walk distance, chronic respiratory questionnaire, EQ-5D-5L, dyspnoea-12, physical activity and sedentary time at the end of rehabilitation and 12 months following rehabilitation.Direct healthcare costs, indirect costs and changes in EQ-5D-5L will be used to evaluate cost-effectiveness. A process evaluation will be undertaken to understand how the choice model is implemented and explore sustainability beyond the clinical trial. ETHICS AND DISSEMINATION: Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients across Australia with support from national lung charities and societies. TRIAL REGISTRATION NUMBER: NCT04217330.

Primary stroke prevention worldwide: translating evidence into action.

Stroke is the second leading cause of death and the third leading cause of disability worldwide and its burden is increasing rapidly in low-income and middle-income countries, many of which are unable to face the challenges it imposes. In this Health Policy paper on primary stroke prevention, we provide an overview of the current situation regarding primary prevention services, estimate the cost of stroke and stroke prevention, and identify deficiencies in existing guidelines and gaps in primary prevention. We also offer a set of pragmatic solutions for implementation of primary stroke prevention, with an emphasis on the role of governments and population-wide strategies, including task-shifting and sharing and health system re-engineering. Implementation of primary stroke prevention involves patients, health professionals, funders, policy makers, implementation partners, and the entire population along the life course.

Telerehabilitation for chronic respiratory disease: a randomised controlled equivalence trial.

RATIONALE: Pulmonary rehabilitation is an effective treatment for people with chronic respiratory disease but is delivered to <5% of eligible individuals. This study investigated whether home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation in people with chronic respiratory disease. METHODS: A multicentre randomised controlled trial with assessor blinding, powered for equivalence was undertaken. Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural) were eligible and randomised using concealed allocation to pulmonary rehabilitation or telerehabilitation. Both programmes were two times per week for 8 weeks. The primary outcome was change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation, with a prespecified equivalence margin of 2.5 points. Follow-up was at 12 months. Secondary outcomes included exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being. RESULTS: 142 participants were randomised to pulmonary rehabilitation or telerehabilitation with 96% and 97% included in the intention-to-treat analysis, respectively. There were no significant differences between groups for any outcome at either time point. Both groups achieved meaningful improvement in dyspnoea and exercise capacity at end-rehabilitation. However, we were unable to confirm equivalence of telerehabilitation for the primary outcome ΔCRQ-D at end-rehabilitation (mean difference (MD) (95% CI) -1 point (-3 to 1)), and inferiority of telerehabilitation could not be excluded at either time point (12-month follow-up: MD -1 point (95% CI -4 to 1)). At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD -6 m, 95% CI -26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI -10 to 38). CONCLUSION: telerehabilitation may not be equivalent to centre-based pulmonary rehabilitation for all outcomes, but is safe and achieves clinically meaningful benefits. When centre-based pulmonary rehabilitation is not available, telerehabilitation may provide an alternative programme model. TRIAL REGISTRATION NUMBER: ACtelerehabilitationN12616000360415.

ASHA-Led Community-Based Groups to Support Control of Hypertension in Rural India Are Feasible and Potentially Scalable.

Background: To improve the control of hypertension in low- and middle-income countries, we trialed a community-based group program co-designed with local policy makers to fit within the framework of India's health system. Trained accredited social health activists (ASHAs), delivered the program, in three economically and developmentally diverse settings in rural India. We evaluated the program's implementation and scalability. Methods: Our mixed methods process evaluation was guided by the United Kingdom Medical Research Council guidelines for complex interventions. Meeting attendance reports, as well as blood pressure and weight measures of attendees and adherence to meeting content and use of meeting tools were used to evaluate the implementation process. Thematic analysis of separate focus group discussions with participants and ASHAs as well as meeting reports and participant evaluation were used to investigate the mechanisms of impact. Results: Fifteen ASHAs led 32 community-based groups in three rural settings in the states of Kerala and Andhra Pradesh, Southern India. Overall, the fidelity of intervention delivery was high. Six meetings were delivered over a 3-month period to each of the intervention groups. The mean number of meetings attended by participants at each site varied significantly, with participants in Rishi Valley attending fewer meetings [mean (SD) = 2.83 (1.68)] than participants in West Godavari (Tukeys test, p = 0.009) and Trivandrum (Tukeys test, p < 0.001) and participants in West Godavari [mean (SD) = 3.48 (1.72)] attending significantly fewer meetings than participants in Trivandrum [mean (SD) = 4.29 (1.76), Tukeys test, p < 0.001]. Culturally appropriate intervention resources and the training of ASHAs, and supportive supervision of them during the program were critical enablers to program implementation. Although highly motivated during the implementation of the program ASHA reported historical issues with timely remuneration and lack of supportive supervision. Conclusions: Culturally appropriate community-based group programs run by trained and supported ASHAs are a successful and potentially scalable model for improving the control of hypertension in rural India. However, consideration of issues related to unreliable/insufficient remuneration for ASHAs, supportive supervision and their formal role in the wider health workforce in India will be important to address in future program scale up. Trial Registration: Clinical Trial Registry of India [CTRI/2016/02/006678, Registered prospectively].

Home-based pulmonary rehabilitation early after hospitalisation in COPD (early HomeBase): protocol for a randomised controlled trial.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is characterised by exacerbations of respiratory disease, frequently requiring hospital admission. Pulmonary rehabilitation can reduce the likelihood of future hospitalisation, but programme uptake is poor. This study aims to compare hospital readmission rates, clinical outcomes and costs between people with COPD who undertake a home-based programme of pulmonary rehabilitation commenced early (within 2 weeks) of hospital discharge with usual care. METHODS: A multisite randomised controlled trial, powered for superiority, will be conducted in Australia. Eligible patients admitted to one of the participating sites for an exacerbation of COPD will be invited to participate. Participants will be randomised 1:1. Intervention group participants will undertake an 8-week programme of home-based pulmonary rehabilitation commencing within 2 weeks of hospital discharge. Control group participants will receive usual care and a weekly phone call for attention control. Outcomes will be measured by a blinded assessor at baseline, after the intervention (week 9-10 posthospital discharge), and at 12 months follow-up. The primary outcome is hospital readmission at 12 months follow-up. ETHICS AND DISSEMINATION: Human Research Ethics approval for all sites provided by Alfred Health (Project 51216). Findings will be published in peer-reviewed journals, conferences and lay publications. TRIAL REGISTRATION NUMBER: ACTRN12619001122145.

Is there an association between public spending on health and choice of healthcare providers across socioeconomic groups in India? - Evidence from a national sample.

The role of public spending on health in reducing socioeconomic inequalities in healthcare is an emerging area of research, little supporting empirical evidence is available from low- and middle-income countries. This study examined: (1) the relationship between public spending on health per capita and the decision whether to seek healthcare or not, (2) the relationships between public spending on health per capita and choice of medical provider, and (3) whether these relationships varied by socioeconomic groups in India. Our study utilized the nationally representative 71st National Sample Survey of India, using 26,142 people who had been ailing in the past 15 days, the survey took place between the 1st of January and June 30, 2014. Two regression-based approaches were used to examine the association between public spending and choice of medical providers: (1) Multilevel multinomial regression; and (2) Instrumental variable regression. We examined the differential impacts of public spending on healthcare utilisation by socioeconomic groups. Increased public spending on health was not associated with changes in ailing people's decision whether to seek care or not (p > 0.05 in all analyses). However, increased public spending on health was associated with reductions in patients choosing private medical providers [adjusted odds ratio = 0.88 (95%CI 0.85-0.91) for outpatient private clinics] compared to outpatient government clinics. These associations may be greater among the lower economic groups compared with their counterparts. Across India, higher levels of government investment in health services are recognised by healthcare users and shown in their pattern of healthcare utilisation. That an increase in public spending on health results in a decrease in the use of private providers, particularly outpatient facilities with no inpatient capabilities, provides strong evidence for the effectiveness of 'regulation by competition'. This is a strong argument for focusing health system strengthening, and strategies for achieving universal healthcare on public investment.

Community Participation by People with Chronic Obstructive Pulmonary Disease.

Little is known regarding community participation in individuals with chronic obstructive pulmonary disease (COPD). The aim of this study was to explore community participation in individuals with COPD and to determine whether there is an association between community participation and activity-related outcome variables commonly collected during pulmonary rehabilitation assessment. We also sought to investigate which of these variables might influence community participation in people with COPD. Ninety-nine individuals with COPD were enrolled (67 ± 9 years, FEV1: 55 ± 22% predicted). We assessed community participation (Community Participation Indicator (CPI) and European Social Survey (ESS) for formal and informal community participation), daily physical activity levels (activity monitor), exercise capacity (6-minute walk test), breathlessness (Modified Medical Research Council, MMRC scale), self-efficacy (Pulmonary Rehabilitation Adapted Index of Self-Efficacy) and anxiety and depression (Hospital Anxiety and Depression Scale). Higher levels of community participation on the CPI were associated with older age and greater levels of physical activity (total, light and moderate-to-vigorous) (all rs = 0.30, p < 0.05). Older age and more moderate-to-vigorous physical activity independently predicted greater community participation measured by CPI. Higher levels of depression symptoms were associated with less formal and informal community participation on ESS (rs = -0.25). More formal community participation on ESS was weakly (rs = 0.2-0.3) associated with older age, better lung function, exercise capacity and self-efficacy, and less breathlessness. Self-efficacy, exercise capacity, and age independently predicted formal community participation in individuals with COPD. Strategies to optimize self-efficacy and improve exercise capacity may be useful to enhance community participation in people with COPD.