Community Control of Hypertension and Diabetes (CoCo-HD) program in the Indian states of Kerala and Tamil Nadu: a study protocol for a type 3 hybrid trial.

INTRODUCTION: India grapples with a formidable health challenge, with an estimated 315 million adults afflicted with hypertension and 100 million living with diabetes mellitus. Alarming statistics reveal rates for poor treatment and control of hypertension and diabetes. In response to these pressing needs, the Community Control of Hypertension and Diabetes (CoCo-HD) program aims to implement structured lifestyle interventions at scale in the southern Indian states of Kerala and Tamil Nadu. AIMS: This research is designed to evaluate the implementation outcomes of peer support programs and community mobilisation strategies in overcoming barriers and maximising enablers for effective diabetes and hypertension prevention and control. Furthermore, it will identify contextual factors that influence intervention scalability and it will also evaluate the program's value and return on investment through economic evaluation. METHODS: The CoCo-HD program is underpinned by a longstanding collaborative effort, engaging stakeholders to co-design comprehensive solutions that will be scalable in the two states. This entails equipping community health workers with tailored training and fostering community engagement, with a primary focus on leveraging peer supportat scale in these communities. The evaluation will undertake a hybrid type III trial in, Kerala and Tamil Nadu states, guided by the Institute for Health Improvement framework. The evaluation framework is underpinned by the application of three frameworks, RE-AIM, Normalisation Process Theory, and the Consolidated Framework for Implementation Research. Evaluation metrics include clinical outcomes: diabetes and hypertension control rates, as well as behavioural, physical, and biochemical measurements and treatment adherence. DISCUSSION: The anticipated outcomes of this study hold immense promise, offering important learnings into effective scaling up of lifestyle interventions for hypertension and diabetes control in low- and middle-income countries (LMICs). By identifying effective implementation strategies and contextual determinants, this research has the potential to lead to important changes in healthcare delivery systems. CONCLUSIONS: The project will provide valuable evidence for the scaling-up of structured lifestyle interventions within the healthcare systems of Kerala and Tamil Nadu, thus facilitating their future adaptation to diverse settings in India and other LMICs.

Professional care workforce: a rapid review of evidence supporting methods of recruitment, retention, safety, and education.

BACKGROUND: Across the care economy there are major shortages in the health and care workforce, as well as high rates of attrition and ill-defined career pathways. The aim of this study was to evaluate current evidence regarding methods to improve care worker recruitment, retention, safety, and education, for the professional care workforce. METHODS: A rapid review of comparative interventions designed to recruit, retain, educate and care for the professional workforce in the following sectors: disability, aged care, health, mental health, family and youth services, and early childhood education and care was conducted. Embase and MEDLINE databases were searched, and studies published between January 2015 and November 2022 were included. We used the Quality Assessment tool for Quantitative Studies and the PEDro tools to evaluate study quality. RESULTS: 5594 articles were initially screened and after applying the inclusion and exclusion criteria, 30 studies were included in the rapid review. Studies most frequently reported on the professional nursing, medical and allied health workforces. Some studies focused on the single domain of care worker education (n = 11) while most focused on multiple domains that combined education with recruitment strategies, retention strategies or a focus on worker safety. Study quality was comparatively low with a median PEDro score of 5/10, and 77% received a weak rating on the Quality Assessment tool for Quantitative Studies. Four new workforce strategies emerged; early career rural recruitment supports rural retention; workload management is essential for workforce well-being; learning must be contextually relevant; and there is a need to differentiate recruitment, retention, and education strategies for different professional health and care workforce categories as needs vary. CONCLUSIONS: Given the critical importance of recruiting and retaining a strong health and care workforce, there is an immediate need to develop a cohesive strategy to address workforce shortfalls. This paper presents initial evidence on different interventions to address this need, and to inform care workforce recruitment and retention. Rapid Review registration PROSPERO 2022 CRD42022371721 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022371721.

An integrated approach to health, wellbeing, and productivity at work: a design of a stepped wedge worksite intervention study.

BACKGROUND: Despite an intensive focus on workers' health during recent decades, the prevalence of work-related diseases remains unchanged in Denmark and internationally. Therefore, USA and Australian researchers have initiated new paradigms for integration of health promotion, prevention of work-related disease, and organization of work. Inspired by the Australian WorkHealth Improvement Network program (WIN), this paper describes the background, design, intervention methodologies, and evaluation methods of an Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA) intervention aiming to prevent work-related injuries and diseases and promote the health, safety, and wellbeing of the worker. METHODS: Using a stepped wedge design, worksites will be enrolled at baseline and offered the intervention starting at different times. Data will be collected at baseline, before the off-set of the intervention, and after each implementation period. The effect evaluation will be based on a mixed-methods approach. The qualitative data are based on semi-structured interviews and focus groups. The quantitative data consists of questionnaires, anthropometrics, and resting blood pressure and will be analyzed based on the intention-to-treat principle in linear mixed models with random slope and intercept. DISCUSSION: Integrated interventions are shown to increase overall health and safety at worksites more effectively and rapidly than more narrowly focused programs. Still, previous integrated interventions are lacking successful implementation. In ITASPA, the effects of the intervention is tested in a strong scientific mixed-methods design. Thus, the ITASPA project contributes to the knowledge about what characterizes a best practice for the implementation of integrated worksite interventions. TRIAL REGISTRATION: ITASPA is retrospectively registered in Clinicaltrials.gov on May 19, 2023 (NCT05866978).

A systematic review of the clustering and correlates of physical activity and sedentary behavior among boys and girls.

Identifying the clustering and correlates of physical activity (PA) and sedentary behavior (SB) is very important for developing appropriate lifestyle interventions for children and adolescents. This systematic review (Prospero CRD42018094826) aimed to identify PA and SB cluster patterns and their correlates among boys and girls (0-19 years). The search was carried out in five electronic databases. Cluster characteristics were extracted in accordance with authors' descriptions by two independent reviewers and a third resolved any disagreements. Seventeen studies met the inclusion criteria and the population age ranged from six to 18 years old. Nine, twelve, and ten cluster types were identified for mixed-sex samples, boys, and girls, respectively. While girls were in clusters characterized by "Low PA Low SB" and "Low PA High SB", the majority of boys were in clusters defined by "High PA High SB" and "High PA Low SB". Few associations were found between sociodemographic variables and all cluster types. Boys and girls in "High PA High SB" clusters had higher BMI and obesity in most of the tested associations. In contrast, those in the "High PA Low SB" clusters presented lower BMI, waist circumference, and overweight and obesity. Different cluster patterns of PA and SB were observed in boys and girls. However, in both sexes, a better adiposity profile was found among children and adolescents in "High PA Low SB" clusters. Our results suggest that it is not enough to increase PA to manage the adiposity correlates, it is also necessary to reduce SB in this population.

Putting non-communicable disease data to work in Vietnam: an investigation of community health surveillance capacity.

INTRODUCTION: Despite the public health system's critical role in non-communicable disease (NCD) surveillance in Vietnam, limited evidence exists on the implementation of NCD surveillance activities within these systems and the need for capacity building across different system levels to meet expected NCD surveillance goals. This study aimed to evaluate the status of and describe factors affecting the implementation of NCD surveillance activities and to identify the NCD surveillance capacity building needs of the public health system in Vietnam. METHODS: We used a mixed-methods approach in four provinces, conducting self-completed surveys of staff from six Preventive Medicine Institutes (PHI), 53 Centres for Disease Control (CDC) and 148 commune health stations (CHS), as well as 14 in-depth interviews and 22 focus group discussions at four PHI, four CDC, and eight district health centres and CHS. RESULTS: Study findings highlighted that although Vietnam has a well-functioning NCD surveillance system, a number of quality issues related to NCD surveillance data were salient. Multifactorial reasons were identified for incomplete, unconfirmed, and inaccurate mortality data and current disease surveillance data. Data on NCD management and treatment were reported to be of better quality than data for screening, targeted treatment, and counselling communication. Main factors affected the effective implementation of NCD surveillance, namely lack of complete and specific guidelines for NCD surveillance, limitations in human resource capacity within NCD departments, and shortage of funding for NCD surveillance activities. CONCLUSION: Study findings provide practical strategies for strengthening health system capacity for NCD surveillance through developing policies, guidelines, and standardised tools to guide NCD surveillance and a road map for integrated NCD surveillance, developing training packages and manuals for all levels of the health system, and conducting utilisation-focused surveillance training programs.

A peer support program results in greater health benefits for peer leaders than other participants: evidence from the Kerala diabetes prevention program.

BACKGROUND: Peer support programs are promising approaches to diabetes prevention. However, there is still limited evidence on the health benefits of peer support programs for lay peer leaders. PURPOSE: To examine whether a peer support program designed for diabetes prevention resulted in greater improvements in health behaviors and outcomes for peer leaders as compared to other participants. METHODS: 51 lay peer leaders and 437 participants from the Kerala Diabetes Prevention Program were included. Data were collected at baseline, 12 months, and 24 months. We compared behavioral, clinical, biochemical, and health-related quality of life parameters between peer leaders and their peers at the three time-points. RESULTS: After 12 months, peer leaders showed significant improvements in leisure time physical activity (+ 17.7% vs. + 3.4%, P = 0.001) and health-related quality of life (0.0 vs. + 0.1, P = 0.004); and a significant reduction in alcohol use (-13.6% vs. -6.6%, P = 0.012) and 2-hour plasma glucose (-4.1 vs. + 9.9, P = 0.006), as compared to participants. After 24 months, relative to baseline, peer leaders had significant improvements in fruit and vegetable intake (+ 34.5% vs. + 26.5%, P = 0.017) and leisure time physical activity (+ 7.9% vs. -0.9%, P = 0.009); and a greater reduction in alcohol use (-13.6% vs. -4.9%, P = 0.008), and waist-to-hip ratio (-0.04 vs. -0.02, P = 0.014), as compared to participants. However, only the changes in fruit and vegetable intake and waist-to-hip ratio were maintained between 12 and 24 months. CONCLUSION: Being a peer leader in a diabetes prevention program was associated with greater health benefits during and after the intervention period. Further studies are needed to examine the long-term sustainability of these benefits.

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.

Continuous usage intention of mobile health services: model construction and validation.

BACKGROUND: Mobile health (mHealth) services can not give full play to their value if only it is used in the short term, and their continuous usage can achieve better effects in health management. This study aims to explore the factors that affect continuous usage intentions of mHealth services and their mechanism of action. METHODS: First, considering the uniqueness of health services and social environmental factors, this study constructed an extended Expectation Confirmation Model of Information System Continuance (ECM-ISC) to investigate factors that may influence the intention of continuous usage of mHealth services based on three dimensions, namely individual characteristics, technology and environment. Second, the survey method was used to validate the research model. The questionnaire items were derived from validated instruments and discussed by experts and data were collected both online and offline. The structural equation model was used for data analysis. RESULTS: There were 334 avidity questionnaires through cross-sectional data and these participants had used mHealth services ever. The reliability and validity of the test model were good, in which Cronbach's Alpha values of 9 variables exceeded 0.9, composite reliability 0.8, the average variance extracted value 0.5, and the factor loading 0.8. The modified model had a good fitting effect and strong explanatory power. It accounted for 89% of the variance in expectation confirmation, 74% of the variance in perceived usefulness, 92% of the variance in customer satisfaction, and 84% of the variance in continuous usage intention. Compared with the initial model hypotheses, perceived system quality was deleted according to the heterotrait-monotrait ratio, so paths related to it were deleted; perceived usefulness wasn't positively associated with customer satisfaction, and its path was also deleted. Other paths were consistent with the initial hypothesis. The two new added paths were that subjective norm was positively associated with perceived service quality (ß = 0.704, P < 0.001), and perceived information quality (ß = 0.606, P < 0.001). Electronic health literacy (E-health literacy) was positively associated with perceived usefulness (ß = 0.379, P < 0.001), perceived service quality (ß = 0.200, P < 0.001), and perceived information quality (ß = 0.320, P < 0.001). Continuous usage intention was influenced by perceived usefulness (ß = 0.191, P < 0.001), customer satisfaction (ß = 0.453, P < 0.001), and subjective norm (ß = 0.372, P < 0.001). CONCLUSIONS: The study constructed a new theoretical model including E-health literacy, subjective norm and technology qualities to clarify continuous usage intention of mHealth services, and empirically validated the model. Attention should be paid to E-health literacy, subjective norm, perceived information quality, and perceived service quality to improve continuous usage intention of users and self-management by mHealth Apps managers and governments. This research provides solid evidence for the validity of the expanded model of ECM-ISC in the mHealth field, which can be a theoretical and practical basis for mHealth operators' product research and development.

Optimising the implementation of digital-supported interventions for the secondary prevention of heart disease: a systematic review using the RE-AIM planning and evaluation framework.

BACKGROUND: mHealth technologies are now widely utilised to support the delivery of secondary prevention programs in heart disease. Interventions with mHealth included have shown a similar efficacy and safety to conventional programs with improvements in access and adherence. However, questions remain regarding the successful wider implementation of digital-supported programs. By applying the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework to a systematic review and meta-analysis, this review aims to evaluate the extent to which these programs report on RE-AIM dimensions and associated indicators. METHODS: This review extends our previous systematic review and meta-analysis that investigated the effectiveness of digital-supported programs for patients with coronary artery disease. Citation searches were performed on the 27 studies of the systematic review to identify linked publications that reported data for RE-AIM dimensions. All included studies and, where relevant, any additional publications, were coded using an adapted RE-AIM extraction tool. Discrepant codes were discussed amongst reviewers to gain consensus. Data were analysed to assess reporting on indicators related to each of the RE-AIM dimensions, and average overall reporting rates for each dimension were calculated. RESULTS: Searches found an additional nine publications. Across 36 publications that were linked to the 27 studies, 24 (89%) of the studies were interventions solely delivered at home. The average reporting rates for RE-AIM dimensions were highest for effectiveness (75%) and reach (67%), followed by adoption (54%), implementation (36%) and maintenance (11%). Eleven (46%) studies did not describe relevant characteristics of their participants or of staff involved in the intervention; most studies did not describe unanticipated consequences of the intervention; the ongoing cost of intervention implementation and maintenance; information on intervention fidelity; long-term follow-up outcomes, or program adaptation in other settings. CONCLUSIONS: Through the application of the RE-AIM framework to a systematic review we found most studies failed to report on key indicators. Failing to report these indicators inhibits the ability to address the enablers and barriers required to achieve optimal intervention implementation in wider settings and populations. Future studies should consider alternative hybrid trial designs to enable reporting of implementation indicators to improve the translation of research evidence into routine practice, with special consideration given to the long-term sustainability of program effects as well as corresponding ongoing costs. REGISTRATION: PROSPERO-CRD42022343030.

Frequent hospital presenters' use of health information during COVID-19: results of a cross-sectional survey.

BACKGROUND: High-frequency hospital users often present with chronic and complex health conditions and are at increased risk of serious morbidity and mortality if they contract COVID-19. Understanding where high-frequency hospital users are sourcing their information, whether they understand what they find, and how they apply the information to prevent the spread of COVID-19 is essential for health authorities to be able to target communication approaches. METHODS: Cross-sectional survey of 200 frequent hospital users (115 with limited English proficiency) informed by the WHO's "Rapid, simple, flexible behavioral insights on COVID-19". Outcome measures were source of, and trust in information, and knowledge of symptoms, preventive strategies, restrictions, and identification of misinformation. RESULTS: The most frequently cited source of information was television (n = 144, 72%) followed by the internet (n = 84, 42%). One in four television users sought their information from overseas news outlets from their country of origin, while for those using the internet, 56% relied on Facebook and other forms of social media including YouTube and WeChat. Overall, 41.2% of those surveyed had inadequate knowledge about symptoms, 35.8% had inadequate knowledge about preventative strategies, 30.2% had inadequate knowledge about government-imposed restrictions, and 69% believed in misinformation. Half of the respondents (50%) trusted all information, and only one in five (20%) were uncertain or untrusting. English-speaking participants were almost three times more likely to have adequate knowledge about symptoms (OR 2.69, 95%CI 1.47;4.91) and imposed restrictions (OR 2.10 95%CI 1.06; 4.19), and 11 times more likely to recognize misinformation (OR 11.52 95%CI 5.39; 24.60) than those with limited English. CONCLUSION: Within this population of high-frequency hospital users with complex and chronic conditions, many were sourcing their information from less trustworthy or locally relevant sources, including social media and overseas news outlets. Despite this, at least half were trusting all the information that they found. Speaking a language other than English was a much greater risk factor for having inadequate knowledge about COVID-19 and believing in misinformation. Health authorities must look for methods to engage diverse communities, and tailor health messaging and education in order to reduce disparities in health outcomes.

Effects of a lifestyle intervention on depression and anxiety among adults at risk for diabetes in India: A secondary analysis of the Kerala Diabetes Prevention Program.

The impact of lifestyle interventions on diabetes and mental health conditions have been documented among people with diabetes. However, the mental health benefits of lifestyle interventions designed for diabetes prevention have not been systematically investigated among people at high risk of diabetes, particularly in low- and middle-income countries. We examined the effects of a 12-month peer support lifestyle intervention designed for diabetes prevention on depression and anxiety symptomology in the sample population of the Kerala Diabetes Prevention Program. Mixed-effects linear regression models were used to examine the effect of the intervention on depression and anxiety scores at 12 and 24 months in the total sample of 1007 adults at risk for diabetes and among those with mild-severe depressive or anxiety symptoms at baseline (n = 326 for depression; n = 203 for anxiety). Among all participants, the intervention group had a significantly higher reduction of depressive symptoms as compared to the control group at 12 months (mean diff score = -0.51; 95% CI: -0.95, -0.07; P = 0.02). This effect was not sustained at 24 months. There were no significant intervention effects for anxiety. Among those with mild-severe symptoms at baseline, the intervention group had a significantly higher reduction of depressive symptoms (mean diff score = -1.55; 95% CI -2.50, -0.6; P = 0.001) and anxiety symptoms (mean diff score = -1.64; 95% CI -2.76, -0.52; P = 0.004) at 12 months. The effect was sustained at 24 months for depression, but not anxiety. Lifestyle interventions designed for prevention of diabetes might improve depressive and anxiety symptoms in the short-term, particularly among those with mild-severe symptoms.

Working out dads (WOD): a study protocol for a randomised controlled trial of a group-based peer support intervention for men experiencing mental health difficulties in early fatherhood.

BACKGROUND: Approximately one in ten men experience mental health difficulties during the early years of fatherhood, and these can have negative impacts on children and families. However, few evidence-based interventions targeting fathers' mental health are available. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of Working Out Dads (WOD) - a facilitated peer support group intervention for fathers of young children, in reducing psychological distress and other mental health symptoms. METHODS: This trial will employ a parallel-arm randomised controlled trial (RCT) to evaluate the effectiveness and cost effectiveness of WOD peer support group intervention compared to usual care (a 30-min mental health and service focused phone consultation with a health professional). A total of 280 fathers of young children (aged 0-4 years) who are experiencing mental health difficulties and/or are at risk of poor mental health will be recruited. Randomisation and analyses will be at the level of the individual participant. The primary outcome is psychological distress symptoms, measured by the Kessler Psychological Distress Scale (K10) from baseline to 24 weeks post randomisation. A range of secondary outcomes will be assessed including suicidal ideation; mental health disorders, specific symptoms of depression, anxiety, and stress; social support, quality of life, health service use, and health care costs. Data will be collected at baseline, 10- and 24 weeks post-randomisation. DISCUSSION: This trial will examine the effectiveness of a novel group-based peer support intervention in reducing the psychological distress and other mental health symptoms of fathers compared to usual care. The economic and process evaluation will guide policy decision making along with informing the future implementation of WOD on a larger scale if effectiveness is demonstrated. TRIAL REGISTRATION: The current trial has been registered with ClinicalTrials.gov (Registration ID - NCT04813042 ). Date of Registration: March 22nd, 2021.

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial.

BACKGROUND: Managing noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China. METHODS AND FINDINGS: Based on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in "timed up and go" test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: -2.8 mm Hg (95% CI -4.8, -0.9; p = 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p < 0.001), health-related quality of life (p = 0.008), physical activity level (p < 0.001), adherence in statin (p = 0.003) and antihypertensive medicines (p = 0.039), and performance in "timed up and go" test (p = 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting. CONCLUSIONS: In this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China. TRIAL REGISTRATION: ClinicalTrials.gov NCT03185858.

The impact of mental and physical multimorbidity on healthcare utilization and health spending in China: A nationwide longitudinal population-based study.

BACKGROUND: In China, little evidence exists on the effect of mental and physical multimorbidity on individuals and the health system. This study aims to examine the prevalence of mental-physical multimorbidity and its impact on health service utilization and health expenditures. METHODS: We conducted a panel study using two waves of data (in 2011 and 2015) from the China Health and Retirement Longitudinal Study, including 10,181 participants aged 45 years and older. Generalized linear regression models were used to assess the association of multimorbidity with total health expenditure and out-of-pocket expenditure (OOPE) on outpatient and inpatient care. Random-effects logistic regression models were used to examine the impact of multimorbidity on outpatient visits, admission to hospital and incidence of catastrophic health expenditure (CHE). RESULTS: Overall, 3210 participants (31.53% of 10,181) had mental-physical multimorbidity in 2015 in China. Compared to patients with a single physical disease, individuals with physical-mental multimorbidity had over 150% of the increase in the number of outpatient visits and days of hospitalization. The percentage change of OOPE for outpatient and inpatient care was 156.8% and 163.6%, respectively. Mental-physical multimorbidity was associated with an increased likelihood of experiencing CHE (OR = 2.205, 95% CI = 2.048, 2.051). CONCLUSION: Multimorbidity, particularly mental-physical multimorbidity, is associated with higher levels of health service use and a greater financial burden to individuals in China. Healthcare system needs to shift from single-disease models to new financing and service delivery models to more effectively manage mental-physical multimorbidity.

Development of Chinese mental health first aid guidelines for assisting a person affected by a traumatic event: a Delphi expert consensus study.

BACKGROUND: People who experience traumatic events have an increased risk of developing a range of mental disorders. Appropriate early support from people in a person's social network may help to prevent the onset of a mental disorder or minimize its severity. Mental health first aid guidelines for assisting people who have experienced traumatic events have been developed for high-income English-speaking countries. However, they may not be appropriate for use in China due to cultural and health care system differences. The aim of this study was to develop culturally appropriate guidelines for people providing mental health first aid to people affected by traumatic events in China. METHODS: A Delphi expert consensus study was conducted with two panels of experts in mainland China. Experts recruited to the panels included 32 professionals with expertise in the treatment of people affected by traumatic events and 31 people with lived experience of trauma or their carers. Panel members were sent a Chinese translation of the questionnaire used for developing English-language mental health first aid guidelines. This contained 168 items describing how to help people experiencing a potentially traumatic event. Panelists were asked to rate the importance of each statement for inclusion in the Chinese guidelines. They were also encouraged to suggest any additional statements that were not included in the original questionnaire. Statements were accepted for inclusion in the adapted guidelines if they were endorsed by at least 80% of each panel as very important or important. RESULTS: Consensus was achieved after three survey rounds on 134 statements for inclusion in the adapted guidelines for China, with 127 adopted from the guidelines for English-speaking countries and 7 new items from the comments of panelists. CONCLUSIONS: While many of the statements are similar to the guidelines for English-speaking countries, the panelists adapted the guidelines to China's context, including more detailed actions on how to discuss trauma and to help the person. These guidelines will be used to form the basis of a Mental Health First Aid (MHFA) training course for China, aimed at educating the public in providing support and advice to a person who is experiencing a potentially traumatic event. Further research is needed to investigate the use of the guidelines by the Chinese public and the implementation of MHFA training in appropriate settings in China.

Resting Heart Rate and Heart Rate Variability in the Year Following Acute Coronary Syndrome: How Do Women Fare?

BACKGROUND: Women experience poorer health outcomes following acute coronary syndrome (ACS). Heart rate (HR) and heart rate variability (HRV) have emerged as sensitive and cost-effective markers of autonomic function and prognostic risk factors of poor cardiac outcomes. The aim of the current study was to investigate whether sex-specific differences existed across HR and five parameters of HRV, at 1 and 12 months following ACS diagnosis. METHODS: Between January 2013 and June 2014, a sample of 416 ACS patients was enrolled in the Anxiety Depression & Heart Rate Variability in cardiac patients: Evaluating the impact of Negative emotions on functioning after Twenty four months (ADVENT) longitudinal cohort study. At 1 and 12 months following discharge, patient HR and HRV (root mean square of successive differences [RMSDD], standard deviation of RR intervals [SDRR], high frequency power [HF], low frequency power [LF], very low frequency power [VLF]) was measured via three-lead electrocardiogram. RESULTS: At 1 month post-ACS, sex was a significant predictor of HR and VLF power in fully- adjusted models. At 12 months post-ACS, sex was a predictor of HR, SDRR and VLF power in fully-adjusted models. CONCLUSION: Sex-specific differences in resting HR and HRV were observed in the year following ACS, whereby women had higher HR and lower HRV, suggestive of poorer autonomic function. Further large-scale cohort studies examining autonomic function as a driver of sex-specific outcomes following ACS are required.

Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial.

BACKGROUND: New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS: We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS: While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION: The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Association of technologically assisted integrated care with clinical outcomes in type 2 diabetes in Hong Kong using the prospective JADE Program: A retrospective cohort analysis.

BACKGROUND: Diabetes outcomes are influenced by host factors, settings, and care processes. We examined the association of data-driven integrated care assisted by information and communications technology (ICT) with clinical outcomes in type 2 diabetes in public and private healthcare settings. METHODS AND FINDINGS: The web-based Joint Asia Diabetes Evaluation (JADE) platform provides a protocol to guide data collection for issuing a personalized JADE report including risk categories (1-4, low-high), 5-year probabilities of cardiovascular-renal events, and trends and targets of 4 risk factors with tailored decision support. The JADE program is a prospective cohort study implemented in a naturalistic environment where patients underwent nurse-led structured evaluation (blood/urine/eye/feet) in public and private outpatient clinics and diabetes centers in Hong Kong. We retrospectively analyzed the data of 16,624 Han Chinese patients with type 2 diabetes who were enrolled in 2007-2015. In the public setting, the non-JADE group (n = 3,587) underwent structured evaluation for risk factors and complications only, while the JADE (n = 9,601) group received a JADE report with group empowerment by nurses. In a community-based, nurse-led, university-affiliated diabetes center (UDC), the JADE-Personalized (JADE-P) group (n = 3,436) received a JADE report, personalized empowerment, and annual telephone reminder for reevaluation and engagement. The primary composite outcome was time to the first occurrence of cardiovascular-renal diseases, all-site cancer, and/or death, based on hospitalization data censored on 30 June 2017. During 94,311 person-years of follow-up in 2007-2017, 7,779 primary events occurred. Compared with the JADE group (136.22 cases per 1,000 patient-years [95% CI 132.35-140.18]), the non-JADE group had higher (145.32 [95% CI 138.68-152.20]; P = 0.020) while the JADE-P group had lower event rates (70.94 [95% CI 67.12-74.91]; P < 0.001). The adjusted hazard ratios (aHRs) for the primary composite outcome were 1.22 (95% CI 1.15-1.30) and 0.70 (95% CI 0.66-0.75), respectively, independent of risk profiles, education levels, drug usage, self-care, and comorbidities at baseline. We reported consistent results in propensity-score-matched analyses and after accounting for loss to follow-up. Potential limitations include its nonrandomized design that precludes causal inference, residual confounding, and participation bias. CONCLUSIONS: ICT-assisted integrated care was associated with a reduction in clinical events, including death in type 2 diabetes in public and private healthcare settings.

Cost-effectiveness of a lifestyle intervention in high-risk individuals for diabetes in a low- and middle-income setting: Trial-based analysis of the Kerala Diabetes Prevention Program.

BACKGROUND: Data on the cost-effectiveness of lifestyle-based diabetes prevention programs are mostly from high-income countries, which cannot be extrapolated to low- and middle-income countries. We performed a trial-based cost-effectiveness analysis of a lifestyle intervention targeted at preventing diabetes in India. METHODS: The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial of 1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state. Participants (30-60 years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test. The intervention group received a 12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders. There were also linked community activities to sustain behavior change. The control group received a booklet on lifestyle change. Costs were estimated from the health system and societal perspectives, with 2018 as the reference year. Effectiveness was measured in terms of the number of diabetes cases prevented and quality-adjusted life years (QALYs). Three times India's gross domestic product per capita (US$6108) was used as the cost-effectiveness threshold. The analyses were conducted with a 2-year time horizon. Costs and effects were discounted at 3% per annum. One-way and multi-way sensitivity analyses were performed. RESULTS: Baseline characteristics were similar in the two study groups. Over 2 years, the intervention resulted in an incremental health system cost of US$2.0 (intervention group: US$303.6; control group: US$301.6), incremental societal cost of US$6.2 (intervention group: US$367.8; control group: US$361.5), absolute risk reduction of 2.1%, and incremental QALYs of 0.04 per person. From a health system perspective, the cost per diabetes case prevented was US$95.2, and the cost per QALY gained was US$50.0. From a societal perspective, the corresponding figures were US$295.1 and US$155.0. For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively. The corresponding figures for QALY gained were 99.1% and 97.8%. The results were robust to discounting and sensitivity analyses. CONCLUSIONS: A community-based peer-support lifestyle intervention was cost-effective in individuals at high risk of developing diabetes in India over 2 years. TRIAL REGISTRATION: The trial was registered with Australia and New Zealand Clinical Trials Registry ( ACTRN12611000262909 ). Registered 10 March 2011.

Trends and socio-economic disparities in catastrophic health expenditure and health impoverishment in China: 2010 to 2016.

OBJECTIVES: To investigate trends and socio-economic disparities in the catastrophic health expenditure (CHE) and health impoverishment in China after major reform of the health system and to examine the impacts of the chronic disease on CHE and impoverishment. METHODS: We obtained data from four rounds of the China Family Panel Studies 2010-2016, with a sample size of 14 960 households. We defined CHE as the point at which annual household health payments exceeded 40% of annual capacity to pay. Impoverishment is measured by the $1.90 per day poverty line. Multivariate logistic regression models were performed to identify impacts of the family member with chronic disease on CHE and impoverishment. RESULTS: Between 2010 and 2016, the incidence of CHE in China decreased from 19.37% to 15.11% and from 7.39% to 5.14% for health impoverishment; however, the decrease in level of impoverishment was less in rural areas (from 6.16% down to 3.03%) than in urban areas (from 8.46% down to 7.81%). The gap between impoverishment rates across the income quartiles is growing. Multivariable analysis showed that households with two or more members suffering chronic diseases were significantly more likely to incur CHE (aOR: 2.46, 95% CI: 1.93-3.13) and impoverishment (aOR: 2.66, 95% CI: 1.87-3.78) than households with no members suffering chronic diseases, after adjusting for sociodemographic covariates. CONCLUSIONS: Important advances have been made in achieving greater financial protection for Chinese citizens. Nevertheless, greater attention to the poor households with chronic disease members is needed. Policymakers in China should focus on optimising integrated rural-urban health insurance by expanding the current benefit packages and strengthening poverty alleviation efforts.

OBJECTIFS: Investiguer les tendances et les disparités socioéconomiques dans les dépenses de santé catastrophiques (DSC) et l'appauvrissement de la santé en Chine après une réforme majeure du système de santé et examiner les impacts de la maladie chronique sur les DSC et l'appauvrissement. MÉTHODES: Nous avons obtenu des données provenant de quatre séries des Etudes du Panel de la Famille de Chine 2010-2016 sur un échantillon de 14.960 ménages. Nous avons défini la DSC comme le point à partir duquel les paiements annuels pour la santé des ménages dépassaient 40% de la capacité de paiement annuelle. L'appauvrissement a été mesuré par le seuil de pauvreté de 1,90 $ par jour. Des modèles de régression logistique multivariée ont été effectués pour identifier les impacts du membre de la famille atteint d'une maladie chronique sur la DSC et l'appauvrissement. RÉSULTATS: Entre 2010 et 2016, l'incidence des DSC en Chine est passée de 19,37% à 15,11% et de 7,39% à 5,14% pour l'appauvrissement de la santé. Cependant, la baisse du niveau d'appauvrissement a été moindre dans les zones rurales (de 8,46% à 7,81%) que dans les zones urbaines (de 6,16% à 3,03%). L'écart entre les taux d'appauvrissement dans les quartiles de revenu se creuse. L'analyse multivariée a montré que les ménages comptant deux membres ou plus souffrant de maladies chroniques étaient significativement plus susceptibles de subir une DSC (aOR: 2,46; IC95%: 1,93-3,13) et un appauvrissement (aOR: 2,66 ; IC95%: 1,87-3,78) que les ménages sans membres souffrant de maladies chroniques, après ajustement pour les covariables sociodémographiques. CONCLUSIONS: D'importants progrès ont été réalisés pour assurer une meilleure protection financière des citoyens chinois. Néanmoins, une plus grande attention aux ménages pauvres comptant des membres atteints de maladies chroniques reste nécessaire. Les décideurs de politiques en Chine devraient se concentrer sur l'optimisation de l'assurance maladie intégrée rurale-urbaine en élargissant les avantages sociaux actuels et en renforçant les efforts de lutte contre la pauvreté.