Managing high cardiovascular disease risk among adults in Argentina using a multicomponent strategy linking key aspects of care: A two-arm cluster-randomized clinical trial (PRIMECare) protocol.

BACKGROUND: Cardiovascular disease (CVD) imposes a significant burden on the Argentinian population. Management of its leading risk factors can significantly reduce the CVD burden in high-resource settings, but there is insufficient evidence for effective implementation of evidence-based interventions in lower-resource settings like Argentina. METHODS: In this two-arm cluster-randomized trial we seek to compare the effective implementation, of a multicomponent intervention, versus usual care, to improve the management of high CVD risk across the care continuum in three provinces of Argentina. The multicomponent intervention strategy links five primary components of the CVD care continuum to improve its management: (1) a data management system linking a digital mHealth (mobile health) screening tool used by community health workers (CHWs), (2) an electronic appointment scheduler that is integrated with the primary care center electronic appointment system, (3) point of care testing for lipid profiles, (4) a clinical decision support (CDS) system for medication initiation, and (5) a text message (SMS) reminder system to improve treatment adherence and life-style changes. The primary outcome is the mean change in Framingham laboratory-based, 10-year absolute CVD risk score between the study arms from baseline to twelve months after enrollment. CONCLUSIONS: This protocol describes the development of a multicomponent intervention to implement effective management of CVD, developed with partners at the National and provincial Departments of Health in Argentina, with the goal of understanding its effective implementation in a primary health care system strengthened by universal health coverage, provision of free health care services, and provision of free medication.

Blood Pressure Association with the 8-Item Morisky Medication Adherence Scale in Hypertensive Adults from Low-Resource Primary Care Settings: Results from a Prospective Cohort Nested within a Randomised Controlled Trial.

INTRODUCTION: One of the self-report adherence scales most widely used is the 8-item Morisky Medication Adherence Scale (MMAS-8). AIM: To evaluate construct validity and reliability of the MMAS-8 in hypertensive adults from low-resource settings within the public primary care level in Argentina. METHODS: Prospective data from hypertensive adults under antihypertensive pharmacological treatment that participated in the "Hypertension Control Program in Argentina" study was analyzed. Participants were followed at baseline, 6, 12 and 18 months. Based on MMAS-8, adherence was defined as low (score < 6), medium (score 6 to < 8) and high (score of 8). RESULTS: 1214 participants were included in the analysis. In comparison to low adherence, high adherence category was associated with a reduction of - 5.6 mmHg (CI 95%: - 7.2; - 4.0) in systolic blood pressure (BP) and - 3.2 mmHg (CI 95%: - 4.2; - 2.2) in diastolic BP; and with a 56% higher likelihood to have controlled BP (p < .0001). Among those participants with baseline score ≤ 6, two points increase in MMAS-8 along follow-up showed a tendency to reduce BP in almost all-time points and a 34% higher likelihood of having controlled BP at the end of the follow-up (p = 0.0039). Cronbach's alpha total-item values in all time-points were higher than 0.70. CONCLUSIONS: Higher MMAS-8 categories were positively associated with BP reduction and higher likelihood of BP control over time. Internal consistency was acceptable and in line with previous studies.

Acceptability of short message service (SMS) as a tool for malaria treatment adherence in the Brazilian Amazon: a qualitative study.

BACKGROUND: Malaria is one of the leading causes of morbidity worldwide, and patient adherence to prescribed antimalarials is essential for effective treatment. METHODS: This cross-sectional study, with in-depth telephone interviews, analyzed participants' perceptions of short message service (SMS) in adherence to treatment. RESULTS: Five thematic categories emerged: decreased forgetfulness, the novelty of the tool, easy-to-understand language, the impact of SMS messages during treatment, and suggestions for improvement and complaints. CONCLUSIONS: SMS could assist patients in adhering to prescribed antimalarials.

Effectiveness of a diabetes program based on digital health on capacity building and quality of care in type 2 diabetes: a pragmatic quasi-experimental study.

Health systems in Latin America face many challenges in controlling the increasing burden of diabetes. Digital health interventions are a promise for the provision of care, especially in developing countries where mobile technology has a high penetration. This study evaluated the effectiveness of the implementation of a Diabetes Program (DP) that included digital health interventions to improve the quality of care of persons with type 2 Diabetes (T2DM) in a vulnerable population attending the public primary care network. MATERIALS AND METHODS: A quasi-experimental pre-post uncontrolled study was conducted in 19 primary care centers and hospitals in the province of Corrientes, Argentina. We included persons with T2DM, age > = 18 years with access to a mobile phone. The multicomponent intervention included a mobile app with a diabetes registry, a clinical decision support tool for providers and a text messaging intervention for patients. RESULTS AND DISCUSSION: One thousand sixty-five participants were included, 72.8% had less than 12 years of formal education and 53.5% lacked health coverage. Comorbidities were hypertension (60.8%) and overweight/obesity (88.2%). During follow-up there was a significant increase in the proportion of participants who underwent laboratory check-ups (HbA1c 20.3%-64.4%; p < 0.01) and foot exams (62.1%-87.2%; p < 0.01). No changes were observed at 12 and 24 months in the proportion of participants with poor metabolic control. The proportion of participants with uncontrolled blood pressure (≥ 140/90 mmHg) decreased from 47.2% at baseline to 30.8% at 24 months in those with a follow-up visit. CONCLUSION: The DP was innovative by integrating digital health interventions in the public primary care level. The study showed improvements in quality indicators related with diabetes care processes and in blood pressure control.

Acceptability of short message service (SMS) as a tool for malaria treatment adherence in the Brazilian Amazon: a qualitative study

ABSTRACT Background: Malaria is one of the leading causes of morbidity worldwide, and patient adherence to prescribed antimalarials is essential for effective treatment. Methods: This cross-sectional study, with in-depth telephone interviews, analyzed participants' perceptions of short message service (SMS) in adherence to treatment. Results: Five thematic categories emerged: decreased forgetfulness, the novelty of the tool, easy-to-understand language, the impact of SMS messages during treatment, and suggestions for improvement and complaints. Conclusions: SMS could assist patients in adhering to prescribed antimalarials.

The Use of 2 e-Learning Modalities for Diabetes Education Using Facebook in 2 Cities of Argentina During the COVID-19 Pandemic: Qualitative Study.

BACKGROUND: The COVID-19 pandemic and the confinement that was implemented in Argentina generated a need to implement innovative tools for the strengthening of diabetes care. Diabetes self-management education (DSME) is a core element of diabetes care; however, because of COVID-19 restrictions, in-person diabetes educational activities were suspended. Social networks have played an instrumental role in this context to provide DSME in 2 cities of Argentina and help persons with diabetes in their daily self-management. OBJECTIVE: The aim of this study is to evaluate 2 diabetes education modalities (synchronous and asynchronous) using the social media platform Facebook through the content of posts on diabetes educational sessions in 2 cities of Argentina during the COVID-19 pandemic. METHODS: In this qualitative study, we explored 2 modalities of e-learning (synchronous and asynchronous) for diabetes education that used the Facebook pages of public health institutions in Chaco and La Rioja, Argentina, in the context of confinement. Social media metrics and the content of the messages posted by users were analyzed. RESULTS: A total of 332 messages were analyzed. We found that in the asynchronous modality, there was a higher number of visualizations, while in the synchronous modality, there were more posts and interactions between educators and users. We also observed that the number of views increased when primary care clinics were incorporated as disseminators, sharing educational videos from the sessions via social media. Positive aspects were observed in the posts, consisting of messages of thanks and, to a lesser extent, reaffirmations, reflections or personal experiences, and consultations related to the subject treated. Another relevant finding was that the educator/moderator role had a greater presence in the synchronous modality, where posts were based on motivation for participation, help to resolve connectivity problems, and answers to specific user queries. CONCLUSIONS: Our findings show positive contributions of an educational intervention for diabetes care using the social media platform Facebook in the context of the COVID-19 pandemic. Although each modality (synchronous vs asynchronous) could have differential and particular advantages, we believe that these strategies have potential to be replicated and adapted to other contexts. However, more documented experiences are needed to explore their sustainability and long-term impact from the users' perspective.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

Strengthening therapeutic adherence and pharmacovigilance to antimalarial treatment in Manaus, Brazil: a multicomponent strategy using mHealth.

BACKGROUND: Public health initiatives for improving adherence to primaquine based regimens and enhancing effective pharmacovigilance are needed to support the efforts for malaria elimination in real world conditions. METHODS: A multicomponent patient-oriented strategy using a Smart Safety Surveillance (3S) approach including: (1) educational materials for treatment counselling and identification of warning symptoms of haemolytic anaemia; (2) an mHealth component using Short Message Service (SMS) treatment reminders and (3) development and implementation of follow-up phone surveys three days after treatment completion, using a web-based platform linked to the local information system of malaria. Adherence was measured using the Morisky Medication Adherence Scale. Self-reported events were registered using a structured questionnaire and communicated to the Brazilian Health Regulatory Agency. RESULTS: Educational materials were disseminated to 5594 patients, of whom 1512 voluntarily entered the mHealth component through the local information system; 7323 SMS were sent, and 1062 participants completed a follow-up survey after treatment. The mean age of patients was 37.36 years (SD 13.65), 61.24% were male, 98.54% were infected with. Plasmodium vivax and 95.90% received a short regimen of chloroquine plus primaquine (CQ + PQ 7 days), as per malaria case management guidelines in Brazil. From the 1062 surveyed participants 93.31% were considered adherent to the treatment. Most of the patients (95.20%) reported at least one adverse event. Headache, lack of appetite and nausea/vomiting were the most frequently reported adverse events by 77.31%, 70.90% and 56.78% of the patients respectively. A quarter of the patients reported anxiety or depression symptoms; 57 (5.37%) patients reported 5 to 6 warning symptoms of haemolytic anaemia including jaundice and dark urine in 44 (4.14%). Overall, three patients presenting symptoms of haemolytic anaemia attended a hospital and were diagnosed with G6PD deficiency, and one had haemolysis. All of them recovered. CONCLUSIONS: Under real world conditions, a multicomponent patient-oriented strategy using information and communication technologies allowed health care providers to reinforce treatment adherence and enhance safety surveillance of adverse events associated with regimens using primaquine. Active monitoring through phone surveys also reduced under-reporting of ADRs. This approach is low-cost, scalable and able to support prioritized activities of the national malaria programme.

Health care access and health-related quality of life among people with diabetes in the Southern Cone of Latin America-a cross-sectional analysis of data of the CESCAS I study.

PURPOSE: Little is known on the association of health care access and health-related quality of life (HRQoL) in people with diabetes in the Southern Cone of Latin America (SCLA). METHODS: We analyzed data of 1025 participants of CESCAS I. To determine HRQoL, we used the SF-12 physical (PCS-12) and mental component summary (MCS-12). We compared four groups regarding HRQoL: (a) insured people without self-reported barriers to health care, (b) uninsured people without self-reported barriers to health care, (c) insured people with self-reported barriers to health care, and (d) uninsured people with self-reported barriers to health care. We conducted linear regressions with PCS-12 and MCS-12 as outcome. We adjusted for sociodemographic and disease-related factors and having access to a primary physician. RESULTS: In the first group, there were 407, in the second 471, in the third 44, and in the fourth group 103 participants. Compared to the first group, PCS-12 was 1.9 points lower (95% Confidence Interval, CI: - 3.5, - 0.3) in the second, 4.5 points (95% CI: - 8.1, - 1) lower in the third, and 6.1 points lower (95% CI: - 8.7, - 3.6) in the fourth group. Compared to the first group, MCS-12 was 0.6 points lower (95% CI: - 2.7, 1.4) in the second, 4.8 points lower (95% CI: - 9.3, - 0.3) in the third, and 5.8 points lower (95% CI: - 9.1, - 2.5) in the fourth group. CONCLUSION: In the SCLA, impeded access to care is common in people with diabetes. Self-reported barriers to care may be more important than insurance status in determining HRQoL.

Cluster Randomized Trial for Hypertension Control: Effect on Lifestyles and Body Weight.

INTRODUCTION: Lifestyle modification, such as healthy diet habits, regular physical activity, and maintaining a normal body weight, must be prescribed to all hypertensive individuals. This study aims to test whether a multicomponent intervention is effective in improving lifestyle and body weight among low-income families. STUDY DESIGN: Cluster randomized trial conducted between June 2013 and October 2016. SETTING/PARTICIPANTS: A total of 1,954 uninsured adult patients were recruited in the study within 18 public primary healthcare centers of Argentina. INTERVENTION: Components targeting the healthcare system, providers, and family groups were delivered by community health workers; tailored text messages were sent for 18 months. MAIN OUTCOME MEASURES: Changes in the proportion of behavioral risk factors and body weight from baseline to end of follow-up. Data were analyzed in 2017. RESULTS: Low fruit and vegetable consumption (fewer than 5 servings per day) decreased from 96.4% at baseline to 92.6% at 18 months in the intervention group, whereas in the control group it increased from 97.0% to 99.9% (p=0.0110). The proportion of low physical activity (<600 MET-minutes/week) decreased from 54.3% at baseline to 46.2% at 18 months in the intervention group and kept constant around 52% (p=0.0232) in the control group. The intervention had no effect on alcohol intake (p=0.7807), smoking (p=0.7607), addition of salt while cooking or at the table (p=0.7273), or body weight (p=0.4000). CONCLUSIONS: The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01834131.

Stakeholder Engagement in the Translation of a Hypertension Control Program to Guatemala's Public Primary Health Care System: Lessons Learned, Challenges, and Opportunities.

BACKGROUND: There is an urgent need to define appropriate intervention strategies to control blood pressure in low- and middle-income countries. In 2018, a program proven effective in Argentina was translated to Guatemala's public primary health care system in rural and primarily indigenous communities. OBJECTIVES: This paper describes the stakeholder engagement process used to adapt the program to the Guatemalan rural context prior to implementing a type II hybrid effectiveness-implementation trial and shares lessons learned. METHODS: We identified key differences in the 2 contexts that are relevant to translating the intervention to the Guatemalan context. Alongside interviews and focus group discussions, we conducted consultation workshops in July and August 2018, applying a participatory translation process involving patients, family members, community members, health care providers, and Ministry of Health officials. The process consisted of multiple meetings in Guatemala City, as well as meetings in each of the 5 departments where the study will be implemented, and 1 district per department. During the workshops, we presented the evidence-based experience from Argentina and then focused on the challenges and recommended solutions that the participants identified for each of the intervention's 6 components. The process concluded with a meeting in which the research team and Ministry of Health officials defined specific details of the intervention. RESULTS: The outcome of the process is an adapted approach appropriate to integrate into Guatemala's public primary health care system in the trial phase. The approach considers the challenges and recommended strategies for each of the 6 intervention components. CONCLUSIONS: We identified lessons learned, challenges, and opportunities during the adaptation process. Findings will inform ongoing stakeholder engagement during the study implementation and future scale-up and efforts to translate evidence-based hypertension control strategies to low- and middle-income countries globally.

An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina.

INTRODUCTION: Statins are essential drugs for high cardiovascular disease (CVD) risk management; however, there is still low adherence to good clinical practice guidelines for statin use at the primary care level in low- and middle-income countries. This study aimed to test whether a complex intervention targeting physicians improves treatment and control of hypercholesterolemia among patients with moderate to high CVD risk in Argentina. STUDY DESIGN: Cluster RCT. SETTING/PARTICIPANTS: Ten primary care centers from the public healthcare system of Argentina. INTERVENTION: Primary care physicians in the intervention group received an educational program with three main components: (1) an intensive 2-day training workshop; (2) educational outreach visits; and (3) a mobile health application installed on the physician's smartphones. MAIN OUTCOME MEASURES: Reduction in mean low-density lipoprotein cholesterol level, reduction in mean Framingham risk score, proportion of patients receiving an appropriate statin dose, and mean annual number of primary care center visits. RESULTS: Data were analyzed in 2017-2018. Between April 2015 and April 2016, a total of 357 participants were enrolled (179 patients in the intervention group and 178 in the control group). The global follow-up rate was 97.2%. At the end of the follow-up period, there was no difference in low-density lipoprotein cholesterol levels in any of the follow-up points among the groups. Mean CVD risk had a significant net difference in the first 6 months in the intervention group versus the control group (-4.0, 95% CI = -6.5, -1.5). At the end of follow-up, there was an absolute 41.5% higher rate of participants receiving an appropriate statin dose in the intervention group versus the control group. CONCLUSIONS: Although the intervention did not reach a reduction in cholesterol levels, it had a significant positive impact on the promotion of adequate use of clinical practice guidelines. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02380911.

Using mH ealth Tools to Improve Access and Coverage of People With Public Health Insurance and High Cardiovascular Disease Risk in Argentina: A Pragmatic Cluster Randomized Trial.

Background Control of cardiovascular disease ( CVD ) risk factors is suboptimal in Argentina, despite the government's provision of free blood pressure and cholesterol-lowering medications for people without private insurance. We assessed whether community health workers' use of an integrated mH ealth tool encourages patients to attend visits at primary care clinics to improve CVD risk management in 2 provinces of Argentina. Methods and Results We conducted a pragmatic cluster randomized trial, with primary care clinics randomly assigned to intervention or control. Eligible people were aged 40 to 79 years, lived in the catchment area of primary care clinics, possessed a mobile phone for personal use, had public health coverage, and a 10-year CVD risk ≥10%. In the control arm, community health workers screened for CVD risk using a paper-based tool and encouraged high-risk people to present to the primary care clinics for care. In the intervention arm, community health workers used the mH ealth tool to calculate CVD risk and confirm a scheduled physician appointment. Primary outcomes were the proportion of participants who attended a baseline visit and completed at least 1 follow-up, respectively. We enrolled 755 people (376 interventions; 379 controls). Intervention participants were significantly more likely to complete baseline visits (49.4% versus 13.5%, P value 0.0008) and follow-up visits (31.9% versus 7.7%; P value 0.0041). The use of chronic medication and current smoking were significant predictors of primary outcomes. Conclusions Use of mH ealth tools identifies patients at high CVD risk in their home, increases the likelihood of participating in chronic CVD risk factor management, and strengthens referrals. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02913339.

Perceptions and Acceptability of Text Messaging for Diabetes Care in Primary Care in Argentina: Exploratory Study.

BACKGROUND: Engagement in self-care behaviors that are essential to optimize diabetes care is challenging for many patients with diabetes. mHealth interventions have been shown to be effective in improving health care outcomes in diabetes. However, more research is needed on patient perceptions to support these interventions, especially in resource settings in low- and middle-income countries. OBJECTIVE: The goal of the research was to explore perceptions and acceptability of a short message service (SMS) text messaging intervention for diabetes care in underserved people with diabetes in Argentina. METHODS: A qualitative exploratory methodology was adopted as part of the evaluation of a program to strengthen diabetes services in primary care clinics located in low-resource settings. The diabetes program included a text messaging intervention for people with diabetes. A total of 24 semistructured telephone interviews were conducted with people with diabetes. RESULTS: Twenty-four middle-aged persons with diabetes were interviewed. Acceptability was considered adequate in terms of its actual use, frequency, and the role of texts as a reminder. We found that text messages could be a mediating device in the patient's learning processes. Also, being exposed to the texts seemed to help bring about changes in risk perception and care practices and to function as psychosocial support. Another relevant finding was the role of text messaging as a potential facilitator in diabetes care. In this sense, we observed a strong association between receiving text messages and having a better patient-physician relationship. Additionally, social barriers that affect diabetes care such as socioeconomic and psychosocial vulnerability were identified. CONCLUSIONS: Our findings show positive contributions of a text messaging intervention for the care of people with diabetes. We consider that an SMS strategy has potential to be replicated in other contexts. However, further studies are needed to explore its sustainability and long-term impact from the perspective of patients.

Cost-Effectiveness of a Comprehensive Approach for Hypertension Control in Low-Income Settings in Argentina: Trial-Based Analysis of the Hypertension Control Program in Argentina.

BACKGROUND: A recent cluster randomized trial evaluating a multicomponent intervention showed significant reductions in blood pressure in low-income hypertensive subjects in Argentina. OBJECTIVES: To assess the cost-effectiveness of this intervention. METHODS: A total of 1432 hypertensive participants were recruited from 18 primary health care centers. The intervention included home visits led by community health workers, physician education, and text messaging. Resource use and quality of life data using the three-level EuroQol five-dimensional questionnaire were prospectively collected. The study perspective was that of the public health care system, and the time horizon was 18 months. Intention-to-treat analysis was used to analyze cost and health outcomes (systolic blood pressure [SBP] change and quality-adjusted life-years [QALYs]). A 1 time gross domestic product per capita per QALY was used as the cost-effectiveness threshold (US $14,062). RESULTS: Baseline characteristics were similar in the two arms. QALYs significantly increased by 0.06 (95% confidence interval [CI] 0.04-0.09) in the intervention group, and SBP net difference favored the intervention group: 5.3 mm Hg (95% CI 0.27-10.34). Mean total costs per participant were higher in the intervention arm: US $304 in the intervention group and US $154 in the control group (adjusted difference of US $140.18; 95% CI US $75.41-US $204.94). The incremental cost-effectiveness ratio was $3299 per QALY (95% credible interval 1635-6099) and US $26 per mm Hg of SBP (95% credible interval 13-46). Subgroup analysis showed that the intervention was cost-effective in all prespecified subgroups (age, sex, cardiovascular risk, and body mass index). CONCLUSIONS: The multicomponent intervention was cost-effective for blood pressure control among low-income hypertensive patients.

Implementation Tells Us More Beyond Pooled Estimates: Secondary Analysis of a Multicountry mHealth Trial to Reduce Blood Pressure.

BACKGROUND: The uptake of an intervention aimed at improving health-related lifestyles may be influenced by the participant's stage of readiness to change behaviors. OBJECTIVE: We conducted secondary analysis of the Grupo de Investigación en Salud Móvil en América Latina (GISMAL) trial according to levels of uptake of intervention (dose-response) to explore outcomes by country, in order to verify the consistency of the trial's pooled results, and by each participant's stage of readiness to change a given lifestyle at baseline. The rationale for this secondary analysis is motivated by the original design of the GISMAL study that was independently powered for the primary outcome-blood pressure-for each country. METHODS: We conducted a secondary analysis of a mobile health (mHealth) multicountry trial conducted in Argentina, Guatemala, and Peru. The intervention consisted of monthly motivational phone calls by a trained nutritionist and weekly tailored text messages (short message service), over a 12-month period, aimed to enact change on 4 health-related behaviors: salt added to foods when cooking, consumption of high-fat and high-sugar foods, consumption of fruits or vegetables, and practice of physical activity. Results were stratified by country and by participants' stage of readiness to change (precontemplation or contemplation; preparation or action; or maintenance) at baseline. Exposure (intervention uptake) was the level of intervention (<50%, 50%-74%, and ≥75%) received by the participant in terms of phone calls. Linear regressions were performed to model the outcomes of interest, presented as standardized mean values of the following: blood pressure, body weight, body mass index, waist circumference, physical activity, and the 4 health-related behaviors. RESULTS: For each outcome of interest, considering the intervention uptake, the magnitude and direction of the intervention effect differed by country and by participants' stage of readiness to change at baseline. Among those in the high intervention uptake category, reductions in systolic blood pressure were only achieved in Peru, whereas fruit and vegetable consumption also showed reductions among those who were at the maintenance stage at baseline in Argentina and Guatemala. CONCLUSIONS: Designing interventions oriented toward improving health-related lifestyle behaviors may benefit from recognizing baseline readiness to change and issues in implementation uptake. TRIAL REGISTRATION: ClinicalTrials.gov NCT01295216; http://clinicaltrials.gov/ct2/show/NCT01295216 (Archived by WebCite at http://www.webcitation.org/72tMF0B7B).

Using mHealth strategies in a Diabetes Management Program to improve the quality of care in Argentina: Study design and baseline data.

AIM: To evaluate the one-year post effect of the implementation of a diabetes program that includes mHealth interventions on the quality of diabetic care in public primary care centers. METHOD: It is a quasi-experimental study with outcome measurements at baseline, 6 and 12months. The program includes primary care team training, a diabetes registry with a decision support tool in an app. and text messages for patients. RESULTS: At baseline, 947 patients were included in the registry, 62.3% women with a mean age of 53.6±11.5years and 92% with type 2 diabetes. Common comorbidities were hypertension (61.3%) and obesity (59%). Only 16.9% had one HbA1c and 48.9% a cholesterol lab in the last year, 61.9% were screened for diabetic peripheral neuropathy, and 29.0% had one eye exam in the previous year. With respect to blood sugar, lipid and blood pressure control: 44.4% of those with HbA1c measurements had levels ≥8%, total cholesterol was over 200mg/dL in 40.6% and 48.2% had uncontrolled blood pressure values. CONCLUSION: Patients with diabetes received a low quality of care at public primary care clinics. A diabetes registry allowed us to draw an epidemiological profile of diabetic patients and determine the quality of care provided.

Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial.

Importance: Despite extensive knowledge of hypertension treatment, the prevalence of uncontrolled hypertension is high and increasing in low- and middle-income countries. Objective: To test whether a community health worker-led multicomponent intervention would improve blood pressure (BP) control among low-income patients with hypertension. Design, Setting, and Participants: A cluster randomized trial was conducted in 18 centers for primary health care within a national public system providing free medications and health care to uninsured patients in Argentina. A total of 1432 low-income adult patients with uncontrolled hypertension were recruited between June 2013 and April 2015 and followed up to October 2016. Interventions: Nine centers (743 patients) were randomized to the multicomponent intervention, which included a community health worker-led home intervention (health coaching, home BP monitoring, and BP audit and feedback), a physician intervention, and a text-messaging intervention over 18 months. Nine centers (689 patients) were randomized to usual care. Main Outcomes and Measures: The coprimary outcomes were the differences in systolic and diastolic BP changes from baseline to the end of follow-up of patients with hypertension. Secondary outcomes included the proportion of patients with controlled hypertension (BP <140/90 mm Hg). Three BP measurements were obtained at each of 2 baseline and 2 termination visits using a standard protocol, the means of which were used for analyses. Results: Of 1432 participants (mean age, 55.8 years [SD, 13.3]; 772 women [53.0%]), 1357 (94.8%) completed the trial. Baseline mean systolic BP was 151.7 mm Hg for the intervention group and 149.8 mm Hg for the usual care group; the mean diastolic BP was 92.2 mm Hg for the intervention group and 90.1 mm Hg for the usual care group. Systolic BP reduction from baseline to month 18 was 19.3 mm Hg (95% CI, 17.9-20.8 mm Hg) for the intervention group and 12.7 mm Hg (95% CI, 11.3-14.2 mm Hg) for the usual care group; the difference in the reduction was 6.6 mm Hg (95% CI, 4.6-8.6; P < .001). Diastolic BP decreased by 12.2 mm Hg (95% CI, 11.2-13.2 mm Hg) in the intervention group and 6.9 mm Hg (95% CI, 5.9-7.8 mm Hg) in the control group; the difference in the reduction was 5.4 mm Hg (95% CI, 4.0-6.8 mm Hg; P < .001). The proportion of patients with controlled hypertension increased from 17.0% at baseline to 72.9% at 18 months in the intervention group and from 17.6% to 52.2% in the usual care group; the difference in the increase was 20.6% (95% CI, 15.4%-25.9%; P < .001). No adverse events were reported. Conclusions and Relevance: Low-income patients in Argentina with uncontrolled hypertension who participated in a community health worker-led multicomponent intervention experienced a greater decrease in systolic and diastolic BP than did patients who received usual care over 18 months. Further research is needed to assess generalizability and cost-effectiveness of this intervention and to understand which components may have contributed most to the outcome. Trial Registration: clinicaltrials.gov Identifier: NCT01834131.