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.

Effectiveness of financial incentives and message framing to improve clinic visits of people with moderate-high cardiovascular risk in a vulnerable population in Argentina: A cluster randomized trial.

In Argentina, cardiovascular disease (CVD) represents the first cause of mortality, but effective coverage for CVD prevention is low. Strategies based on behavioral economics are emerging worldwide as key pieces to increase the effectiveness of CVD prevention approaches. The aim of this study was to evaluate whether the implementation of two strategies based on financial incentives and framing increased attendance to clinical visits as proposed by the national program for CVD risk factors management among the uninsured and poor population with moderate or high CVD risk in Argentina. We conducted a cluster randomized trial in nine primary care clinics (PCCs) in Argentina. Three PCCs were assigned to financial incentives, 3 to framing-text messages (SMS) and 3 to usual care. The incentive scheme included a direct incentive for attending the first clinical visit and the opportunity to participate in a lottery when attending a second clinical visit. The framing-text messages group received messages with a gain-frame format. The main outcome was the proportion of participants who attended the clinical visits. A total of 918 individuals with a risk ≥10% of suffering a CVD event within the next 10 years were recruited to participate in the study. The financial incentive group had a significantly higher percentage of participants who attended the first (59.0% vs 33.9%, p˂ 0.001) and the follow up visit (34.4% and 16.6%, p˂ 0.001) compared to control group. However, the framing-SMS group did not show significant differences compared to the control group. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.govNCT03300154.

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.

Effectiveness of peer mentoring and self-monitoring to improve blood pressure control in a vulnerable population in Argentina: Pragmatic randomized open-label controlled trial.

OBJECTIVE: To evaluate the effectiveness of blood pressure (BP) self-monitoring and peer mentoring to improve the control of hypertension in clinical practice in primary care centers (PCCs) located in low-resource settings in Argentina. METHODS: An individual randomized controlled trial was carried out to test two different approaches based on behavioral interventions in PCCs in Argentina. Hypertensive adults were randomly assigned to one of three arms: BP self-monitoring, peer mentoring, and usual care. The primary outcome was the change in BP values from baseline to the end of follow-up at 3 months. A qualitative approach of participants' experiences of the peer mentoring arm was also conducted. RESULTS: A total of 442 participants with hypertension were included in the study. Self-monitoring and peer mentoring interventions did not show a significant difference in BP control compared to usual care. However, this trial showed an improvement regarding antihypertensive medication adherence among those assigned to the peer mentoring intervention compared to the control at the end of follow-up (p = 0.031). DISCUSSION: Self-monitoring and peer mentoring interventions did not demonstrate to be effective in BP control compared to usual care. Implementing a peer support strategy was demonstrated to be feasible and effective in improving medication adherence in this population.

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.

Barriers to hypertension and diabetes management in primary health care in Argentina: qualitative research based on a behavioral economics approach.

Despite efforts to improve detection and treatment of adults with hypertension and diabetes in Argentina, many public healthcare system users remain undiagnosed or face barriers in managing these diseases. The purpose of this study is to identify health system, provider, and user-related factors that may hinder detection and treatment of hypertension and diabetes using a traditional and behavioral economics approach. We did qualitative research using in-depth semistructured interviews and focus groups with healthcare providers and adult users of Public Primary Care Clinics. Health system barriers included inadequate care accessibility; poor integration between primary care clinics and local hospitals; lack of resources; and gender bias and neglect of adult chronic disease. Healthcare provider-related barriers were inadequate training; lack of availability or reluctance to adopt Clinical Practice Guidelines; and lack of counseling prioritization. From a behavioral economics perspective, bottlenecks were related to inertia and a status quo, overconfidence, and optimism biases. User-related barriers for treatment adherence included lack of accurate information; resistance to adopt lifelong treatment; affordability; and medical advice mistrust. From a behavioral economics perspective, the most significant bottlenecks were overconfidence and optimism, limited attention, and present biases. Based on these findings, new interventions that aim to improve prevention and control of chronic conditions can be proposed. The study provides empirical evidence regarding the barriers and bottlenecks in managing chronic conditions in primary healthcare settings. Results may contribute to the design of behavioral interventions targeted towards healthcare provision for the affected population.

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.

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.

Challenges and opportunities for implementation of interventions to prevent and control CVD in low-resource settings: a report from CESCAS in Argentina.

In Argentina, cardiovascular diseases cause an estimated 100,000 deaths and more than 250,000 coronary heart disease and stroke events annually, at a cost of more than $1 billion international dollars. Despite progress in the implementation of several programs to combat noncommunicable diseases in Argentina over the past few years, most health resources are still dedicated to infectious diseases and maternal and child health. The Institute for Clinical Effectiveness and Health Policy, an independent academic institution affiliated with the University of Buenos Aires medical school, runs the South American Centre of Excellence in Cardiovascular Health (CESCAS), a center devoted to epidemiology, implementation, and policy research. At the CESCAS, there are 3 ongoing randomized clinical trials focused on implementation science: 1) a mobile health intervention, for preventing the progression of prehypertension in low-income, urban settings in Argentina, Guatemala, and Peru; 2) a comprehensive approach to preventing and controlling hypertension in low-resource settings in Argentina; and 3) an educational approach to improving physicians' effectiveness in the detection, treatment, and control of hypercholesterolemia and high cardiovascular disease risk in low-resource settings in Argentina. All of these trials involve the design and implementation of complex interventions for changing the behaviors of providers and patients. The rationale of each of the 3 studies, the design of the interventions, and the evaluation of processes and outcomes are described in this article, together with the barriers and enabling factors associated with implementation-research studies. There is a strong need in Argentina and all of Latin America for building the health-research capacity and infrastructure necessary for undertaking implementation studies that will translate evidence from research findings into improvements in health policy and practice with regard to cardiovascular diseases and their risk factors.