Statins use for primary prevention of cardiovascular disease: A population-based digitally enabled real-world evidence cross-sectional study in primary care in Brazil.

BACKGROUND: Statins consist of the main strategy to reduce dyslipidemia-related cardiovascular risk. Nevertheless, there is scarce evidence on the real-world statins use in primary care settings in low-middle-income countries. OBJECTIVE: We conducted a cross-sectional retrospective study using anonymized data routinely collected by community health workers in Brazil aimed to evaluate statin use and associated factors in a primary prevention population with cardiovascular risk enhancers. METHODS: Study population consisted of adults with hypertension, diabetes and/or dyslipidemia. The primary and secondary outcomes were the proportion of individuals self-reporting statins use on any dose, and high-dose statins/high-intensity lipid lowering therapy (LLT) respectively. RESULTS: Of the 2,133,900 adult individuals on the database, 415,766 (19.5%) were included in the study cohort. From this cohort, 89.1% had hypertension, 28.9% diabetes and 5.5% dyslipidemia. The mean age was 61.5 (SD 14.5) years, 63.4% were female and 61.0% were of mixed-race. Only 2.6% and 0.1% of individuals self-reported the use of statins and high-dose statins/high-intensity LLT, respectively. Older age (OR 1.96; 95% CI 1.88,2.05;p < 0.001), living in the South region of Brazil (OR 4.39; 95%CI 3.97,4.85,p < 0.001), heart failure (OR 2.60; 95%CI 2.33,2.89,p < 0.001), chronic kidney disease (OR 1.49; 95%CI 1.35,1.64,p < 0.001) and anti-hypertensive medications use (OR 4.38; 95%CI 4.07,4.71,p < 0.001) were independently associated with statin use. CONCLUSION: In a real-world evidence study analyzing data routinely collected in a digitized primary care setting, we observed a very low use of statins in a primary prevention population with cardiovascular risk enhancers in Brazil. Socio-demographic factors and co-morbidities were associated to higher statins use rates.

Integrated Text Messaging (ITM) for people attending cardiac and pulmonary rehabilitation: A multicentre randomised controlled trial.

BACKGROUND: People living with cardiac and respiratory disease require improved post-hospital support that is readily available and efficient. OBJECTIVES: To 1) test the effectiveness of an automated, semi-personalised text message support program on clinical and lifestyle outcomes amongst people attending cardiac and pulmonary rehabilitation. Also, 2) to evaluate the program's acceptability and utility using patient-reported outcome and experience measures. METHODS: Multicentre randomised controlled trial (3:1, intervention:control) amongst cardiac and pulmonary rehabilitation attendees. Control received usual care (no message program). Intervention also received a 6-month text message lifestyle and support program. Primary outcome was 6-minute walk distance (6MWD). Secondary outcomes included clinical measures, lifestyle, patient-reported outcome and experience measures, medication adherence and rehabilitation attendance. RESULTS: A total of 316 participants were recruited. They had a mean age of 66.7 (SD 10.1) years. Sixty percent were male (190/316) and 156 were cardiac rehabilitation participants. The cohort's mean baseline 6MWD was higher in the intervention than the control group. At 6 months, 6MWD improved in both groups; it was significantly greater amongst intervention than control participants (unadjusted mean difference of 43.4 m, 95 % CI 4.3 to 82.4; P = 0.0296). After adjustment for baseline values, there was no significant difference between intervention and control groups for 6MWD (adjusted mean difference 2.2 m, -21.2 to 25.6; P = 0·85), medication adherence, or cardiovascular risk factors. At 6-month follow-up, intervention participants reported significantly lower depression scores (adjusted mean difference -1.3, 95 % CI -2.2 to -0.3; P = 0.0124) and CAT scores (adjusted mean difference -3.9, 95 % CI -6.6 to -1.3; P = 0.0038), and significantly lower anxiety (adjusted mean difference -1.1, 95 %CI -2.1 to 0; P = 0.0456). Most participants (86 %) read most of their messages and strongly/agreed that the intervention was easy to understand (99 %) and useful (86 %). CONCLUSIONS: An educational and supportive text message program for cardiac and pulmonary rehabilitation attendees improved anxiety and depression plus program attendance. The program was acceptable to, and useful for, participants and would be suitable for implementation alongside rehabilitation programs. TRIAL REGISTRATION NUMBER: ACTRN12616001167459.

Assessing statins use in a real-world primary care digital strategy: a cross-sectional analysis of a population-wide digital health approach.

Background: The digitization of the primary care system provides an opportunity to evaluate the current use of statins in secondary prevention populations (myocardial infarction or stroke). Methods: We conducted a cross-sectional study (ClinicalTrials.gov, NCT05285085), analysing anonymised data routinely collected by community health workers (CHW) in Brazil between May 2016 and September 2021 to assess the proportion of self-reported statins use and associated factors. Findings: From the 2,133,900 individuals on the database, 35,103 (1.6%), mean age 66.2 years (SD14.6), 49.5% (17,382/35,103) male sex, 50.5% (17,721/35,103) female sex, and 29.6% (10,381/34,975) Caucasians, had a previous myocardial infarction (MI) (n = 11,628; 33.1%) or stroke (n = 25,925; 73.9%). Approximately 50% (17,020/35,103) were from the Northeast region, 78.7% (27,605) from urban zones, and 39.4% (13,845) with social development index (SDI) >0.7. Overall, 6.7% (2346) and 0.6% (212) reported statins and high dose statins use, respectively. Age over 60 years old (OR 1.32 [95% CI 1.19-1.47), living in the Southern region (OR 4.53 [95% CI 3.66-5.60]), having a previous diagnosis of MI (OR 4.53 [95% CI 3.66-5.60]), heart failure (OR 2.29 [95% CI 1.13-1.47]), diabetes (OR 1.50 [95% CI 1.37-1.64]), dyslipidaemia (OR 2.90 [95% CI 2.55-3.29]), chronic kidney disease (OR 1.27 [95% CI 1.08-1.48]) and use of anti-hypertensives (OR 5.47 [95% CI 4.60-6.47]) were associated with statin use. Interpretation: The analysis of a real-world database from a digitized primary care system, allowed us to identify a very low use of statins in secondary prevention Brazilian patients, mostly influenced by socio-demographic factors and co-morbidities. Funding: Novartis Biociências, Brazil.

The Challenges of Implementing a Text Message Intervention to Promote Behavioral Change in Primary Care Patients With Hypertension and Diabetes

Abstract Background Controlling blood pressure and glycemic levels is a challenge that requires innovative solutions. Objective To assess the feasibility of implementing a text message intervention among low-income primary care patients, as well as to assess self-reported behavioral change. Methods A set of 200 text messages was developed on healthy eating, physical activity, adherence, and motivation. Participants from Vale do Mucuri, MG, Brazil diagnosed with diabetes or hypertension or undergoing screening for those diseases, received 5 to 8 messages per week for 6 months. They answered a questionnaire to report their satisfaction and behavioral changes. Results Of the 136 patients, 117 (86.0%) answered the questionnaire. Most reported that the messages were very useful (86.3%), easy to understand (90.6%), and were very helpful for behavioral change (65.0%); 84.6% reported that they had started eating healthier. The most frequent reported lifestyle changes were: improved diet quality (85.5%), reduced portions (65.8%), and weight loss (56.4%). The majority of patients shared the messages (60.7%) with family or other acquaintances, considered the number of messages to be adequate (89.7%) and would recommend the program to others (95.7%). Conclusion An intervention based on text messages to promote behavioral change in patients with hypertension or diabetes in primary care is feasible in low-resource settings. Future studies are needed to assess the program's long-term effects on clinical outcomes.

A importância do controle pressórico e alcance de metas pressóricas intensivas em pacientes diabéticos e em pacientes com acidente vascular cerebral: os estudos optimal-diabetes e optimal-stroke / The importance of blood pressure control and intensive blood pressure targets in patients with diabetes and stroke: the optimaldiabetes and optimal-stroke trials

A hipertensão arterial sistêmica representa um dos principais problemas de saúde pública no Brasil e no mundo. O controle pressórico estrito é essencial para a redução de eventos cardiovasculares maiores, pois a pressão arterial sistólica elevada é o principal fator de risco modificável para doenças cardiovasculares e mortalidade total. Ensaios clínicos randomizados prévios, como o SPRINT trial e o STEP trial, geraram evidências robustas sobre os benefícios do alcance de metas pressóricas intensivas na redução de eventos cardiovasculares maiores em pacientes hipertensos de alto risco cardiovascular não-diabéticos e sem acidente vascular cerebral (AVC) prévio. Porém, ainda há dúvidas sobre o benefício de tal estratégia nestas duas populações de pacientes. Para dar uma resposta definitiva a esta questão, os estudos OPTIMAL-DIABETES e OPTIMAL-STROKE estão sendo conduzidos com alto rigor científico no Brasil e estes já são os maiores estudos sobre o tema em nível global. Os resultados destes dois estudos, previstos para 2024/2025, são muito esperados para nos dar as evidências necessárias sobre o benefício do controle pressórico intensivo em pacientes diabéticos e pós-AVC (AU).

Hypertension represents one of the main public health problems in Brazil and in the world. Blood pressure (BP) control is essential to reduce major cardiovascular events, as high systolic BP is the main modifiable risk factor for cardiovascular diseases and any-cause deaths. Previous randomized clinical trials, such as the SPRINT trial and the STEP trial, have provided robust evidence on the benefits of intensive BP targets on the reduction of major cardiovascular events in hypertensive patients with high cardiovascular risk without diabetes and previous stroke. However, there is still uncertainty about the benefits of such strategy on this two populations of patients. To provide a definitive answer to this question, the OPTIMAL-DIABETES and OPTIMAL-STROKE trials are being conducted with high scientific rigor in Brazil and these are already the biggest studies in this area globally. The results of these two trials, expected in 2024/2025, are long awaited to provide us the necessary evidence on the benefits of intensive BP control in patients with diabetes and patients with stroke (AU).

Can Digital Health Solutions Fill in the Gap for Effective Guideline Implementation in Cardiovascular Disease Prevention: Hope or Hype?

PURPOSE OF REVIEW: To evaluate the use of digital health solutions in improving the implementation of cardiovascular disease (CVD) prevention guidelines and review current evidence supporting it. RECENT FINDINGS: Healthy diet guideline recommendations can be improved by text-messaging programs and apps for reinforcing healthy food intake and reducing unhealthy nutrients purchase and consumption. Wearable activity trackers are also effective in increasing physical activity levels. Text-messaging programs for smoking cessation have demonstrated benefits in increasing quitting rates; however, evidence on smartphone apps for smoking cessation is still lacking. Smartphone apps have the potential to improve medication adherence; however, better quality evidence is needed. Digital pills are another promising digital solution to improve medication adherence. The use of digital health solutions in CVD prevention is an evolving field and, to date, there is an increasing body of evidence that supports that such technologies are effective in improving CVD prevention guideline implementation.

Adherence Clubs to Improve Hypertension Management in Nigeria: Clubmeds, a Feasibility Study.

Background: Hypertension control remains a significant challenge in reducing the cardiovascular disease burden worldwide. Community peer-support groups have been identified as a promising strategy to improve medication adherence and blood pressure (BP) control. Objectives: The study aimed to evaluate the feasibility and impact of adherence clubs to improve BP control in Southeast Nigeria. Methods: This was a mixed-methods research involving a formative (pre-implementation) research, pilot study and process evaluation. Hypertensive patients in two communities were recruited into peer-support adherence clubs under the leadership of role-model patients to motivate and facilitate medication adherence, BP monitoring, and monthly medication delivery for six months. The primary outcome was medication adherence measured using visual analogue scale (VAS), with BP level at six months as a key secondary outcome. Results: We recruited a total of 104 participants. The mean age was 56.8 (SD-10.7) years, 72 (69.2%) were women, mean BP was 146.7 (SD-20.1)/86.9 (SD-11.2) mmHg, and the mean percentage of medication adherence on the VAS was 41.4% (SD-11.9%). At six months, 67 patients were assessed; self-reported adherence on the VAS increased to 57.3% (SD-25.3%) (mean difference between baseline and follow-up of 15.5%, p < 0.0001), while the mean BP decreased to 132.3 (SD-22.0)/82.9 (SD-12.2) mmHg (mean difference of 13.0 mmHg in systolic BP, p < 0.0001 and of 3.6 mmHg in diastolic BP, p = 0.02). Five in-depth interviews and four focus groups discussions were conducted as part of the qualitative analyses of the study. The participants saw hypertension as a big issue, with many unaware of the diagnosis, and they accepted the CLUBMEDS differential service delivery (DSD) model concept in hypertension. Conclusions: The study demonstrates that the implementation of adherence clubs for hypertension control is feasible and led to a statistically significant and clinically meaningful improvement in self-reported medication adherence, resulting in BP reduction. Upscaling the intervention may be needed to confirm these findings.

Utilization Rates of SGLT2 Inhibitors and GLP-1 Receptor Agonists and Their Facility-Level Variation Among Patients With Atherosclerotic Cardiovascular Disease and Type 2 Diabetes: Insights From the Department of Veterans Affairs.

OBJECTIVE: There is mounting evidence regarding the cardiovascular benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA) among patients with atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes mellitus (T2DM). There is paucity of data assessing real-world practice patterns for these drug classes. We aimed to assess utilization rates of these drug classes and facility-level variation in their use. RESEARCH DESIGN AND METHODS: We used the nationwide Veterans Affairs (VA) health care system data set from 1 January 2020 to 31 December 2020 and included patients with established ASCVD and T2DM. Among these patients, we assessed the use of SGLT2i and GLP-1 RA and the facility-level variation in their use. Facility-level variation was computed using median rate ratios (MRR), a measure of likelihood that two random facilities differ in use of SGLT2i and GLP-1 RA in patients with ASCVD and T2DM. RESULTS: Among 537,980 patients with ASCVD and T2DM across 130 VA facilities, 11.2% of patients received an SGLT2i while 8.0% of patients received a GLP-1 RA. Patients receiving these cardioprotective glucose-lowering drug classes were on average younger and had a higher proportion of non-Hispanic Whites. Overall, median (10th-90th percentile) facility-level rates were 14.92% (9.31-22.50) for SGLT2i and 10.88% (4.44-17.07) for GLP-1 RA. There was significant facility-level variation among SGLT2i use-MRRunadjusted: 1.41 (95% CI 1.35-1.47) and MRRadjusted: 1.55 (95% CI 1.46 -1.63). Similar facility-level variation was observed for use of GLP-1 RA-MRRunadjusted: 1.34 (95% CI 1.29-1.38) and MRRadjusted: 1.78 (95% CI 1.65-1.90). CONCLUSIONS: Overall utilization rates of SGLT2i and GLP-1 RA among eligible patients are low, with significantly higher residual facility-level variation in the use of these drug classes. Our results suggest opportunities to optimize their use to prevent future adverse cardiovascular events among these patients.

Community Group-Based Models of Medication Delivery: Applicability to Cardiovascular Diseases.

The rising global burden of chronic non-communicable diseases (NCDs) has put a strain on healthcare systems globally, especially in low- and middle-income countries, which have seen disproportionate mortality rates due to non-communicable diseases. These deaths are in part due to challenges with medication adherence, which are compounded by lack of access to medication and weak community support systems. This paper aims to propose a potential solution using models of service delivery in HIV/AIDS, given the many similarities between NCD and HIV/AIDS. Models that have been particularly effective in HIV/AIDS are the community-based peer-support medication delivery groups: medication adherence clubs and community antiretroviral therapy (ART) groups. The positive outcomes from these models, including improved medication adherence and patient satisfaction, provide evidence for their potential success when applied to non-communicable diseases, particularly hypertension and cardiovascular disease.

Mobile Apps for Dental Caries Prevention: Systematic Search and Quality Evaluation.

BACKGROUND: Dental caries is the most common multifactorial oral disease; it affects 60% to 90% of the global population. Dental caries is highly preventable through prevention behaviors aimed at improving oral hygiene, adequate fluoride usage, and dietary intake. Mobile apps have the potential to support patients with dental caries; however, little is known about the availability, target audience, quality, and features of these apps. OBJECTIVE: This review aims to systematically examine dental caries prevention apps; to describe their content, availability, target audience, and features; and to assess their quality. METHODS: We systematically identified and evaluated apps in a process paralleling a systematic review. This included a search strategy using search terms; an eligibility assessment using inclusion and exclusion criteria focused on accessibility and dental caries self-management behaviors, including oral hygiene, dietary intake, and fluoride usage; data extraction on app characteristics, including app store metrics; prevention behavior categorization; feature identification and description; a quality appraisal of all apps using the validated Mobile App Rating Scale (MARS) assessment tool; and data comparison and analysis. RESULTS: Using our search strategy, we retrieved 562 apps from the Google Play Store and iTunes available in Australia. Of these, 7.1% (40/562) of the apps fit our eligibility criteria, of which 55% (22/40) targeted adults, 93% (37/40) were free to download, and 65% (26/40) were recently updated. Oral hygiene was the most common dental caries prevention behavior domain, addressed in 93% (37/40) of the apps, while dietary intake was addressed in 45% (18/40) of the apps and fluoride usage was addressed in 42% (17/40) of the apps. Overall, 50% (20/40) of the apps addressed only 1 behavior, and 38% (15/40) of the apps addressed all 3 behaviors. The mean MARS score was 2.9 (SD 0.7; range 1.8-4.4), with 45% (18/40) of the apps categorized as high quality, with a rating above 3.0 out of 5.0. We identified 21 distinctive features across all dental caries prevention behaviors; however, the top 5 most common features focused on oral hygiene. The highest-ranking app was the Brush DJ app, with an overall MARS score of 4.4 and with the highest number of features (n=13). We did not find any apps that adequately addressed dental caries prevention behaviors in very young children. CONCLUSIONS: Apps addressing dental caries prevention commonly focus on oral hygiene and target young adults; however, many are not of high quality. These apps use a range of features to support consumer engagement, and some of these features may be helpful for specific patient populations. However, it remains unclear how effective these apps are in improving dental caries outcomes, and further evaluation is required before they are widely recommended.

Validation of the Mobile Application Rating Scale (MARS).

BACKGROUND: Mobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity. OBJECTIVE: This study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS. METHODS: Data was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation. RESULTS: In total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (ps<.05). CONCLUSION: The metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.

Digital Health Innovations to Improve Cardiovascular Disease Care.

PURPOSE OF REVIEW: To review the current evidence supporting the use of digital health technologies in cardiovascular disease (CVD) care. RECENT FINDINGS: Studies have evaluated the impact of the use of digital health technologies to improve CVD outcomes through several modalities: text-messaging programmes, smartphone applications (apps) and wearable devices. Text-messaging programmes are to date the most studied type of digital health interventions, and studies have demonstrated reduced CVD risk and improved medication adherence. Literature supporting the use of smartphone apps is also growing but remains limited, with some studies favouring the use of health apps but others showing negative results. Wearable devices are the latest type of technology investigated, and studies have shown positive outcomes in terms of physical activity and detection of arrhythmias. Digital health is a growing and evolving area of investigation. To date, the scientific evidence overall supports the use of such technologies in CVD care and management. Future research using new models are needed to continue to evaluate these new technologies.

Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis.

Background: A variety of small mobile phone text-messaging interventions have indicated improvement in risk factors for cardiovascular disease (CVD). Yet the extent of this improvement and whether it impacts multiple risk factors together is uncertain. We aimed to conduct a systematic review and individual patient data (IPD) meta-analysis to investigate the effects of text-messaging interventions for CVD prevention. Methods: Electronic databases were searched to identify trials investigating a text-messaging intervention focusing on CVD prevention with the potential to modify at least two CVD risk factors in adults. The main outcome was blood pressure (BP). We conducted standard and IPD meta-analysis on pooled data. We accounted for clustering of patients within studies and the primary analysis used random-effects models. Sensitivity and subgroup analyses were performed. Results: Nine trials were included in the systematic review involving 3779 participants and 5 (n=2612) contributed data to the IPD meta-analysis. Standard meta-analysis showed that the weighted mean differences are as follows: systolic blood pressure (SBP), -4.13 mm Hg (95% CI -11.07 to 2.81, p<0.0001); diastolic blood pressure (DBP), -1.11 mm Hg (-1.91 to -0.31, p=0.002); and body mass index (BMI), -0.32 (-0.49 to -0.16, p=0.000). In the IPD meta-analysis, the mean difference are as follows: SBP, -1.3 mm Hg (-5.4 to 2.7, p=0.5236); DBP, -0.8 mm Hg (-2.5 to 1.0, p=0.3912); and BMI, -0.2 (-0.8 to 0.4, p=0.5200) in the random-effects model. The impact on other risk factors is described, but there were insufficient data to conduct meta-analyses. Conclusion: Mobile phone text-messaging interventions have modest impacts on BP and BMI. Simultaneous but small impacts on multiple risk factors are likely to be clinically relevant and improve outcome, but there are currently insufficient data in pooled analyses to examine the extent to which simultaneous reduction in multiple risk factors occurs. PROSPERO registration number: CRD42016033236.

The Potential of mHealth Applications in Improving Resistant Hypertension Self-Assessment, Treatment and Control.

PURPOSE OF REVIEW: To review the evidence supporting the use of mobile health (mHealth) apps to improve resistant hypertension self-assessment, treatment and control. RECENT FINDINGS: mHealth apps have been used to directly measure blood pressure (BP) levels, either using the oscillometric method with automated inflatable cuffs or using pulse wave signals detected by smartphone technology without the need for cuffs. These app-based BP monitors tend to over or underestimate BP levels when compared to a gold standard aneroid sphygmomanometer. However, the differences in BP measurements are within the acceptable range of 5 mmHg pre-defined by the European Society of Hypertension International Protocol Revision 2010. mHealth apps are also used as tools to support physicians in improving hypertension treatment. App-based clinical decision support systems are innovative solutions, in which patient information is entered in the app and management algorithms provide recommendations for hypertension treatment. The use of these apps has been shown to be feasible and easily integrated into the workflow of healthcare professionals, and, therefore particularly useful in resource-limited settings. In addition, apps can be used to improve hypertension control by facilitating regular BP monitoring, communication between patients and health professionals, and patient education; as well as by reinforcing behaviours through reminders, including medication-taking and appointment reminders. Several studies provided evidence supporting the use of apps for hypertension control. Although some of the results are promising, there is still limited evidence on the benefits of using such mHealth tools, as these studies are relatively small and with a short-term duration. Recent research has shown that mHealth apps can be beneficial in terms of improving hypertension self-assessment, treatment and control, being especially useful to help differentiate and manage true and pseudo-resistant hypertension. However, future research, including large-scale randomised clinical trials with user-centred design, is crucial to further evaluate the potential scalability and effectiveness of such mHealth apps in the resistant hypertension context.

Adapting a club-based medication delivery strategy to a hypertension context: the CLUBMEDS Study in Nigeria.

INTRODUCTION: The prevalence of hypertension in sub-Saharan Africa is among the world's highest; however, awareness, treatment and control of hypertension in this region are suboptimal. Among other barriers, the overburdened healthcare system poses a great challenge for hypertension control. Community peer-support groups are an alternative and promising strategy to improve adherence and blood pressure (BP) control. The CLUBMEDS study aims to evaluate the feasibility and impact of adherence clubs to improve hypertension control in Nigeria. METHODS AND ANALYSIS: The CLUBMEDS study will include a formative (pre-implementation) qualitative evaluation, a pilot study and a process (postimplementation) qualitative evaluation. At the formative stages, focus group discussions with patient groups and in-depth interviews with healthcare providers, managers and key decision makers will be conducted to understand the feasibility, barriers and facilitators, opportunities and challenges for the successful implementation of the CLUBMEDS strategy. The CLUBMEDS pilot study will be implemented in two primary healthcare facilities, one urban and one rural, in Southeast Nigeria. Each adherence club, which consists of a group of 10-15 patients with hypertension under the leadership of a role-model patient, serves as a support group to encourage and facilitate adherence, BP self-monitoring and medication delivery on a monthly basis. A process evaluation will be conducted at the end of the pilot study to evaluate the acceptability and engagement with the CLUBMEDS strategy. To date, 104 patients were recruited and grouped into nine clubs, in which patients will be followed-up for 6 months. ETHICS AND DISSEMINATION: The study was approved by the University of Abuja Teaching Hospital and the Federal Teaching Hospital Abakaliki Human Research Ethics Committees and all patients provided informed consent. Our findings will provide preliminary data on the potential effectiveness and acceptance of this strategy in a hypertension context. Study findings will be disseminated via scientific forums.

Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation.

OBJECTIVE: The aim of this study was to assess the reach, acceptability, utility, and engagement with the apps that were used in the MEDication reminder APPlications (apps) to improve medication adherence in Coronary Heart Disease (MedApp-CHD) study, a randomised clinical trial to improve medication adherence, using a mixed-methods approach. METHODS: The MedApp-CHD study randomised 163 patients with coronary heart disease (CHD) to one of three groups: (i) usual care (n = 56), (ii) a basic medication reminder app (n = 54), or (iii) an advanced medication reminder app (n = 53). For this mixed-methods evaluation, the data sources included patient screening logs, feedback questionnaires collected at three-month follow-up, focus groups discussions, and analytical data from the app software. RESULTS: Ninety-four percent (98/104) of participants who received a medication reminder app completed the three-month feedback questionnaire and 15 participated in the focus group discussions. The themes that were identified included that participants (i) found the medication reminders useful in reminding them to take the medications on the correct time every day, (ii) liked having the medication list as an easily-accessible record of medications' names and dosages, (iii) reported being likely to continue to use the apps after the study completion, (iv) would be likely to recommend the apps to their family and friends, and (v) those who used the clinical measurements feature found it useful as a tool to track and graph the blood pressure and glucose levels over time (especially those with diabetes and/or hypertension). In addition, analytical data from the app software demonstrated that the participants used the medication-related features more than the clinical measurements feature. Furthermore, data from the patient screening logs showed that the main reason for exclusion, other than not meeting the CHD criteria, was not having a suitable smartphone, and those that were excluded for this reason were older and had a higher proportion of females than those enrolled in the study. CONCLUSION: This study provides important insights regarding the features that are most useful in apps that aim to improve medication adherence. This mixed-methods evaluation suggests that, currently, young male patients with CHD are more likely to use such apps, that the apps were well-accepted and useful in reminding the patients to take the medications, and that the patients were engaged in regularly using the apps.

ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial.

INTRODUCTION: Simple and scalable strategies are needed to improve 'out-of-hospital' support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation. METHODS AND ANALYSIS: Pragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation. ETHICS AND DISSEMINATION: Primary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease. TRIAL REGISTRATION NUMBER: ACTRN12616001167459.

Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial.

OBJECTIVE: The aim of the MEDication reminder APPs to improve medication adherence in Coronary Heart Disease Study was to evaluate the effectiveness and feasibility of using publicly available high-quality medication reminder applications (apps) to improve medication adherence compared with usual care in patients with coronary heart disease (CHD). An additional aim was to examine whether an app with additional features improved adherence further. METHODS: Patients with CHD (n=163) were randomised to one of three groups: (1) usual care, (2) a basic app or (3) an advanced app with interactive/customisable features. The primary analysis compared usual care versus app use on the primary outcome of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 3 months. Secondary outcomes included blood pressure and cholesterol levels. RESULTS: The mean age was 57.9 years and 87.7% were male. At 3 months, patients using an app had higher adherence (mean MMAS-8 score 7.11) compared with the usual care group (mean MMAS-8 score 6.63) with a mean difference between groups of 0.47 (95% CI 0.12 to 0.82, p=0.008). There was no significant difference in patients using the basic app versus the advanced app (mean difference -0.16, 95% CI -0.56 to 0.24, p=0.428). There were no significant differences in secondary clinical outcome measures. CONCLUSION: Patients with CHD who used medication reminder apps had better medication adherence compared with usual care, and using apps with additional features did not improve this outcome further. These data suggest medication apps are likely to help patients with chronic health conditions adhere to medicines, but further examination of whether such benefits are sustained is warranted. CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12616000661471; Results.