Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial.

Introduction: Digital interventions, such as smartphone applications (apps), are becoming an increasingly common way to support medication adherence and self-management in chronic illness.Aim: To evaluate the effectiveness of the intervention in pharmacological therapeutic adherence in mild to moderate arterial hypertension (AHT), through an app installed on a mobile phone, as well as the degree of control reached by the patient with this tool.Methods: Prospective, randomized controlled trial, full study and multicenter study. Four primary care centers participated. One hundred and fifty-four hypertensive patients under antihypertensive treatment were included. Two groups were established: a control group (CG) with usual intervention (n = 77) and an intervention group (n = 77) (IG), targeting hypertensive people who owned and regularly used a mobile smartphone, specifically using the app called AlerHTA to promote health education and reminder of appointments. There were three visits: initial, 6 and 12 months. Drug adherence was measured by electronic monitors (MEMSs). The primary outcomes were average daily percentage adherence between 80 and 100%, and AHT control.Results: A total of 148 patients finished the study. Mean age was 57.5 ± 9.9. Global adherence was 77.02% (CI = 70.25-83.79) and daily adherence was 74.32% (CI = 67.29-81.35%). Daily adherence was 93.15% and 86.3% in IG, and 70.66% and 62.66% in CG after 6 and 12 months respectively (p < .05). The percentage of uncontrolled patients was 28.3% (CI = 21.05-35.55%). The control of high blood pressure at 12 months was 17.8% and 38.6% for IG and CG respectively (p < .05). The number of patients needed to treat to avoid non-adherence (NNT) was 4.23 patients.Conclusions: The intervention with an app installed on the mobile phones of hypertensive patients favors pharmacological therapeutic adherence and improves the percentage of hypertensive patient control.Trial registration: Spanish Agency of Medicine: EPA-SP UN-HTA-2015-01.

Effect of moderate and regular consumption of Cinco Jotas acorn-fed 100% Iberian ham on overall cardiovascular risk: A cohort study.

OBJECTIVE: To evaluate the impact that the moderate and regular consumption of Cinco Jotas acorn-fed 100% Iberian ham has on overall cardiovascular risk, lipid parameters, blood pressure, and weight. METHODS: A longitudinal, analytical, and quasi-experimental clinical study with repeated measures was carried out with 100 randomly selected individuals in primary care. The sample population included men and women (64%) between the ages of 25 and 55 (42.08, SD 9.6) who were not diagnosed with any cardiovascular illness or diabetes, were not undergoing antihypertensive treatment, nor taking lipid-lowering drugs. There were four visits during a 2-week washout period for the first of three phases. Phases 2 and 3 included an 8-week habitual diet phase followed by an 8-week intervention phase when participants consumed 40 g daily of acorn-fed 100% Cinco Jotas Iberian ham. Measurements of cardiovascular risk factors were taken following the SCORE table. These included total cholesterol, high-density lipoproteins cholesterol (HDL-c), low-density lipoproteins cholesterol (LDL-c), triglycerides (TG), and weight. RESULTS: The average vascular risk (SCORE) was 0.20 (SD 0.49) before the consumption phase and 0.18 (SD 0.48) at the end of the study (p > 0.05). An increase in HDL-c of 5 mg/dl was observed while there was a decrease in LDL-c and TG of 10 mg/dl (p < 0.05). There were no differences in total cholesterol levels, blood pressure, or weight; nor were differences observed in average consumption of calories, protein, lipids, carbohydrates, or alcohol (p > 0.05). CONCLUSIONS: The daily consumption of 40 g of Cinco Jotas acorn-fed 100% Iberian ham does not increase the risk of cardiovascular disease and has a favorable impact on lipid levels without affecting blood pressure or weight.

Validation of the electronic prescription as a method for measuring treatment adherence in hypertension.

OBJECTIVE: To validate electronic prescriptions (e-prescriptions) as a method for measuring treatment adherence in patients with hypertension. METHODS: This prospective study initially included 120 patients treated for hypertension in primary care centers. Adherence was measured using the gold standard, the medication event monitoring system (MEMS), versus the index test, the e-prescription program, at baseline and at 6, 12, 18 and 24 months. We calculated the adherence rate using the MEMS and the medication possession ratio (MPR) for the e-prescriptions. We considered patients adherent if they had an adherence rate of 80% to 100%. To validate the e-prescription, we obtained measures of diagnostic accuracy, the Kappa concordance index, and the area under the ROC curve (AUC). RESULTS: We included 102 patients. Overall adherence was 77.4% by MEMS (95%CI: 66.8-88) and 80.4% (95%CI: 70.3-90.5) by MPR. At 24 months, sensitivity was 87% and specificity, 93.7%. The AUC was 0.903 (95%CI: 0.817-0.989). CONCLUSION: Measures of treatment adherence were not significantly different between e-prescription and gold standard at most visits, and the e-prescription showed good discriminatory diagnostic capacity. PRACTICE IMPLICATIONS: If patients are included in an e-prescription program for at least 2 years, e-prescription is an inexpensive method to measure adherence in hypertension.

Strategies for improving dabigatran adherence for stroke prevention in patients with non-valvular atrial fibrillation: education and drug intake reminders (FACILITA study).

Objective To assess the efficacy of a mixed intervention, educational, and reminder calendar of the intake, as a strategy to improve therapeutic adherence with dabigatran in patients with non-valvular atrial fibrillation (NVAF). Methods This was a prospective, longitudinal, multi-center study, carried out in 110 specialized healthcare centers in Spain. Seven hundred and twenty-six patients treated with dabigatran prescribed for stroke prevention were included. A cluster randomization was performed based on two groups: (1) Control Group (CG) as usual clinical practice, and (2) Intervention Group (IG) with a mixed strategy: (a) Healthcare education, and (b) Use of a reminder calendar for taking the anticoagulant medication. Three visits took place: baseline and follow-up at 6 and 12 months. Compliance was measured by using electronic monitors (MEMS). Average adherence percentage (%; Average AP) and daily compliance (%; Daily AP) was calculated. A patient was considered adherent when AP was 80-100%. Results Six hundred and twenty-five patients completed the study (315 in the IG and 310 in the CG). Daily AP was 91.97% at 6 months and 91.05% after 12 months in the IG and 82.26% and 82.63% in the CG. Average adherence was 90.79% and 89.20% in the IG and 64.51% and 63.22% in the CG at 6 and 12 months, respectively. Significant differences were observed in the Daily AP and Average AP, with higher percentages in the IG. In the non-adherents group, the number of concomitant drugs, baseline, and 6 months SBP values, 6 and 12 months DBP values, and weight, total cholesterol, and LDL cholesterol were significantly higher. The number needed to treat (NNT) was 3.84 patients to prevent one non-adherence. Conclusions A mixed intervention, consisting of patient education and a simple calendar reminder of drug intake, is an effective strategy to improve dabigatran therapeutic adherence in patients with NVAF. The percentage of adherence with dabigatran was high.

Quality of life with rivaroxaban in patients with non-valvular atrial fibrilation by therapeutic compliance.

OBJECTIVE: To assess the quality of life (QOL) with rivaroxaban in patients with non-valvular atrial fibrilation (NVAF) related to therapeutic compliance. METHODS: Prospective, longitudinal, multicenter study was developed in 160 Spanish primary or specialized care centers. We included 412 patients treated with rivaroxaban, prescribed for stroke prevention. Three visits were conducted: baseline, 6 and 12 months. Compliance was measured by electronic monitoring systems. QOL was measured by a specific questionnaire. We calculated the percentage of compliance means, the percentage of daily compliers and the score of QOL. RESULTS: Three hundred and seventy patients finished the study (mean age 75.19 SD: 7.5 years). Daily compliance was 83.5% (CI 78.53-88.57%) (n = 309) and 80% (CI 74.65-85.35%) at 6 and 12 months, respectively. Average QOL rating was 112.85 (SD 29.31) in non-compliant and 111.80 (SD 29.31) in the compliant group (p = Not significant), and after 12 months of 124.67 (SD 30.78) and 83.47 (SD 26.44), respectively (p < 0.0001), with a decrease in the score compliers (p < 0.01) and an increase in non-compliant group (p < 0.05). A higher number of drugs consumed, as well as the number of diseases/conditions suffered, the older age of the patients and having been previously treated with VKA were associated with a higher overall score (worse QOL). CONCLUSIONS: QOL in NVAF patients treated with rivaroxaban improved significantly over the study group at the expense of compliers. A worse QOL was associated with pluripathology, polymedication, older patients and previous treatment with VKA.

Therapeutic compliance with rivaroxaban in preventing stroke in patients with non-valvular atrial fibrillation: CUMRIVAFA study.

OBJECTIVE: To assess compliance with treatment with rivaroxaban in patients with non-valvular atrial fibrillation. METHODS: Prospective, longitudinal, multicenter study, developed in 160 Spanish primary or specialized care centers. We included 412 patients treated with rivaroxaban, prescribed for stroke prevention. Three visits were conducted: baseline, 6 and 12 months. Compliance was measured by using electronic monitors (MEMSs) that use a digital record in the form of a microchip in the lid of the drug container that automatically controls its opening and registers the time and date of the opening. We calculated the average compliance percentage (CP), global and daily compliance. We considered compliance to be when CP was 80-100%. RESULTS: Three hundred and seventy patients ended the study (mean age 75.19, SD: 7.5 years). Global compliance was 84.1% (CI = 79.21-88.99%) and 80.3% (CI = 74.98-85.62%) after 6 and 12 months respectively. Daily compliance was 83.5% (CI = 78.53-88.57%) and 80% (CI = 74.65-85.35%) at 6 and 12 months. Significant differences in the CP between 6 and 12 months were observed. Global CP was 90.77% after 6 months and 89.65% at the end of the study. Daily CP was 90.14% and 87.66% at 6 and 12 months. There were significant CP differences between 6 and 12 months. Non-compliance was associated with a higher number of concomitant diseases, number of drugs taken and weight. CONCLUSIONS: The percentage of compliance with rivaroxaban was high. A profile of variables that need to be modified in current medical practice, associated with non-compliance, was detected.