Effectiveness of a multifactorial intervention, consisting of a self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs. The MEDICHY study

[eng] Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure. Methods/Design: This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales). Discussion: This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise). Abbreviations: ACC = American College of Cardiology, ACE = angiotensin-converting-enzyme, AHA = American Heart Association, ARB = Angiotensin II Receptor Blockers, BMI = body mass index, BP = blood pressure, BPSM = BP self-monitoring, CCB = calcium channel blocker, COPD = chronic obstructive pulmonary disease, CVR = cardiovascular risk, DASH = Dietary Approaches to Stop Hypertension, DBP = dyastolic blood pressure, ESC = European Society of Cardiology, ESH = European Society of Hypertension, FITT of exercise = frequency, intensity, time, and type, GP = general practitioner, IPAQ = International Physical activity Questionnaire, ITT = intention-to-treat, MPR = medication possession ratio, MTD = maximum tolerated dose, NNT = number needed to treat, NSAIDs = non-steroidal anti-inflammatory drugs, SBP = systolic blood pressure, VAS = visual analogue scale. Keywords: blood pressure control, hypertension, low sodium diet, physical exercise, self-management, self-monitorin

A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial.

The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818