Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
Plain language summary
COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
Evaluation of a community health worker home visit intervention to improve child development in South Africa: A cluster-randomized controlled trial.
PLoS medicine. 2023;(4):e1004222
BACKGROUND Effective integration of home visit interventions focused on early childhood development into existing service platforms is important for expanding access in low- and middle-income countries (LMICs). We designed and evaluated a home visit intervention integrated into community health worker (CHW) operations in South Africa. METHODS AND FINDINGS We conducted a cluster-randomized controlled trial in Limpopo Province, South Africa. CHWs operating in ward-based outreach teams (WBOTs; clusters) and caregiver-child dyads they served were randomized to the intervention or control group. Group assignment was masked from all data collectors. Dyads were eligible if they resided within a participating CHW catchment area, the caregiver was at least 18 years old, and the child was born after December 15, 2017. Intervention CHWs were trained on a job aid that included content on child health, nutrition, developmental milestones, and encouragement to engage in developmentally appropriate play-based activities, for use during regular monthly home visits with caregivers of children under 2 years of age. Control CHWs provided the local standard of care. Household surveys were administered to the full study sample at baseline and endline. Data were collected on household demographics and assets; caregiver engagement; and child diet, anthropometry, and development scores. In a subsample of children, electroencephalography (EEG) and eye-tracking measures of neural function were assessed at a lab concurrent with endline and at 2 interim time points. Primary outcomes were as follows: height-for-age z-scores (HAZs) and stunting; child development scores measured using the Malawi Developmental Assessment Tool (MDAT); EEG absolute gamma and total power; relative EEG gamma power; and saccadic reaction time (SRT)-an eye-tracking measure of visual processing speed. In the main analysis, unadjusted and adjusted impacts were estimated using intention-to-treat analysis. Adjusted models included a set of demographic covariates measured at baseline. On September 1, 2017, we randomly assigned 51 clusters to intervention (26 clusters, 607 caregiver-child dyads) or control (25 clusters, 488 caregiver-child dyads). At endline (last assessment June 11, 2021), 432 dyads (71%) in 26 clusters remained in the intervention group, and 332 dyads (68%) in 25 clusters remained in the control group. In total, 316 dyads attended the first lab visit, 316 dyads the second lab visit, and 284 dyads the third lab visit. In adjusted models, the intervention had no significant impact on HAZ (adjusted mean difference (aMD) 0.11 [95% confidence interval (CI): -0.07, 0.30]; p = 0.220) or stunting (adjusted odds ratio (aOR) 0.63 [0.32, 1.25]; p = 0.184), nor did the intervention significantly impact gross motor skills (aMD 0.04 [-0.15, 0.24]; p = 0.656), fine motor skills (aMD -0.04 [-0.19, 0.11]; p = 0.610), language skills (aMD -0.02 [-0.18, 0.14]; p = 0.820), or social-emotional skills (aMD -0.02 [-0.20, 0.16]; p = 0.816). In the lab subsample, the intervention had a significant impact on SRT (aMD -7.13 [-12.69, -1.58]; p = 0.012), absolute EEG gamma power (aMD -0.14 [-0.24, -0.04]; p = 0.005), and total EEG power (aMD -0.15 [-0.23, -0.08]; p < 0.001), and no significant impact on relative gamma power (aMD 0.02 [-0.78, 0.83]; p = 0.959). While the effect on SRT was observed at the first 2 lab visits, it was no longer present at the third visit, which coincided with the overall endline assessment. At the end of the first year of the intervention period, 43% of CHWs adhered to monthly home visits. Due to the COVID-19 pandemic, we were not able to assess outcomes until 1 year after the end of the intervention period. CONCLUSIONS While the home visit intervention did not significantly impact linear growth or skills, we found significant improvement in SRT. This study contributes to a growing literature documenting the positive effects of home visit interventions on child development in LMICs. This study also demonstrates the feasibility of collecting markers of neural function like EEG power and SRT in low-resource settings. TRIAL REGISTRATION PACTR 201710002683810; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2683; South African Clinical Trials Registry, SANCTR 4407.
A physiotherapy-led transition to home intervention for older adults following Emergency Department discharge: a pilot feasibility randomised controlled trial.
Rural and remote health. 2023;(1):8154
INTRODUCTION Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. Our aim was to evaluate the feasibility of a physiotherapy-led integrated care intervention for older adults discharged from the ED (ED-PLUS). METHODS Older adults presenting to the ED with undifferentiated medical complaints and discharged within 72 hours were computer randomised in a ratio of 1:1:1 to deliver usual care, Comprehensive Geriatric Assessment (CGA) in the ED, or ED-PLUS (trial registration: NCT04983602). ED-PLUS is an evidence-based and stakeholder-informed intervention to bridge the care transition between the ED and community by initiating a CGA in the ED and implementing a 6-week, multi-component, self-management programme in the patient's own home. Feasibility (recruitment and retention rates) and acceptability of the programme were assessed quantitatively and qualitatively. Functional decline was examined post-intervention using the Barthel Index. All outcomes were assessed by a research nurse blinded to group allocation. RESULTS Twenty-nine participants were recruited, indicating 97% of our recruitment target; 90% of participants completed the ED-PLUS intervention. All participants expressed positive feedback about the intervention. The incidence of functional decline at 6 weeks was 10% in the ED-PLUS group versus 70%-89% in the usual care and CGA-only groups. DISCUSSION High adherence and retention rates were observed among participants and preliminary findings indicate a lower incidence of functional decline in the ED-PLUS group. Recruitment challenges existed in the context of COVID-19. Data collection is ongoing for 6-month outcomes.
Adjuvant pomegranate juice intake improves the inflammatory status of hospitalized COVID-19 patients: A randomized and placebo-controlled trial.
Complementary therapies in medicine. 2023;:102958
BACKGROUND This study aimed to evaluate the effect of pomegranate juice intake on the inflammatory status and complete blood count in hospitalized Covid-19 patients. METHODS This randomized, double-blinded placebo-controlled trial included 48 patients with two parallel arms. In addition to the standard care provided at the hospital, the patients consumed 500 mL of whole pomegranate juice (PJ) daily or a placebo for 14 days. Inflammatory markers (C-reactive protein (CRP), interleukin-6 (IL-6), erythrocyte sedimentation rate (ESR)) and complete blood count were determined at baseline and after the 14 days of intervention. RESULTS At the end of the intervention, a significant decreased was observed in primary outcomes [mean difference (95 %CI)] including IL-6 [5.24(0.87-9.61)], CRP [23.19(11.93-34.44)] and ESR [10.52(1.54-19.50)] in the PJ group vs. before the intervention. In addition, significant changes were also observed in the some of the secondary outcomes, including neutrophils, lymphocytes, platelets, platelets-to-lymphocyte(PLR) and neutrophils-to-lymphocyte (NLR) ratios (p < 0.05) in the PJ group compared to before the intervention. At the end of the intervention period, the mean change of IL-6 [- 7.09(-12.21 to - 1.96)], white blood cells [- 3.09(- 6.14 to - 0.05)], neutrophils [- 9.12(-18.08 to -0.15)], lymphocyte [7.05(0.17-13.92)], platelets [- 94.54(- 139.33 to - 49.75)], PLR [- 15.99(- 29.31 to - 2.67)], blood oxygen saturation [1.75(0.13-3.37)] and MCV [0.31(- 0.25 to 0.88)] levels were significantly different between groups while no difference was observed between the two groups in other blood indices. CONCLUSION Our results suggest that pomegranate juice intake might slightly improve the inflammatory status and CBC outcomes of COVID-19 patients and it may be beneficial.
Effectiveness of a Sodium-Reduction Smartphone App and Reduced-Sodium Salt to Lower Sodium Intake in Adults With Hypertension: Findings From the Salt Alternatives Randomized Controlled Trial.
JMIR mHealth and uHealth. 2023;:e43675
BACKGROUND Even modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category; and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor. OBJECTIVE Our aim was to determine whether a 12-week intervention with a sodium-reduction package comprising the SaltSwitch smartphone app and an RSS could reduce urinary sodium excretion in adults with high BP. METHODS A 2-arm parallel randomized controlled trial was conducted in New Zealand (target n=326). Following a 2-week baseline period, adults who owned a smartphone and had high BP (≥140/85 mm Hg) were randomized in a 1:1 ratio to the intervention (SaltSwitch smartphone app + RSS) or control (generic heart-healthy eating information from The Heart Foundation of New Zealand). The primary outcome was 24-hour urinary sodium excretion at 12 weeks estimated via spot urine. Secondary outcomes were urinary potassium excretion, BP, sodium content of food purchases, and intervention use and acceptability. Intervention effects were assessed blinded using intention-to-treat analyses with generalized linear regression adjusting for baseline outcome measures, age, and ethnicity. RESULTS A total of 168 adults were randomized (n=84, 50% per group) between June 2019 and February 2020. Challenges associated with the COVID-19 pandemic and smartphone technology detrimentally affected recruitment. The adjusted mean difference between groups was 547 (95% CI -331 to 1424) mg for estimated 24-hour urinary sodium excretion, 132 (95% CI -1083 to 1347) mg for urinary potassium excretion, -0.66 (95% CI -3.48 to 2.16) mm Hg for systolic BP, and 73 (95% CI -21 to 168) mg per 100 g for the sodium content of food purchases. Most intervention participants reported using the SaltSwitch app (48/64, 75%) and RSS (60/64, 94%). SaltSwitch was used on 6 shopping occasions, and approximately 1/2 tsp per week of RSS was consumed per household during the intervention. CONCLUSIONS In this randomized controlled trial of a salt-reduction package, we found no evidence that dietary sodium intake was reduced in adults with high BP. These negative findings may be owing to lower-than-anticipated engagement with the trial intervention package. However, implementation and COVID-19-related challenges meant that the trial was underpowered, and it is possible that a real effect may have been missed. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12619000352101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377044 and Universal Trial U1111-1225-4471.
Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2023;(2):185-191
BACKGROUND Zinc supplementation has been considered a potential therapy for coronavirus disease 2019 (COVID-19). We aimed to examine zinc efficacy in adult patients with COVID-19 infection. METHODS We conducted a prospective, randomized, double-blind, placebo-controlled multicenter trial. Patients who were tested positive for COVID-19 without end-organ failure were randomized to oral zinc (n = 231) or matching placebo (n = 239) for 15 days. The primary combined outcome was death due to COVID-19 or intensive care unit (ICU) admission ≤30 days after randomization. Secondary outcomes included length of hospital stay for inpatients and duration of COVID-19 symptoms with COVID-19-related hospitalization for outpatients. RESULTS 190 patients (40.4%) were ambulatory and 280 patients (59.6%) were hospitalized. Mortality at 30 days was 6.5% in the zinc group and 9.2% in the placebo group (OR: .68; 95% CI .34-1.35); ICU admission rates were, respectively, 5.2% and 11.3% (OR: .43; 95% CI .21-.87). Combined outcome was lower in the zinc group versus the placebo group (OR: .58; 95% CI .33-.99). Consistent results were observed in prespecified subgroups of patients aged <65 years, those with comorbidity, and those who needed oxygen therapy at baseline. Length of hospital stay was shorter in the zinc group versus the placebo group (difference: 3.5 days; 95% CI 2.76-4.23) in the inpatient group; duration of COVID-19 symptoms decreased with zinc treatment versus placebo in outpatients (difference: 1.9 days; 95% CI .62-2.6). No severe adverse events were observed during the study. CONCLUSIONS Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials Registration. ClinicalTrials.gov, NCT05212480.
Weight management in young adults with type 1 diabetes: The advancing care for type 1 diabetes and obesity network sequential multiple assignment randomized trial pilot results.
Diabetes, obesity & metabolism. 2023;(3):688-699
AIMS: Co-management of weight and glycaemia is critical yet challenging in type 1 diabetes (T1D). We evaluated the effect of a hypocaloric low carbohydrate, hypocaloric moderate low fat, and Mediterranean diet without calorie restriction on weight and glycaemia in young adults with T1D and overweight or obesity. MATERIALS AND METHODS We implemented a 9-month Sequential, Multiple Assignment, Randomized Trial pilot among adults aged 19-30 years with T1D for ≥1 year and body mass index 27-39.9 kg/m2 . Re-randomization occurred at 3 and 6 months if the assigned diet was not acceptable or not effective. We report results from the initial 3-month diet period and re-randomization statistics before shutdowns due to COVID-19 for primary [weight, haemoglobin A1c (HbA1c), percentage of time below range <70 mg/dl] and secondary outcomes [body fat percentage, percentage of time in range (70-180 mg/dl), and percentage of time below range <54 mg/dl]. Models adjusted for design, demographic and clinical covariates tested changes in outcomes and diet differences. RESULTS Adjusted weight and HbA1c (n = 38) changed by -2.7 kg (95% CI -3.8, -1.5, P < .0001) and -0.91 percentage points (95% CI -1.5, -0.30, P = .005), respectively, while adjusted body fat percentage remained stable, on average (P = .21). Hypoglycaemia indices remained unchanged following adjustment (n = 28, P > .05). Variability in all outcomes, including weight change, was considerable (57.9% were re-randomized primarily due to loss of <2% body weight). No outcomes varied by diet. CONCLUSIONS Three months of a diet, irrespective of macronutrient distribution or caloric restriction, resulted in weight loss while improving or maintaining HbA1c levels without increasing hypoglycaemia in adults with T1D.
Efficacy and safety of add-on Viola odorata L. in the treatment of COVID-19: A randomized double-blind controlled trial.
Journal of ethnopharmacology. 2023;:116058
ETHNOPHARMACOLOGICAL RELEVANCE Severe Acute Respiratory Syndrome (SARS) due to the novel coronavirus has become the highest priority that threatens human health. This situation demands widespread vaccination and the innovation of new therapeutic methods. Despite drug discoveries, the need for approving new medicaments is felt because of adverse effects and lack of efficacy. Several medicinal plants including Viola odorata L. are recommended in traditional Persian medicine for alleviating respiratory infection symptoms. Recent studies showed anti-inflammatory, antioxidant, anti-asthmatic, antitussive, analgesic, and antibacterial activities of sweet violet. These enhance respiratory functions, reduce pulmonary inflammation, and decline mucous membrane edema. This study aimed to evaluate the efficacy of sweet violet syrup in alleviating the manifestations of COVID-19 infection. MATERIAL AND METHODS A randomized parallel-group double-blind controlled trial was conducted at Al-Zahra general hospital, Isfahan, Iran. A total of 108 outpatients were enrolled in the study. The patients were randomly allocated to intervention and placebo groups, with 54 patients in each group. The allocation was concealed using sealed opaque envelopes. The intervention group received violet syrup and the control group received placebo syrup, an add-on to the conventional treatment. The outcomes were COVID-19 manifestations, such as dyspnea, cough, myalgia, headache, and diarrhea, considered as outcomes of the study and were evaluated twice using a visual analog scale before the intervention and after 7 days, at the end of the study. Patients were followed daily by phone calls to monitor proper drug consumption and possible side effects. RESULTS No significant difference was between groups regarding demographic characteristics and vital signs before and after the treatment. Although all symptoms have improved significantly in both groups, patients who received violet syrup recovered faster and the mean severity scores of cough (P = 0.025), myalgia (P = 0.036), headache (P = 0.037), and diarrhea (P = 0.044) decreased greater in comparison to control group. CONCLUSION This study, the first clinical trial on the effectiveness of Viola odorata on SARS-CoV-2 patients, showed that Viola odorata L. effectively controls prevalent manifestations of COVID-19 including cough, myalgia, headache, and diarrhea. Regarding this survey, the violet syrup can be mentioned as a complementary treatment for viral influenza-like infections in which cough, myalgia, headache, and diarrhea are prominent.
Mouth rinses efficacy on salivary SARS-CoV-2 viral load: A randomized clinical trial.
Journal of medical virology. 2023;(1):e28412
Considering the global trend to confine the COVID-19 pandemic by applying various preventive health measures, preprocedural mouth rinsing has been proposed to mitigate the transmission risk of SARS-CoV-2 in dental clinics. The study aimed to investigate the effect of different mouth rinses on salivary viral load in COVID-19 patients. This study was a single-center, randomized, double-blind, six-parallel-group, placebo-controlled clinical trial that investigated the effect of four mouth rinses (1% povidone-iodine, 1.5% hydrogen peroxide, 0.075% cetylpyridinium chloride, and 80 ppm hypochlorous acid) on salivary SARS-CoV-2 viral load relative to the distilled water and no-rinse control groups. The viral load was measured by quantitative reverse transcription PCR (RT-qPCR) at baseline and 5, 30, and 60 min post rinsing. The viral load pattern within each mouth rinse group showed a reduction overtime; however, this reduction was only statistically significant in the hydrogen peroxide group. Further, a significant reduction in the viral load was observed between povidone-iodine, hydrogen peroxide, and cetylpyridinium chloride compared to the no-rinse group at 60 min, indicating their late antiviral potential. Interestingly, a similar statistically significant reduction was also observed in the distilled water control group compared to the no-rinse group at 60 min, proposing mechanical washing of the viral particles through the rinsing procedure. Therefore, results suggest using preprocedural mouth rinses, particularly hydrogen peroxide, as a risk-mitigation step before dental procedures, along with strict adherence to other infection control measures.
Compromised skin barrier induced by prolonged face mask usage during the COVID-19 pandemic and its remedy with proper moisturization.
Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI). 2023;(1):e13214
BACKGROUND Prolonged face mask usage, a daily practice for the public due to the COVID-19 pandemic, creates high levels of humidity underneath the mask, which may cause unexpected skin concerns. OBJECTIVE To investigate the impact of repeated mask usage on the face by comparing skin properties inside and outside of the mask-covered areas. METHODS A double-blinded, randomized, split-face clinical study was conducted with 21 healthy female participants who wore face masks at least 6 h every day for 1 week, with one side of their face treated with a moisturizer three times daily. On day 8, after 5 h of wearing the mask, skin properties (sebum, hydration, and trans-epidermal water loss [TEWL]) were evaluated at 15, 60, and 120 min post-mask removal, followed by barrier disruption and recovery assessment. RESULTS Mask usage weakened stratum corneum (SC) on facial skin compared to uncovered areas, including reduced SC hydration (p < 0.02 at 15 min) and increased TEWL in response to tape stripping challenge (p < 0.03 after stripping). In addition, sebum production also increased after mask removal (p < 0.01 at 15 min). Notably, a daily moisturizer mitigated these effects by increasing SC hydration (p < 0.001) and improving SC resilience against barrier disruption. CONCLUSION Daily prolonged usage of a facial mask, essential due to the COVID-19 situation, generated a high-humidity microenvironment and led to compromised SC, which was revealed by a barrier challenge technique. Moreover, proper facial moisturization may help to maintain skin homeostasis and prevent the barrier impairment caused by repeated mask usage.