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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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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.
Abstract
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.
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Increasing Natural Killer Cell Activity of Mineral Nanomaterial ALP1018 in Healthy Adults: A Randomized, Double-Blind, Placebo Comparative Clinical Trial.
Kim, SA, Kim, S, Chai, H, Cho, J, Paek, YJ
Nutrients. 2024;(6)
Abstract
This randomized, double-blind, placebo comparative clinical trial aimed to determine the immune-enhancing effects and safety of a nanomaterial with iron and zinc (ALP1018) in healthy adults. Participants who met the inclusion criteria were recruited for this study (n = 80) and randomly assigned to either the test group (n = 40), which was given Alp1018 in capsule form, or the placebo group (n = 40), which was given crystal cellulose capsules of identical appearance, weight, and flavor for 8 weeks. Compared to baseline, natural killer (NK) cell activity (%) increased in the test group after 8 weeks, although there were no changes in the placebo group. Furthermore, in the subgroup analysis of Coronavirus disease 2019 (COVID-19) affected participants, significantly increased NK cell activity was observed in the test group at 4 (p < 0.05) and 8 weeks (p < 0.05). No significant differences were observed in cytokine levels between the two groups. ALP1018 supplementation appeared to enhance immune function by improving NK cell activity without adverse effects in healthy adults.
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Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial.
van Brakel, L, Mensink, RP, Lütjohann, D, Plat, J
The American journal of clinical nutrition. 2024;(4):969-980
Abstract
BACKGROUND People with overweight/obesity generally have impaired immune responses, resulting among others in increased risk of severe complaints and hospitalization after infections with severe acute respiratory syndrome coronavirus 2 (COVID-19), as well as decreased antibody production after vaccinations. Plant stanol ester previously increased the combined IgM/IgG antibody titers toward a hepatitis A vaccination in patients with allergic asthma, but the underlying mechanism is unknown. OBJECTIVES We evaluated whether plant stanol ester consumption improved the immune response in subjects with overweight/obesity after a COVID-19 vaccination. METHODS A double-blind, randomized, placebo-controlled trial was performed. Thirty-two subjects with overweight/obesity consumed products with added plant stanols (4 g/d; provided as plant stanol ester) or control ≥2 wk before receiving their COVID-19 vaccination until 4 wk after vaccination. Antibody titers were analyzed weekly and statistically analyzed using mixed models. Serum metabolic markers and cytokine profiles were also analyzed. RESULTS IgM concentrations against the COVID-19 Spike protein were increased in the plant stanol ester group compared with the control group, with the largest difference observed 2 wk after vaccination [31.2 (0.43, 62.1) BAU/mL, or +139%; Group × Time: P = 0.031]. Subjects that produced very low IgM antibodies produced, as expected, hardly any IgG antibodies. In those with IgG seroconversion, IgG Spike concentrations were also increased in the plant stanol ester group compared with the control group [71.3 (2.51, 140.1) BAU/mL; Group P = 0.043]. Stimulated cytokine concentrations decreased in the plant stanol ester group compared with the control group in all 3 cytokine domains (that is, proinflammatory, T helper [Th1]/Th17, and Th2/regulatory T cells). Between-group differences in serum LDL cholesterol or other metabolic markers were not observed. CONCLUSIONS Consuming plant stanols (4 g/d) affects immune responses to COVID-19 vaccinations, translating into increased serum anti-COVID-19 IgM concentrations in subjects with overweight/obesity. Only in IgG seroconverted subjects, serum anti-COVID-19 IgG concentrations also increase. These effects are independent of reductions in LDL cholesterol. These results suggest that this high-risk group for COVID-19 complications could benefit from plant stanol consumption. This trial was registered at clinicaltrials.gov as NCT04844346.
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Safety of bempedoic acid in patients at high cardiovascular risk and with statin intolerance.
Bays, HE, Bloedon, LT, Lin, G, Powell, HA, Louie, MJ, Nicholls, SJ, Lincoff, AM, Nissen, SE
Journal of clinical lipidology. 2024;(1):e59-e69
Abstract
BACKGROUND Bempedoic acid is an oral adenosine triphosphate citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) blood levels. The Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes study demonstrated that bempedoic acid reduced cardiovascular (CV) risk in patients at high risk for CV events who were unwilling or unable to take guideline-recommended doses of statins. OBJECTIVE To describe detailed safety information from CLEAR Outcomes, including events in the United States (US) prescribing information based on previous phase 3 hyperlipidemia studies. METHODS CLEAR Outcomes was a double-blind trial conducted in 13,970 patients randomized to oral bempedoic acid 180 mg daily or placebo and followed for a median of 3.4 years. RESULTS In patients who received at least one dose (7,001 bempedoic acid, 6,964 placebo), treatment emergent adverse events (AE) occurred in 86.3 % and 85 % of patients, respectively. COVID-19 was the most frequently reported AE in both groups. Changes in serum creatinine, blood urea nitrogen, hemoglobin, aminotransaminases, and uric acid were consistent with the known safety profile of bempedoic acid. Gout or gouty arthritis occurred in 3.2 % of bempedoic acid and 2.2 % of placebo patients. AE associated with tendinopathies, including tendon rupture, occurred in 2 % of patients in both treatment groups. Cholelithiasis occurred in 2.2 % of bempedoic acid and 1.2 % of placebo patients; AE related to gallbladder disease were similar between treatment groups. CONCLUSIONS Bempedoic acid was well-tolerated compared with placebo. Safety data from the long-term CLEAR Outcomes study reinforce the positive benefit-risk profile of bempedoic acid.
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Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial.
Ptomey, LT, Washburn, RA, Sherman, JR, Mayo, MS, Krebill, R, Szabo-Reed, AN, Honas, JJ, Helsel, BC, Bodde, A, Donnelly, JE
Disability and health journal. 2024;(2):101587
Abstract
BACKGROUND Remote delivery of multi-component weight management interventions results in clinically meaningful weight loss in adults without intellectual disabilities (ID), but the effectiveness of remotely delivered weight management interventions in adults with ID has not previously been evaluated. OBJECTIVE To determine if a weight management intervention delivered remotely could achieve weight loss (kg) at 6 months that is non-inferior to in-person visits in adults with ID and overweight or obesity (BMI ≥25 kg/m2). METHODS Participants were randomized to a 24-mo. trial (6 mos weight loss,12 mos weight maintenance, 6 mos. no-contact follow up) to compare weight loss achieved with the same multicomponent intervention delivered to individual participants in their home either remotely (RD) or during face-to-face home visits (FTF). RESULTS One hundred twenty adults with ID (∼32 years of age, 53 % females) were randomized to the RD (n = 60) or the FTF arm (n = 60). Six-month weight loss in the RD arm (-4.9 ± 7.8 kg) was superior to 6-month weight loss achieved in the FTF arm (-2.1 ± 6.7 kg, p = 0.047). However, this may be partially attributed to the COVID-19 pandemic, since weight loss in the FTF arm was greater in participants who completed the intervention entirely pre-COVID (n = 33,-3.2 %) compared to post-COVID (n = 22, -0.61 %). Weight loss across did not differ significantly between intervention arms at 18 (p = 0.33) or 24 months (p = 0.34). CONCLUSION Our results suggest that remote delivery is a viable option for achieving clinically relevant weight loss and maintenance in adults with ID. NCT REGISTRATION NCT03291509.
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The effect of Aromatherapy with Pelargonium graveolens (P. graveolens) on the fatigue and sleep quality of critical care nurses during the Covid-19 pandemic: A randomized controlled trial.
Karimi, N, Hasanvand, S, Beiranvand, A, Gholami, M, Birjandi, M
Explore (New York, N.Y.). 2024;(1):82-88
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OBJECTIVES Measures to reduce nurses' fatigue are necessary to improve the patient's care and the nurse's health and well-being. This study investigated the effectiveness of aromatherapy with Pelargonium graveolens (P. graveolens) essential oil on fatigue and sleep quality of nurses working in intensive care units (ICU). METHODS In this double-blind, randomized, controlled clinical trial, 84 nurses working in the ICU of Covid-19 patients were assigned to two groups of P. graveolens and placebo by the stratified block method. The intervention group inhaled one drop of pure P. graveolens. The placebo group inhaled one drop of pure sunflower oil in three consecutive shifts (morning or evening) and each shift twice for 20 min. Using the Visual Analog Fatigue Scale (VAS-F), fatigue was measured 30 min before the intervention, immediately, and 60 min later. Also, on the morning of the intervention days, sleep quality was assessed with the Verran and Snyder-Halpern (VSH) Sleep Scale. Data analysis was performed using SPSS, version 24. Independent t-tests, Mann-Whitney, Chi-square tests, and MANOVA, were used. RESULTS The mean score of fatigue immediately and 60 min after aromatherapy in the P. graveolens group was lower than in the control group (P ˂ 0.05). There was no significant difference between the mean sleep scores of nurses in the P. graveolens group before and after the intervention (P > 0.05). CONCLUSION Inhalation aromatherapy with P. graveolens essential oil can reduce nurses' fatigue in the ICU. The findings of this study can make nurses interested in using aromatherapy as a self-care method.
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Preoperative dietitian-led Very Low Calorie Diet (VLCD) Clinic for adults living with obesity undergoing gynaecology, laparoscopic cholecystectomy and hernia repair procedures: a pilot parallel randomised controlled trial.
Griffin, SB, Palmer, MA, Strodl, E, Lai, R, Chuah, TL, Burstow, MJ, Ross, LJ
The British journal of nutrition. 2024;(8):1436-1446
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Obesity can increase the risk of postoperative complications. Despite increased demand for patients living with obesity to lose weight prior to common surgical procedures, the impact of intentional weight loss on surgical outcomes is largely unknown. We aimed to conduct a pilot study to assess the feasibility of a full-scale randomised controlled trial (RCT) to examine the effect of preoperative dietitian-led Very Low Calorie Diet (VLCD) Clinic on surgical outcomes in gynaecology and general surgeries. Between August 2021 and January 2023, a convenience sample of adults living with obesity (BMI ≥ 30 kg/m2) awaiting gynaecology, laparoscopic cholecystectomy and ventral hernia repair procedures were randomised to dietitian-led VLCD (800-1000 kcal using meal replacements and allowed foods), or control (no dietary intervention), 2-12 weeks preoperatively. Primary outcome was feasibility (recruitment, adherence, safety, attendance, acceptability and quality of life (QoL)). Secondary outcomes were anthropometry and 30-d postoperative outcomes. Outcomes were analysed as intention-to-treat. Fifty-one participants were recruited (n 23 VLCD, n 28 control), mean 48 (sd 13) years, 86 % female, and mean BMI 35·8 (sd 4·6) kg/m2. Recruitment was disrupted by COVID-19, but other thresholds for feasibility were met for VLCD group: high adherence without unfavourable body composition change, high acceptability, improved pre/post QoL (22·1 ± 15 points, < 0·001), with greater reductions in weight (-5·5 kg VLCD v. -0·9 kg control, P < 0·05) waist circumference (-6·6 cm VLCD v. +0·6 control, P < 0·05) and fewer 30-d complications (n 4/21) than controls (n 8/22) (P > 0·05). The RCT study design was deemed feasible in a public hospital setting. The dietitian-led VLCD resulted in significant weight loss and waist circumference reduction compared with a control group, without unfavourable body composition change and improved QoL.
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Effect of 1% H2O2 on Three Salivary Stress Biomarkers, Cortisol, Alpha-Amylase, and sIgA.
Jirakittayakorn, N, Tamboon, E, Mitrirattanakul, S
International dental journal. 2024;(2):343-351
Abstract
BACKGROUND Due to the COVID-19 pandemic, several associations worldwide have been recommending the use of 1% hydrogen peroxide solution as a preprocedural mouth rinse before dental treatments to reduce viral load in saliva. This protocol is also employed in stress studies, especially in the context of dental treatment that uses salivary biomarkers as an indicator. However, the effect of 1% hydrogen peroxide as mouth rinse on salivary biomarkers remains unclear. OBJECTIVE This study aims to investigate the effects of 1% hydrogen peroxide solution as a preprocedural mouth rinse on 3 salivary stress biomarkers-salivary cortisol, salivary secretory IgA, and salivary α-amylase-both on chemical influence and mechanical irrigation. MATERIALS AND METHODS Ninety healthy participants with confirmed negative Reverse Transcription Polymerase Chain Reaction results for COVID-19 at most 2 days prior to the experiment were included in this study. All participants were randomly allocated into 3 groups: experimental (1% hydrogen peroxide solution), positive control (distilled water), and negative control (no mouth rinse). Saliva samples were collected before and after mouth rinsing with the respective solutions. Salivary biomarkers were analysed using specific enzyme-linked immunosorbent assay kits. RESULTS Salivary cortisol and salivary α-amylase did not significantly differ before and after rinsing, whilst salivary sIgA levels decreased in all 3 groups. Nonetheless, there were no significant differences in the changes of these biomarkers across the 3 groups. CONCLUSIONS This study shows that using 1% hydrogen peroxide solution as a preprocedural mouth rinse for universal precaution does not alter the levels of these 3 salivary biomarkers.
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Melatonin, vitamins and minerals supplements for the treatment of Covid-19 and Covid-like illness: A prospective, randomized, double-blind multicenter study.
Mahjoub, L, Youssef, R, Yaakoubi, H, Salah, HB, Jaballah, R, Mejri, M, Sekma, A, Trabelsi, I, Nouira, S, Khrouf, M, et al
Explore (New York, N.Y.). 2024;(1):95-100
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BACKGROUND Melatonin, zinc, and multivitamins are among most recommended supplements in the fight against coronavirus disease 2019 (COVID-19). We aimed to examine the efficacy and safety of this association in the treatment of COVID-19 and COVID-like illnesses. METHODS We conducted a multicenter prospective, randomized, double-blind, controlled trial. Patients with no medical history consulting the emergency department for covid and covid-like illness and who were not hospitalized were included. Patients were assigned in a 1:1 ratio to the treatment or the placebo group. The primary outcome was studying the effectiveness of zinc multivitamin supplement and melatonin in the treatment of COVID and -like illnesses symptoms' according to the time from randomization to clinical improvement. The pre-specified secondary outcomes were date of disappearance of symptoms present on admission, appearance of an adverse effect due to the administration of the treatment, number of patients developing complications, requiring hospitalization, requiring respiratory support. RESULTS One hundred sixty four patients were eligible for the study and were randomized to either the treatment group or the placebo group. Overall, 128 of the 164 patients had a PCR for SARS-CoV-2, yielding a positive PCR result in 49.1% of them. Regarding the disappearance of all initial presenting symptoms: on the 5th day of the follow-up, there was a significant difference between the two groups with a p value 0.04;On the 10th day, there was a significant difference too with p value of 0.038. There were no significant differences between the two groups in recovery during the 15th day of follow-up p>0.5. Finally, 100% of patients fully recovered in the treatment group vs 98.8% in the placebo group. No severe adverse events were reported throughout the trial. CONCLUSIONS Our results showed that daily doses of Melatonin, zinc and vitamins did significantly reduce the duration of symptoms accelerating its disappearance among patients consulting with COVID-19 or COVID-19 like illness.
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Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial.
Song, MK, Manatunga, A, Plantinga, L, Metzger, M, Kshirsagar, AV, Lea, J, Abdel-Rahman, EM, Jhamb, M, Wu, E, Englert, J, et al
JAMA network open. 2024;(1):e2351511
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IMPORTANCE Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed. OBJECTIVES To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes. DESIGN, SETTING, AND PARTICIPANTS This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death. INTERVENTION Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records. MAIN OUTCOMES AND MEASURES The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created. RESULTS Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (β, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (β, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (β, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (β, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (β, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03138564.