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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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Reliability and Validity of Diabetes Nutrition Self-Efficacy and Behavior Measures for the "What Can I Eat" Diabetes Nutrition Education Program for American Indian and Alaska Native Adults With Type 2 Diabetes.
Brega, AG, Stotz, SA, Moore, KR, McNulty, MC, Jiang, L
Journal of the Academy of Nutrition and Dietetics. 2025;(1):78-89.e1
Abstract
BACKGROUND American Indian and Alaska Native (AI/AN) people have high rates of diabetes and limited access to nutrition education. The "What Can I Eat? Healthy Choices for People With Type 2 Diabetes" (WCIE) diabetes nutrition education program was culturally adapted for AI/AN adults. OBJECTIVE This analysis was designed to evaluate the reliability and validity of items developed to measure diabetes nutrition self-efficacy (ie, confidence one can engage in specific behaviors) and diabetes nutrition behavior among participants in the WCIE program for AI/AN adults. DESIGN This study was a secondary analysis of data from a randomized controlled trial designed to evaluate the WCIE program for AI/AN adults. Baseline data were used to assess the reliability and validity of the self-efficacy and behavior items, which were collected via survey. Due to COVID-19 safety protocols, the intervention was conducted via Zoom (Zoom Video Communications), and both survey and clinical data were collected at home by participants. PARTICIPANTS/SETTING The study was conducted from January to December 2021 with 5 AI/AN-serving health care programs in Oklahoma, Illinois, North Carolina, California, and New York. AI/AN adults with type 2 diabetes who spoke English and had internet access were eligible. Sixty people participated. MAIN OUTCOME MEASURES Analyses examined validity and reliability of diabetes nutrition self-efficacy and behavior items. STATISTICAL ANALYSIS PERFORMED To test reliability, internal consistency and factor structures of the scales were examined. To evaluate convergent validity, Pearson correlations were computed to examine the association of the self-efficacy and behavior measures with each other and with clinical indicators (ie, body mass index, blood pressure, and hemoglobin A1c). RESULTS Two self-efficacy factors were identified. Each showed strong internal consistency (Cronbach α ≥ 0.85; McDonald ω ≥ 0.88) and was directly associated with diabetes nutrition behavior (P < .001). The factor assessing Confidence in Using the Diabetes Plate was inversely associated with hemoglobin A1c (Pearson correlation = -0.32, P = .0243). The behavior measure capturing Healthy Nutrition Behavior showed strong internal consistency (α = 0.89; ω = 0.92) and was inversely associated with hemoglobin A1c (Pearson correlation = -0.38, P = .0057). CONCLUSIONS Diabetes nutrition self-efficacy and behavior items developed for the WCIE program for AI/AN adults are valid and reliable. These items can facilitate rigorous and consistent evaluation of the AI/AN WCIE program.
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Short-term efficacy of moderate-intensity rosuvastatin in coronavirus disease 2019 patients: A randomized clinical trial.
Rafsanjani, K, Ghaseminejad-Raeini, A, Azarboo, A, Parsa, S
Journal of investigative medicine : the official publication of the American Federation for Clinical Research. 2025;(1):85-93
Abstract
As the coronavirus disease 2019 (COVID-19) pandemic persists, the exploration of adjunct therapies to mitigate disease severity remains a priority. Statins, known for their pleiotropic effects, have been under investigation for their potential role in managing COVID-19 complications. The study was conducted in a single referral hospital and adhered to Consolidated Standards of Reporting Trials guidelines. Eligible participants were randomized in a 1:1 ratio into either the rosuvastatin group or the control group. Outcome measures included vital signs, laboratory data, clinical outcomes, and patient symptoms. Statistical analysis was performed using SPSS software (version 26.0, IBM Corp., Armonk, New York). A total of 100 patients were enrolled. No significant differences were observed between the rosuvastatin and control groups in terms of baseline characteristics and laboratory parameters, except for the fact that rosuvastatin-treated patients showed lower levels of C-reactive protein in comparison with the controls on both the 1st and 5th days (38.1 ± 16.3 vs 50.5 ± 25.3) compared to the control group. Clinical outcomes, including hospital length of stay, intensive care unit admission, need for intubation, and 1-month mortality, did not differ significantly between the two groups. Symptom scales, as assessed by the Borg Rating of Perceived Exertion and Leicester Cough Questionnaire, showed significant improvement in the rosuvastatin group compared to controls. Our study provides insights into the short-term efficacy of moderate-intensity rosuvastatin in COVID-19 patients. Further research is warranted to elucidate the long-term effects and optimal dosing of statins in COVID-19 management.
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The Effect of Semaglutide on Mortality and COVID-19-Related Deaths: An Analysis From the SELECT Trial.
Scirica, BM, Lincoff, AM, Lingvay, I, Bogdanski, P, Buscemi, S, Colhoun, H, Craciun, AE, Ezhov, M, Hardt-Lindberg, S, Kleist Jeppesen, O, et al
Journal of the American College of Cardiology. 2024;(17):1632-1642
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BACKGROUND Patients with overweight and obesity are at increased risk of death from multiple causes, including cardiovascular (CV) death, with few therapies proven to reduce the risk. OBJECTIVES This study sought to assess the effect of semaglutide 2.4 mg on all-cause death, CV death, and non-CV death, including subcategories of death and death from coronavirus disease-2019 (COVID-19). METHODS The SELECT (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity) trial randomized 17,604 participants ≥45 years of age with a body mass index ≥27 kg/m2 with established CV disease but without diabetes to once-weekly subcutaneous semaglutide 2.4 mg or placebo; the mean trial duration was 3.3 years. Adjudicated causes of all deaths, COVID-19 cases, and associated deaths were captured prospectively. RESULTS Of 833 deaths, 485 (58%) were CV deaths, and 348 (42%) were non-CV deaths. Participants assigned to semaglutide vs placebo had lower rates of all-cause death (HR: 0.81; 95% CI: 0.71-0.93), CV death (HR: 0.85; 95% CI: 0.71-1.01), and non-CV death (HR: 0.77; 95% CI: 0.62-0.95). The most common causes of CV death with semaglutide vs placebo were sudden cardiac death (98 vs 109; HR: 0.89; 95% CI: 0.68-1.17) and undetermined death (77 vs 90; HR: 0.85; 95% CI: 0.63-1.15). Infection was the most common cause of non-CV death and occurred at a lower rate in the semaglutide vs the placebo group (62 vs 87; HR: 0.71; 95% CI: 0.51-0.98). Semaglutide did not reduce incident COVID-19; however, among participants who developed COVID-19, fewer participants treated with semaglutide had COVID-19-related serious adverse events (232 vs 277; P = 0.04) or died of COVID-19 (43 vs 65; HR: 0.66; 95% CI: 0.44-0.96). High rates of infectious deaths occurred during the COVID-19 pandemic, with less infectious death in the semaglutide arm, and resulted in fewer participants in the placebo group being at risk for CV death. CONCLUSIONS Compared to placebo, patients treated with semaglutide 2.4 mg had lower rates of all-cause death, driven similarly by CV and non-CV death. The lower rate of non-CV death with semaglutide was predominantly because of fewer infectious deaths. These findings highlight the effect of semaglutide on mortality across a broad population of patients with CV disease and obesity. (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity [SELECT]; NCT03574597).
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Telerehabilitation improves cardiorespiratory and muscular fitness and body composition in older people with post-COVID-19 syndrome.
Pleguezuelos, E, Del Carmen, A, Moreno, E, Serra-Prat, M, Serra-Payá, N, Garnacho-Castaño, MV
Journal of cachexia, sarcopenia and muscle. 2024;(5):1785-1796
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BACKGROUND The effects of post-coronavirus disease 2019 (COVID-19) syndrome on the cardiorespiratory and muscular fitness in older people are of utmost relevance. This study aimed to evaluate the effects of a 12-week telerehabilitation programme on cardiorespiratory and muscular fitness and body composition in older patients with post-COVID-19 syndrome. METHODS One hundred twenty older patients with post-COVID-19 syndrome were randomly assigned to one of two groups: patients who carried out the telerehabilitation programme (n = 60; age: 65.0 ± 5.2; female: 14.2%) and a control group (n = 60; age: 64.3 ± 5.0; female: 24.5%). An incremental cardiopulmonary exercise testing, isokinetic strength test, and bioelectrical impedance analysis were performed to compare cardiorespiratory and muscle strength responses and body composition between telerehabilitation and control groups. RESULTS A significant increase in the cardiopulmonary exercise testing duration was found in the telerehabilitation group compared to the control group (mean difference = 88.9 s, P = 0.001). Peak oxygen uptake increased in the telerehabilitation group (mean difference = 3.0 mL·kg-1·min-1, P < 0.001) and control group (mean difference = 1.9 mL·kg-1·min-1, P < 0.001). Power output in cycle ergometer (mean difference = 25.9 watts, P < 0.001), fat free mass (mean difference = 2.1 kg, P = 0.004), soft lean mass (mean difference = 2.1 kg, P = 0.003), and skeletal muscle mass (mean difference = 1.4 kg, P = 0.003) only increased in the telerehabilitation group. A significant increase in the power output was observed in the telerehabilitation group compared with the control group in both lower limbs after isokinetic strength test of the leg extension at a speed of 60° (right: mean difference = 18.7 watts, P = 0.012; left: mean difference = 15.3 watts, P = 0.010). The peak torque of right leg extension increased only in the telerehabilitation group after isokinetic strength test at a speed of 60° (mean difference = 13.1 N·m, P < 0.001). A significant increase in the power output was observed in the telerehabilitation group compared with the control group in the left leg extension after isokinetic strength test at a speed of 180° (mean difference = 30.2 watts, P = 0.003). CONCLUSIONS The telerehabilitation programme improved cardiorespiratory and muscular fitness, and body composition in older patients with post-COVID-19 syndrome to a greater extent than a control group. The telerehabilitation programmes may be an alternative to improve the sequelae of post-COVID-19 syndrome in older patients.
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Evaluation of the efficacy of N-acetylcysteine and bromhexine compared with standard care in preventing hospitalization of outpatients with COVID-19: a double blind randomized clinical trial.
Eslami Ghayour, A, Nazari, S, Keramat, F, Shahbazi, F, Eslami-Ghayour, A
Revista clinica espanola. 2024;(2):86-95
Abstract
INTRODUCTION AND AIM Since its emergence in December 2019, the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 has become a global emergency, spreading rapidly worldwide. In response to the early referral of these patients to outpatient health centers, we decided to seek more effective treatments in the early stages of their referral. This study aims to prevent both the progression and deterioration of the physical conditions of COVID-19 patients, reduce the rate of referrals, and mitigate the risks of hospitalization and death. MATERIAL AND METHODS Conducted at Dibaj Therapeutic Center, Hamadan City, Iran, a double-blind randomized controlled trial encompassed 225 COVID-19 patients from April to September 2022. Ethical approval was obtained from Hamadan University of Medical Sciences (Approval No.: IR.UMSHA.REC.1400.957), with the protocol registered in the Iranian Registry of Clinical Trials (Registration No. : IRCT20220302054167N1). In this study, we included patients who tested positive for COVID-19- PCR and were symptomatic, excluding those who were pregnant or had received a COVID-19 vaccine. Patients with oxygen saturation above 92% were allocated to three groups: Group A received N-acetylcysteine, Group B received Bromhexine, and Group C received standard care. Follow-ups on oxygen levels, symptoms, and hospitalization needs were conducted on days 7 and 14, with hospitalized patients monitored for one month post-hospitalization. RESULTS The study found that both N-acetylcysteine and Bromhexine can effectively reduce hospitalization rates and mortality and shorten the duration of hospitalization. The third visit of patients who received N-acetylcysteine showed an increase of 1.33% in oxygen saturation compared to their first visit, and in patients who received Bromhexine, this increase was 1.19%. The mortality rate was 9.33% in the control group and zero in both groups of patients who received medication. CONCLUSION In conclusion, the results of this study indicate that NAC and bromhexine may be effective in the treatment of patients with positive COVID-19, with a lower hospitalization rate, shorter hospitalization, faster recovery time, and reduced mortality compared to the control group.
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The Effect of Education and Art Therapy with Telehealth Method on Diet-Fluid Restriction and Anxiety in Hemodialysis Patients During the Covid-19 Pandemic.
Mollaoğlu, M, Candan, F, Solmaz, G, Mollaoğlu, S, Başer, E, Yanmiş, S
Alternative therapies in health and medicine. 2024;(7):58-64
Abstract
OBJECTIVES This study was conducted to evaluate the effect of telehealth education and art therapy on diet-fluid restriction and anxiety in hemodialysis patients during the COVID-19 pandemic. METHODS This randomized controlled study included 60 hemodialysis patients (30 in the intervention group and 30 in the control group). Data were collected using the Patient Information Form, Dialysis Diet and Fluid Non-Adherence Questionnaire, Beck Anxiety Inventory, and Modified Morisky Scale. Patients were educated about diet and fluid restriction according to their needs. The forms were applied to the patients at the first interview 6th week, and 12th week. Additionally, training on diet and fluid restriction was given at the first meeting, and an educational booklet was distributed to the patients. Thereafter, the patients were video-called one day a week for 12 weeks and the follow-up evaluation form was applied via telephone. The academician, who works at the University's Faculty of Education, Department of Fine Arts, assisted patients in drawing via video conference. Patients' drawing time is 60 minutes in total, two days a week, 30 minutes each time. RESULTS Following the education and drawing activity, systolic blood pressure, diastolic blood pressure, hemodialysis admission weight, creatinine values, frequency and degree of dietary non-compliance, frequency of non-compliance with fluid restriction, and anxiety levels of patients in the intervention group receiving hemodialysis treatment decreased (P < .05) and their compliance with treatment increased. CONCLUSION Telehealth applications and art therapy are effective in improving compliance with diet and fluid restriction and controlling anxiety among hemodialysis patients. Since the use of telehealth methods to meet the educational needs of patients and integrative methods such as art therapy ensures the continuity of care services for patients during epidemic periods, it is recommended to be used in COVID-19 and other possible epidemics in the future.
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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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Effects of supplementation with low-dose group B vitamins on clinical and biochemical parameters in critically ill patients with COVID-19: a randomized clinical trial.
Majidi, N, Bahadori, E, Shekari, S, Gholamalizadeh, M, Tajadod, S, Ajami, M, Gholami, S, Shadnoush, M, Ahmadzadeh, M, Dehnadi Moghadam, A, et al
Expert review of anti-infective therapy. 2024;(7):579-585
Abstract
BACKGROUND : This study aimed to check the effect of supplementation with low-dose group B vitamins on clinical and biochemical parameters on patients with coronavirus disease 2019 (COVID-19). RESEARCH DESIGN AND METHOD : This double-blind, randomized clinical trial was carried out on 85 critically ill patients with COVID-19. All patients received high protein prescriptions of 30 kcal/kg/d by enteral nutrition. The intervention group (n = 40) received vitamin B complex, including thiamine (10 mg), riboflavin (4 mg), nicotinamide (40 mg), and dexpanthenol (6 mg). The control group received similar nutritional supports, except for group B vitamins. Assessments were carried out at baseline and after 2 weeks of intervention. RESULTS : Vitamin B supplementation had no effects on the biochemical and pathological parameters including kidney function, arterial blood gas parameters, Glasgow coma scale, cell blood count, and serum electrolytes of the intervention group compared with the control group. The 30-day mortality was insignificantly lower in the intervention group than in the control group (83.3% against 96.1%, P = 0.07). CONCLUSIONS The mortality rate of patients with COVID-19 might be improved by low-dose vitamin B supplementation.
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Efficacy of povidone-iodine nasal rinse and mouth wash in COVID-19 management: a prospective, randomized pilot clinical trial (povidone-iodine in COVID-19 management).
Alsaleh, S, Alhussien, A, Alyamani, A, Alhussain, F, Alhijji, A, Binkhamis, K, Khan, A, Javer, A, Alshahrani, FS
BMC infectious diseases. 2024;(1):271
Abstract
OBJECTIVES/HYPOTHESIS To assess the efficacy of 0.23% povidone-iodine (PVP-I) nasal rinses and mouth washes on detectability of the coronavirus disease 2019 (COVID-19) virus and cycle threshold (Ct) values in nasopharyngeal swabs. STUDY DESIGN This was an open-label, prospective, randomized, placebo-controlled clinical trial. SETTING The study was conducted in King Saud University Medical City, Riyadh, Saudi Arabia, from August 2021 to July 2022. METHODS Participants diagnosed with SARS-CoV-2 were randomly assigned to one of three groups, with participants receiving either 0.23% PVP-I, 0.9% normal saline (NS) nasal rinses and mouth washes, or no intervention (control group). Nasopharyngeal swabs were taken 4, 8, 12, and 18 days after the first swab to measure the detectability of the virus and the Ct. RESULTS A total of 19 participants were involved in this study. The mean viral survival was 9.8, 12, and 12.6 days for the PVP-I, NS, and control groups, respectively, with a statistically significant difference (p = 0.046). The Ct mean values were 23 ± 3.4, 23.5 ± 6.3, and 26.3 ± 5.9 at the time of recruitment and 25.2 ± 3.5, 15 ± 11.7, and 26.9 ± 6.4 after 4 days for the PVP-I, NS, and control groups, respectively. CONCLUSIONS When used continuously at a concentration of 0.23%, PVP-I showed promising results in terms of decreasing the pandemic burden by reducing the period of infectiousness and viral load. However, the use of PVP-I did not result in significantly different changes in the quality-of-life parameters in recently vaccinated and mild COVID-19 patients.
