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Methods | pneumonia | PNEUMONIA | We performed a randomized, placebo-controlled, clinical trial in a tertiary hospital (NCT05184205). Patients with a positive SARS-CoV-2 PCR in the last 48 hours were recruited and aleatorily assigned to PDT or placebo. Patients with pneumonia were excluded. Participants and investigators were masked to group assignment... | PMC9905247 |
Findings | infection | ADVERSE EVENTS, INFECTION, DECAY | Patients were recruited between December 2021 and February 2022. Most were previously healthy adults vaccinated against COVID-19 and most carried Omicron variant. 38 patients were assigned to placebo and 37 to PDT. Intranasal PDT reduced infectivity at day 3 post-treatment when compared to placebo with a β-coefficient ... | PMC9905247 |
Interpretation | Intranasal-PDT is safe in pauci-symptomatic COVID-19 patients, it reduces SARS-CoV-2 infectivity and decelerates the decline SARS-CoV-2 specific immune-responses. | PMC9905247 | ||
Introduction | COLD | The COVID-19 pandemic has affected humans of all ages and conditions across the globe (Non-Pharmaceutical Interventions (NPI) including face masks, social distancing, individual isolation or lockdowns have shown to be effective in reducing the reproduction number (R) of SARS-CoV-2 (Intranasal photodynamic therapy (PDT)... | PMC9905247 | |
Methods | PMC9905247 | |||
Study design | This study consisted of a single centre, randomized, placebo-controlled, single-blind, clinical trial of methylene blue-based PDT in SARS-CoV-2 positive individuals. We aimed to evaluate safety, efficacy, and antiviral immune responses.Every participant was informed about the rationale and the characteristics of the st... | PMC9905247 | ||
Patients | allergic reactions | ALLERGIC REACTION | Participants were recruited from the University of Navarra COVID19 Program (Inclusion criteria included to be over 18 years-old and to have a positive SARS-CoV-2 PCR (<27 cycles) in the last 48 hours. Concomitant medications except angiotensin receptor blockers or immunosuppressant agents were allowed. All patients con... | PMC9905247 |
Randomisation, controlling and masking | Participants were randomly assigned to PDT or placebo group (1:1). The investigator who performed randomization did not apply treatments nor collected biological samples. Participants and investigators assessing outcomes were masked to group assignment.The control treatment was performed using saline solution and a sha... | PMC9905247 | ||
Procedures | NPS, Ondine | Photodynamic treatment was performed using the CE-marked Steriwave™ Nasal Photodisinfection System (NPS, SW4000, Ondine Biomedical Inc, Vancouver, BC, Canada). This is a Class II Medical Device that includes a power source, a Nasal Light Illuminator (NLI) and a methylene blue formulation (MBF) approved in Canada and Eu... | PMC9905247 | |
Outcomes | The primary study outcome was infectivity reduction after 3 days of treatment. Because prior works had demonstrated variable PCR response to viral killing due to genomic remnants still permitting primer binding ( | PMC9905247 | ||
Clinical follow-up | Patients were asked about COVID-19 symptoms on the baseline visit, and at day 3 and 7. The list of symptoms was based on previous studies ( | PMC9905247 | ||
Safety analysis | To evaluate safety, immediate and delayed local effects were collected and evaluated. The severity of these and the likelihood of being treatment-related were also noted. The safety questions were asked immediately after treatment and at each subsequent visit. | PMC9905247 | ||
Covariates | Covid-19 infection | Covariates collected included gender, age, COVID-19 vaccination and booster doses, previous Covid-19 infection, weight, height and vital signs such as body temperature, heart rate, blood pressure and blood oxygen saturation. | PMC9905247 | |
Statistical analysis | The sample size calculation was performed based on differences found in the pre- and post-intervention delta-Ct of a preliminary To compare quantitative variables Mann-Whitney U test was performed for those that did not follow normality and Student t test for those that did. Wilcoxon test was performed when paired samp... | PMC9905247 | ||
infection | LYSED, INFECTION | Monolayers of Vero-E6 cells were grown to confluence on 96-well plates and infected with the patients’ samples previously diluted 1:2 with infection medium (Minimum Essential Medium -MEM with 0.2% BSA 0.2%, 2mM glutamine and 20 mM Hepes) and incubated for 4 h at 37°C. After removing the inoculum, Eagle’s MEM with 10% f... | PMC9905247 | |
Specific anti-SARS-CoV-2 humoral and cellular responses | To analyse the participant´s serological response, a blood draw was performed 10 and 20 weeks after entering the clinical trial. Anti-SARS-CoV-2 antibody detection was performed using four commercial chemiluminescence tests. First, quantification of total antibodies (IgG+IgM) against the receptor binding domain of SARS... | PMC9905247 | ||
Sequencing analysis of COVID-19 variants | Libraries were prepared from swab samples using COVIDSeq Assay, (Illumina) and sequenced using a NextSeq2000 (Illumina). Analyses were performed with Kraken (Illumina). The phylogenetic tree was performed with Nextclade.org. | PMC9905247 | ||
Results | PDT-treated, itching, chest tightness, headache | ADVERSE EVENTS, REINFECTION OF, SARS-COV-2 INFECTION, RECRUITMENT | Seventy-nine patients were screened between December 2021, and February 2022. One was excluded for not meeting the inclusion criteria. Of the 78 patients randomized 1:1, two patients abandoned the treatment group (one for local irritation, the other for personal reasons), and one patient abandoned the placebo group (fo... | PMC9905247 |
Discussion | infection, infectious, SARS-CoV-2 infection, otherwise-healthy | VIRUS, SARS-COV-2 INFECTION, ASYMPTOMATIC SARS-COV-2 INFECTION, RECRUITMENT, INFECTION | A 3-day treatment with intranasal PDT can reduce SARS-CoV-2 infectivity and induce specific T-cell responses in COVID-19 patients. When applied in early stages of SARS-CoV-2 infection, local decolonization of nasal passages could be clinically relevant for the inhibition of viral spread both from person to person and f... | PMC9905247 |
Conclusion | ADVERSE EFFECTS | PDT treatment was well tolerated, and no serious adverse effects were detected. Nasal PDT enhances SARS-CoV-2 viral clearance in mild COVID-19 patients, even in vaccinated individuals, rapidly decreasing infectivity. Nasal PDT decelerates the decline of SARS-CoV-2 specific T-cell immune responses in vaccinated individu... | PMC9905247 | |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC9905247 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the Institutional Review Board of the University of Navarra (registry number: EC_2021/1). The patients/participants provided their written informed consent to participate in this study. | PMC9905247 | ||
Author contributions | MR, JP, MP | JA, FC-T and AF-M conceived the study, designed the protocol, submitted the requested changes the Institutional Board Review for its approval, organized the field work, discussed the results, and wrote the manuscript. JK helped on the trial design. AF-M recruited and randomized the patients. JZ, MP-S, LM-N, NM-R, MP, M... | PMC9905247 | |
Acknowledgments | Ondine | ANDERSEN, CROSS | We acknowledge Carolyn Cross, Nicolas Loebel and Roger Andersen from Ondine Biomedical Inc. for the funding of the project and the respect for our independence in the design of the trial, the timing and the evaluation. We thank the scientific inputs from Prof. Trevor Jones along the months of preparation, consecution, ... | PMC9905247 |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9905247 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9905247 | ||
Supplementary material | ADVERSE EFFECTS | The Supplementary Material for this article can be found online at: Antibody assays.Click here for additional data file.T Cell immunity assays.Click here for additional data file.Phylogeny of viral species from patients’ samples.Click here for additional data file.Local ENT adverse effects during the clinical trial.Cli... | PMC9905247 | |
References | PMC9905247 | |||
Introduction | diabetic dyslipidemia, Dyslipidemia, diabetes | PATHOGENESIS, DYSLIPIDEMIA, DIABETES | Dyslipidemia is an imbalance of lipids, especially cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides [On the other hand, Adipolin, assigned with the alias names CTRP12, FAM132A, and C1QTNF12, is a novel adipokine with anti-inflammatory and insulin-... | PMC10717816 |
Material and methods | PMC10717816 | |||
Participants | In this study, 80 subjects were assessed based on the eligibility criteria. In addition, among these 80 subjects, 20 individuals were excluded (Fig. | PMC10717816 | ||
The protocol of the blinding and randomization | The sample size was estimated at 15% alpha levels of 0.05 and 85% power. In this study, we assessed that 60 individuals (each group 15) would be required to recognize the difference between each group. In this study, the analyzer, statistician, expert assistant, trainer, and expert physiologist were blinded to the enti... | PMC10717816 | ||
Study design | DIABETIC DYSLIPIDEMIA | In this study, we performed a controlled clinical trial, single-blinding, randomized, prospective, and pre–post-intervention study to assess 8 weeks of combined training and 500 mg propolis supplement consumption in women with Diabetic dyslipidemia [Dietary intakeOn the other hand, we predicted binding affinity numerat... | PMC10717816 | |
In silico network analysis | T2D, T2DM, dyslipidemia | TYPE 2 DIABETES, PATHOGENESIS, DYSLIPIDEMIA | To signify principal genes involved in type 2 diabetes (T2D) pathogenesis along with dyslipidemia and define the hub genes with significant differential expression in T2D conditions, we analyzed genes expression of microarray dataset, GSE156993, in adults with type 2 diabetes using the Bioconductor-based on Limma packa... | PMC10717816 |
Virtual screening and docking methods | Based on bioinformatics analysis and enrichment tools, we manifested that ADIPOQ and IL-6 are cut-point nodes in the hub genes network and could be druggable drug design and treatment candidates. Accordingly, we browsed the UniProt database [The molecular docking method was conducted in the PyRx software to determine s... | PMC10717816 | ||
Consumption of propolis | The subjects who received the propolis supplementation were blinded to the individual grouping. Each dosage of the propolis supplementation contained 500 mg in the form of capsules [ | PMC10717816 | ||
Exercise training protocol | The exercise training protocol was performed in 3 sessions/week for 8 weeks. It should be noted that the supplement and placebo groups did not participate in any exercise training during the study period. The combined training protocol included 30–50 min of aerobic training (50–70% Vo2Moreover, resistance training cons... | PMC10717816 | ||
Biochemical index measurement | BLOOD, COLD | The blood collection was conducted at the beginning and end of this trial. It should be noted that the participants were fasted for 12 h before blood taking. 10 mL of peripheral blood was collected from each patient; blood samples were submitted to a laboratory for medical diagnosis using the following safety precautio... | PMC10717816 | |
Statistical analysis | We estimated the sample size based on an alpha level of 0.05 and 85% power. Furthermore, based on the analysis, 60 cases (each group of 15) were required to analyze the difference between each group. Moreover, data analysis was performed by repeated measures ANOVA followed by Tukey's post hoc for between-group comparis... | PMC10717816 | ||
Results | PMC10717816 | |||
Protein–protein network construction and social network analysis | diabetic, dyslipidemia | DYSLIPIDEMIA | In this bioinformatics study, the microarray dataset analysis of adult diabetic patients with dyslipidemia showed that among 1812 genes with significant differential expression threshold Protein–protein network construction and social network analysis. Functional and molecular signaling pathway enrichment analysis. | PMC10717816 |
Virtual screening of binding affinity between proteins and ligands | Based on the PPIs network analysis of hub genes, we predicted ADIPOQ and IL-6 as cut-point nodes and suitable genes/proteins for affecting the network function. According to these data, molecular docking was conducted to estimate binding affinity between ADIPOQ and IL-6 as macromolecules and bioactive compounds derived... | PMC10717816 | ||
The antioxidative system was modified by physical activity and supplementation | diabetic | DYSLIPIDEMIA | We found that the SOD and TAC concentration was upregulated, and MDA concentration was down-regulated after receiving the propolis supplement (SUPP group) compared to before the propolis supplement (Fig. Combined training and propolis supplement altered the antioxidative markers in diabetic women with dyslipidemia. | PMC10717816 |
Physical activity and supplementation improved CTRP-12, SFRP5, and the IL-6 concentration | inflammation, diabetic | INFLAMMATION, DYSLIPIDEMIA | Based on our data, the serum concentrations of CTRP-12 and SFRP5 were increased after consumption of the propolis supplement (SUPP group) compared to before receiving the supplement (Fig. Alteration of the anti-inflammation activity and inflammation status in diabetic women with dyslipidemia. | PMC10717816 |
Discussion | T2D, glucose intolerance, diabetic dyslipidemia, weight gain, heart ischemia, dyslipidemia, hypertension, diabetes | GLUCOSE INTOLERANCE, OBESE, HYPERTENSION, PROLIFERATION, DISEASES, DIABETES, INSULIN RESISTANCE, METABOLIC DISORDERS, OXIDATIVE STRESS, TYPE 2 DIABETES, PATHOGENESIS, INSULIN SENSITIVITY, DYSLIPIDEMIA | In this study, we evaluated the effect of the combined exercise training protocol (aerobic and resistance training) along with consumption of the 500 mg propolis on the MDA, SOD, TAC, CTRP12, SFRP5 (as anti-inflammation agents), and IL-6 concentration in diabetic dyslipidemia status in adult women. Here, we indicated t... | PMC10717816 |
Conclusion | diabetic, dyslipidemia, diabetes | CARDIOVASCULAR DISEASES, OTHER METABOLIC DISORDERS, DYSLIPIDEMIA, METABOLIC DISORDERS, COMPLICATIONS, DIABETES | Based on bioinformatics, chemoinformatics, and molecular assessment, we suggest effective compounds of propolis and recommended exercise protocol might be an effective natural complementary medicine for progressive metabolic disorders' prevention, management, and therapeutic strategies such as diabetes, dyslipidemia, c... | PMC10717816 |
Acknowledgements | We thank our colleagues for their association and helpful discussions in this study. | PMC10717816 | ||
Author contributions | SAH, FM | FM and FT did the study's design, and FM performed experiments. Analyses and data mining were performed by FM, KJD, and SAH. The manuscript was written by FM, KJD, and SAH and was approved by FT. | PMC10717816 | |
Funding | There was no funding to support this study. | PMC10717816 | ||
Availability of data and materials | All raw data and materials in the Islamic Azad University Isfahan (Khorasgan) branch are available upon request. | PMC10717816 | ||
Declarations | PMC10717816 | |||
Ethics approval and consent to participate | All procedures were conducted following the research ethics committees of the Islamic Azad University Isfahan (Khorasgan) branch (IR.IAU.KHUISF.REC.1400.265). Furthermore, this study was registered in the Iranian Registry of Clinical Trials; IRCT code: IRCT20211229053561N1. Registered 26 January 2022, | PMC10717816 | ||
Consent for publication | All authors support submission to this journal. | PMC10717816 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10717816 | ||
References: | PMC10717816 | |||
KEYWORDS | PMC10269734 | |||
INTRODUCTION | coronavirus disease, human immunodeficiency virus protease ( | CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has caused the coronavirus disease (COVID-19) pandemic, has been a global health concern since its identification in December 2019 (Nelfinavir is an orally administered inhibitor of human immunodeficiency virus protease ( | PMC10269734 |
RESULTS | dysgeusia, anosmia, diarrhea | ADVERSE EVENT, ADVERSE EVENT, CORONAVIRUS, RESOLUTION, SEVERE ACUTE RESPIRATORY SYNDROME | During the study, 127 patients were assessed for eligibility, and 123 were randomly assigned to the study arms: 63 in the nelfinavir group and 60 in the control group (Flowchart of the study patients. Analysis sets: intention-to-treat (ITT) population, all randomly assigned patients; safety analysis set (SAS) and full ... | PMC10269734 |
DISCUSSION | nausea, SARS-CoV-2 infection, diarrhea | DISEASE PROGRESSION, SARS-COV-2 INFECTION, ADVERSE EVENTS, SECONDARY, ADVERSE EVENT | In this exploratory, randomized, controlled clinical trial, compared with standard-of-care alone, nelfinavir combined with standard-of-care treatment did not significantly reduce the time to clearance of SARS-CoV-2. Analyses of the secondary endpoints, viral load, and COVID-19-related symptoms indicated similar results... | PMC10269734 |
MATERIALS AND METHODS | PMC10269734 | |||
Study design and ethical considerations. | This was a prospective, randomized, open-label, blinded-endpoint, parallel-group trial conducted between July 2020 and October 2021 at 11 universities and teaching hospitals in Japan. The study was conducted in accordance with the Declaration of Helsinki and compliance with Good Clinical Practice and other applicable r... | PMC10269734 | ||
Study population. | diarrhea, inadequate hepatic or renal function | POORLY CONTROLLED DIABETES MELLITUS | The study design has been previously reported (Patients were excluded if they had a history of SARS-CoV-2 vaccination or if they wished to receive vaccination during the study period. Other exclusion criteria were as follows: (i) onset of symptoms ≥8 days before enrollment; (ii) oxygen saturation measured by pulse oxim... | PMC10269734 |
Study arms. | This study consisted of a 14-day treatment period and a 14-day follow-up period. Before starting the treatment period, patients were randomly assigned in a 1:1 ratio to receive nelfinavir combined with standard-of-care, or standard-of-care alone. Random and concealed allocation was implemented using an interactive web ... | PMC10269734 | ||
Outcomes. | cough, COVID-19-related symptoms, dyspnea, headache | INFECTIOUS DISEASES, SECONDARY, ADVERSE EVENT | From the beginning of the treatment (day 1) to the end of the follow-up period (day 28), saliva samples were obtained from patients once daily, and viral load was measured only using quantitative RT-PCR at the National Institute of Infectious Diseases (Tokyo, Japan). Furthermore, patients kept a daily diary to record t... | PMC10269734 |
Viral genome sequencing. | RNA was extracted from the saliva samples exhibiting Cp of <31 in quantitative RT-PCR of SARS-CoV-2. cDNA synthesis, multiplex PCR, and Illumina library prep (Illumina K.K., Tokyo, Japan) were performed as described previously ( | PMC10269734 | ||
Statistical analysis. | SECONDARY | Details of sample size calculation were explained in the previous article (Baseline characteristics were expressed as mean ± standard deviation (SD) or number with a percentage. Following the CONSORT guidelines (We estimated the time to viral clearance using the Kaplan-Meier survival curves for each treatment group. Fo... | PMC10269734 | |
Data availability. | The data that support the findings of this study are available from the corresponding author upon special request. | PMC10269734 | ||
ACKNOWLEDGMENTS | We thank all patients who participated in this study and their families. We also thank the clinicians, investigators, technicians, and clinical research coordinators who collaborated in this study. The collaborators are listed in the supplemental material.This work was supported by the Japanese Ministry of Health, Labo... | PMC10269734 | ||
REFERENCES | PMC10269734 | |||
Key Points | PMC9898821 | |||
Question | UNCONTROLLED HYPERTENSION | Is a telephone coaching and blood pressure self-monitoring intervention effective in reducing blood pressure compared with usual care among young adults with uncontrolled hypertension? | PMC9898821 | |
Findings | In this randomized clinical trial of 316 participants, the intervention did not demonstrate a significant difference in systolic or diastolic blood pressures at 6 or 12 months between the intervention and control groups; however, both groups experienced blood pressure reduction. Compared with the control group, partici... | PMC9898821 | ||
Meaning | Hypertension | UNCONTROLLED HYPERTENSION, HYPERTENSION | In this study, intervention participants did not experience a significant difference in blood pressure reduction when compared with control participants but did demonstrate behavior changes.This randomized clinical trial evaluates the effect of the My Hypertension Education And Reaching Target (MyHEART) intervention, a... | PMC9898821 |
Importance | UNCONTROLLED HYPERTENSION | Uncontrolled hypertension (ie, a 24-hour ambulatory systolic blood pressure of ≥130 mm Hg and diastolic blood pressure of ≥80 mm Hg or clinic systolic blood pressure of ≥140 mm Hg and diastolic blood pressure of ≥90 mm Hg) in young adults is a US public health burden. | PMC9898821 | |
Objective | To evaluate the effect of a telephone coaching and blood pressure self-monitoring intervention compared with usual care on changes in systolic and diastolic blood pressures and behaviors at 6 and 12 months. | PMC9898821 | ||
Design, Setting, and Participants | UNCONTROLLED HYPERTENSION | This randomized clinical trial included male and female participants aged 18 to 39 years with uncontrolled hypertension confirmed by 24-hour ambulatory blood pressure testing. This was a geographically diverse, multicentered study within 2 large, Midwestern health care systems. Data were collected from October 2017 to ... | PMC9898821 | |
Interventions | hypertension, Hypertension | HYPERTENSION, HYPERTENSION | The My Hypertension Education and Reaching Target (MyHEART) intervention consisted of telephone coaching every 2 weeks for 6 months, with home blood pressure monitoring. Control participants received routine hypertension care. | PMC9898821 |
Main Outcomes and Measures | hypertension | SECONDARY, HYPERTENSION | The co-primary clinical outcomes were changes in 24-hour ambulatory and clinic systolic and diastolic blood pressure at 6 and 12 months. The secondary outcomes were hypertension control (defined as ambulatory systolic blood pressure <130 mm Hg and diastolic blood pressure <80 mm Hg or clinic systolic blood pressure <14... | PMC9898821 |
Results | A total of 316 participants were randomized (159 to the control group and 157 to the intervention group) from October 2017 to December 2020. The median (IQR) age was 35 (31-37) years, 145 of 311 participants (46.6%) were female, and 166 (53.4%) were male; 72 (22.8%) were Black, and 222 (70.3%) were White. There were no... | PMC9898821 | ||
Conclusions and Relevance | UNCONTROLLED HYPERTENSION | The MyHEART intervention did not demonstrate a significant change in systolic or diastolic blood pressures at 6 or 12 months between study groups; however, both study groups had an appreciable reduction in blood pressure. Intervention participants had a significant reduction in dietary sodium intake, increased physical... | PMC9898821 | |
Trial Registration | ClinicalTrials.gov Identifier: | PMC9898821 | ||
Introduction | hypertension, Hypertension | HYPERTENSION, HYPERTENSION | More than 10 million individuals aged 18 to 39 years (1 in 5 men; 1 in 6 women) have hypertension,Prior to the My Hypertension Education and Reaching Target (MyHEART) program, there were limited clinical trials dedicated to young adults and hypertension control. Previously, trials predominantly targeted adults aged 50 ... | PMC9898821 |
Methods | PMC9898821 | |||
Trial Design | RECRUITMENT | This multicenter randomized clinical trial was designed to support recruitment of a geographically and racially and ethnically diverse group of young adults. Additional details of the rationale and study design has been previously published. | PMC9898821 | |
Study Outcomes | hypertension, Hypertension | SECONDARY, HYPERTENSION, HYPERTENSION | The co-primary (clinical) outcomes were changes in systolic and diastolic BP after 6 and 12 months. The secondary clinical outcome was hypertension control at 6 and 12 months. Hypertension control was defined as 24-hour ambulatory BP (AMBP) of less than 130 mm Hg for systolic BP and less than 80 mm Hg for diastolic BP ... | PMC9898821 |
Participants | hypertension | HYPERTENSION | Participants were recruited between October 2017 and December 2020 from 2 large, Midwestern health care systems. Potential participants were identified using the electronic health record linked with the Wisconsin Collaborative for Health Quality (WCHQ) hypertension registry.Potential participants were mailed an introdu... | PMC9898821 |
Participant Enrollment and Randomization | Cancer | CANCER | Participants were eligible if the mean 24-hour AMBP was systolic 130 mm Hg or greater and/or diastolic 80 mm Hg or greater and/or the mean awake AMBP was a systolic 135 mm Hg or greater and/or diastolic 85 mm Hg or greater.The visit 2 assessment also included self-report of baseline medical history, social history (tob... | PMC9898821 |
Study Protocol | hypertension | HYPERTENSION | Intervention participants received up to 12 coaching calls (20 min/call), scheduled every 2 weeks for the first 6 months. Coaches were trained on self-determination theory and motivational interviewing. A random sampling of coaches’ calls was assessed with a fidelity checklist, and coaches were given feedback monthly w... | PMC9898821 |
Sample Size Estimation | reductions in systolic and diastolic BP | The power analysis used prior trials to determine clinically meaningful reductions in systolic and diastolic BP. | PMC9898821 | |
Statistical Analysis | The study analysis followed intention-to-treat principles. Continuous variables are described by mean (SD) and tested with analysis of covariance. Categorical variables are described by count (percentage) and tested with χAnalysis of covariance was run for the following outcomes: change in systolic and diastolic AMBP a... | PMC9898821 | ||
Results | PMC9898821 | |||
Recruitment and Participant Characteristics | As outlined in the study flow diagram, 6385 invitations were sent. After completion of preliminary study visits, 316 participants were randomized, with 157 to the intervention group and 159 to the control group. ( | PMC9898821 | ||
Study Recruitment and Randomization | PMC9898821 | |||
Retention and Adherence | After randomization, 57 intervention participants (36.3%) and 55 control participants (34.6%) were withdrawn, dropped out, or were lost to follow-up by the 6-month end point and an additional 14 intervention participants (8.9%) and 17 control participants (10%) by the 12-month end point. There were 86 intervention and ... | PMC9898821 | ||
Study Follow-up, Including Detailed Loss to Follow-up | AMBP indicates ambulatory blood pressure. | PMC9898821 | ||
Primary Results | A total of 316 participants (159 control and 157 intervention) were randomized. There was equal distribution of male (166 [52.5%]) and female (145 [45.9%]) participants; 72 (22.8%) were Black, and 222 (70.3%) were White. The median (IQR) age was 35 (31-37) years. The baseline mean (SD) 24-hour AMBPs were systolic 133.0... | PMC9898821 | ||
Summary of Baseline Characteristics of Intervention and Control Participants | Abbreviations: ASA24, Automated Self-Administered 24-hour; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); BP, blood pressure.Other race was a composite of the following self-reported races: American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific Islander,... | PMC9898821 | ||
Prespecified Secondary Outcomes | hypertension, Hypertension | HYPERTENSION, HYPERTENSION | Hypertension control improved in both groups throughout the study; however, there was no significant change comparing groups. Hypertension control using AMBP values of systolic BP less than 130 mm Hg and diastolic BP less than 80 mm Hg between study groups was achieved in 21 of 102 control participants (20.6%) and 20 o... | PMC9898821 |
Home Blood Pressure Monitoring Frequency | BLOOD | Abbreviation: NA, not applicable.Blood pressure monitoring frequency with Mann-Whitney-Wilcoxon | PMC9898821 | |
Health Coaching | The mean (SD) duration for health coaching calls was 19.8 (6.8) minutes. Participants who reached the 6-month study end point participated in more mean (SD) coaching calls compared with participants who did not (10.89 [2.81] vs 4.93 [4.14] of 12 total calls). The random sampling of coaches’ calls demonstrated the major... | PMC9898821 |
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