A Stress and Pain Self-management m-Health App for Adult Outpatients with Sickle Cell Disease (RADIANCE Study): Protocol for a Randomized Controlled Study (Preprint)

2021 ◽  
Author(s):  
Miriam O. Ezenwa ◽  
Yingwei Yao ◽  
Molly W. Mandernach ◽  
David A. Fedele ◽  
Robert J. Lucero ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Data Entry ◽  
Self Management ◽  
Opioid Use ◽  
Short Term ◽  
Self Monitoring ◽  
Randomized Controlled

BACKGROUND The purpose of this article is to describe the research protocol for a randomized controlled trial of a self-management intervention for adults diagnosed with sickle cell disease (SCD). People living with SCD suffer with lifelong recurrent episodes of acute and chronic pain, both of which are exacerbated by stress. OBJECTIVE The aims of this study are to decrease stress and improve SCD pain control with reduced opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Building on our prior findings of formative studies, this study is designed to test the efficacy of YCWS on stress intensity, pain intensity, and opioid use in adults with SCD. METHODS A randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on stress, pain, and opioid use will be conducted with 170 adults with SCD. Patients will be randomized based on a 1:1 ratio (stratified on pain intensity [<=5; >5]) to be either in the experimental (Self-monitoring of outcomes + alerts/reminders + use of YCWS [RDE + Support]) or control (Self-monitoring of outcomes + alerts/reminders) group. Patients will be asked to report outcomes daily. During weeks 1-8, patients in both groups will receive system-generated alerts/reminders via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the participant does not enter data after 24 hours, the study support staff will contact him/her for data entry troubleshooting (both groups) and YCWS use (experimental). We will time stamp and track patients' online activities to understand the study context and conduct exit interviews on the acceptability of system-generated and staff support. RESULTS The study was funded by the National Institute of Nursing Research of the National Institutes of Health in 2020. Our Institutional Review Board approved this study. Currently in the recruitment phase, the study began in March 2021 and will be concluded in June 2025. As of September 2021, we have enrolled 40 patients. We will analyze the data using the mixed-effects regression models (short-term, long-term) to account for the repeated measurements over time and utilize machine-learning to construct and evaluate prediction models. Due to the COVID-19 pandemic, the study was modified to allow for a mail-in consent process and a virtual consent process via email or Zoom video conference. CONCLUSIONS We expect that the intervention group will report reductions in pain intensity (primary outcome, 0-10 scale) and in stress intensity (0-10 scale) and opioid use, which are secondary outcomes. Our study will contribute to advancing the use of non-opioid therapy such as guided relaxation/distraction techniques for managing sickle cell pain. CLINICALTRIAL ClinicalTrials.gov NCT04484272

scholarly journals Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

2021 ◽  
Author(s):  
Ferdows Atiq ◽  
Jens van de Wouw ◽  
Oana Sorop ◽  
Ilkka Heinonen ◽  
Moniek P. M. de Maat ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Endothelial Dysfunction ◽  
Controlled Trial ◽  
Short Term ◽  
Randomized Controlled ◽  
Von Willebrand ◽  
Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

scholarly journals Short-Term Effects of PENS versus Dry Needling in Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle: A Randomized Controlled Trial

2020 ◽  
Vol 9 (6) ◽  
pp. 1665 ◽  
Author(s):  
Santiago Garcia-de-Miguel ◽  
Daniel Pecos-Martin ◽  
Tamara Larroca-Sanz ◽  
Beatriz Sanz-de-Vicente ◽  
Laura Garcia-Montes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Trigger Points ◽  
Mean Difference ◽  
Dry Needling ◽  
Short Term ◽  
Myofascial Trigger Points ◽  
Randomized Controlled

Procedures such as dry needling (DN) or percutaneous electrical nerve stimulation (PENS) are commonly proposed for the treatment of myofascial trigger points (MTrP). The aim of the present study is to investigate if PENS is more effective than DN in the short term in subjects with mechanical neck pain. This was an evaluator-blinded randomized controlled trial. Subjects were recruited through announcements and randomly allocated into DN or PENS groups. Pain intensity, disability, pressure pain threshold (PPT), range of motion (ROM), and side-bending strength were measured. The analyses included mixed-model analyses of variance and pairwise comparisons with Bonferroni correction. The final sample was composed of 44 subjects (22 per group). Both groups showed improvements in pain intensity (ηp2 = 0.62; p < 0.01), disability (ηp2 = 0.74; p < 0.01), PPT (ηp2 = 0.79; p < 0.01), and strength (ηp2 = 0.37; p < 0.01). The PENS group showed greater improvements in disability (mean difference, 3.27; 95% CI, 0.27–6.27) and PPT (mean difference, 0.88–1.35; p < 0.01). Mixed results were obtained for ROM. PENS seems to produce greater improvements in PPT and disability in the short term.

scholarly journals Effectiveness of Smartphone App–Based Interactive Management on Glycemic Control in Chinese Patients With Poorly Controlled Diabetes: Randomized Controlled Trial

10.2196/15401 ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. e15401 ◽  
Author(s):  
Lei Zhang ◽  
Xingxing He ◽  
Yun Shen ◽  
Haoyong Yu ◽  
Jiemin Pan ◽  
...  
Keyword(s):  
Glycemic Control ◽  
Controlled Trial ◽  
Chinese Patients ◽  
Self Management ◽  
Control Groups ◽  
Randomized Controlled ◽  
Management Group ◽  
Interactive Management ◽  
And Control

Background In recent years, the rapid development of mobile medical technology has provided multiple ways for the long-term management of chronic diseases, especially diabetes. As a new type of management model, smartphone apps are global, convenient, cheap, and interactive. Although apps were proved to be more effective at glycemic control, compared with traditional computer- and Web-based telemedicine technologies, how to gain a further and sustained improvement is still being explored. Objective The objective of this study was to investigate the effectiveness of an app-based interactive management model by a professional health care team on glycemic control in Chinese patients with poorly controlled diabetes. Methods This study was a 6-month long, single-center, prospective randomized controlled trial. A total of 276 type 1 or type 2 diabetes patients were enrolled and randomized to the control group (group A), app self-management group (group B), and app interactive management group (group C) in a 1:1:1 ratio. The primary outcome was the change in glycated hemoglobin (HbA1c) level. Missing data were handled by multiple imputation. Results At months 3 and 6, all 3 groups showed significant decreases in HbA1c levels (all P<.05). Patients in the app interactive management group had a significantly lower HbA1clevel than those in the app self-management group at 6 months (P=.04). The average HbA1c reduction in the app interactive management group was larger than that in the app self-management and control groups at both months 3 and 6 (all P<.05). However, no differences in HbA1c reduction were observed between the app self-management and control groups at both months 3 and 6 (both P>.05). Multivariate line regression analyses also showed that the app interactive management group was associated with the larger reduction of HbA1c compared with groups A and B at both months 3 and 6 (all P>.05). In addition, the app interactive management group had better control of triglyceride and high-density lipoprotein cholesterol levels at both months 3 and 6 compared with baseline (both P<.05). Conclusions In Chinese patients with poorly controlled diabetes, it was difficult to achieve long-term effective glucose improvement by using app self-management alone, but combining it with interactive management can help achieve rapid and sustained glycemic control. Trial Registration ClinicalTrials.gov NCT02589730; https://clinicaltrials.gov/ct2/show/NCT02589730.

scholarly journals Effectiveness of Smartphone App–Based Interactive Management on Glycemic Control in Chinese Patients With Poorly Controlled Diabetes: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Lei Zhang ◽  
Xingxing He ◽  
Yun Shen ◽  
Haoyong Yu ◽  
Jiemin Pan ◽  
...  
Keyword(s):  
Glycemic Control ◽  
Controlled Trial ◽  
Chinese Patients ◽  
Self Management ◽  
Control Groups ◽  
Randomized Controlled ◽  
Management Group ◽  
Interactive Management ◽  
And Control

BACKGROUND In recent years, the rapid development of mobile medical technology has provided multiple ways for the long-term management of chronic diseases, especially diabetes. As a new type of management model, smartphone apps are global, convenient, cheap, and interactive. Although apps were proved to be more effective at glycemic control, compared with traditional computer- and Web-based telemedicine technologies, how to gain a further and sustained improvement is still being explored. OBJECTIVE The objective of this study was to investigate the effectiveness of an app-based interactive management model by a professional health care team on glycemic control in Chinese patients with poorly controlled diabetes. METHODS This study was a 6-month long, single-center, prospective randomized controlled trial. A total of 276 type 1 or type 2 diabetes patients were enrolled and randomized to the control group (group A), app self-management group (group B), and app interactive management group (group C) in a 1:1:1 ratio. The primary outcome was the change in glycated hemoglobin (HbA<sub>1c</sub>) level. Missing data were handled by multiple imputation. RESULTS At months 3 and 6, all 3 groups showed significant decreases in HbA<sub>1c</sub> levels (all <italic>P</italic>&lt;.05). Patients in the app interactive management group had a significantly lower HbA<sub>1c</sub>level than those in the app self-management group at 6 months (<italic>P</italic>=.04). The average HbA<sub>1c</sub> reduction in the app interactive management group was larger than that in the app self-management and control groups at both months 3 and 6 (all <italic>P</italic>&lt;.05). However, no differences in HbA<sub>1c</sub> reduction were observed between the app self-management and control groups at both months 3 and 6 (both <italic>P</italic>&gt;.05). Multivariate line regression analyses also showed that the app interactive management group was associated with the larger reduction of HbA<sub>1c</sub> compared with groups A and B at both months 3 and 6 (all <italic>P</italic>&gt;.05). In addition, the app interactive management group had better control of triglyceride and high-density lipoprotein cholesterol levels at both months 3 and 6 compared with baseline (both <italic>P</italic>&lt;.05). CONCLUSIONS In Chinese patients with poorly controlled diabetes, it was difficult to achieve long-term effective glucose improvement by using app self-management alone, but combining it with interactive management can help achieve rapid and sustained glycemic control. CLINICALTRIAL ClinicalTrials.gov NCT02589730; https://clinicaltrials.gov/ct2/show/NCT02589730.

scholarly journals Safety and Efficacy of Ayurvedic Interventions and Yoga on Long Term Effects of COVID-19: a Structured Summary of a Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Babita Yadav ◽  
Amit Rai ◽  
Pallavi Suresh Mundada ◽  
Richa Singhal ◽  
BCS Rao ◽  
...  
Keyword(s):  
Exploratory Study ◽  
Controlled Trial ◽  
Primary Objective ◽  
Self Management ◽  
Intervention Period ◽  
Long Term Effects ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Objectives: Primary Objective• To assess the efficacy of Ayurveda interventions and Yoga in rehabilitation of COVID-19 cases suffering with long term effects of COVID 19 as compared to WHO Rehabilitation Self-Management after COVID-19- Related Illness.Secondary Objective• To assess the safety of Ayurvedic interventions in cases suffering with long term effects of COVID 19Trial design: Multi-centric, randomized, controlled, parallel group, open-label, exploratory study. The study duration is 9 months and the intervention period is 90 days from the day of enrolment of the participant.

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