SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

Abstract Background Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs). Methods In a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence. Results The 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m2, and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively. Conclusions A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout. Trial registration Registered at ClinicalTrials.gov NCT02741700

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A Randomized Controlled Trial to Reduce Lifestyle Related Risk Factors for Non-Communicable Diseases through Funeral Societies in Sri Lanka

Gestão e Sociedade ◽

10.21171/ges.v12i31.2287 ◽

2017 ◽

Vol 12 (31) ◽

pp. 2194-2212

Author(s):

Thushani Marie Elizabeth Dabrera ◽

Arunasalem Pathmeswaran ◽

Anuradhani Kasturirathna ◽

Gayani Tillekeratne ◽

Truls Østbye

Keyword(s):

Randomized Controlled Trial ◽

Sri Lanka ◽

Fruits And Vegetables ◽

Controlled Trial ◽

Communicable Diseases ◽

Control Group ◽

Control Groups ◽

Non Communicable Diseases ◽

Randomized Controlled ◽

Western Province

A cluster randomized controlled trial was conducted to change diet, physical activity, smoking and alcohol consumption among participants through funeral societies in the Western Province. Twenty one administrative subdivisions in the Ragama area were randomized into intervention and control groups. Ten administrative subdivisions in the North Western Province were selected as an additional control group. The primary outcome was change in the proportion of individuals who consumed 5 servings or more of fruits and vegetables per day. The study showed only a modest, not significant increase in the proportion of people consuming 5 servings of fruits and vegetables or more per day. Of the secondary outcomes assessed, their intake of green leaves and mean MET minutes spent on leisure activities increased significantly more in the intervention group than in the control groups, but the differences were small. To effectively reduce non-communicable diseases (NCD) in Sri Lanka, community-based organizations could be utilized to deliver prevention programs.

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Effects of Phase IV Pedometer Feedback Home-Based Cardiac Rehabilitation on Cardiovascular Functional Capacity in Patients With Myocardial Infarction: A Randomized Controlled Trial

International journal of basic science in medicine ◽

10.15171/ijbsm.2019.15 ◽

2019 ◽

Vol 4 (2) ◽

pp. 75-80

Author(s):

Mostafa Dehghani ◽

Mostafa Cheraghi ◽

Mehrdad Namdari ◽

Valiollah Dabidi Roshan

Keyword(s):

Myocardial Infarction ◽

Randomized Controlled Trial ◽

Cardiac Rehabilitation ◽

Functional Capacity ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

Randomized Controlled ◽

Home Based

Introduction: Pedometer feedback home-based cardiac rehabilitation (PFHCR) programs have been effective in augmenting exercise tolerance. Our aim was to investigate the effects of PFHCR on cardiovascular functional capacity in patients with myocardial infarction (MI).Methods: Forty MI patients were divided into two intervention and two control groups (n=10)in a randomized controlled trial. The intervention group received a PFHCR program including routine medications along with continuous exercise program, whereas the control group received traditional care without PFHCR. Baseline evaluations and cardiovascular stresses were controlled during the 8-week follow-up rehabilitation program in all patients. Data analysis was conducted using one-way ANOVA and paired sample student’s t-test (P ≤ 0.05).Results: At baseline, no significant differences were observed between the groups. After eight weeks of PFHCR, the intervention groups had significantly higher metabolic equivalent(P = 0.001), VO2max (P = 0.001), total exercise times (P = 0.001), and total distance traveled(P = 0.003) when compared with the control groups. However, no significant intra-group or inter-group differences in variables were observed between the men and women.Conclusion: Our results showed that PFHCR exhibited significant optimal effects on the cardiovascular functional capacity in MI patients.

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Acupuncture to Improve Symptoms for Stable Angina (AIMS-A): Study Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.14705 ◽

2019 ◽

Author(s):

Judith Schlaeger ◽

Hui Yan Cai ◽

Alana D. Steffen ◽

Veronica Angulo ◽

Adhir R. Shroff ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Stable Angina ◽

Controlled Trial ◽

Treatment Protocol ◽

Attention Control ◽

Chinese Patients ◽

Control Group ◽

Mcgill Pain Questionnaire ◽

Analgesic Effects ◽

Randomized Controlled

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834

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Doxycycline Combined With Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis: A Multicenter Randomized Controlled Trial

Circulation ◽

10.1161/circulationaha.121.055953 ◽

2021 ◽

Author(s):

Kai-ni Shen ◽

Wei-jun Fu ◽

Yu Wu ◽

Yu-jun Dong ◽

Zhong-xia Huang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Light Chain ◽

Controlled Trial ◽

Hazard Ratio ◽

Stage Ii ◽

Control Group ◽

Al Amyloidosis ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Background: Doxycycline was demonstrated in a retrospective study to be associated with greater survival in patients with light chain (AL) amyloidosis. Therefore, we prospectively compared the efficacy of bortezomib-cyclophosphamide-dexamethasone (CyBorD) and CyBorD combined with doxycycline for cardiac AL amyloidosis. Methods: This was a multicenter, open-label randomized controlled trial. Patients with Mayo 2004 stage II-III AL amyloidosis were included. Patients were randomized to doxycycline 100 mg twice daily along with 9 cycles of CyBorD (doxycycline group) or to 9 cycles of CyBorD alone (control group). The primary outcome was 2-year progression-free survival (PFS). PFS was defined as the time from randomization to death, hematologic progression or organ progression (heart, kidney or liver). Hematologic progression was defined based on substantial increase in free light chain. Increase in either N-terminal pro B-type natriuretic peptide or cardiac troponin was the main criterion for defining cardiac progression. Cardiac PFS, defined as the time from randomization to cardiac progression or death, was compared between groups in an exploratory analysis. The corresponding treatment hazard ratio was estimated using a Cox regression model. Results: 140 patients underwent randomization, with 70 in each group. The median age was 61 (range, 33-78) years with a male: female ratio of 1.75:1. Stage II disease was present in 34 (48.6%) and 33 (47.1%) patients in the doxycycline and control groups, respectively. After a median follow-up duration of 24.4 months, 32/70 (45.7%) of patients in the doxycycline group and 30/70 (42.9%) of patients in the control group experienced progression. PFS was not significantly different between groups (hazard ratio 0.97, 95% CI, 0.59-1.60, p =0.91). Cardiac progression occurred in 29/70 (41.4%) of patients in the doxycycline group and 26/70 (37.1%) of patients in the control group. The death rates for both groups by the end of follow-up was the same, 25/70 (35.7%). There were no significant differences observed for either cardiac PFS (hazard ratio 0.91, 95% CI, 0.54-1.55, p =0.74) or overall survival (hazard ratio 1.04, 95% CI, 0.60-1.81, p =0.89). Conclusions: Our trial demonstrated that doxycycline combined with CyBorD failed to prolong PFS or cardiac PFS compared with CyBorD alone in cardiac AL amyloidosis. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03401372.

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Exercise and Horticultural Programs for Older Adults with Depressive Symptoms and Memory Problems: A Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm9010099 ◽

2019 ◽

Vol 9 (1) ◽

pp. 99 ◽

Cited By ~ 3

Author(s):

Hyuma Makizako ◽

Kota Tsutsumimoto ◽

Takehiko Doi ◽

Keitaro Makino ◽

Sho Nakakubo ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Controlled Trial ◽

Exercise Group ◽

Control Group ◽

Control Groups ◽

Post Intervention ◽

Randomized Controlled ◽

Memory Problems

Depressive symptoms and memory problems are risk factors for dementia. Exercise can reduce these in older people, and horticultural activity can benefit people with dementia. This study assessed the efficacy of exercise and horticultural interventions for community-dwelling older adults with depressive symptoms and mild memory decline. In this randomized controlled trial, older adults (n = 89) were assigned to exercise, horticultural, or control groups. Exercise and horticultural programs included 20 weekly 90-min sessions. The control group attended two 90-min classes. Outcomes were assessed at baseline, and then 6- and 12-months post-intervention. Primary outcome measures were the Geriatric Depression Scale-15 (GDS-15) and Wechsler Memory Scale-Revised. Walking speed, two-minute walking test scores, social network, life space, and subjective daily physical activity were secondary outcome measures. Compared with the control group, the exercise group obtained higher immediate and delayed recall logical memory scores, and the increase in immediate recall scores remained 12-months post-intervention. Two-minute walking performance improved in the exercise group, but not after 12 months. GDS-15 scores showed no significant improvements. The horticultural and control groups showed no differences. Exercise may improve memory, while horticultural activity may not. The effects of exercise and horticultural interventions on depressive symptoms remain unclear.

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The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126615 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6615

Author(s):

Rosa Cabanas-Valdés ◽

Lídia Boix-Sala ◽

Montserrat Grau-Pellicer ◽

Juan Antonio Guzmán-Bernal ◽

Fernanda Maria Caballero-Gómez ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Core Stability ◽

Control Group ◽

Stroke Patients ◽

Randomized Controlled ◽

Subacute Stroke ◽

Local Strength ◽

Multicenter Randomized Controlled Trial ◽

Dynamic Sitting

Background: Trunk impairment produces disorders of motor control, balance and gait. Core stability exercises (CSE) are a good strategy to improve local strength of trunk, balance and gait. Methods and analysis: This is a single-blind multicenter randomized controlled trial. Two parallel groups are compared, and both perform the same type of therapy. A control group (CG) (n = 110) performs conventional physiotherapy (CP) (1 h per session) focused on improving balance. An experimental group (EG) (n = 110) performs CSE (30 min) in addition to CP (30 min) (1 h/session in total). EG is divided in two subgroups, in which only half of patients (n = 55) perform CSE plus transcutaneous electrical nerve stimulation (TENS). Primary outcome measures are dynamic sitting, assessed by a Spanish version of Trunk Impairment Scale and stepping, assessed by Brunel Balance Assessment. Secondary outcomes are postural control, assessed by Postural Assessment Scale for Stroke patients; standing balance and risk of fall assessed by Berg Balance Scale; gait speed by BTS G-Walk (accelerometer); rate of falls, lower-limb spasticity by Modified Ashworth Scale; activities of daily living by Barthel Index; and quality of life by EQ-5D-5L. These are evaluated at baseline (T0), at three weeks (T1), at five weeks (end of the intervention) (T2), at 17 weeks (T3) and at 29 weeks (T4). Study duration per patient is 29 weeks (a five-week intervention, followed by a 24-week post-intervention).

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Mindfulness-Based Stress Reduction Specifically Improves Social Anhedonia among Adults with Chronic Stress

10.31234/osf.io/wztr3 ◽

2021 ◽

Author(s):

Corinne Carlton ◽

Ligia Antezana ◽

Katelyn Mallory Garcia ◽

Holly Sullivan-Toole ◽

John Richey

Keyword(s):

Randomized Controlled Trial ◽

Chronic Stress ◽

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Social Anhedonia ◽

Randomized Controlled ◽

Waitlist Control Group ◽

The Relationship

This randomized controlled trial examined the effects of mindfulness on anhedonic symptoms in a sample of adults reporting high levels of chronic stress. Meditation-naïve adults (N=68, Mage=32, 62% female) were randomized to either an 8-week MBSR intervention group (N=35), or to a waitlist control group (N=33). We hypothesized that changes in mindfulness would mediate the relationship between condition and changes in anhedonic symptoms. Additionally, the present study aimed to determine if other theoretically-linked mechanisms (i.e., stress, negative affect(NA), depression) were involved in producing changes in anhedonic symptoms. Results provided evidence for full mediation of the effect of MBSR on social anhedonia through its essential mechanism of ΔMindfulness. These results highlight specificity of anhedonic symptoms targeted by MBSR, with social anhedonia symptoms being modified by changes in mindfulness whereas other anhedonic domains were not. Additionally, although associative relationships were present for stress, depression, NA, and anhedonic symptoms, no mediational relationships emerged.

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Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/14705 ◽

2019 ◽

Vol 8 (7) ◽

pp. e14705 ◽

Cited By ~ 2

Author(s):

Judith Schlaeger ◽

Hui Yan Cai ◽

Alana D Steffen ◽

Veronica Angulo ◽

Adhir R Shroff ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Stable Angina ◽

Controlled Trial ◽

Treatment Protocol ◽

Attention Control ◽

Chinese Patients ◽

Control Group ◽

Mcgill Pain Questionnaire ◽

Analgesic Effects ◽

Randomized Controlled

BackgroundAcupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.ObjectiveThis study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.MethodsWe are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.ResultsThis study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.ConclusionsWe will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.International Registered Report Identifier (IRRID)DERR1-10.2196/14705

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Protocol for a randomized controlled trial testing inhaled nitric oxide therapy in spontaneously breathing patients with COVID-19

10.1101/2020.03.10.20033522 ◽

2020 ◽

Cited By ~ 5

Author(s):

Chong Lei ◽

Binxiao Su ◽

Hailong Dong ◽

Bijan Safaee Fakhr ◽

Luigi Giuseppe Grassi ◽

...

Keyword(s):

Nitric Oxide ◽

Randomized Controlled Trial ◽

Hospital Care ◽

Massachusetts General Hospital ◽

Controlled Trial ◽

Control Group ◽

Research Committee ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Inhaled No

AbstractIntroductionthe current worldwide outbreak of Coronavirus disease 2019 (COVID-19) due to a novel coronavirus (SARS-CoV-2) is seriously threatening the public health. The number of infected patients is continuously increasing and the need for Intensive Care Unit admission ranges from 5 to 26%. The mortality is reported to be around 3.4% with higher values for the elderly and in patients with comorbidities. Moreover, this condition is challenging the healthcare system where the outbreak reached its highest value. To date there is still no available treatment for SARS-CoV-2. Clinical and preclinical evidence suggests that nitric oxide (NO) has a beneficial effect on the coronavirus-mediated acute respiratory syndrome, and this can be related to its viricidal effect. The time from the symptoms’ onset to the development of severe respiratory distress is relatively long. We hypothesize that high concentrations of inhaled NO administered during early phases of COVID-19 infection can prevent the progression of the disease.Methods and analysisThis is a multicenter randomized controlled trial. Spontaneous breathing patients admitted to the hospital for symptomatic COVID-19 infection will be eligible to enter the study. Patients in the treatment group will receive inhaled NO at high doses (140-180 parts per million) for 30 minutes, 2 sessions every day for 14 days in addition to the hospital care. Patient in the control group will receive only hospital care. The primary outcome is the percentage of patients requiring endotracheal intubation due to the progression of the disease in the first 28 days from enrollment in the study. Secondary outcomes include mortality at 28 days, proportion of negative test for SARS-CoV-2 at 7 days and time to clinical recovery.Ethics and disseminationThe trial protocol has been approved at the Investigation Review Boards of Xijing Hospital (Xi’an, China) and The Partners Human Research Committee of Massachusetts General Hospital (Boston, USA) is pending. Recruitment is expected to start in March 2020. Results of this study will be published in scientific journals, presented at scientific meetings, and on related website or media in fighting this widespread contagious disease.Trial registrationClinicaltrials.gov. NCT submitted

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Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups

10.31219/osf.io/u7ewz ◽

2021 ◽

Author(s):

David Scheim ◽

Jennifer A. Hibberd ◽

Juan Chamie-Quintero

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Controlled Trial ◽

Control Group ◽

High Dose ◽

Control Groups ◽

Over The Counter ◽

Randomized Controlled ◽

Widespread Availability ◽

And Control

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.

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