Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial
ConclusionThis study is among the first clinical trials exploring the development of DD from diagnosis to 12 months post-diagnosis. Many previous interventions did not directly target DD as the primary outcome. This research provides new insights into DD progression in patients newly diagnosed with T2DM and examines an intervention designed to lower DD in early diabetes stages, contributing to a better u nderstanding of the development of DD and how this intervention affects patient well-being.Trial registrationClinicalTrial.gov NCT05571306. Registered on 07 October 2022. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Correction: Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda
(Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study)
The increasing prevalence of childhood obesity has become an urgent public health problem, evidence showed that intervention for childhood obesity bring enormous health benefits. However, an effective individu... (Source: Trials)
Source: Trials - March 20, 2024 Category: General Medicine Authors: Ping-ping Zhang, You-xin Wang, Fang-jing Shen, Yun-fei Xing, Jia-ying Gu, Xue-ying Li, Han Jin, Shi-feng Jin, Miao Xu, Hai-jun Wang, Hui Wang and Li Li Tags: Study protocol Source Type: research
Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial
Acute viral bronchiolitis is the most common reason for hospitalization of infants in the USA. Infants hospitalized for bronchiolitis are at high risk for recurrent respiratory symptoms and wheeze in the subse... (Source: Trials)
Source: Trials - March 20, 2024 Category: General Medicine Authors: Kelly Cowan, Erin O. Semmens, Jeannette Y. Lee, Ethan S. Walker, Paul G. Smith, Linda Fu, Rosalyn Singleton, Sara McClure Cox, Jennifer Faiella, Laurie Chassereau, Lora Lawrence, Jun Ying, Jaime Baldner, Maryam Garza, Robert Annett, Sheva K. Chervinskiy & Tags: Study protocol Source Type: research
Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan
Infants born with congenital diaphragmatic hernia (CDH) are at high risk of respiratory insufficiency and pulmonary hypertension. Routine practice includes immediate clamping of the umbilical cord and endotrac... (Source: Trials)
Source: Trials - March 20, 2024 Category: General Medicine Authors: Emily J. J. Horn-Oudshoorn, Marijn J. Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B. te Pas, Stuart B. Hooper, Suzan C. M. Cochius-den Otter, Rene M. H. Wijnen, Kelly J. Crossley, Neysan Rafat, Thomas Schaible, Willem P. de Boode, Anne Debeer, Berndt Tags: Methodology Source Type: research
The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation
Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (... (Source: Trials)
Source: Trials - March 20, 2024 Category: General Medicine Authors: David N. Matlock, Sarah J. Ratcliffe, Sherry E. Courtney, Haresh Kirpalani, Kimberly Firestone, Howard Stein, Kevin Dysart, Karen Warren, Mitchell R. Goldstein, Kelli C. Lund, Aruna Natarajan, Ejigayehu Demissie and Elizabeth E. Foglia Tags: Study protocol Source Type: research
A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study
Chronic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes, and heart failure, often coexist and contribute to a significant burden on individuals and health systems. The A... (Source: Trials)
Source: Trials - March 20, 2024 Category: General Medicine Authors: Christian J. Wiedermann, Pasqualina Marino, Angelika Mahlknecht, Verena Barbieri, Giuliano Piccoliori, Adolf Engl and Annerika H. M. Gidding-Slok Tags: Study protocol Source Type: research
Choosing and evaluating randomisation methods in clinical trials: a qualitative study
ConclusionThere is a wide variety in practice on how randomisation methods are selected and researcher ’s opinions on methods. The difference in practice observed when looking at randomisation method selection can be explained by a difference in unit practice, and also by a difference in researchers prioritisation of balance and predictability. The findings of this study show a need for more guidan ce on randomisation method selection. (Source: Trials)
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Transcranial alternating current stimulation improves quality of life in Parkinson ’s disease: study protocol for a randomized, double-blind, controlled trial
The objective of this study is to investigate whether the addition of tACS to multidisciplinary intensive rehabilitation tr eatment (MIRT) can improve symptoms of PWP so as to enhance the quality of life in individuals with Parkinson’s disease based on the central-peripheral-central theory.MethodsThe present study was a randomized, double-blind trial that enrolled 60 individuals with Parkinson ’s disease aged between 45 and 70 years, who had Hoehn-Yahr scale scores ranging from 1 to 3. Participants were randomly assigned in a 1:1 ratio to either the tACS + MIRT group or the sham-tACS + MIRT group. The trial co...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial
DiscussionWe propose to test the use of HEPA filtration to improve indoor air quality as a strategy to reduce post-bronchiolitis respiratory symptom burden in at-risk infants with severe bronchiolitis. If the intervention proves successful, this trial will support use of HEPA filtration for children with bronchiolitis to reduce respiratory symptom burden following hospitalization.Trial registrationNCT05615870. Registered on November 14, 2022. (Source: Trials)
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation
DiscussionThe DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites.Trial registrationwww.ClinicalTrials.gov, trial identifierNCT05446272, registered July 6, 2022. (Source: Trials)
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study
This study aims to validate the German and Italian versions of the ABCC tool and evaluate its effectiveness and cost-effectiveness in the South Tyrolean Primary Care setting.MethodsThis is a cluster-randomized study involving approximately 400 patients with COPD, asthma, type 2 diabetes, and heart failure who received care from the South Tyrolean General Practices. Initially, the ABCC tool will be translated into German and Italian and validated. Subsequently, half of the participants will use the validated ABCC tool for patient-reported outcome measurement assessments, while the other half will receive usual care. The pri...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study)
This study aimed to develop an m-Health-assisted lifestyle intervention program targeting overweight/obese children and assess its effectiveness on indicators of adiposity and NAFLD.MethodsThis is a cluster-randomized controlled trial that conducted in children with overweight/obesity in Ningbo city, Zhejiang Province, China. Students in Grade 3 (8 –10 years old) were recruited from six primary schools, with three be randomized to intervention group and three to usual practice group. The intervention program will last for one academic year and consists of health education, dietary guidance, and physical activity reinfor...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan
We describe the statistical analysis plan for the clinical trial evaluating the effects of PBCC versus immediate cord clamping on pulmonary hypertension in infants with CDH (PinC trial).DesignThe PinC trial is a multicentre, randomised controlled trial in infants with isolated left-sided CDH, born ≥ 35.0 weeks of gestation. The primary outcome is the incidence of pulmonary hypertension in the first 24 h after birth. Maternal outcomes include estimated maternal blood loss. Neonatal secondary outcomes include mortality before discharge, extracorporeal membrane oxygenation therapy, and number of days of mechanical ventilati...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
The IMPROVE trial: study protocol for a pragmatic cluster randomised controlled trial to assess the effectiveness of using lay health workers to improve uptake and completion of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease
Pulmonary rehabilitation (PR) is a programme of exercise and education and the most effective treatment for the symptoms and disability associated with chronic obstructive pulmonary disease. However, the benef... (Source: Trials)
Source: Trials - March 19, 2024 Category: General Medicine Authors: Gill Gilworth, Katherine Harris, Toby L. Morgan, Salma Ayis, Julia Fox-Rushby, Emma Godfrey, Nicholas S. Hopkinson, Simon Lewin, Ka Keat Lim, Arietta Spinou, Stephanie J. C. Taylor and Patrick White Tags: Study protocol Source Type: research
