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
This study examines an intervention that targets DD through enhanced cross-sectoral coll... (Source: Trials)
Source: Trials - March 21, 2024 Category: General Medicine Authors: Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders L. S ønderlund and Jens Søndergaard Tags: Study protocol Source Type: research
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: General Medicine Authors: Catharina F. van der Boor, Dalili Taban, Wietse A. Tol, Josephine Akellot, Melissa Neuman, Helen A. Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts and Daniela C. Fuhr Tags: Correction Source Type: research
Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial
This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population.Trial registrationClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation
DiscussionDIG is a promising intervention to evaluate for people with disabilities, adapted to be disability inclusive across programme components through extensive consultations and collaboration, and has proven efficacy at reducing poverty in other marginalised groups. However, evaluating a well-evidenced intervention among a new target group poses ethical considerations.Trial registrationRegistry for International Development Impact Evaluations, RIDIE-STUDY-ID-626008898983a (20/04/22). ISRCTN registry,ISRCTN78592382. Retrospectively registered on 17/08/2023. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies
ConclusionFIONA is evaluating the use of finerenone in children with CKD and proteinuria. Should safety, tolerability, and efficacy be demonstrated, finerenone could become a useful additional therapeutic agent in managing proteinuria and improving kidney outcomes in children with CKD.Trial registrationClinicalTrials.gov NCT05196035. Registered on 19 January 2022. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Developing generic templates to shape the future for conducting integrated research platform trials
ConclusionsThis publication is intended to enhance the use, understanding, and dissemination of the EU-PEARL suite of templates for designing IRPs. The reference user manual and the associated website (http://www.eu-pearl) should facilitate the designing of IRP trials. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
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
