Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks —a systematic review of studies within randomized controlled trials
ConclusionFew published studies have investigated the impact of e-IC on enrolment and findings were mixed. e-IC may improve participant ’s comprehension and recall of information. High-quality studies are needed to evaluate the potential benefit of e-IC to increase clinical trial enrolment.Trial registrationPROSPEROCRD42021231035. Registration date: 19-Feb-2021. (Source: Trials)
Source: Trials - February 21, 2023 Category: Research Source Type: clinical trials
Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial
DiscussionThe COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-...
Source: Trials - October 28, 2022 Category: Research Source Type: clinical trials
Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention
DiscussionThe original Pasos PA intervention showed efficacy in helping Latinas increase PA; we expect the Enhanced Intervention to help a larger proportion of participants to increase and maintain their PA long term. This web- and text-based enhanced intervention could have great reach and dissemination potential, which could be capitalized on in the future to help to advance health equity. Adaptations made in response to the COVID-19 pandemic are also described in this manuscript.Trial registrationClinical Trial Number:NCT03491592. First posted April 9, 2018. (Source: Trials)
Source: Trials - August 1, 2022 Category: Research Source Type: clinical trials
Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD ® program in Spanish children with autism and preterm children with communication and/or socialization difficulties
AbstractHaving access to parenting interventions in the early years is key to improve the developmental outcomes of children with neurodevelopmental problems. The Incredible Years ® (IY) Parent Program is a group intervention that has demonstrated efficacy in terms of reducing stress in parents, as well as improving behavioral, emotional, and social outcomes in children. The program has been recently adapted for families of children with autism or language delays (IY-ASLD®) . This intervention has not yet been implemented in the Spanish Public Health System, where there is a scarcity of evidence-based interventions being...
Source: Trials - April 20, 2021 Category: Research Source Type: clinical trials
Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial
AbstractObjectivesThe aim of this study is to assess the efficacy of the use of pre-exposure prophylaxis (PrEP) with hydroxychloroquine against placebo in healthcare workers with high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in reducing their risk of coronavirus disease 2019 (COVID-19) disease during an epidemic period.As secondary objectives, we would like to: i) assess the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of exposure to SARS-CoV-2 (defined by seroconversion) during a...
Source: Trials - July 28, 2020 Category: Research Source Type: clinical trials
Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial
DiscussionWe will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement. We intend to investigate a field not previously studied, such as the repercussion of carrying out a toning and respiratory exercise program in these patients, in historical circumstances that no one had previously observed in Spain, since the general population has never been forced to remain confined in their homes, due to a pandemic i...
Source: Trials - June 28, 2020 Category: Research Source Type: clinical trials
Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
Condition: Infection in Solid Organ Transplant RecipientsIntervention: Biological: Influenza vaccineSponsors: Fundación Pública Andaluza Progreso y Salud; Spanish Network for Research in Infectious DiseasesCompleted - verified April 2015 (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 13, 2012 Category: Research Source Type: clinical trials
