Trials
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Randomized Controlled Trial Multicenter Study
The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial.
Although available evidence relating to its effectiveness is weak, acupuncture is used as an alternative therapy for stress urinary incontinence. We report a protocol of a randomized controlled trial using electroacupuncture (the passing of a weak current between inserted acupuncture needles) to treat women with pure stress urinary incontinence. ⋯ This trial will help to identify whether electroacupuncture is effective for stress urinary incontinence, and, if so, whether it is a therapeutic effect rather than a placebo effect.
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Randomized Controlled Trial Multicenter Study
A randomized blinded controlled trial of mobile phone reminders on the follow-up medical care of HIV-exposed and HIV-infected children in Cameroon: study protocol (MORE CARE).
In Cameroon, only two-thirds of children with HIV exposure or infection receive appropriate HIV-directed medical care. Mortality, antiretroviral therapy resistance and suboptimal virological response are strongly related to missed opportunities for treatment, and, more specifically, to skipped scheduled medical appointments. The present trial, MORE CARE (Mobile Reminders for Cameroonian Children Requiring HIV Care) seeks to determine if reminders sent by text message (SMS), phone call, or concomitant SMS and phone calls most increase the presence at medical appointments of HIV-infected or -exposed children (efficacy), and which is the most efficient related to working time and financial cost (efficiency). ⋯ This trial investigates the potential of SMS and phone calls as motivational reminders to improve children's adherence to medical appointments for HIV-related care in Cameroon. The intervention will act to end missed appointment due to forgetfulness.
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Randomized Controlled Trial Multicenter Study
Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial.
Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults. ⋯ The questions being posed through this research are important given the increasing numbers of older people, pressure on the public purse and the associated need to support good health in the extended lifespan. The proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The results will support commissioners and providers with decisions about implementation.
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Randomized Controlled Trial Multicenter Study
Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial.
Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational and relationship functioning for many years after the end of treatment or, in fact, lifelong. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. We previously developed a nurse-led supportive care program (SurvivorCare) and tested it in a pilot study involving 10 CRC survivors. The intervention was found to be highly acceptable, appropriate, relevant and useful. ⋯ This supportive care package has the potential to significantly reduce individual suffering, whilst reducing the burden of follow-up on acute cancer services through enhanced engagement with and utilisation of general practitioners and community based services. If the intervention is successful in achieving the expected health benefits, it could be disseminated readily. All training and supporting materials have been developed and standardised. Furthermore, the intervention could easily be adapted to other cancer or chronic disease settings.
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Randomized Controlled Trial Multicenter Study
Reversal of the neurological deficit in acute stroke with the signal of efficacy trial of auto-BPAP to limit damage from suspected sleep apnea (Reverse-STEAL): study protocol for a randomized controlled trial.
Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies have shown its tolerability and safety, yet no controlled randomized sequential phase studies exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients. ⋯ We expect that this study will advance our understanding of how early treatment with non-invasive ventilation can counterbalance, or possibly reverse, the deleterious effects of sleep apnea in the acute phase of ischemic stroke. The study will provide preliminary data to power a subsequent phase III study.