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Pilot and Feasibility Studies

Helena de Oliveira Braga, Elaine Cristina Gregório, Rafaela Simon Myra, Ana Sofia Kauling de Souza, Talita Vitorina Kunh, Jessica Klug, Adriana Coutinho de Azevedo Guimarães, Alessandra Swarowsky
Background: One of the greatest barriers found by physical therapy treating individuals with Parkinson's disease (PD) is the adherence to treatment, associated with the lack of motivation to remain active. Therefore, there is a need to change the look given to physical therapy and for the individual, seeking the centralization of the therapy in their preferences. This study aims to present the EMPOWER-PD, a protocol based on individual preferences and its design for feasibility. Method: A 12-week pilot for a randomized clinical trial will assess the feasibility and preliminary effectiveness of the EMPOWER-PD and make comparisons with conventional physical therapy (CPh)...
2019: Pilot and Feasibility Studies
Matthew R Sandbulte, Brad J Gautney, May Maloba, Catherine Wexler, Melinda Brown, Natabhona Mabachi, Kathy Goggin, Raphael Lwembe, Niaman Nazir, Thomas A Odeny, Sarah Finocchario-Kessler
Background: Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants' first 2-3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis...
2019: Pilot and Feasibility Studies
J R Vaag, M L Lara-Cabrera, O Hjemdal, B Gjervan, T Torgersen
Background: Psychoeducation is included in the Norwegian national guidelines for treatment of adult ADHD. Despite some promising results for the treatment of other conditions and ADHD, little is known about the efficacy of such interventions. This paper presents a protocol for a pilot randomized controlled trial featuring a psychoeducational group program for patients with ADHD. The main objective of this pilot trial is to investigate adherence, feasibility, and preliminary efficacy of a ten-session psychoeducational group designed to address specific challenges faced by adults diagnosed with ADHD...
2019: Pilot and Feasibility Studies
Gemma Taylor, Paul Aveyard, Kate Bartlem, Alison Shaw, Jeremy Player, Chris Metcalfe, David Kessler, Marcus Munafò
Background: People with depression/anxiety are twice as likely to smoke and are less responsive to standard tobacco treatments, leading to a reduced life expectancy of up to  13.6 years compared to people without depression/anxiety. However, this group of smokers is motivated to quit, and as a result of quitting smoking, their depression/anxiety is likely to improve. In England, people with depression/anxiety are referred to a primary care-based psychological therapies service known as 'Improving Access to Psychological Therapies' (IAPT), which could offer smoking cessation treatment as part of usual care but currently does not...
2019: Pilot and Feasibility Studies
Yvonne Dimitropoulos, Anthony Blinkhorn, Michelle Irving, John Skinner, Steven Naoum, Alexander Holden, Angela Masoe, Boe Rambaldini, Vita Christie, Heiko Spallek, Kylie Gwynne
Background: Australian Aboriginal children experience high levels of dental caries (tooth decay) and are less likely to access preventive dental health services. High-strength fluoride varnish has been shown to reduce the incidence of dental caries and is commonly used in community-based preventive dental health service programs. In New South Wales, Australia, the application of fluoride varnish is restricted to dental and medical professionals. This is problematic in communities with a high Aboriginal population and limited access to oral health services, contributing to the increased risk of developing dental caries in Aboriginal children...
2019: Pilot and Feasibility Studies
Katerina Hilari, Nicholas Behn, Jane Marshall, Alan Simpson, Shirley Thomas, Sarah Northcott, Chris Flood, Sally McVicker, Mireia Jofre-Bonet, Becky Moss, Kirsty James, Kimberley Goldsmith
Background: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. Methods/design: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress...
2019: Pilot and Feasibility Studies
Rebecca Meiksin, Elizabeth Allen, Joanna Crichton, Gemma S Morgan, Christine Barter, Diana Elbourne, Kate Hunt, G J Melendez-Torres, Steve Morris, H Luz Mc Naughton Reyes, Joanna Sturgess, Bruce Taylor, Honor Young, Rona Campbell, Chris Bonell
Background: Dating and relationship violence (DRV)-intimate partner violence during adolescence-encompasses physical, sexual and emotional abuse. DRV is associated with a range of adverse health outcomes including injuries, sexually transmitted infections, adolescent pregnancy and mental health issues. Experiencing DRV also predicts both victimisation and perpetration of partner violence in adulthood.Prevention targeting early adolescence is important because this is when dating behaviours begin, behavioural norms become established and DRV starts to manifest...
2019: Pilot and Feasibility Studies
Elizabeth Stewart, Cathy Catroppa, Suncica Lah
Background: Children with epilepsy have significant social impairments, yet evidence-based interventions to address these social difficulties are lacking. Emerging research has shown that social difficulties in children with epilepsy relate to underlying impairments in Theory of Mind (ToM). This paper outlines the protocol for a pilot study that will evaluate the feasibility, acceptability, and efficacy of a novel cognitive behavioural intervention with ToM training for children with epilepsy...
2019: Pilot and Feasibility Studies
Joshua P Totty, Amy E Harwood, Paris L Cai, Louise H Hitchman, George E Smith, Ian C Chetter
Background: Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early research has suggested that DACC-coated wound dressings are effective in reducing surgical site infection when applied to wounds healing by primary intention post-operatively, therefore this trial aims to assess the feasibility of producing high-quality evidence assessing this theory...
2019: Pilot and Feasibility Studies
Joshua Troche, Arielle Willis, Janet Whiteside
Background: Dementia can lead to difficulties in communication between caregivers and patients. Teaching conversational strategies has been effective for a wide array of clients with acquired neurologic disorders and their caregivers. Research indicates positive results for Supported Conversation for adults with Aphasia (SCA) secondary to stroke. Applying this method to work with caregivers of individuals with dementia could prove to be a valid intervention tool. This investigation examined the applicability of SCA with individuals with dementia and their familial caregivers...
2019: Pilot and Feasibility Studies
J Tekampe, H van Middendorp, F C G J Sweep, S H P P Roerink, A R M M Hermus, A W M Evers
Background: Conditioning of physiological responses can be achieved by repeatedly pairing a previously neutral conditioned stimulus with the administration of a pharmacologically salient unconditioned stimulus. This type of conditioning has been effective for specific immune and endocrine responses, but results with regard to conditioning of cortisol, a key stress-regulatory parameter, are currently unclear. This paper describes a pharmacological conditioning design, optimized for the examination of effects of cortisol conditioning under both basal conditions and in response to stress...
2019: Pilot and Feasibility Studies
Julie Williams, Nick Sevdalis, Fiona Gaughran
Background: People with serious mental illness (SMI) have poorer physical health and reduced lifespans compared to the general population. Reasons for this are complex, but one important area is the identification and treatment of physical health conditions. In England, services are structured into primary and secondary care; physical and mental secondary health services are separate. This often leads to a lack of co-ordination of care, with people missing the screening and treatment they need...
2019: Pilot and Feasibility Studies
Edith Angellotti, John B Wong, Ayal Pierce, Benjamin Hescott, Anastassios G Pittas
Background: The long-term management of cardiometabolic diseases, such as type 2 diabetes and hypertension, is complex and can be facilitated by supporting patient-directed behavioral changes. The concurrent application of wireless technology and personalized text messages (PTMs) based on behavioral economics in managing cardiometabolic diseases, although promising, has not been studied. The aim of this pilot study was to evaluate the feasibility and acceptability of the concurrent application of wireless home blood pressure (BP) monitoring (as an example of "automated hovering") and PTMs (as an example of "nudging") targeting pharmacotherapy and lifestyle habits in patients with cardiometabolic disease (type 2 diabetes and/or hypertension)...
2019: Pilot and Feasibility Studies
Deborah Rohm Young, Miki K Nguyen, Ayae Yamamoto, Magdalena Pomichowski, Melissa Cornejo, Silvia Paz, Karen J Coleman, Robert E Sallis, Stephen P Fortmann
Background: Diabetes and prediabetes are chronic conditions that affect over 40% of the US adult population combined. Regular physical activity can benefit people with diabetes through improved glucose control and can reduce the conversion of prediabetes to diabetes. Studies are needed in settings where people with these conditions can be identified and provided the skills and support to increase physical activity. The primary care setting meets this need, but there are insufficient high-quality trials to recommend this approach be broadly implemented...
2019: Pilot and Feasibility Studies
Saahil Mehta, Suzie Cro Cro, Billie Coomber, Rachel Rolph, Victoria Cornelius, Jian Farhadi
Objective: preHEAT was a randomised controlled feasibility trial to determine how best to measure skin necrosis in breast reconstruction to inform the design of a larger multicentre trial. Background: Mastectomy skin flap necrosis (MSFN) is a serious complication resulting in prolonged wound healing. Local heat preconditioning of the MSF before surgery has been shown to reduce skin necrosis in immediate breast reconstruction patients (IBR). Method: preHEAT was a single-centre, randomised control two-arm single-blind parallel arm feasibility trial of local heat preconditioning in breast cancer patients undergoing SSM and NSM at Guy's and St Thomas' Hospital, London, UK...
2019: Pilot and Feasibility Studies
Sandeep Reddy, Kevin Mc Namara, Mary Malakellis, Tim Denton, Cathy McDonald, Jane Opie, Andrew Sanigorski, Vincent Versace
Background: Cardiovascular diseases (CVD) are the largest cause of death and disability in Australia. Australian national guidelines for the primary prevention of CVD recommend that all adults without CVD and aged 45 years or more are screened for their absolute risk of CVD every 2 years. Despite the compelling evidence to address CVD risk, treatment gaps remain and evidence suggests that much of the shortcomings are attributed to the performance of primary care practices. To address this issue, a quality improvement initiative is being implemented in a large urban multidisciplinary primary care practice in the South West region of Victoria, Australia...
2019: Pilot and Feasibility Studies
Scott S Malinowski, Katie E Barber, Omayma A Kishk, Andrew A Mays, Sara R Jones, Adrian L Turner, Daniel M Riche
Objectives: Anecdotally, several strategies have been suggested in order to improve tolerability of fish oil supplements, but there is little evidence supporting any of these strategies. The aim of this study was to determine if there is a difference among four methods of oral administration of fish oil supplementation in terms of tolerability and adherence. Methods: A randomized, prospective, open-label, four-arm pilot study was conducted on 60 healthy adult subjects randomized to different fish oil supplement administration methods with (1) milk, (2) food, (3) an empty stomach, and (4) frozen capsules prior to ingestion...
2019: Pilot and Feasibility Studies
Robert Fleischmann, Steffi Traenkner, Antje Kraft, Sein Schmidt, Stephan J Schreiber, Stephan A Brandt
Background: Pathophysiological concepts in delirium are not sufficient to define objective biomarkers suited to improve clinical approaches. Advances in neuroimaging have revalued electroencephalography (EEG) as a tool to assess oscillatory network activity in neuropsychiatric disease. Yet, research in the field is limited to small populations and largely confined to postoperative delirium, which impedes generalizability of findings and planning of prospective studies in other populations...
2019: Pilot and Feasibility Studies
Claire Carswell, Joanne Reid, Ian Walsh, Helen McAneney, Helen Noble
Background: End-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions...
2019: Pilot and Feasibility Studies
Charlie C Hall, Lucy Norris, Liz Dixon, Jane Cook, Matthew Maddocks, Catriona Graham, Sharon Tuck, Erna Haraldsdottir, Duncan Brown, Anna Lloyd, Anne Finucane, Peter Hall, Katharina Diernberger, Richard J E Skipworth, Marie Fallon, Barry J Laird
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2018: Pilot and Feasibility Studies
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