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Pilot and Feasibility Studies

Elaine Denny, Annalise Weckesser, Georgina Jones, Stavroula Bibila, Jane Daniels, Siladitya Bhattacharya
Background: Endometriosis is a common cause of chronic pelvic pain which can relapse after surgery, yet little research has been conducted on women's experience of medical treatments for prevention of recurrence and the influence of this on participation in clinical trials. Methods: This study explored women's past experiences with medical treatments for endometriosis symptoms and the impact this has on their motivation to enter the pilot phase of a post-conservative surgery clinical trial, PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy...
2018: Pilot and Feasibility Studies
Martin J Thomas, Stephanie Butler-Walley, Trishna Rathod-Mistry, Zoe Mayson, Emma L Parry, Christopher Pope, Tuhina Neogi, George Peat
Background: Osteoarthritis (OA) is a leading cause of persistent pain and disability. Traditionally viewed as a slowly progressive disease, the impact of symptom variability on prognosis remains unclear. 'Acute-on-chronic' episodes are a well-recognised feature of many long-term conditions but only recently formally described in OA. This study aimed to develop a web-based data collection platform and establish key methodological design parameters, to develop a larger community-based study investigating acute flares of knee OA in England...
2018: Pilot and Feasibility Studies
Guillermo Perez Algorta, Anna Van Meter, Bernadka Dubicka, Steven Jones, Eric Youngstrom, Fiona Lobban
Background: Late adolescence and early adulthood is a period of highest incidence for onset of mental health problems. Transition to college environment has been associated with many risk factors such as the initial disruption-and subsequent irregularity-of the student's sleep and activity schedule. We tested the feasibility of using blue blocking glasses (BBG) at night in first year higher education students with sleep complaints, to obtain preliminary evidence for the impact of BBG on sleep, activity, and mood...
2018: Pilot and Feasibility Studies
Wendy Duggleby, Kathya Jovel Ruiz, Jenny Ploeg, Carrie McAiney, Shelley Peacock, Cheryl Nekolaichuk, Jayna Holroyd-Leduc, Sunita Ghosh, Kevin Brazil, Jennifer Swindle, Dorothy Forbes, Sandra Woodhead Lyons, Jasneet Parmar, Sharon Kaasalainen, Laura Cottrell, Jillian Paragg
Background: Following institutionalization of a relative with Alzheimer disease and related dementias (ADRD), family carers continue to provide care. They must learn to negotiate with staff and navigate the system all of which can affect their mental health. A web-based intervention, My Tools 4 Care-In Care (MT4C-In Care) was developed by the research team to aid carers through the transitions experienced when their relative/friend with ADRD resides in a long-term care (LTC) facility...
2018: Pilot and Feasibility Studies
A M Russell, J L O'Dwyer, L D Bryant, A O House, J C Birtwistle, S Meer, A Wright-Hughes, R E A Walwyn, E Graham, A J Farrin, C T Hulme
Background: In trials incorporating a health economic evaluation component, reliable validated measures for health-related quality of life (HRQOL) are essential. The EQ-5D is the preferred measure for cost-effectiveness analysis in UK trials. This paper presents a qualitative evaluation of the use of the EQ-5D-3L in a feasibility randomised control trial with participants who had a mild- to  moderate learning disability and type 2 diabetes. Methods: Researchers administered the EQ-5D-3L to 82 participants at baseline and 77 at follow-up...
2018: Pilot and Feasibility Studies
Patrick Lavoie, Sean P Clarke, Christina Clausen, Margaret Purden, Jessica Emed, Tanya Mailhot, Valerie Frunchak
Background: The portability and multiple functionalities of mobile devices make them well suited for collecting field data for naturalistic research, which is often beset with complexities in recruitment and logistics. This paper describes the implementation of a research protocol using mobile devices to study nurses' exchanges of patient information at change of shift. Methods: Nurses from three medical and surgical units of an acute care teaching hospital in Montreal, Canada, were invited to participate...
2018: Pilot and Feasibility Studies
Corjena Cheung, Rozina Bhimani, Jean F Wyman, Jürgen Konczak, Lei Zhang, Usha Mishra, Marcia Terluk, Reena V Kartha, Paul Tuite
Objective: To examine the feasibility, acceptability, and preliminary effects of Hatha yoga on oxidative stress, motor function, and non-motor symptoms among individuals with Parkinson's disease (PD). Methods: The study has a pilot randomized controlled trial design with two arms: an immediate treatment group and a wait-list control group. The yoga-for-PD program was implemented via twice weekly 60-min group-based classes for 12 weeks. Participants were assessed at baseline, 12 weeks, and 6 months post-intervention...
2018: Pilot and Feasibility Studies
Lisa Keay, Kate Hunter, Martyn Ralph, Bobby Porykali, Marilyn Lyford, Kathleen Clapham, Winston Lo, Rebecca Ivers
Background: Little is known about the barriers to use of child car seats in Australian Aboriginal communities, or the acceptability of programs to increase appropriate car seat use. This formative evaluation sought to consult and partner with Aboriginal Community Controlled Health Services (ACCHS) to develop and evaluate the feasibility and acceptability of a program intended to improve optimal use of child car seats. Methods: Focus groups were conducted with parents and carers of Aboriginal children to identify the barriers and facilitating factors for child car seat use, and staff of two ACCHS were interviewed to inform program development...
2018: Pilot and Feasibility Studies
Joanne Bayly, Bethany M Edwards, Nicola Peat, Geoffrey Warwick, Ivo M Hennig, Arvind Arora, Andrew Wilcock, Irene J Higginson, Matthew Maddocks
Background: Access to rehabilitation to prevent disability and optimise function is recommended for patients with cancer, including following cancer diagnosis. Models to integrate rehabilitation within oncology services as cancer treatment commences are required, but must be informed by those they are intended to support. We aimed to identify views of patients, carers and clinicians to develop and refine a rehabilitation model to be tested in a feasibility trial for people newly diagnosed with lung cancer or mesothelioma...
2018: Pilot and Feasibility Studies
Mark E Murphy, Molly Byrne, Fiona Boland, Derek Corrigan, Paddy Gillespie, Tom Fahey, Susan M Smith
Background: Poorly controlled type 2 diabetes mellitus (T2DM) is associated with significant morbidity, mortality and healthcare costs. Control of T2DM can be challenging for healthcare professionals for a number of reasons, including poor concordance with medications, difficulties modifying lifestyle behaviour and also clinical inertia, which is defined as a reluctance among health professionals to intensify medications. A complex intervention, called ComputeriseD dECisIonal support for poorly controlleD typE 2 Diabetes mellitus in Irish General Practice (DECIDE), was developed, identifying T2DM patients with poor glycaemic and blood pressure control and aiming to target clinical inertia, by supporting therapeutic action, including GP-led medication intensification where appropriate...
2018: Pilot and Feasibility Studies
Anna Volkmer, Aimee Spector, Jason D Warren, Suzanne Beeke
Background: Primary progressive aphasia is a language-led dementia, often associated with frontotemporal dementia. It presents as insidious deterioration of language skills (e.g. naming objects and understanding complex sentences), with relative sparing of cognitive skills initially. There is little research examining the effectiveness of communication skills training for primary progressive aphasia, yet speech and language therapists (SLTs) report regularly using this in clinical practice...
2018: Pilot and Feasibility Studies
Sophie Lawrie, Yun Dong, Dax Steins, Zhidao Xia, Patrick Esser, Shanbin Sun, Fei Li, James D Amor, Christopher James, Hooshang Izadi, Yi Cao, Derick Wade, Nancy Mayo, Helen Dawes
Background: The majority of stroke patients are inactive outside formal therapy sessions. Tailored activity feedback via a smartwatch has the potential to increase inpatient activity. The aim of the study was to identify the challenges and support needed by ward staff and researchers and to examine the feasibility of conducting a randomised controlled trial (RCT) using smartwatch activity monitors in research-naive rehabilitation wards. Objectives (Phase 1 and 2) were to report any challenges and support needed and determine the recruitment and retention rate, completion of outcome measures, smartwatch adherence rate, (Phase 2 only) readiness to randomise, adherence to protocol (intervention fidelity) and potential for effect...
2018: Pilot and Feasibility Studies
Virginia Stulz, David Campbell, Biing Yin, Wafa Al Omari, Robin Burr, Heather Reilly, Kenny Lawson
Background: The peanut ball has only been recently used as a support for women labouring with epidurals. The peanut ball is shaped like a peanut and fits snugly between the woman's legs so that both legs are maintained as opening the pelvic outlet to increase the progress of labour and facilitate descent of the fetal head. Using position changes during labour to enhance widening of the pelvic outlet can be beneficial but a woman who has an epidural is limited in the number of positions she can adopt...
2018: Pilot and Feasibility Studies
Molly A Martin, Helen H Lee, Jazmin Landa, Mark Minier, David Avenetti, Anna Sandoval
Background: The COordinated Oral health Promotion (CO-OP) Chicago trial will test the efficacy of a community health worker (CHW) intervention to improve oral health behaviors for children at high risk for early childhood caries. Before implementing the cluster-randomized controlled trial, we conducted a formative assessment to determine the final design. We used qualitative methods to assess the feasibility and acceptability of the proposed recruitment, data collection, and intervention plan...
2018: Pilot and Feasibility Studies
Arthur H Owora, Najah Salaam, Sydney H Russell Leed, Dessa Bergen-Cico, Timothy Jennings-Bey, Arnett Haygood El, Robert A Rubinstein, Sandra D Lane
Background: Our study objective was to examine the feasibility of implementing a culturally congruent mentorship pilot program, Youth-First (YF), that targets behavior modification among elementary school-aged children with disruptive behavior and a history of school suspension. We hypothesize that it is feasible to implement the YF program to reduce disruptive behaviors and recidivism of level III/IV infractions in school settings among at-risk African American students. Methods: We assessed program feasibility based on the success of program acceptance by parents/guardians, study enrollment, and intervention compliance by students...
2018: Pilot and Feasibility Studies
Laura C Hopkins, Mary Fristad, Jacqueline D Goodway, Bernadette Melnyk, Ihuoma Eneli, Chris Holloman, Julie A Kennel, Alison Webster, Amy R Sharn, Carolyn Gunther
Background: The most efficacious childhood obesity prevention interventions have involved caregivers directly or indirectly. Due to the high reliance on technology, research examining technological intervention approaches is warranted, particularly during the summer when parents may be more difficult to engage and the risk for excess weight gain among children is high. Methods: The feasibility and acceptability of a multi-component childhood obesity prevention intervention incorporating a caregiver component utilizing technology-based approaches-texting and social media-was explored...
2018: Pilot and Feasibility Studies
Kulsum Patel, Caroline L Watkins, Chris J Sutton, Emma-Joy Holland, Valerio Benedetto, Malcolm F Auton, David Barer, Kausik Chatterjee, Catherine E Lightbody
Background: Management of psychological adjustment and low mood after stroke can result in positive health outcomes. We have adapted a talk-based therapy, motivational interviewing (MI), and shown it to be potentially effective for managing low mood and supporting psychological adjustment post-stroke in a single-centre trial. In the current study, we aimed to explore the feasibility of delivering MI using clinical stroke team members, and using an attention control (AC), to inform the protocol for a future definitive trial...
2018: Pilot and Feasibility Studies
Allison I Daniel, Meta van den Heuvel, Melissa Gladstone, Mike Bwanali, Wieger Voskuijl, Celine Bourdon, Isabel Potani, Sara Fernandes, Jenala Njirammadzi, Robert H J Bandsma
Background: Children admitted to nutritional rehabilitation units (NRUs) for inpatient treatment of severe acute malnutrition (SAM) are at high risk of poor developmental and nutritional outcomes. The Kusamala Program is an interactive hospital-based counseling program for primary caregivers of children with SAM that integrates three modules: nutrition and feeding; water, sanitation, and hygiene (WASH); and psychosocial stimulation. This mixed methods feasibility study aimed to evaluate the implementation of the Kusamala Program in an NRU setting and developmental outcomes in children with SAM 6 months after inpatient treatment...
2018: Pilot and Feasibility Studies
A N L M De Silva, Andrew H Dawson, Indika B Gawarammana, Sampath Tennakoon, Thilini Rajapakse
Background: Deliberate self-harm in the form of non-fatal self-poisoning is a major public health problem in Sri Lanka. Previous work suggests that many nurses in Sri Lanka-particularly those who work in primary care in the medical treatment of persons who attempt self-poisoning-already approach their role in a holistic fashion and consider "advising" or "counseling" patients after self-poisoning to be a part of their nursing role. But there is no formal training given to such nurses at present nor has the efficacy or feasibility of such an intervention been assessed in Sri Lanka...
2018: Pilot and Feasibility Studies
Eric Kai Chung Wong, Justin Yusen Lee, Darryl P Leong, Lawrence Mbuagbaw, Haroon Yousuf, Sabina Keen, Sharon E Straus, Christopher J Patterson, Catherine Demers
Background: Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency occurs in 33% of patients with HF. However, the effectiveness of thiamine supplementation in HF is not known. Methods: In a placebo-controlled randomized two-period crossover feasibility trial, patients age ≥ 60 years with HF and reduced ejection fraction (HFrEF, EF ≤ 45%) will be randomized to thiamine 500 mg oral capsule once daily or placebo for 3 months, then crossed over to the other intervention after a 6-week washout period...
2018: Pilot and Feasibility Studies
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