Articles

A novel cognitive behavioural intervention with Theory of Mind (ToM) training for children with epilepsy: protocol for a case series feasibility study

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 w...

Authors: Elizabeth Stewart, Cathy Catroppa and Suncica Lah

Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial

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 woun...

Authors: Joshua P. Totty, Amy E. Harwood, Paris L. Cai, Louise H. Hitchman, George E. Smith and Ian C. Chetter

Exploring supported conversation with familial caregivers of persons with dementia: a pilot study

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 thei...

Authors: Joshua Troche, Arielle Willis and Janet Whiteside

Conditioning cortisol in humans: design and pilot study of a randomized controlled trial

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 ...

Authors: J. Tekampe, H. van Middendorp, F. C. G. J. Sweep, S. H. P. P. Roerink, A. R. M. M. Hermus and A. W. M. Evers

Evaluation of a Physical health plan for people with psychosis: a protocol for a quality improvement study

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 tre...

Authors: Julie Williams, Nick Sevdalis and Fiona Gaughran

Combining Wireless Technology and Behavioral Economics to Engage Patients (WiBEEP) with cardiometabolic disease: a pilot study

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 o...

Authors: Edith Angellotti, John B. Wong, Ayal Pierce, Benjamin Hescott and Anastassios G. Pittas

Telephone-based motivational interviewing versus usual care in primary care to increase physical activity: a randomized pilot study

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 red...

Authors: Deborah Rohm Young, Miki K. Nguyen, Ayae Yamamoto, Magdalena Pomichowski, Melissa Cornejo, Silvia Paz, Karen J. Coleman, Robert E. Sallis and Stephen P. Fortmann

A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial

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.

Authors: Saahil Mehta, Suzie Cro Cro, Billie Coomber, Rachel Rolph, Victoria Cornelius and Jian Farhadi

Evaluation of clinical quality improvement interventions: feasibility of an integrated approach

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 year...

Authors: Sandeep Reddy, Kevin Mc Namara, Mary Malakellis, Tim Denton, Cathy McDonald, Jane Opie, Andrew Sanigorski and Vincent Versace

Effect of fish oil supplement administration method on tolerability and adherence: a randomized pilot clinical trial

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 deter...

Authors: Scott S. Malinowski, Katie E. Barber, Omayma A. Kishk, Andrew A. Mays, Sara R. Jones, Adrian L. Turner and Daniel M. Riche

Delirium is associated with frequency band specific dysconnectivity in intrinsic connectivity networks: preliminary evidence from a large retrospective pilot case-control study

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...

Authors: Robert Fleischmann, Steffi Traenkner, Antje Kraft, Sein Schmidt, Stephan J. Schreiber and Stephan A. Brandt

Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol

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 ot...

Authors: Claire Carswell, Joanne Reid, Ian Walsh, Helen McAneney and Helen Noble

A randomised, phase II, unblinded trial of an Exercise and Nutrition-based Rehabilitation programme (ENeRgy) versus standard care in patients with cancer: feasibility trial protocol

Authors: 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 and Barry J. Laird

Does a new spatial design in psychiatric inpatient care influence patients’ and staff’s perception of their care/working environment? A study protocol of a pilot study using a single-system experimental design

Research shows that worn-out physical environments are obstacles to psychiatric inpatient care. Patients want better relationships with staff and things to do; staff want an environment that offers hope, a cal...

Authors: Britt-Marie Lindgren, Jenny Molin, Mats Lundström, Maria Strömbäck, Ellinor Salander Renberg and Anders Ringnér

Study protocol for a randomised pilot study of a computer-based, non-pharmacological cognitive intervention for motor slowing and motor fatigue in Parkinson’s disease

Parkinson’s disease (PD) is a chronic, neurodegenerative disorder affecting over 137,000 people in the UK and an estimated five million people worldwide. Treatment typically involves long-term dopaminergic the...

Authors: Joshua S. Payne, John V. Hindle, Aaron W. Pritchard, R. Rhys Davies, Rudi Coetzer, Giovanni D’Avossa, R. Martyn Bracewell and E. Charles Leek

Visual training program for body dysmorphic disorder: protocol for a novel intervention pilot and feasibility trial

Body dysmorphic disorder (BDD) is a characterised by perceived defects or flaws in appearance which are associated with distressing thoughts, repetitive or obsessive behaviours, and significant impairment in s...

Authors: Francesca Beilharz, David J. Castle, Andrea Phillipou and Susan L. Rossell

Patch-augmented rotator cuff surgery (PARCS) study—protocol for a feasibility study

A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is...

Authors: Jonathan A. Cook, Naomi Merritt, Jonathan L. Rees, Joanna C. Crocker, Sally Hopewell, Melina Dritsaki, David J. Beard, Amar Rangan, Cushla Cooper, Lucksy Kottam, Dair Farrar-Hockley, Michael Thomas, Robert Earle and Andrew J. Carr

Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults: protocol for a feasibility study

Low-quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other h...

Authors: Anastasia V. Shvedko, Janice L. Thompson, Carolyn A. Greig and Anna C. Whittaker

Reducing weight gain in people with schizophrenia, schizoaffective disorder, and first episode psychosis: describing the process of developing the STructured lifestyle Education for People With SchizophrEnia (STEPWISE) intervention

Obesity is twice as common in people with schizophrenia as the general population and associated with significantly worsened psychiatric and physical health. Despite National Institute for Health and Care Exce...

Authors: Marian E. Carey, Janette Barnett, Yvonne Doherty, Katherine Barnard, Heather Daly, Paul French, Rebecca Gossage-Worrall, Michelle Hadjiconstantinou, Daniel Hind, Jonathan Mitchell, Alison Northern, John Pendlebury, Shanaya Rathod, David Shiers, Cheryl Taylor and Richard I. G. Holt

Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study

Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilita...

Authors: Paula Rogers, Sayed Al-Aidrous, Winston Banya, Shelley Rahman Haley, Tarun Mittal, Tito Kabir, Vasileois Panoulas, Shahzad Raja, Sunil Bhudia, Heather Probert, Claire Prendergast, Mark S. Spence, Simon Davies, Neil Moat, Rod S. Taylor and Miles Dalby

Feasibility study of goal setting discussions between older adults and volunteers facilitated by an eHealth application: development of the Health TAPESTRY approach

In keeping with the changing needs of the Canadian population, primary care systems need to become more person-focused in providing quality care to older adults. As part of Health TAPESTRY, a complex intervent...

Authors: Dena Javadi, Larkin Lamarche, Ernie Avilla, Raied Siddiqui, Jessica Gaber, Mehreen Bhamani, Doug Oliver, Laura Cleghorn, Dee Mangin and Lisa Dolovich

Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial

Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive beh...

Authors: Alyssa T. Brooks, Ralph T. Tuason, Subhajit Chakravorty, Shravya Raju, Lee M. Ritterband, Frances P. Thorndike and Gwenyth R. Wallen

Population-based paediatric respiratory infection surveillance: a prospective inception feasibility cohort study

There is a need to reduce unnecessary general practitioner (GP) consultations and improve antibiotic stewardship in primary care. Respiratory tract infections (RTIs) in children are the most common reason for ...

Authors: Emma C. Anderson, Suzanne Ingle, Peter Muir, Charles R. Beck, John P. Leeming, Joanna Kesten, Christie Cabral and Alastair D. Hay

Multimorbidity rehabilitation versus disease-specific rehabilitation in people with chronic diseases: a pilot randomized controlled trial

Multimorbidity (the co-existence of two or more chronic conditions in an individual) is a growing healthcare burden internationally; however, healthcare and disease management, including rehabilitation, is oft...

Authors: Kathryn Barker, Anne E. Holland, Annemarie L. Lee, Terry Haines, Kathryn Ritchie, Claire Boote, Joanne Saliba, Stephanie Lowe, Fiona Pazsa, Lee Thomas, Monica Turczyniak and Elizabeth H. Skinner

Peer-led intervention to prevent and reduce STI transmission and improve sexual health in secondary schools (STASH): protocol for a feasibility study

Young people in the UK are at highest risk of sexually transmitted infections and report higher levels of unsafe sex than any other age group. Involving peer supporters in intervention delivery is acceptable t...

Authors: Ross Forsyth, Carrie Purcell, Sarah Barry, Sharon Simpson, Rachael Hunter, Lisa McDaid, Lawrie Elliot, Julia Bailey, Kirsty Wetherall, Mark McCann, Chiara Broccatelli, Laurence Moore and Kirstin Mitchell

Safety and feasibility of an interactive workshop and facilitated outdoor walking group compared to a workshop alone in increasing outdoor walking activity among older adults: a pilot randomized controlled trial

Limited outdoor walking is a marker of frailty and a risk factor for decline in mobility and self-care functioning, social isolation, and reduced health-related quality of life (HRQL). Objectives were to evalu...

Authors: Ruth Barclay, Sandra Webber, Jacquie Ripat, Theresa Grant, C. Allyson Jones, Lisa M. Lix, Nancy Mayo, Cornelia van Ineveld and Nancy M. Salbach

A study protocol “saving futures: developing an integrated model of rehabilitation and paediatric HIV care to foster success at school”

A significant number of children experience disabilities as a result of living with HIV, including those on antiretroviral therapy (ART). Current paediatric HIV care does not prioritise rehabilitation. Further...

Authors: Verusia Chetty, Stacy Maddocks, Saul Cobbing and Jill Hanass-Hancock

Correction to: The help for people with money, employment or housing problems (HOPE) intervention: pilot randomised trial with mixed methods feasibility research

Abstract

Authors: M. C. Barnes, A. M. Haase, L. J. Scott, M-J Linton, A. M. Bard, J. L. Donovan, R. Davies, S. Dursley, S. Williams, D. Elliott, J. Potokar, N. Kapur, K. Hawton, R. C. O’Connor, W. Hollingworth, C. Metcalfe…

Point-of-care ultrasound-guided cannulation versus standard cannulation in haemodialysis vascular access: protocol for a controlled random order crossover pilot and feasibility study

Point-of-care ultrasound (POCUS) has been used in various vascular access contexts; however, to date, it has not been widely adopted in haemodialysis clinics. People with end-stage kidney disease receiving hae...

Authors: Monica L. Schoch, Judy Currey, Liliana Orellana, Paul N. Bennett, Vicki Smith and Alison M. Hutchinson

A cluster-randomised feasibility trial of a children’s weight management programme: the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study

Community-based programmes for children with excess weight are widely available, but few have been developed to meet the needs of culturally diverse populations. We adapted an existing children’s weight manage...

Authors: Miranda Pallan, Kiya L. Hurley, Tania Griffin, Emma Lancashire, Jacqueline Blissett, Emma Frew, Paramjit Gill, Karla Hemming, Louise Jackson, Kate Jolly, Eleanor McGee, Jayne Parry, Janice L. Thompson and Peymane Adab

Co-production and evaluation of an e-learning resource to improve African-Caribbean families’ knowledge about schizophrenia and engagement with services: a pilot randomised controlled trial protocol

A higher proportion of African-Caribbean people in the UK are diagnosed with schizophrenia spectrum disorders than other ethnic groups. High levels of shame and stigma at individual and community levels contri...

Authors: Henna Lemetyinen, Juliana Onwumere, Richard James Drake, Kathryn Abel, Carol Haigh, Georgina Moulton and Dawn Edge

A randomized controlled feasibility study to evaluate the effects of a goal-setting coaching intervention using feedback from an accelerometer on sedentary time in older people at risk of falls (SMART-MOVE): a study protocol

Sedentary behaviour and falls are important interrelated health issues in older people. One in three people aged 65 years and above fall at least once a year and sedentary behaviour has been identified as one ...

Authors: Kareeann Sok-Fun Khow, Joanne Dollard, Kathy Bray, Carla Smyth, Mellick Chehade, Olga Theou and Renuka Visvanathan

The help for people with money, employment or housing problems (HOPE) intervention: pilot randomised trial with mixed methods feasibility research

Job loss, austerity measures, financial difficulties and house repossession contribute to the risk of self-harm and suicide during recessions. Navigating the benefits system and accessing sources of welfare an...

Authors: M. C. Barnes, A. M. Haase, L. J. Scott, M-J Linton, A. M. Bard, J. L. Donovan, R. Davies, S. Dursley, S. Williams, D. Elliott, J. Potokar, N. Kapur, K. Hawton, R. C. O’Connor, W. Hollingworth, C. Metcalfe…

Research protocol: general practice organ donation intervention—a feasibility study (GPOD)

New interventions are required to increase the number of people donating their organs after death. In the United States of America (USA), general practice has proved to be a successful location to increase org...

Authors: Catrin Pedder Jones, Chris Papadopoulos, Gurch Randhawa and Zeeshan Asghar

Is it feasible to deliver a complex intervention to improve the outcome of falls in people with dementia? A protocol for the DIFRID feasibility study

People with dementia (PWD) experience ten times as many incident falls as people without dementia. Little is known about how best to deliver services to people with dementia following a fall. We used an integr...

Authors: Louise M. Allan, Alison Wheatley, Elizabeth Flynn, Amy Smith, Chris Fox, Denise Howel, Robert Barber, Tara Marie Homer, Louise Robinson, Steve Wayne Parry, Lynne Corner, Jim Anthony Connolly, Lynn Rochester and Claire Bamford

Testing the effectiveness of REACH Pregnancy Circles group antenatal care: protocol for a randomised controlled pilot trial

Antenatal care is an important public health priority. Women from socially disadvantaged, and culturally and linguistically diverse groups often have difficulties with accessing antenatal care and report more ...

Authors: Meg Wiggins, Mary Sawtell, Octavia Wiseman, Christine McCourt, Lauren Greenberg, Rachael Hunter, Sandra Eldridge, Penny Haora, Inderjeet Kaur and Angela Harden

Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study

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 i...

Authors: Elaine Denny, Annalise Weckesser, Georgina Jones, Stavroula Bibila, Jane Daniels and Siladitya Bhattacharya

Acute flares of knee osteoarthritis in primary care: a feasibility and pilot case-crossover study

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...

Authors: Martin J. Thomas, Stephanie Butler-Walley, Trishna Rathod-Mistry, Zoe Mayson, Emma L. Parry, Christopher Pope, Tuhina Neogi and George Peat

Blue blocking glasses worn at night in first year higher education students with sleep complaints: a feasibility study

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 disru...

Authors: Guillermo Perez Algorta, Anna Van Meter, Bernadka Dubicka, Steven Jones, Eric Youngstrom and Fiona Lobban

Mixed-methods single-arm repeated measures study evaluating the feasibility of a web-based intervention to support family carers of persons with dementia in long-term care facilities

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 ...

Authors: 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 and Jillian Paragg

The feasibility of using the EQ-5D-3L with adults with mild to moderate learning disabilities within a randomized control trial: a qualitative evaluation

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 a...

Authors: 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 and C. T. Hulme

Acceptability and feasibility of recruitment and data collection in a field study of hospital nurses’ handoffs using mobile devices

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. Th...

Authors: Patrick Lavoie, Sean P Clarke, Christina Clausen, Margaret Purden, Jessica Emed, Tanya Mailhot and Valerie Frunchak

Effects of yoga on oxidative stress, motor function, and non-motor symptoms in Parkinson’s disease: a pilot randomized controlled trial

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).

Authors: Corjena Cheung, Rozina Bhimani, Jean F. Wyman, Jürgen Konczak, Lei Zhang, Usha Mishra, Marcia Terluk, Reena V. Kartha and Paul Tuite

Overcoming barriers to use of child car seats in an urban Aboriginal community—formative evaluation of a program for Aboriginal Community Controlled Health Services

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 con...

Authors: Lisa Keay, Kate Hunter, Martyn Ralph, Bobby Porykali, Marilyn Lyford, Kathleen Clapham, Winston Lo and Rebecca Ivers

Developing an integrated rehabilitation model for thoracic cancer services: views of patients, informal carers and clinicians

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 a...

Authors: Joanne Bayly, Bethany M Edwards, Nicola Peat, Geoffrey Warwick, Ivo M Hennig, Arvind Arora, Andrew Wilcock, Irene J Higginson and Matthew Maddocks

Supporting general practitioner-based care for poorly controlled type 2 diabetes mellitus (the DECIDE study): feasibility study and protocol for a pilot cluster randomised controlled trial

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 reaso...

Authors: Mark E Murphy, Molly Byrne, Fiona Boland, Derek Corrigan, Paddy Gillespie, Tom Fahey and Susan M Smith

The ‘Better Conversations with Primary Progressive Aphasia (BCPPA)’ program for people with PPA (Primary Progressive Aphasia): protocol for a randomised controlled pilot study

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 s...

Authors: Anna Volkmer, Aimee Spector, Jason D Warren and Suzanne Beeke

Evaluation of a smartwatch-based intervention providing feedback of daily activity within a research-naive stroke ward: a pilot randomised controlled trial

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 ...

Authors: 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 and Helen Dawes

Using a peanut ball during labour versus not using a peanut ball during labour for women using an epidural: study protocol for a randomised controlled pilot study

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...

Authors: Virginia Stulz, David Campbell, Biing Yin, Wafa Al Omari, Robin Burr, Heather Reilly and Kenny Lawson

Formative research implications on design of a randomized controlled trial for oral health promotion in children

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...

Authors: Molly A Martin, Helen H Lee, Jazmin Landa, Mark Minier, David Avenetti and Anna Sandoval