Articles

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

Advancing global health through cardiovascular research, mentorship, and capacity building: in memoriam, professor Bongani Mayosi (1967–2018)

Authors: Jean B. Nachega, Mpiko Ntsekhe, Jimmy Volmink and Lehana Thabane

Feasibility and acceptability of technology-based caregiver engagement strategies delivered in a summertime childhood obesity prevention intervention: results from an internal pilot of the Camp NERF (Nutrition, Education, Recreation, and Fitness) study

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...

Authors: Laura C. Hopkins, Mary Fristad, Jacqueline D. Goodway, Bernadette Melnyk, Ihuoma Eneli, Chris Holloman, Julie A. Kennel, Alison Webster, Amy R. Sharn and Carolyn Gunther

Motivational interviewing for low mood and adjustment early after stroke: a feasibility randomised trial

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 eff...

Authors: Kulsum Patel, Caroline L Watkins, Chris J Sutton, Emma-Joy Holland, Valerio Benedetto, Malcolm F Auton, David Barer, Kausik Chatterjee and Catherine E Lightbody

A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi

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 ...

Authors: Allison I Daniel, Meta van den Heuvel, Melissa Gladstone, Mike Bwanali, Wieger Voskuijl, Celine Bourdon, Isabel Potani, Sara Fernandes, Jenala Njirammadzi and Robert H J Bandsma

Study protocol: a pilot randomized controlled trial to evaluate the acceptability and feasibility of a counseling intervention, delivered by nurses, for those who have attempted self-poisoning in Sri Lanka

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 t...

Authors: A. N. L. M. De Silva, Andrew H. Dawson, Indika B. Gawarammana, Sampath Tennakoon and Thilini Rajapakse

Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF)

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.

Authors: Eric Kai Chung Wong, Justin Yusen Lee, Darryl P. Leong, Lawrence Mbuagbaw, Haroon Yousuf, Sabina Keen, Sharon E. Straus, Christopher J. Patterson and Catherine Demers

Development, acceptability and feasibility of a communication skills training package for therapeutic radiographers to reduce fear of recurrence development in breast cancer patients (FORECAST2)

Many patients who have been treated for breast cancer experience high levels of fear that the cancer will return. The FORECAST pilot study showed that for a third of the patients, fears of cancer recurrence (F...

Authors: Mara van Beusekom, Josie Cameron, Carolyn Bedi, Elspeth Banks, Tom Kelsey and Gerry Humphris

Culturally congruent mentorship can reduce disruptive behavior among elementary school students: results from a pilot study

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 wi...

Authors: Arthur H. Owora, Najah Salaam, Sydney H. Russell Leed, Dessa Bergen-Cico, Timothy Jennings-Bey, Arnett Haygood El, Robert A. Rubinstein and Sandra D. Lane

Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study)

Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM ca...

Authors: Respati W. Ranakusuma, Amanda R. McCullough, Eka D. Safitri, Yupitri Pitoyo, Widyaningsih, Christopher B. Del Mar and Elaine M. Beller

Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial

Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflamm...

Authors: Kenneth S. Rankin, Jayasree Ramaskandhan, Michelle Bardgett, Katie Merrie, Rajkumar Gangadharan, Ian Wilson and David Deehan

‘Get Healthy!’ A physical activity and nutrition program for older adults with intellectual disability: pilot study protocol

Older adults with intellectual disability have high rates of lifestyle-related illness yet remain poorly engaged in physical activity and nutrition interventions. There is a need to clarify what types of healthy ...

Authors: Carmela Salomon, Jessica Bellamy, Elizabeth Evans, Renae Reid, Michelle Hsu, Scott Teasdale and Julian Trollor

Home-based balance training using Wii Fit™: a pilot randomised controlled trial with mobile older stroke survivors

Several studies have reported that using the Wii™ Balance Board can provide added value regarding balance (re-)training in neurological diseases. However, for the large group of mobile older stroke survivors, ...

Authors: André Golla, Tobias Müller, Kai Wohlfarth, Patrick Jahn, Kerstin Mattukat and Wilfried Mau

Post-infectious sequelae after Campylobacter enteric infection: a pilot study in Maricopa County, Arizona, USA

Campylobacter is a leading cause of gastroenteritis across the globe caused by the ingestion of contaminated food, water, or contact with animals carrying Campylobacter bacteria. The resulting disease, campylo...

Authors: Erika Barrett, Dametreea Carr, Melanie L. Bell and Kristen Pogreba-Brown

Adaptation of the Ambulatory and Home Care Record for collecting palliative care service utilisation data from family carers in the UK: a pilot study

Measuring service use and costs is an important aspect of service delivery evaluation. In end-of-life care, there is heavy reliance on care by family/friends (informal carers) and this should be reflected in t...

Authors: Laura M. Holdsworth, Heather Gage, Peter Williams and Claire Butler

Preoperative Behavioural Intervention versus standard care to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS): protocol for a multicentre pilot randomised controlled trial

Evidence suggests that increased preoperative alcohol consumption increases the risk of postoperative complications; therefore, a reduction or cessation in alcohol intake before surgery may reduce perioperativ...

Authors: Christopher Snowden, Ellen Lynch, Leah Avery, Craig Gerrand, Eilish Gilvarry, Nicola Goudie, Catherine Haighton, Lesley Hall, Nicola Howe, Denise Howel, Elaine McColl, James Prentis, Elaine Stamp and Eileen Kaner

Treating anxiety after stroke (TASK): the feasibility phase of a novel web-enabled randomised controlled trial

Anxiety affects a quarter of strokes. It can be disabling even after mild stroke and transient ischaemic attack (TIA). It is not feasible to deliver conventional psychological therapies to the large population...

Authors: Ho-Yan Yvonne Chun, Alan J. Carson, Martin S. Dennis, Gillian E. Mead and William N. Whiteley

The effect of alcohol strength on alcohol consumption: a randomised controlled cross-over pilot trial

Effective interventions are required to reduce alcohol consumption and its associated harms at the population level. Reducing the alcohol content of beverages has the potential to reduce alcohol consumption th...

Authors: Parvati R. Perman-Howe, Emma L. Davies and David R. Foxcroft

Pilot and feasibility studies in exercise, physical activity, or rehabilitation research

Clinical trials of physical activity and rehabilitation interventions can be challenging. Pilot or feasibility studies can be conducted prior to a definitive randomized controlled trial (RCT), to improve the c...

Authors: Rasha El-Kotob and Lora M. Giangregorio

A mixed-methods feasibility study protocol to assess the communication behaviours within the dental health professional-parent-child triad in a general dental practice setting

The promotion of twice yearly application of fluoride varnish (FVA) to the teeth of pre-school children in the dental practice is one component of Scotland’s child oral health improvement programme (Childsmile...

Authors: Siyang Yuan, Gerry Humphris, Al Ross, Lorna MacPherson, Yuefang Zhou and Ruth Freeman

Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations

Chronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality. Individuals with COPD experience inc...

Authors: Juthaporn Cowan, Sunita Mulpuru, Shawn Aaron, Gonzalo Alvarez, Antonio Giulivi, Vicente Corrales-Medina, Venkatesh Thiruganasambandamoorthy, Kednapa Thavorn, Ranjeeta Mallick and D. William Cameron

A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol

Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of comm...

Authors: M. M. Husted, A. M. Beck and L. K. Ulrikkeholm

Computerized positive mental imagery training versus cognitive control training versus treatment as usual in inpatient mental health settings: study protocol for a randomized controlled feasibility trial

Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training...

Authors: Simon E. Blackwell, Katharina Westermann, Marcella L. Woud, Jan C. Cwik, Torsten Neher, Christian Graz, Peter W. Nyhuis and Jürgen Margraf

Esmolol infusion in patients with septic shock and tachycardia: a prospective, single-arm, feasibility study

High adrenergic tone appears to be associated with mortality in septic shock, while adrenergic antagonism may improve survival. In preparation for a randomized trial, we conducted a prospective, single-arm pil...

Authors: Samuel M. Brown, Sarah J. Beesley, Michael J. Lanspa, Colin K. Grissom, Emily L. Wilson, Samir M. Parikh, Todd Sarge, Daniel Talmor, Valerie Banner-Goodspeed, Victor Novack, B. Taylor Thompson and Sajid Shahul

Evaluating a knowledge translation tool for parents about pediatric acute gastroenteritis: a pilot randomized trial

Pediatric acute gastroenteritis (AGE) is a common childhood illness with substantial health, family, and system impacts. Connecting parents to evidence-based patient education is key to effective decision-maki...

Authors: Lauren Albrecht, Shannon D. Scott and Lisa Hartling

A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint

It has been argued that true endpoints (or ‘hard’ endpoints) for clinical trials, which are meaningful to clinicians, researchers and patients alike, are limited to those that measure health status, survival a...

Authors: M. J. Campbell, G. A. Lancaster and S. M. Eldridge

Feasibility and outcomes of an out-of-school and home-based obesity prevention pilot study for rural children on an American Indian reservation

Children living in rural areas are at higher risk for obesity compared to urban children, and Native American (NA) children have the highest prevalence of overweight/obesity for all races combined. Out-of-scho...

Authors: Blakely Brown, Kari Jo Harris, Daniel Heil, Michael Tryon, Aric Cooksley, Erin Semmens, James Davis and Krupa Gandhi

Personalized behavior change program for glaucoma patients with poor adherence: a pilot interventional cohort study with a pre-post design

About half of people with glaucoma do not adhere to their recommended medications. Interventions for other chronic conditions have successfully utilized reminder systems and motivational interviewing (MI)-base...

Authors: Paula Anne Newman-Casey, Leslie M. Niziol, Chamisa K. Mackenzie, Kenneth Resnicow, Paul P. Lee, David C. Musch and Michele Heisler

Getting fit for hip and knee replacement: a protocol for the Fit-Joints pilot randomized controlled trial of a multi-modal intervention in frail patients with osteoarthritis

Joint replacement provides significant improvements in pain, physical function, and quality of life in patients with osteoarthritis. With a growing body of evidence indicating that frailty can be treated, it i...

Authors: Ahmed M. Negm, Courtney C. Kennedy, George Ioannidis, Olga Gajic-Veljanoski, Justin Lee, Lehana Thabane, Jonathan D. Adachi, Sharon Marr, Arthur Lau, Stephanie Atkinson, Danielle Petruccelli, Justin DeBeer, Mitchell Winemaker, Victoria Avram, Benjamin Deheshi, Dale Williams…

Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+)

The prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psycho...

Authors: Manaswi Sangraula, Edith van’t Hof, Nagendra P. Luitel, Elizabeth L. Turner, Kedar Marahatta, Jolene H. Nakao, Mark van Ommeren, Mark J. D. Jordans and Brandon A. Kohrt

Pilot trials in physical activity journals: a review of reporting and editorial policy

Since the early 2000s, a number of publications in the medical literature have highlighted inadequacies in the design, conduct and reporting of pilot trials. This work led to two notable publications in 2016: ...

Authors: Elsie Horne, Gillian A. Lancaster, Rhys Matson, Ashley Cooper, Andy Ness and Sam Leary

On the Road to Recovery psychological therapy versus treatment as usual for forensic mental health patients: study protocol for a randomized controlled feasibility trial

On the Road to Recovery (OTRTR) is a brief low intensity group psychological therapy that aims to improve patients’ insight into their mental disorder and develop adaptive coping skills to help manage distress. O...

Authors: Lindsey G. McIntosh, Morag Slesser, Suzanne O’Rourke and Lindsay D. G. Thomson