Pilot and Feasibility Studies

BACKGROUND: There is a need to develop psychological interventions for depression in people with skin conditions. This study aimed to investigate the acceptability, feasibility, and effects of an online compassion-based self-help intervention for depression in people with skin conditions. METHODS: Adult participants (n = 34) with skin conditions and mild-moderate depressive symptoms were invited to undertake a six-week, compassion-based online intervention for depression with email support...

BACKGROUND: Health advances due to developments in genomic medicine are unequally experienced in the USA; racial differences in the uptake of genetic testing are one factor in this disparity. In collaboration with Black patients and diverse health care providers, we are developing a patient-centered video intervention to increase cancer genetic testing among eligible Black Americans. The objective of the pilot work is to explore the acceptability of and support for the intervention and key content components...

BACKGROUND: Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group. METHODS: The design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis...

BACKGROUND: Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients with impalpable disease. However, radical inguinal lymphadenectomy is associated with a high morbidity rate, and there is increasing usage of a videoendoscopic approach as an alternative. METHODS: A pragmatic, UK-wide multicentre feasibility randomised controlled trial (RCT), comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy...

BACKGROUND: Children's overall psychological well-being is a concern for parents and adults worldwide. Mindfulness appears to be a promising intervention for enhancing children's psychological well-being, and its effectiveness has been well-documented. However, there is a paucity of data on the feasibility and acceptability of implementing mindfulness-based interventions (MBIs) for children; this is a crucial factor in determining whether MBIs can be utilized to benefit children. The aim of this study was to determine the feasibility and acceptability of implementing MBIs among Hong Kong children...

BACKGROUND: Diabetes mellitus is the third most prevalent chronic metabolic disorder and a significant contributor to disability and impaired quality of life globally. Diabetes self-management coaching is an emerging empowerment strategy for individuals with type 2 diabetes, enabling them to achieve their health and wellness goals. The current study aims to determine the feasibility of a diabetes self-management coaching program and its preliminary effectiveness on the clinical and psychosocial outcomes in the Ethiopian primary healthcare context...

BACKGROUND: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS...

BACKGROUND: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. OBJECTIVES: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees...

BACKGROUND: Half of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement and attention to the child to promote social-emotional well-being and thereby mental health resilience...

BACKGROUND: Clinical guidelines for people with Parkinson's disease (pwPD) stress that, complementary to pharmacological treatment, exercise and physiotherapy should be given a central role in disease management. Adhering to regular exercise of the right type, and with high repetition, remains a challenge for pwPD. Exergaming has the potential to increase adherence through play and personalised interventions, both in clinic and at home. Reality DTx® is an augmented-reality (AR) home-based gait-and-balance exergaming intervention specifically designed for pwPD as an extension of supervised physiotherapy...

BACKGROUND: A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK), and there have been issues relating to low engagement when it has been used in a real-world context...

BACKGROUND: Setting healthy lifestyle habits during the formative years of childhood is critical as habits can track to adulthood and help prevent obesity and chronic disease risks in later life. While multicomponent interventions have been shown to be effective in changing the lifestyle behaviours of children, there is a limited understanding of the feasibility of such interventions in primary schools in Singapore. A multiphase mixed method study was conducted to develop and examine the feasibility of a theory-based multicomponent school-based intervention-Promoting hEatlthy Eating and Active Lifestyle (PEDAL)...

BACKGROUND: Food insecurity is common in the United States, especially in Rhode Island, where it affects up to 33% of residents. Food insecurity is associated with adverse health outcomes and disproportionally affects people from minoritized backgrounds. Produce prescription programs, in which healthcare providers write "prescriptions" for free or reduced cost vegetables, have been used to address food insecurity and diet-related chronic disease. Although there is growing evidence for the effectiveness of produce prescription programs in improving food security and diet quality, there have been few efforts to use implementation science methods to improve the adoption of these programs...

BACKGROUND: Patients with minor stroke or transient ischemic attacks have an increased risk of future strokes. These patients are often discharged home with limited specialized follow-up, although close to half of them experience cognitive deficits. Simple encouragements to avoid smoking, be physically active, and to take preventive medication are often insufficient to ensure adherence and more comprehensive interventions are needed to support the patients in adapting healthy behaviour...

BACKGROUND: Physical activity is identified as a key modifiable factor towards good short- and long-term mental health and has shown positive effects on anxiety and depression in children and adolescents. However, physical activity-based interventions are not a part of standard mental health care and evidence on the effect of such interventions is still lacking. A transdiagnostic, physical activity-based intervention was developed as a supplement to routine clinical care for youth in specialized child and adolescent mental health services...

INTRODUCTION: People with severe mental illness have physical comorbidities which result in significant reductions in quality of life and premature mortality. Effective interventions are required that are suitable for people in secure forensic mental health services. We conducted pilot work of a multidisciplinary weight management intervention (Motiv8) which showed improvements in physical and mental health and high levels of satisfaction. We aim to test the feasibility of Motiv8 under cluster randomised conditions, with an aim to investigate the acceptability, feasibility and potential effectiveness of this intervention to supplement standard secure care...

BACKGROUND: Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives' implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures...

Oral anti-cancer medications (OAMs) are being used increasingly within cancer care. OAMs offer the potential to improve patient convenience and increase hospital capacity. The clinical assessment for each cycle of OAMs requires specialist patient review often performed in hospital-based oncology units. Consequently, any potential improvement in patient expediency or increased hospital capacity that OAMs can offer is not realised. This study aimed to develop and pilot the specialist assessment of patients receiving OAMs by an Advanced Nurse Practitioner (ANP) in a community-based location...

BACKGROUND: Hypoxaemia occurs in approximately 30% of children during anaesthesia for flexible bronchoscopy. High-flow nasal oxygen (HFNO) can prolong safe apnoea time and be used in children with abnormal airways. During flexible bronchoscopy, there is limited evidence if HFNO confers advantages over current standard practice in avoiding hypoxaemia. The aim is to investigate feasibility of HFNO use during anaesthesia for flexible bronchoscopy to reduce frequency of rescue oxygenation and hypoxaemia...

BACKGROUND: During the COVID-19 pandemic, there was a substantial interruption of care, with patients and workers fearful to return to the dental office. As dental practice creates a highly aerosolized environment, the potential for spread of airborne illness is magnified. As a means to increase safety and mitigate risk, pre-visit testing for SARS-CoV-2 has the potential to minimize disease transmission in dental offices. The Pragmatic Return to Effective Dental Infection Control through Testing (PREDICT) Feasibility Study examined the logistics and impact of two different testing mechanisms (laboratory-based PCR viral testing and point-of-care antigen testing) in dental offices...