Pilot and Feasibility Studies

BACKGROUND: To date, evaluations of take-home fentanyl (and/or benzodiazepine) test strip use - the most common form of drug checking services - and potential effects on overdose risk have relied on retrospective accounts for some preceding time period, usually a week to several months. Such accounts, however, are subject to recall and memory biases. This pilot study assessed the feasibility of using experiential sampling to collect daily information in situ on drug checking and associated overdose risk reduction - the primary outcomes - among a sample of street opioid users and compared the results to retrospective reports...

OBJECTIVE: To determine the feasibility and acceptability of a diabetes insulin self-management education (DIME) group intervention for people with type 2 diabetes starting insulin. DESIGN: Single-centre parallel randomised pilot trial. SETTING: Primary care, South London, UK. SUBJECTS: Adults with type 2 diabetes, requiring insulin treatment, on maximum tolerated dose of 2 or more oral antidiabetic drugs with HbA1c > / = 7...

INTRODUCTION: The goal of paediatric hand and foot burn management is hypertrophic scar and/or contracture prevention. The risk of scar formation may be minimised by integrating negative pressure wound therapy (NPWT) as an acute care adjunct as it decreases the time to re-epithelialisation. NPWT has known associated therapeutic burden; however, this burden is hypothesised to be outweighed by an increased likelihood of hypertrophic scar prevention. This study will assess the feasibility, acceptability and safety of NPWT in paediatric hand and foot burns with secondary outcomes of time to re-epithelialisation, pain, itch, cost and scar formation...

BACKGROUND: Muscle tension dysphonia (MTD) results from inefficient or ineffective voice production and is the cause of voice and throat complaints in up to 40% of patients presenting with hoarseness. Standard treatment is voice therapy (SLT-VT) delivered by specialist speech therapists in voice disorders (SLT-V). The Complete Vocal Technique (CVT) is a structured, pedagogic method which helps healthy singers and other performers optimise their vocal function enabling them to produce any sound required...

BACKGROUND: There has been a growing focus on functional communication interventions for primary progressive aphasia (PPA). These interventions aim to support individuals to participate in life situations. One such intervention, communication partner training (CPT) aims to change conversation behaviours in both the person with PPA and their communication partner (CP). CPT has a growing evidence base in stroke aphasia; however, these programmes are not designed to meet the needs of people with progressive communication difficulties...

BACKGROUND: Chronic heat therapy may have beneficial effects on cardiovascular function. These effects may be more pronounced in older adults. We performed a pilot feasibility study of repeated heat therapy sessions in a hot tub (40.5 °C) in older adults while wearing a noninvasive hemodynamic monitor. As part of the protocol, the volunteers underwent cardiovascular performance testing pre- and post-intervention. METHODS: Fifteen volunteers > 50 years old underwent 8-10 separate 45-min hot tub session over 14 days in this exploratory and mixed methods trial...

BACKGROUND: Patients with multiple myeloma (MM) increasingly face complicated treatment regimens. E-health may support patients and healthcare providers in enhancing a patient-centered healthcare approach. Therefore, we aimed to develop a patient-centered multi-modality e-health application, to assess the application for usability and end-user experiences. METHODS: The application was developed following an iterative "action-based" methodology using the design thinking approach...

BACKGROUND: Polypharmacy is associated with poorer health outcomes in older adults. Other than the associated multimorbidity, factors contributing to this association could include medication adverse effects and interactions, difficulties in managing complicated medication regimes, and reduced medication adherence. It is unknown how reversible these negative associations may be if polypharmacy is reduced. The purpose of this study was to determine the feasibility of implementing an operationalized clinical pathway aimed to reduce polypharmacy in primary care and to pilot measurement tools suitable for assessing change in health outcomes in a larger randomized controlled trial (RCT)...

BACKGROUND: This study assessed the initial feasibility and preliminary efficacy of providing children a free summer day camp and a parent intervention to improve self-regulation and mitigate accelerated summer BMI gain. METHODS: This pilot 2x2 factorial randomized control trial used a mixed-methods design to evaluate providing children a free summer day camp (SCV), a parent intervention (PI), and the combination of these two strategies (SCV+PI) to mitigate accelerated summer body mass index (BMI) gain...

BACKGROUND: Exposure to secondhand tobacco smoke (SHS) and child maltreatment are preventable threats to child health. Few evidence-based interventions target both SHS and child maltreatment risk. The purpose of this paper is to describe the systematic braiding process of two evidence-based programs to address child SHS in the home and maltreatment perpetration risk, and present results from the formative work and pilot study. METHODS: The first 4 steps of the systematic braiding process were completed, including the following: (1) the identification of core elements of both programs, (2) the development of an initial draft of the braided curriculum (Smoke-Free Home SafeCare - SFH-SC), (3) an acceptability and feasibility pilot of SFH-SC with caregivers of young children who reported a smoker living in the home (N = 8), and (4) feedback collection on the braided curriculum from SafeCare Providers (N = 9)...

BACKGROUND: OptiBreech Care is a care pathway for breech presentation at term, including where chosen, physiological breech birth attended by professionals with advanced training and/or proficiency. We aimed to assess the feasibility of implementing OptiBreech team care prior to proceeding with a planned pilot randomised controlled trial. METHODS: Our design was an observational implementation feasibility assessment across England and Wales, January 2021-June 2022...

PURPOSE: The primary objective was to investigate the feasibility of a synchronous, online-delivered, group-based, supervised, exercise oncology maintenance program supported with health coaching. METHODS: Participants had previously completed a 12-week group-based exercise program. All participants received synchronous online delivered exercise maintenance classes, and half were block randomized to receive additional weekly health coaching calls. A class attendance rate of ≥ 70%, a health coaching completion rate of ≥ 80%, and an assessment completion rate of ≥ 70% were set as markers of feasibility...

OBJECTIVE: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. METHODS: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy...

BACKGROUND: Hepatitis C virus (HCV) is the leading indication for liver transplantation and liver-related mortality. The development of direct-acting antivirals (DAA) and a simplified treatment algorithm with a > 97% cure rate should make global elimination of HCV an achievable goal. Yet, vulnerable populations with high rates of HCV still have limited access to treatment. By designing locally contextualized site-specific HCV treatment workflows, we aim to cure HCV in vulnerable, high-risk populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), in Austin, TX, USA...

BACKGROUND: Parkinson's disease (PD) is a common neurodegenerative disease. No disease-modifying treatment is available, and therapy is symptomatic. The histopathologic hallmark is the loss of dopaminergic neurons and accumulation of α-synuclein (α-syn) in surviving neurons, but the underlying pathophysiology is unclear. Inflammatory mechanisms seem to play a prominent role, with an imbalance of immune functions and neurotoxicity caused by reactive oxygen species (ROS). Involvement of peripheral adaptive immunity, with an imbalance in T cell subpopulations and in the expression of transcriptional factors in CD4+ T cells, has also been reported...

BACKGROUND: Apathy is among the most common behavioral symptoms in dementia and is consistently associated with negative outcomes in Alzheimer's disease (AD). Despite its prevalence and clinical relevance, available pharmacological and non-pharmacological strategies to treat apathy in AD have been marked, respectively, by potentially severe side effects and/or limited efficacy. Transcranial direct current stimulation (tDCS) is a relatively novel non-pharmacological method of neuromodulation with promising results...

BACKGROUND: Despite effective treatments, one fifth of patients develop chronic depression. Music therapy may offer a different approach. This study aimed to assess feasibility and acceptability of a music therapy intervention and trial methodology. METHODS: A parallel two-arm randomised controlled trial with wait-list control, mixed feasibility/acceptability measures and nested process evaluation. Adults with long-term depression (symptom duration > 1 year) were recruited from community mental health services and computer randomised to 42 sessions of group music therapy with songwriting three times per week or wait-list control...

BACKGROUND: Homelessness is associated with high prevalence of psychiatric disorders such as substance use disorders, including alcohol use disorder, and depression. METHODS: This case series and feasibility trial evaluated a novel integrated cognitive behavioral treatment (ICBT), which was adapted specifically for homeless individuals and developed to treat substance use and depressive symptoms simultaneously. The ICBT was delivered among four homeless individuals enrolled in the Treatment First program (a social services program where treatment is offered in conjunction with temporary transitional housing), who had access to stable and sober housing milieus...

BACKGROUND: Despite a number of clinicians having been trained in Parent-Child Interaction Therapy (PCIT) in Aotearoa/New Zealand, few are regularly delivering the treatment, with barriers to use including a lack of suitable equipment and lack of professional support. This pragmatic, parallel-arm, randomised, controlled pilot trial includes PCIT-trained clinicians who are not delivering, or only rarely utilising, this effective treatment. The study aims to assess the feasibility, acceptability and cultural responsivity of study methods and intervention components and to collect variance data on the proposed future primary outcome variable, in preparation for a future, larger trial...

BACKGROUND: The reduction of goal-directed behavior is the main characteristic in motivational negative symptoms of psychosis as it accounts for the long-term decline in psychological well-being and psychosocial functioning. However, the available treatment options are largely unspecific and show only small effects on motivational negative symptoms. Interventions that directly target the relevant psychological mechanisms are likely to be more effective. For "Goals in Focus", we translated findings from basic clinical research on mechanisms underlying motivational negative symptoms into a tailored and comprehensive novel psychological outpatient treatment program...