Pilot and Feasibility Studies最新文献

Background: Supervision of opioid agonist treatment (OAT) ensures that individuals take their correct daily dose to minimise withdrawal and craving, safeguard against diversion and overdose, and receive optimal benefit from OAT. There is an urgent need to develop effective interventions to increase medication adherence and technological solutions to streamline communication between pharmacies and prescribers. The authors have developed technology to deliver contingency management (CM) remotely by mobile telephone (mCM) and alert prescribers of missed doses. In a previous feasibility study, the authors found mCM was feasible to deliver and acceptable to patients, prescribers, and pharmacists but encountered difficulty recruiting patients starting methadone treatment. Since COVID-19, supervision guidelines have changed to focus on patients at risk of/not adhering to their medication. This study aims to assess the feasibility of conducting a future confirmatory trial to assess the clinical and cost-effectiveness of mCM to encourage adherence with supervised methadone or buprenorphine. It will use broader eligibility criteria, including patients receiving buprenorphine, and target a revised group of serial re-starters.

Methods: Using a cluster randomised design, three drug services will be randomised 1:1:1 and 20 patients, attending seven pharmacies linked to each service, will be recruited (i.e. a total of N = 60). Each drug service providing supervised medication will be randomly allocated to deliver: (i) telephone-delivered text-message reinforcement with modest financial incentives; (ii) telephone-delivered text-message reminders; or (iii) no telephone text-messages. Prescribers will receive reports of patient attendance. Feasibility will be determined based on four progression criteria: the number of patients enrolled, the percentage of screened patients who are eligible, adherence to the telephone system, based on matches between sign-in at the pharmacy and pharmacy dispensing records and follow-up rates. We will also undertake qualitative assessments of clinicians' perspectives on the revised eligibility criteria undertaken.

Discussion: This study will assess the feasibility of using mCM to target a clinically important group of patients non-adhering to their supervised medication. In the future, and if effective, mCM will encourage medication adherence among patients, enabling them to achieve an optimum dose and full benefit from OAT.

Trial registration: ISRCTN33965312 (26/06/2023). This manuscript was submitted on February 27th, 2024. While recruitment was due to end on February 29th, we recruited our last patient on February 12th. The last patient/last visit took place on May 2nd, 2024.

Background: People with Parkinson's disease can experience psychological distress and have difficulties accessing face-to-face psychological support due to symptom burden and limited availability of psychological services. Digital options for psychological support can bridge this gap. We have developed an app based on acceptance and commitment therapy (ACT) to support people with Parkinson's to improve psychological wellbeing.

Aim: To assess the acceptability of the app and the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of using the app to improve wellbeing for people with Parkinson's.

Methods: We will conduct a parallel-group randomised controlled feasibility trial comparing a digital app based on ACT (intervention group) to usual care (waitlist control group). We will recruit 60 people with Parkinson's, 40 to the intervention group and 20 to the control group. Primary feasibility outcomes include recruitment and retention rate, intervention engagement and satisfaction. Secondary outcomes include measures of clinical effectiveness (anxiety and depression), quality of life and cost-effectiveness. Interviews will be conducted to assess acceptability of the app. Primary feasibility outcome data will be analysed descriptively and compared against pre-defined feasibility criteria. Secondary outcomes will be analysed based on an intention-to-treat principle, and a cost-consequence analysis will be used to estimate cost-effectiveness. Interviews will be analysed using a deductive thematic analysis based on the Theoretical Framework of Acceptability.

Discussion: This trial will provide data on the feasibility of conducting a full-scale RCT of the effectiveness and cost-effectiveness of the app to improve psychological wellbeing for people with Parkinson's disease.

Background: Maintaining mobility in the long term after stroke can be challenging. Furthermore, access to ongoing physiotherapy or exercise programs is limited. There is a need to investigate new models of service delivery to improve mobility in the longer term after stroke. A mobility booster program may be a solution, facilitating short-term access to physiotherapy on an as-needed basis. The aim of this project is to determine the feasibility of conducting a clinical trial of a short-term, high-dose mobility booster program (HiWalk) and measure clinical outcomes in order to estimate the power for a future efficacy trial.

Method: A multi-site, assessor-blinded pilot randomized trial will be undertaken to compare HiWalk in addition to usual care with usual care alone in 50 participants. Feasibility outcomes include recruitment, adherence, and safety. Clinical outcomes include walking speed, capacity and self-efficacy at 1-month and 6-months.

Discussion: A mobility booster program may be a successful way to deliver mobility training in the longer term after stroke. This pilot trial will progress the investigation of this model and assist in planning a future definitive trial. Most importantly, it will confirm the feasibility of delivering a novel high-dose, short-term booster program.

Trial registration: ANZCTR (ACTRN: ACTRN12623000316606p).

Background: Chronic musculoskeletal pain conditions affect millions of people worldwide and place a significant burden on individuals and the healthcare systems. Managing chronic musculoskeletal pain requires a multidisciplinary approach that considers biological, psychological, and social factors. However, access to multidisciplinary pain care is challenging, and long wait times can lead to increased stress and health deterioration. Mindfulness-based stress reduction (MBSR) is a mind-body approach developed specifically to reduce the distress of living with chronic conditions, such as chronic musculoskeletal pain. This study proposed a novel approach by offering an online MBSR program to patients on waitlists to attend a multidisciplinary pain clinic in Australia's public healthcare system that could improve health outcomes. The study aims to assess the feasibility, acceptability, and potential efficacy of this approach using a pilot study design with a mixed-methods approach.

Methods: This is a mixed-methods pilot randomised controlled trial with an embedded qualitative study. Participants will be recruited from waitlists at two multidisciplinary pain management centres within the Sydney Local Health District in New South Wales, Australia. This pilot trial will randomly assign 32 individuals with chronic musculoskeletal pain to either an online MBSR group or a usual care control group. Feasibility outcomes, patient-reported outcomes, adherence to mindfulness practice, and adverse events will be assessed using validated questionnaires. Semi-structured interviews will be conducted with participants in the MBSR group to explore their experiences and evaluate acceptability, and barriers and facilitators of engagement with the intervention.

Discussion: This pilot study will evaluate a novel approach to integrating MBSR into the Australian public healthcare system as a mechanism for providing support to individuals with chronic musculoskeletal pain who are waitlisted for a multidisciplinary pain management program. Findings from this study will indicate the feasibility, acceptability, safety, and preliminary efficacy of this approach in terms of patient-reported outcomes to guide the design of future large-scale clinical trials.

Trial registration: This trial was prospectively registered in the Australian New Zealand Clinical Trials Registry (ACTRN12622000822785).

Background: The traditional use of sealed envelopes for randomisation is susceptible to manipulation and the risk of damage to envelopes during shipping and storage. Additionally, the filling and sealing of envelopes are tedious, time-consuming, and error-prone. Other randomisation alternatives such as web-based methods are preferred. However, they are expensive and unsuitable in settings with poor internet infrastructure. Mobile phone-based randomisation using short message service (SMS) potentially offers a low-cost and reliable alternative.

Methods: We developed an SMS-based method for random allocation of treatments. Plain text messaging or an Android app was used to formulate text messages using a fixed syntax consisting of the participant's unique identifier, trial site, stratum, and the trial name as input parameters. The system verified the input parameters and obtained an allocation from the database before returning a response to the sender. The text response contained the details of the treatment allocation. This was a Study Within A Trial (SWAT) conducted in two sites of a multi-site 3 × 2 factorial clinical trial in Kenya involving two interventions with up to nine possible allocations. SMS randomisation feasibility was assessed by comparing treatment allocations against the master randomisation list for each processed SMS, measuring SMS latency (in seconds), and gathering user feedback via a post-implementation survey.

Results: A total of 218 participants were randomised between the 7th of February 2022 and the 11th of April 2022, out of which 179 were randomised to only one arm while 39 were randomised to both treatment arms. Allocation accuracy was 100%. Median latency was 22 s with the fastest message processed in 10 s and the slowest (non-network delayed) message processed in 2129 s. Four users completed a post-implementation survey.

Conclusions: The pilot study demonstrated that SMS randomisation is easy, user-friendly, fast, accurate, and a feasible alternative randomisation technique.

Background: Multiple Sclerosis (MS) is a long-term condition that significantly diminishes quality of life (QoL). Sexual difficulties (SDs) are common, but often overlooked symptom, affecting 50-80% of people with MS (PwMS). The emergence of SDs in MS results from the intricate interplay of disease processes, treatments, and psychosocial factors, contributing to a further decline in QoL and adverse effects on body image, relationships, and psychological well-being. Despite the limited treatment options, which mainly include medications and physiotherapy, there is promise in psychological interventions for addressing SDs in PwMS, although integrating them into routine care poses challenges. This protocol details the trial assessing the acceptability and feasibility of an eight-session, clinicians supported integrated Psychosexual Intervention for people with Multiple Sclerosis (PIMS).

Methods: This is a multicentre interventional two-arm randomized feasibility trial with a nested qualitative study to gather preliminary data about the intervention and the feasibility of conducting a full-scale trial. We aim to recruit 50 PwMS across three research sites in England's National Health Service (NHS). Participants will be randomised to either the PIMS intervention (comprised of 8 sessions: 6 self-led and 2-facilitator led over the course of 12 weeks) or psychosexual education (one appointment with a facilitator to discuss treatment options). Feasibility will be assessed by collecting descriptive data on recruitment and retention rates and willingness to be randomised according to Consolidated Standards of Reporting Trials (CONSORT) feasibility and pilot trial guidelines. Patient reported outcomes (e.g., measures of sexual functioning and distress, psychological functioning, and quality of life) will be measured at baseline and follow up 14-weeks after randomisation. We will also use a nested qualitative study will use inductive thematic analysis to identify barriers to engagement with and delivery of the intervention, and to make appropriate modifications to PIMS.

Discussion: The PIMS intervention will be the first integrated psychosexual intervention developed for people with Multiple Sclerosis in the UK. Assessing the feasibility of PIMS is an important first step to establishing future implementation and efficacy via a definitive randomised controlled trial.

Trial registration: This trial is registered at ISRCTN: 12202900 . Registration date: 28th February 2023; Retrospectively registered. IRAS identification: 305830. NIHR award reference: NIHR202006. Trial sponsorship: This trial is co-sponsored by South London and Maudsley NHS Foundation Trust and King's College London.

Contact:  slam-ioppn.research@kcl.ac.uk.

Protocol version:  2.0, 10th February, 2025.

Background: Clinical guidelines recommend that people with chronic non-specific neck pain self-manage symptoms with physiotherapy-led exercise. However, current exercise strategies have modest short-term effects, engagement is poor, and 48% of people continue to experience long-term and recurrent pain. Updated exercise strategies co-produced using complex intervention development frameworks are required that consider the behavioural, psychological, environmental, and technical aspects of exercise prescription and patient adherence to optimise symptom outcomes, long-term engagement, and self-management. This study tests the feasibility and acceptability of the EPIC-Neck programme ("Exercise Prescription Improved through Co-design") which is grounded in evidence and theory and was co-produced using intervention mapping principles. The aim of the EPIC-Neck programme is to optimise the short-term outcomes of and long-term engagement with neck exercise.

Methods: This is a randomised feasibility study with process evaluation to assess the feasibility and acceptability of the EPIC-Neck programme and inform the design of a large-scale definitive trial evaluating the clinical and cost-effectiveness of the EPIC-Neck programme. A multicentre two-arm randomised controlled feasibility study aiming to recruit 45 adults with chronic non-specific neck pain will be conducted in UK NHS musculoskeletal physiotherapy departments. Recruitment will be from waiting lists and clinic advertisements. Participants will be individually randomised in 2:1 ratio to either the EPIC-Neck programme (n = 30) or usual exercise care (n = 15). The primary feasibility objective is to determine whether to continue to a large-scale definitive trial by evaluating delivery fidelity, acceptability, contamination, and rates of recruitment and retention (outcome completion at follow-up). Other feasibility objectives are to evaluate safety, define usual exercise care, refine the EPIC-Neck programme and training, and explore the demographics of people who do and do not enrol onto the study. Outcomes will be assessed by questionnaires at baseline and at 3- and 6-month post-randomisation, appointment audio-recordings, and one-to-one semi-structured interviews with participants receiving the EPIC-Neck programme (n = 12-15) and physiotherapists.

Discussion: This feasibility study will provide evidence of the feasibility and acceptability of the EPIC-Neck programme and guide the development of a definitive randomised controlled trial evaluating its clinical and cost-effectiveness within the NHS.

Trial registrations: ISRCTN81746901.

Background: Despite extensive resilience research with military personnel, progress in developing effective resilience-specific interventions for military service members (MSM) has been limited. To inform the design of effective prevention and intervention strategies, a better understanding of the neurocognitive, behavioral, and social processes associated with resilience is needed. This paper reports on a pilot study testing the feasibility of methods and procedures, to be used in the Advancing Research on Mechanisms of Resilience (ARMOR) longitudinal cohort study. Pilot trial objectives were to evaluate the feasibility of recruitment, retention, and data collection against pre-specified progression criteria for determining whether to proceed with the large-scale study.

Methods: This pilot trial used a pre-test/post-test design with an embedded laboratory sub-study. Participants were young recruits who had recently enlisted in the US Army National Guard and had not yet shipped to Basic Combat Training (BCT). Recruitment and baseline data collection at local armories involved computerized self-report measures and neurocognitive tests. Participants completed a web-based follow-up survey on personal devices after BCT. A subset of participants was recruited to complete laboratory procedures pre- and post-BCT, including clinical interviews and neurobehavioral tasks. To evaluate the feasibility of collecting real-time assessments of military stressors, participants were randomized to receive web-based surveys during BCT.

Results: Among the 105 military service members approached, 101 (96.2%) were recruited. Baseline data collection and retention methods were considered feasible; the response rate to the follow-up survey was over 70%. Recruitment and data collection for the laboratory sub-study were also considered feasible; more than 90% of participants completed follow-up laboratory visits. The collection of web-based surveys during BCT and computerized neurocognitive testing at follow-up was not considered feasible; the large-scale study will remove these components.

Conclusions: Progression to the large-scale trial, with design refinements, was concluded. Lessons learned and recommendations for future research are discussed.

Background: As patient care becomes more complex, high-quality communication and relationships among healthcare professionals are critical to coordinating care. Relational coordination (RC), a process of high-quality communication supported by shared goals, shared knowledge, and mutual respect, is positively associated with better patient (e.g., quality of care) and staff (e.g., job satisfaction, and retention) outcomes. A few researchers have found that communication skills training improves RC in civilian hospitals. However, researchers have not tested the feasibility of conducting communication skills training based on the RC framework among healthcare professionals in military hospitals. To address this gap, we propose conducting an RC training intervention in a military hospital. The primary aim of the proposed pilot study is to determine the feasibility (e.g., recruitment, retention, and completion rates) of conducting an RC training intervention in an Army medical center. The secondary aim is to explore the acceptability and usability of the RC training intervention. We will also explore changes in RC, quality of care, job satisfaction, and intent to stay among participants following the RC training intervention.

Methods: A single-group feasibility study will be conducted among nurses and physicians from three units (intensive care unit, medical-surgical, and labor and delivery unit). A convenience sample of licensed practical nurses (LPNs), registered nurses (RNs), resident physicians, and physicians from the participating units will be invited to complete a 1-h RC training intervention once a month for 3 months. Participants will complete RC, quality of care, job satisfaction, and intent to stay measures at baseline and 2 weeks after each RC training intervention session. To assess the feasibility of conducting an RC training intervention, we will examine recruitment/retention rates, intervention session completion rates, and survey measure completion rates. Acceptability will be assessed qualitatively through focus group interviews, and results will be used to refine the intervention and determine if the selected measures align with participant experiences. For our secondary aim, we will explore the acceptability of the RC training intervention through focus group interviews. We will also explore changes in outcome measures using descriptive statistics with 95% confidence intervals.

Discussion: Findings will establish the feasibility and acceptability of conducting an RC intervention in a military hospital and inform refinement of the intervention and study procedures prior to conducting a larger randomized controlled trial to establish efficacy.

Background: Cerebral visual impairment (CVI) refers to brain-related vision difficulties, which are often undiagnosed and may lead to poor mental health outcomes. We have developed an intervention to improve mental health outcomes for affected children, and it requires evaluation. The aim of this study was to assess the feasibility of methods proposed for a future definitive cluster randomised trial.

Methods: This 18-month study took place in South West England, UK, between 2019 and 2021 including a 6-month pause due to the COVID pandemic. Participants were children aged 7-10 years in mainstream primary schools and their teachers and parents. We recruited head teachers on behalf of their school. The intervention was a resource pack for teachers explaining about CVI, providing universal and targeted strategies to help children with CVI and the offer of CVI assessments at the local eye clinic. The control schools continued with usual practice. Our objectives were to evaluate the feasibility of recruitment and data collection, attrition, acceptability of the study methods and implementation of the intervention. We conducted a process evaluation including interviews and questionnaires.

Results: We sent invitation letters to 297 schools, received responses to 6% and recruited 40% of these (7 schools, 1015 children). Parents of 36/1015 (3.5%) children opted out. Baseline data were collected from teachers for 94% children, and 91% children completed self-report questionnaires; parent-report questionnaires were returned for 19% of children. During the exceptional circumstance of the COVID pandemic, two schools left the study, and many children were not attending school, meaning follow-up data were received from 32% of children, 16% of teachers and 14% of parents. Interview data indicated that the intervention was acceptable, and teachers would have preferred on-site eye tests to the offer of a clinic appointment and a clear timetable for study events. Teachers in intervention schools reported expected changes in the children's and their own behaviour. There was some contamination between study arms.

Conclusions: A full-scale trial would be feasible, enhanced by insights from this feasibility trial, in non-pandemic times. Sharing these data with teachers, education policymakers and parents is planned to refine the design.

Trial registration: ISRCTN13762177.