Protocol For Feasibility Study Research Articles

Evaluation of the usability and acceptability of the P-STEP® mobile app: feasibility study protocol

BackgroundThe new P-STEP® (Personalised Space Technology Exercise Platform) app is designed to bring together tailored exercise guidance and up-to-date air quality information. The app allows individuals to plan outdoor exercise walking routes while minimising their exposure to air pollution. Individuals with chronic long-term conditions, particularly respiratory and cardiovascular conditions, can use the app in order to minimise the risk of their symptoms being exacerbated by pollution, while still gaining the benefits of outdoor exercise.MethodsThis study will measure the usability and acceptability of the P-STEP® app. The study will take the form of a single-arm 12-week app pilot study based in Leicestershire, United Kingdom (UK). We will recruit a maximum of 380 participants from an existing cohort study to pilot the app for 12 weeks. Questionnaire data will be collected at three timepoints, baseline, 6 weeks and 12 weeks. The primary outcome is the System Usability Scale at 12 weeks. Secondary outcomes include the User Engagement Scale Short Form, SF-12, Recent Physical Activity Questionnaire (RPAQ), bespoke, app specific usability questions, and feasibility outcomes. Additional data collected includes participant demographic information, technology self-efficacy and adverse events. Weekly anonymised usage data from the app will also be collected by the app team and analysed separately to complement the questionnaire data.DiscussionThis study will help us better understand the feasibility and acceptability of using the P-STEP® in the community. The results will also help inform future studies.Ethics and disseminationThis study has received ethical approval from the South West Frenchay Research Ethics (23/SW/0060) Committee. There is no need for further approval from the Health Research Authority as the study is not taking place in the NHS. The ClinicalTrials.gov ID number is NCT05830318.

Transition to Adulthood through Coaching and Empowerment in Rheumatology (TRACER): A feasibility study protocol.

The transition from pediatric to adult care for patients with chronic disease is a vulnerable period, with risks of disengagement from care and subsequent complications of inadequately managed disease. This period comes at a time when there are many other transitions occurring in the young person's life, including changes to vocation, social supports, and to their physiology. The aim of the TRACER study is to assess the feasibility of conducting a multi-center, randomized-controlled trial of a virtual Transition Coach Intervention in youth transferring from pediatric to adult rheumatology care. Patients are being recruited at their last pediatric rheumatology visit from McMaster Children's Hospital and Children's Hospital, London Health Sciences Centre in Ontario, Canada. Participants are then randomized to standard of care or to eight transition coaching sessions, covering topics around health management, future planning, and self-advocacy. The primary outcomes of the study are to demonstrate protocol feasibility, including optimal recruitment and consent rates, ≥ 90% coaching session completion, and complete data collection with ≤ 5% missing data. Baseline demographics, transition readiness, global functional assessment, disease activity, and self-efficacy will be collected to characterize the study population. Recruitment has begun and is estimated to last 19 months. This study will inform the design of a robust, multi-centered, randomized-controlled study to investigate the impact of a virtual transition coaching program in supporting the physical, mental, and social well-being of youth with rheumatic disease transitioning into adult care. Clinical trial registration: ClinicalTrials.Gov protocol ID: 14499.

Pharmacist-led DE-eSCALation of opioids post-surgical dischargE (DESCALE) – A multi-centre, non-randomised, feasibility study protocol

Background Opioids are frequently prescribed for short-term acute pain following surgery. Used appropriately, opioids deliver extremely favourable pain relief. Used longer than 90-days, however, can result in health complications, including unintentional overdose and addiction. Globally, >40 million people are dependent on opioids and annually >100,000 die from opioid misuse. With >4.7 million surgical procedures occurring annually in the United Kingdom it is imperative that opioid-use is managed upon discharge. A declining General Practitioner (GP) workforce and increased patient numbers, however, means gaps in healthcare during transfer of care. Here we report a mixed-methods protocol to understand the feasibility, and acceptability of a clinical pharmacist (CP)-led early opioid deprescribing intervention for discharged surgical patients. Methods DESCALE is a multicentre, non-randomised, pragmatic feasibility study. Participants aged ≥18 years who have undergone a surgical procedure at a single NHS trust in Southeast England and discharged with opioids and without a history of long-term opioid use, cancer diagnosis or study contraindications will be offered a Medicines Use Review (MUR) within 7-10 days of discharge. The MUR will be delivered by CPs at participating GP practices. Feasibility outcomes will focus on recruitment, fidelity of CPs to deliver the MUR, and barriers within primary care that affect delivery of the intervention, with a maximum sample size of 100. Clinical outcomes will focus on the number of participants that reduce or stop opioid use within 91 days. Prescribing, medical, surgical, and demographic data for individual participants will be collected and analysed to inform future trial design. Qualitative interviews with participants and associated healthcare professionals will explore acceptability and implementation of the intervention. Conclusion Data collected with respect to opioid use post-surgery, feasibility and acceptability of the intervention, patient experience and outcome data will inform the design of future research and larger clinical trials.

FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study

IntroductionSelective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and...

Study protocol for a single-site feasibility study evaluating the adoption and fidelity of Prep-4-RT: prehabilitation for head and neck cancer patients undergoing radiotherapy

IntroductionPrep-4-RT is a co-designed stepped-care multimodal prehabilitation program for people scheduled to receive radiotherapy for head and neck cancer (HNC). Prehabilitation, which occurs between diagnosis and treatment commencement, aims to improve a patient’s health to reduce the incidence and severity of current and future impairments. HNC treatment can be distressing and has detrimental impacts on function and quality of life. HNC patients have increased social vulnerabilities including higher rates of socio-economic disadvantage and engagement in lifestyle habits which increase cancer risk. High levels of physical and psychological impacts of HNC treatment and increased social vulnerabilities of this population warrant investigation of optimal pathways of care, such as prehabilitation. This paper describes a research protocol to evaluate the feasibility of Prep-4-RT, which was designed to prepare HNC patients for the physical and psychological impacts of radiotherapy.Methods and analysisAt least sixty adult HNC patients, scheduled to receive radiotherapy (with or without chemotherapy), will be recruited over a five-month period. All participants will receive access to Prep-4-RT self-management resources. Participants identified through screening as high-risk will also be offered individualised interventions with relevant allied health professionals prior to the commencement of radiotherapy (psychologists, dietitians, speech pathologists and physiotherapists). Participants will complete evaluation surveys assessing their experiences with Prep-4-RT resources and interventions. Clinicians will also complete program evaluation surveys. Primary feasibility outcomes include adoption (uptake and intention to try) and fidelity (adherence to the specialist prehabilitation pathway). Secondary feasibility outcomes include acceptability (patient and clinician) of and satisfaction (patient) with Prep-4-RT as well as operational costs. Feasibility outcome data will be analysed using exact binomial and one-sample t tests, as appropriate.Ethics and disseminationEthics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national conferences and published in peer-reviewed journal(s) so that it can be accessed by clinicians involved in the care of HNC patients receiving radiotherapy. If the model of care is found to be feasible and acceptable, the transferability and scalability to other cancer centres, or for other cancer types, may be investigated.Registration detailsANZCTA (Australian New Zealand Clinical Trials Registry) ACTRN12623000770662.

Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments.

Early phase research suggests that physiotherapy paired with use of robotic walking aids provides a novel opportunity for children with severe mobility challenges to experience active walking. The Trexo Plus is a pediatric lower limb exoskeleton mounted on a wheeled walker frame, and is adjustable to fit a child's positional and gait requirements. It guides and powers the child's leg movements in a way that is individualized to their movement potential and upright support needs, and can provide progressive challenges for walking within a physiotherapy-based motor learning treatment paradigm. This protocol outlines a single group mixed-methods study that assesses the feasibility of physiotherapy-assisted overground Trexo use in school and outpatient settings during a 6-week physiotherapy block. Children ages 3-6 years (n = 10; cerebral palsy or related disorder, Gross Motor Function Classification System level IV) will be recruited by circle of care invitations to participate. Study indicators/outcomes will focus on evaluation of: (i) clinical feasibility, safety, and acceptability of intervention; (ii) pre-post intervention motor/functional outcomes; (iii) pre-post intervention brain structure characterization and resting state brain connectivity; (iv) muscle activity characterization during Trexo-assisted gait and natural assisted gait; (v) heart rate during Trexo-assisted gait and natural assisted gait; and (vi) user experience and perceptions of physiotherapists, children, and parents. This will be the first study to investigate feasibility indicators, outcomes, and experiences of Trexo-based physiotherapy in a school and outpatient context with children who have mobility challenges. It will explore the possibility of experience-dependent neuroplasticity in the context of gait rehabilitation, as well as associated functional and muscular outcomes. Finally, the study will address important questions about clinical utility and future adoption of the device from the physiotherapists' perspective, comfort and engagement from the children's perspective, and the impressions of parents about the value of introducing this technology as an early intervention. https://clinicaltrials.gov, identifier NCT05463211.

Online peer support groups for individuals who hear voices: protocol for a nonrandomised feasibility study

ABSTRACT Background Hearing Voices Groups (HVGs) have proliferated internationally. They are premised on the notion that connections between peers facilitate personal recovery. Little systematic research exists into if, and how, HVGs may be effective, especially when convened online. This paper aims to harmonise standardised research methodology with the liberatory, survivor-led ethos of many HVGs to outline a protocol for the first longitudinal, nonrandomised trial of an online HVG to take place within UK mental health services. Methods Six to ten adults who hear voices will be recruited from both community and UK National Health Service (NHS) settings to participate in a six-month peer-support group that is delivered via videoconference. Participants will complete questionnaires assessing social support, voice-hearing and feelings of personal recovery and qualitative interviews at baseline and at the end of the group. Participants will also complete measures of group cohesion at weeks 4 and 12. Results Data will be analysed for feasibility, acceptability and safety. Discussion This is the first longitudinal study evaluating the feasibility and acceptability of an online HVG held within the NHS. The findings may provide insights into the impact of such interventions and inform the design of a future, definitive study.

A cognitive-behavioral treatment for suicide prevention among adults with schizophrenia spectrum disorders in community mental health: Study protocol for a pilot feasibility and acceptability randomized clinical trial

BackgroundSuicide is among the leading causes of death for adults with schizophrenia spectrum disorders (SSDs), and there is a paucity of evidence-based suicide prevention-focused interventions tailored for this vulnerable population. Cognitive-Behavioral Suicide Prevention for psychosis (CBSPp) is a promising intervention developed in the UK that required modifications for delivery in community mental health (CMH) settings in the United States of American. This pilot trial evaluates the feasibility, acceptability, and preliminary effectiveness of our modified CBSPp intervention in comparison to services as usual (SAU) within a CMH setting in a Midwestern state of the USA.MethodsThis is a single-site randomized pilot trial with a planned enrollment of 60 adults meeting criteria for both SSD and SI/A. Eligible participants will be randomized 1:1 to either 10 sessions of CBSPp or SAU. Clinical and cognitive assessments will be conducted within a 4-waive design at baseline (prior to randomization and treatment) and approximately 1 month (mid-treatment), 3 months (post-treatment), and 5 months (follow-up) after baseline assessment. Qualitative interviews will also be conducted at post-treatment. The primary objective is to determine whether CBSPp is feasible and acceptable, involving examinations of recruitment rate, treatment engagement and adherence, retention and completion rates, and experiences in the CBSPp treatment and overall study. The secondary objective is to preliminarily evaluate whether modified CBSPp is associated with reductions in clinical (suicide ideation, suicide attempt, symptoms of psychosis, depression, and emergency/hospital service, hopelessness, defeat, and entrapment) and cognitive (information processing biases, appraisals, and schemas) outcomes in comparison to SAU from baseline to post-treatment assessment.DiscussionThis randomized pilot trial will provide clinically relevant information about whether CBSPp can improve SI/A, depression, and psychosis among adults with SSDs. Testing this modified cognitive-behavioral suicide prevention-focused intervention has the potential for a large public health impact by increasing the intervention’s utility and usability in CMH where many individuals with SSDs receive care, and ultimately working towards reductions in premature suicide death.Trial registrationClinicalTrials.gov NCT#05345184. Registered on April 12, 2022.

PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial

BackgroundApproximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.MethodsPETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.DiscussionWe hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.Trial registrationISRCTN: 13,709,798; 15-Oct-2021.

BackTrAC: A Digital Care Pathway for People Presenting to Emergency with Lower Back Pain. A Development and Feasibility Study Protocol

ObjectivesBack pain is a prevalent condition that affects 1 in 6 Australians at any time, with high associated health care costs. To date, there is limited information relating to symptom severity and recovery trajectory in people with back pain who present to the emergency department for care. A digital care pathway (DCP) can track patient outcomes following presentation with back pain. The primary aim of this protocol is to outline the co-development, implementation, and evaluation of a DCP for back pain patients who present to the emergency department. MethodsThe primary aim will be addressed in 3 overlapping phases:Phase 1 (co-design) will include interviews with back pain patients and health care professionals from the Northern Hospital Emergency Department. Interview findings will inform education resources featured on the DCP and establish questionnaire content and frequency acceptability.Phase 2 (implementation) will include the rollout of the DCP and tracking of patient-reported outcome measures, which will be collected over 12 weeks.Phase 3 (evaluation) will include interviews with a subset of back pain patients who have participated in Phase 2 to evaluate the acceptability of the DCP and the barriers and facilitators of using the DCP. Ethics and DisseminationThis project has been approved via the National Health and Medical Research Council of Australia’s National Mutual Acceptance Scheme by St Vincent’s Hospital Human Ethics Committee (2022/PID06476), La Trobe University Research Governance (HEC#206/22), and Northern Health Research Governance (NH-2023-372687). We plan to publish the findings in a peer-reviewed journal and present them at conferences.

Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol

IntroductionType II endoleaks (T2ELs) following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) can lead to aneurysm growth, compromising the stent graft seal and risking rupture. Preventing these endoleaks...

A protocol for the ERICA-ARREST feasibility study of Emergency Resuscitative Endovascular Balloon occlusion of the Aorta in Out-of-Hospital Cardiac Arrest

BackgroundFewer than one in ten out-of-hospital cardiac arrest (OHCA) patients survive to hospital discharge in the UK. For prehospital teams to improve outcomes in patients who remain in refractory OHCA despite advanced life support (ALS); novel strategies that increase the likelihood of return of spontaneous circulation, whilst preserving cerebral circulation, should be investigated. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has been shown to improve coronary and cerebral perfusion during cardiopulmonary resuscitation. Early, prehospital initiation of REBOA may improve outcomes in patients who do not respond to standard ALS. However, there are significant clinical, technical, and logistical challenges with rapidly delivering prehospital REBOA in OHCA; and the feasibility of delivering this intervention in the UK urban–rural setting has not been evaluated. MethodsThe Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out-of-Hospital Cardiac Arrest (ERICA-ARREST) study is a prospective, single-arm, interventional feasibility study. The trial will enrol 20 adult patients with non-traumatic OHCA. The primary objective is to assess the feasibility of performing Zone I (supra-coeliac) aortic occlusion in patients who remain in OHCA despite standard ALS in the UK prehospital setting. The trial’s secondary objectives are to describe the hemodynamic and physiological responses to aortic occlusion; to report key time intervals; and to document adverse events when performing REBOA in this context. DiscussionUsing compressed geography, and targeted dispatch, alongside a well-established femoral arterial access programme, the ERICA-ARREST study will assess the feasibility of deploying REBOA in OHCA in a mixed UK urban and rural setting.Trial registration.ClinicalTrials.gov (NCT06071910), registration date October 10, 2023, https://classic.clinicaltrials.gov/ct2/show/NCT06071910

Detailed description of multidisciplinary prehabilitation in patients admitted to nerve sparring radical prostatectomy – A randomized feasibility study protocol

BackgroundLocalized prostate cancer treated with radical prostatectomy is highly effective, though severe side-effects are common after the surgery. Prehabilitation is an approach to optimize patient's physical and mental resources before surgery, to improve postoperative outcomes. The feasibility of a multi-modal home-based prehabilitation program, delivered using telehealth in patients awaiting radical prostatectomy is unknown. This paper describes the development of a prehabilitation program for patients awaiting radical prostatectomy. MethodA model by The Medical Research Council for developing and evaluating complex interventions (MRC Framework) was used in the development process. The Template for Intervention Description and Replication (TIDieR) checklist was applied for ensuring sufficient description of the interventions. A total of 40 patients will be randomized to either intervention or control group. Patients in the control group will follow standard care. The 4-week prehabilitation programme consists of exercise, pelvic floor exercise, sexual counseling, stress management and nutritional support. The interventions are home-based and delivered using telehealth. Feasibility outcomes will include recruitment, attrition rates, adherence, safety and suitability. ConclusionWe have developed a multimodal prehabilitation programme, which has the potential to bring tangible health benefits to men with prostate cancer awaiting radical prostatectomy. The results of the feasibility study will inform the design of a fully powered randomized controlled trial.

Promotion of a social prescribing pathway to general practitioners in a rural area (a feasibility study protocol)

PurposePsychosocial problems, including social isolation and loneliness, are prevalent in rural communities and can impact the use of health services and health outcomes. Current approaches to managing patients with predominantly psychosocial issues may not be the most appropriate. Social prescribing (SP) is a relatively new way of linking patients with sources of non-medical support within the community. Emerging literature suggests that community-based, non-medical activities are an effective and preferred approach to managing psychosocial problems. However, there is little evidence describing the attitudes of general practitioners (GPs) towards formal SP pathways.Design/methodology/approachThis research will occur in a general practice in a rural area of Tasmania, Australia. The project will deliver an education module to rural GPs to highlight the benefits of SP and provide a streamlined pathway for referring patients to community support hubs. Existing community organisations will act as “link workers” to connect patients with suitable community activities. GPs will complete a baseline and follow-up survey to measure their perception of SP and the acceptability, feasibility and appropriateness of such an intervention.FindingsThe acceptability, feasibility and appropriateness of the pathway will be assessed using published measures. Free-text responses to open-ended questions will be used to complement the quantitative data. A hybrid effectiveness-implementation method will be used to gather information about the rate of uptake and quality of the SP referral process and identify barriers and facilitators of the process in a real-world setting.Research limitations/implicationsWhile qualitative data for SP programmes is predominantly positive, quantitative data is lacking. Although the planned project is relatively short, it will provide a basis for future SP programme implementation and guide the approach to data collection and implementation assessment.Social implicationsThe barriers to and facilitators of introducing a SP programme in a rural general practice setting may be used to guide the development and implementation of future large-scale SP interventions. This research is both timely and relevant as the problem of social isolation and loneliness, especially in rural areas of Australia, is becoming more well-recognised as a driver of poor health and unnecessary health service usage.Originality/valueUsing SP to address psychosocial risks may reduce healthcare burden and costs. Few SP programmes have been delivered and formally assessed in Australia, and the best way to implement SP locally remains unclear. By delivering a SP intervention in a rural setting and assessing GPs’ responses, future SP projects will be better able to design and integrate social and medical care services.

Can on-line gait training improve clinical practice? Study protocol for feasibility randomised controlled trial of an on-line educational intervention to improve clinician’s gait-related decision-making in ambulant children and young people with cerebral palsy

BackgroundInstrumented gait analysis (IGA) is an assessment and research tool with proven impacts on clinical decision-making for the management of ambulant children and young people with cerebral palsy (CYPwCP) but is underused and variably understood by relevant clinicians. Clinicians’ difficulties in gaining expertise and confidence in using IGA are multifactorial and related to access for clinical decision-making, limited training opportunities and inability to translate this training into clinical practice.MethodsThe primary aim of this study is to test the feasibility of an educational intervention to advance clinicians’ application of gait analysis in CYPwCP, to inform a definitive trial. The secondary aim is to measure the effect that appropriate IGA training has on physiotherapists’ knowledge, skills, confidence and behaviours. This will be a two-arm feasibility randomised controlled trial with an experimental and control group. The 6-week on-line intervention uses a multicomponent approach grounded in behavioural change techniques. A repeated measures design will be adopted, whereby participants will complete outcome measures at baseline, immediately after the intervention and at 4 months. The primary outcome measures (trial feasibility-related outcomes) are recruitment and engagement. The secondary outcome measures (trial research-related outcomes) are knowledge, skills, confidence and practice change. Outcome measures will be collected via online questionnaires and during observed skill assessments. Analysis of data will use descriptive statistics, two-way mixed ANOVA model and qualitative content analysis.DiscussionThis study will determine feasibility of the definitive randomised control trial of educational intervention delivered to advance clinicians’ application of gait analysis in CYPwCP. This study offers the shift in emphasis from regarding IGA as a tool to a focus on clinicians’ requirements for access, training and a well-defined role to optimise utilisation of IGA. The impact of this should be better engagement with IGA and clinical practice change. This study will contribute to a body of educational research into clinical education of healthcare professionals and IGA training offering insight into high levels of evaluation evidence including clinical behaviour change.Trial registrationProtocol has been registered with the Open Science Framework (osf.io/nweq6) in June 2023.

Implementing a shared decision-making intervention to support treatment decisions for patients following an anterior cruciate ligament rupture — a protocol for the POP-ACLR feasibility study

BackgroundTreatment for anterior cruciate ligament (ACL) rupture may follow a surgical or nonsurgical pathway. At present, there is uncertainty around treatment choice. Two shared decision-making tools have been codesigned to support patients to make a decision about treatment following an ACL rupture. The shared decision-making tools include a patient information leaflet and an option grid. We report the protocol for a mixed-methods feasibility study, with nested qualitative interviews, to understand feasibility, acceptability, indicators of effectiveness and implementation factors of these shared decision-making tools (combined to form one shared decision-making intervention).MethodsA single-centre non-randomised feasibility study will be conducted with 20 patients. Patients diagnosed with an ACL rupture following magnetic resonance imaging will be identified from an orthopaedic clinic. The shared decision-making intervention will be delivered during a clinical consultation with a physiotherapist. The primary feasibility outcomes include the following: recruitment rate, fidelity, acceptability and follow-up questionnaire completion. The secondary outcome is the satisfaction with decision scale. The nested qualitative interview will explore experience of using the shared decision-making intervention to understand acceptability, implementation factors and areas for further refinement.DiscussionThis study will determine the feasibility of using a newly developed shared decision-making intervention designed to support patients to make a decision about treatment of their ACL rupture. The acceptability and indicators of effectiveness will also be explored. In the long term, the shared decision-making intervention may improve service and patient outcomes and ensure cost-effectiveness for the NHS; ensuring those most likely to benefit from surgical treatment proceed along this pathway.Trial registrationPending registration on ISRCTN.

DIALOR (DIgitAL cOaching for fRailty): protocol for a single-arm mixed-methods feasibility study of a digital health coaching intervention for older people with frailty in primary care

BackgroundMultidomain interventions in older adults offer the best opportunity to prevent, delay or reverse existing symptoms in the earlier stages of frailty and improve independence but can be costly, and...

Role of virtual reality in examining the effect of fear of falling (FOF) on postural stability in individuals without and with Parkinson’s disease in Egypt: a mixed-methods feasibility study protocol

BackgroundFalls are common in older people and individuals with neurological conditions. Parkinson’s disease (PD) is known for postural instability causing mobility disabilities, falls and reduced quality of life. The fear...

Implementation of an internet-based stress management program in micro- and small-sized enterprises: a study protocol for a pre-post feasibility study of the effectiveness-implementation hybrid type 2 trial

BackgroundAlthough 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.ObjectivesThis 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. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials.MethodsFor this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees’ gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees’ burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews.DiscussionThis pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data.ConclusionsThis feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs.Trial registrationUMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022.https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570

Remotely prescribed and monitored home-based gait-and-balance therapeutic exergaming using augmented reality (AR) glasses: protocol for a clinical feasibility study in people with Parkinson’s disease

BackgroundClinical 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. The primary objective of this study is to evaluate the feasibility and potential efficacy of Reality DTx®.MethodsTwenty-four pwPD (Hoehn and Yahr stages 2–4) with self-reported gait and/or balance impairments will participate in this study. The study comprises a 6-week waitlist-controlled AR home-based therapeutic gait-and-balance exergaming intervention. Reality DTx® will initially be prescribed remotely for a minimum of 5 days a week for 30 min per day. We will remotely set and adjust the frequency, difficulty, type of games, and/or duration weekly, based on objective and subjective data from the AR glasses and participant, respectively. In addition to the home-based gait-and-balance exergaming intervention, the study comprises three laboratory visits: before the 6-week waitlist period (t0; baseline), before the 6-week intervention period (t1; pre-intervention), and after the 6-week intervention period (t2; post-intervention). The primary study parameters are feasibility (in terms of safety, adherence, and user experience) and potential efficacy for improving gait and balance (using standard clinical gait-and-balance tests and a targeted walking-related fall-risk assessment). Recruitment started in December 2022 and the final post-intervention assessment will be according to planning in July 2023.ConclusionsThis clinical feasibility trial is the first remotely prescribed and monitored home-based AR gait-and-balance exergaming intervention for pwPD. The results in terms of clinical feasibility (i.e. safety, adherence, and user experience) and potential efficacy (gait, balance, and fall-risk outcomes) form the basis for future randomised controlled studies on the effectiveness of home-based AR gait-and-balance exergaming interventions for pwPD.Trial registrationClinicalTrials.gov, NCT05605249. Registered on 4 November 2022.