Feasibility Randomised Controlled Trial Research Articles

Randomised, controlled, feasibility trial comparing vasopressor infusion administered via peripheral cannula versus central venous catheter for critically ill adults: A study protocol.

When clinicians need to administer a vasopressor infusion, they are faced with the choice of administration via either peripheral intravenous catheter (PIVC) or central venous catheter (CVC). Vasopressor infusions have traditionally been administered via central venous catheters (CVC) rather than Peripheral Intra Venous Catheters (PIVC), primarily due to concerns of extravasation and resultant tissue injury. This practice is not guided by contemporary randomised controlled trial (RCT) evidence. Observational data suggests safety of vasopressor infusion via PIVC. To address this evidence gap, we have designed the "Vasopressors Infused via Peripheral or Central Access" (VIPCA) RCT. The VIPCA trial is a single-centre, feasibility, parallel-group RCT. Eligible critically ill patients requiring a vasopressor infusion will be identified by emergency department (ED) or intensive care unit (ICU) staff and randomised to receive vasopressor infusion via either PIVC or CVC. Primary outcome is feasibility, a composite of recruitment rate, proportion of eligible patients randomised, protocol fidelity, retention and missing data. Primary clinical outcome is days alive and out of hospital up to day-30. Secondary outcomes will include safety and other clinical outcomes, and process and cost measures. Specific aspects of safety related to vasopressor infusions such as extravasation, leakage, device failure, tissue injury and infection will be assessed. VIPCA is a feasibility RCT whose outcomes will inform the feasibility and design of a multicentre Phase-3 trial comparing routes of vasopressor delivery. The exploratory economic analysis will provide input data for the full health economic analysis which will accompany any future Phase-3 RCT.

The Regulate your Sitting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: findings from a randomised-controlled feasibility trial

BackgroundReducing and breaking up sitting is recommended for optimal management of Type 2 diabetes mellitus (T2DM). Yet, there is limited evidence of interventions targeting these outcomes in individuals with this condition. The primary aim of this study was to assess the feasibility and acceptability of delivering and evaluating a tailored online intervention to reduce and break up sitting in adults with T2DM.MethodsA mixed-methods two-arm randomised controlled feasibility trial was conducted in ambulatory adults with T2DM who were randomised 1:1 to the REgulate your SItting Time (RESIT) intervention or usual care control group. The intervention included online education, self-monitoring and prompt tools (wearable devices, smartphone apps, computer apps) and health coaching. Feasibility outcomes were recruitment, attrition, data completion rates and intervention acceptability. Measurements of device-assessed sitting (intended primary outcome for definitive trial), standing and stepping, and physical function, psychosocial health and wellbeing were taken at baseline, 3 months and 6 months. Individual semi-structured interviews were conducted at six-months (post intervention) to explore acceptability, feasibility and experiences of the trial and intervention using the Framework Method.ResultsSeventy participants aged 55 ± 11 years were recruited. Recruitment rate (proportion of eligible participants enrolled into the study) was 67% and participant retention rate at 6 months was 93% (n = 5 withdrawals). Data completion rates for daily sitting were 100% at baseline and ranged from 83 to 91% at 3 months and 6 months. Descriptive analysis demonstrated potential for the intervention to reduce device-measured sitting, which was 30.9 ± 87.2 and 22.2 ± 82.5 min/day lower in the intervention group at 3 and 6 months, respectively, compared with baseline. In the control group, sitting was 4.4 ± 99.5 and 23.7 ± 85.2 min/day lower at 3 and 6 months, respectively. Qualitative analysis identified three themes: reasons for participating in the trial, acceptability of study procedures, and the delivery and experience of taking part in the RESIT intervention. Overall, the measurement visits and intervention were acceptable to participants.ConclusionsThis study demonstrated the feasibility and acceptability of the RESIT intervention and evaluation methods, supporting a future definitive trial. If RESIT is found to be clinically effective, this could lead to changes in diabetes healthcare with a focus on reducing sitting.Trial registrationThe trial was registered with ISRCTN (number ISRCTN14832389).

Client predictors of dropouts and outcomes in psychotherapy for generalized anxiety disorder: an exploratory study

ABSTRACT This study is a secondary analysis exploring client predictors of dropouts and outcomes in the treatment of generalized anxiety disorder (GAD). Data was taken from a feasibility randomized control trial (RCT) exploring the relative efficacy of emotion-focused therapy (EFT) compared with cognitive-behavioral therapy (CBT). Relationships between client characteristics and dropouts were explored using logistic regression analysis. Relationships between client characteristics and psychotherapy outcomes were explored using hierarchical linear regression analyses. For the full dataset (n = 58), a comorbid personality disorder predicted a higher number of dropouts. Eleven participants dropped out of therapy. Having a disability predicted less improvement in symptoms of depression and general distress. Being male-identified predicted a greater reduction in symptoms of anxiety and general distress, and comorbid agoraphobia predicted a greater reduction in symptoms of depression for the CBT condition (n = 21 completers). For the EFT condition (n = 26 completers), being older predicted greater improvements in symptoms of anxiety and comorbid panic disorder predicted a lower reduction in symptoms of depression. Caution should be taken in interpreting these findings given the small number of participants. However, they provide useful insights for the generation of hypotheses in relation to predictors of dropouts and outcomes for future studies.

Exploring behaviour-intention gaps to explain low retention in a community-based video-conferencing intervention for depression: lessons for researchers using technology as interventions

Purpose This paper aims to reflect on the outcomes of a community-based video-conferencing intervention for depression, predating the COVID-19 pandemic. The study investigates the potential implications of its findings for enhancing adherence to digital mental health interventions. The primary objective is to present considerations for researchers aimed at minimising the intention-behaviour gap frequently encountered in digital mental health interventions. Design/methodology/approach A randomised control feasibility trial design was used to implement a telehealth model adapted from an established face-to-face community-based intervention for individuals clinically diagnosed with depression. In total, 60 participants were initially recruited in association with a local mental health charity offering traditional talking-based therapies with only eight opting to continue through all phases of the project. Modifications aligning with technological advancements were introduced. Findings However, the study faced challenges, with low uptake observed after an initial surge in recruitment interest. The behaviour-intention gap highlighted technology as a barrier to service accessibility, exacerbated by participant age. Furthermore, the clinical diagnosis of depression, characterised by low mood and reduced interest in activities, emerged as a potential influencing factor. Research limitations/implications The limitations of the research include its pre-pandemic execution, during a nascent stage of technological mental health interventions when participants were less familiar with online developments. Practical implications Despite these limitations, this study's reflections offer valuable insights for researchers aiming to design and implement telehealth services. Addressing the intention-behaviour gap necessitates a nuanced understanding of participant demographics, diagnosis and technological familiarity. Social implications The study's relevance extends to post-pandemic society, urging researchers to reassess assumptions about technology availability to ensure engagement. This paper contributes to the mental health research landscape by raising awareness of critical considerations in the design and implementation of digital mental health interventions. Originality/value Reflections from a pre-pandemic intervention in line with the developments of a post-pandemic society will allow for research to consider that because the technology is available does not necessarily result in engagement.

High-Flow Humidified Oxygen as an Early Intervention in Children With Acute Severe Asthma: Protocol for a Feasibility Randomized Controlled Trial.

Acute severe asthma (ASA) is a leading cause of hospital attendance in children. Standard first-line therapy consists of high-dose inhaled bronchodilators plus oral corticosteroids. Treatment for children who fail to respond to first-line therapy is problematic: the use of intravenous agents is inconsistent, and side effects are frequent. High-flow humidified oxygen (HiFlo) is widely used in respiratory conditions and is increasingly being used in ASA, but with little evidence for its effectiveness. A well-designed, adequately powered randomized controlled trial (RCT) of HiFlo therapy in ASA is urgently needed, and feasibility data are required to plan such an RCT. In this study, we describe the protocol for a feasibility study designed to fill this knowledge gap. This study aims to establish whether a full RCT of early HiFlo therapy in children with ASA can be conducted successfully and safely, to establish whether recruitment using deferred consent is practicable, and to define appropriate outcome measures and sample sizes for a definitive RCT. The underlying hypothesis is that early HiFlo therapy in ASA will reduce the need for more invasive treatments, allow faster recovery and discharge from hospital, and in both these ways reduce distress to children and their families. We conducted a feasibility RCT with deferred consent to assess the use of early HiFlo therapy in children aged 2 to 11 years with acute severe wheeze not responding to burst therapy (ie, high-dose inhaled salbutamol with or without ipratropium). Children with a Preschool Respiratory Assessment Measure score ≥5 after burst therapy were randomized to commence HiFlo therapy or follow standard care. The candidate primary outcomes assessed were treatment failure requiring escalation and time to meet hospital discharge criteria. Patient and parent experiences were also assessed using questionnaires and telephone interviews. The trial was opened to recruitment in February 2020 but was paused for 15 months owing to the COVID-19 pandemic. The trial was reopened at the lead site in July 2021 and opened at the other 3 sites from August to December 2022. Recruitment was completed in June 2023. This feasibility RCT of early HiFlo therapy in children with ASA recruited to the target despite major disturbances owing to the COVID-19 pandemic. The data are currently being analyzed and will be published separately. International Standard Randomised Controlled Trial Number Registry ISRCTN78297040; https://www.isrctn.com/ISRCTN78297040. DERR1-10.2196/54081.

Illness perceptions, cognitive and behavioural responses to chronic breathlessness in individuals living with advanced respiratory disease: an observational study.

Understanding the complexity and multidimensional nature of chronic breathlessness is key to its successful management. The aim of this study was to explore illness perceptions, cognitive and behavioural responses to chronic breathlessness in individuals living with advanced respiratory disease. This was a cross-sectional secondary analysis of data from a feasibility randomised control trial (SELF-BREATHE) for individuals living with chronic breathlessness due to advanced disease. All participants completed the following questionnaires: numerical rating scale (NRS) breathlessness severity, NRS distress due to breathlessness, NRS self-efficacy for managing breathlessness, Dyspnea-12 (D-12), Chronic Respiratory Disease Questionnaire (CRQ), Brief Illness Perception Questionnaire (Brief IPQ) and the Cognitive and Behavioural Responses Questionnaire, short version (CBRQ-S). The associations between the Brief IPQ and CBRQ-S with NRS breathlessness severity, distress and self-efficacy, D-12 and CRQ were examined using Spearman's rho correlation coefficient rs. A Spearman's rs of ≥0.50 was predefined as the threshold to denote important associations between variables. A p-value of <0.008 was considered statistically significant, to account for the number of comparisons performed. The illness perception items consequences, identity, concern and emotional response were associated with increased breathlessness severity, increased distress, reduced breathlessness self-management ability and lower health-related quality of life. Symptom focusing and embarrassment avoidance were identified as important cognitive responses to chronic breathlessness. Interventions that directly target illness perceptions, cognitive and behavioural responses to chronic breathlessness may improve symptom burden, self-efficacy and health-related quality of life.

Work Engagement and Well-being Study (SWELL): a randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work

BackgroundMindfulness-based programmes (MBPs) are increasingly offered at work, often in online self-guided format. However, the evidence on MBPs’ effect on work performance (WP) is inconsistent.ObjectiveThis pragmatic randomised controlled feasibility trial...

Cognitive Functional Therapy compared with usual physiotherapy care in people with persistent low back pain: a mixed methods feasibility randomised controlled trial in the United Kingdom National Health Service

ObjectivesTo determine the feasibility of completing a definitive randomised controlled trial (RCT), evaluating the clinical and cost-effectiveness of Cognitive Functional Therapy (CFT) in comparison to usual physiotherapy care (UPC), for people with persistent low back pain (LBP). Design and settingA two-arm parallel feasibility RCT completed in a United Kingdom (UK) Secondary Care National Health Service (NHS) physiotherapy service. ParticipantsSixty adult participants who reported LBP lasting for more than three months, that was not attributable to a serious (e.g. cancer) or specific (e.g. radiculopathy) underlying cause, were invited to participate. Participants were allocated at random to receive CFT or UPC. InterventionsCognitive Functional Therapy and Usual Physiotherapy Care for persistent LBP. Main outcome measuresThe primary outcome was the feasibility of completing a definitive RCT, defined by recruitment of at least 5 participants per month, delivery of CFT per protocol and securing relevant and acceptable outcome measures. Data concerning study processes, resources, management and participant reported outcome measures were collected at baseline, 3, 6 and 12-month follow-up. ResultsSixty participants (n = 30 CFT and n = 30 UPC) were recruited with 80% (n = 48), 72% (n = 43) and 53% (n = 32) retained at 3, 6 and 12-month follow-up respectively. NHS physiotherapists were trained to competence and delivered CFT with fidelity. CFT was tolerated by participants with no adverse events. Relevant and clinically important outcome data were collected at all time points (0.4%, 3%, 1% and 0.8% of data was missing from the returned outcome measure booklets at baseline and 3, 6 and 12-month follow-up respectively). The Roland-Morris disability questionnaire was considered the most suitable primary outcome measure with a proposed sample size of 540 participants for a definitive cluster RCT. ConclusionIt is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future study should incorporate an internal pilot to address aspects of feasibility further, including participant retention strategies. Clinical trial registration numberISRCTN12965286 Contribution of the paper•Cognitive Functional Therapy (CFT) has shown encouraging results for reducing pain and disability in people with persistent LBP in previous clinical trials. The clinical and cost-effectiveness of CFT has not previously been evaluated in a definitive trial in the United Kingdom National Health Service. This is the first study to evaluate the feasibility of completing such a trial.•The findings of this study confirmed that;•NHS patients can be recruited on time and to target, with no safety concerns regarding a randomised controlled trial.•NHS physiotherapists can be trained to competence to deliver CFT with fidelity.•Clinically relevant and important data can be collected using standardised outcome measures.•New knowledge about the feasibility of completing a definitive trial of CFT in the UK NHS has been gained.

The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes: a feasibility randomized controlled trial.

Obstructive sleep apnea (OSA) is associated with an increased risk of diabetes-related complications. Hence, it is plausible that Continuous Positive Airway Pressure (CPAP) could have a favorable impact on these complications. To assess the feasibility of conducting a randomized control trial (RCT) in patients with type 2 diabetes (T2D) and OSA over 2 years. An open-label multicenter feasibility RCT of CPAP vs no CPAP in patients with T2D and OSA. Patients with resting oxygen saturation <90%, central apnea index >15/hour or Epworth Sleepiness Scale (ESS) ≥11 were excluded. OSA was diagnosed using a multichannel portable device (ApneaLink Air, ResMed). The primary outcome measures were related to feasibility, and the secondary outcomes were changes in various clinical and biochemical parameters related to diabetes outcomes. Eighty-three (40 CPAP vs 43 no CPAP) patients were randomized, with a median (IQR) follow-up of 645 [545, 861] days. CPAP compliance was inadequate, with a median usage of approximately 3.5 hours/night. Early CPAP use predicted longer-term compliance. The adjusted analysis showed a possible favorable association between being randomized to CPAP and several diabetes-related endpoints (chronic kidney disease (CKD), neuropathy, and quality of life (QoL)). It was feasible to recruit, randomize, and achieve a high follow-up rate over 2 years in patients with OSA and T2D. CPAP compliance might improve by a run-in period before randomization. A full RCT is necessary to assess the observed favorable association between CPAP and CKD, neuropathy, and QoL in patients with T2D. Registry: ISRCTN; URL: https://www.isrctn.com/ISRCTN12361838; Title: The impact of sleep disorders in patients with type 2 diabetes; Identifier: ISRCTN12361838.

Experiences of fatigued persons with multiple sclerosis with multimodal agility-based exercise training and the ReFEx study protocol: a qualitative extension of a feasibility study

Objectives(1) To explore experiences of fatigued persons with multiple sclerosis (pwMS) with a new multimodal agility-based exercise training (MAT) framework and (2) to investigate the demands of the Rehabilitation, Fatigue,...

Self-regulation training for people with knee osteoarthritis: a protocol for a feasibility randomised control trial (MiNT trial).

Knee osteoarthritis (OA) is a chronic secondary musculoskeletal pain condition resulting in disability, reduced quality of life, and high societal costs. Pain associated with knee OA is linked to increased sensitivity in sensory, cognitive, and emotional areas of the brain. Self-regulation training targeting brain functioning related to pain experience could reduce pain and its associated disability. Self-regulatory treatments such as mindfulness meditation (MM) and electroencephalography neurofeedback (EEG-NF) training improve clinical outcomes in people with knee OA. A feasibility clinical trial can address factors that could inform the design of the full trial investigating the effectiveness of self-regulation training programmes in people with knee OA. This clinical trial will evaluate the feasibility, safety, acceptability, experience and perceptions of the self-regulatory training programmes. The proposed feasibility trial is based on a double-blind (outcome assessor and investigators), three-arm (MM usual care, EEG-NF + usual care and usual care control group) randomised controlled parallel clinical trial. Participants with knee OA will be recruited from the community and healthcare practices. A research assistant (RA) will administer both interventions (20-min sessions, four sessions each week, and 12 sessions over three successive weeks). Feasibility measures (participant recruitment rate, adherence to interventions, retention rate), safety, and acceptability of interventions will be recorded. An RA blinded to the group allocation will record secondary outcomes at baseline, immediately post-intervention (4th week), and 3 months post-intervention. The quantitative outcome measures will be descriptively summarised. The qualitative interviews will evaluate the participants' experiences and perceptions regarding various aspects of the trial, which includes identifying the barriers and facilitators in participating in the trial, evaluating their opinions on the research procedures, such as their preferences for the study site, and determining the level of acceptability of the interventions as potential clinical treatments for managing knee OA. Māori participant perceptions of how assessment and training practices could be acceptable to a Māori worldview will be explored. The interviews will be audio-recorded and analysed thematically. This trial will provide evidence on the feasibility, safety, and acceptability of the MM and EEG-NF training in people with knee OA, thus informing the design of a full randomised clinical control trial.

Effectiveness of naturopathy for pregnancy in women with diminished ovarian reserve: feasibility randomized controlled trial

Research questionIs conducting a randomized control trial (RCT) to assess the effectiveness of whole-system naturopathy in improving pregnancy rates among women with diminished ovarian reserve (DOR) feasible? DesignA two-arm, parallel group, assessor-blinded feasibility RCT was conducted. Women with DOR, trying to conceive naturally or by ART, were randomly assigned to naturopathy plus usual care, or usual care alone for 16 weeks. Primary outcomes were feasibility (recruitment, adherence, retention rates), acceptability and safety. Secondary outcomes included ongoing pregnancy rates, live birth rates and health-related outcomes (mental health, quality of life, diet, exercise, sleep and weight). Statistical significance of the differences between the two groups (P-values) were exploratory. ResultsOne hundred and fifteen women completed the screening survey between March and November 2022. Of these, 66 women were assessed for eligibility and 41 (62%) consented. Recruitment resulted in seven enrolments each month. All 41 participants (100%) adhered to the intervention, 38 (93%) completed end-point questionnaires, 32 (78%) found study participation to be acceptable and 18 out of 21 (86%) from the intervention group would recommend a naturopathic intervention to other women with DOR. The naturopathic treatment was associated with only mild and temporary adverse events. No between-group differences were observed for pregnancy and live birth rates. ConclusionThe evaluation of whole-system naturopathy through a RCT was feasible and the treatment was acceptable and well tolerated according to women with DOR. Outcomes from this study will help inform sample size calculations powered for fertility outcomes for future RCTs on this topic.

Optimising physiotherapy for people with lateral elbow tendinopathy – Results of a mixed-methods pilot and feasibility randomised controlled trial (OPTimisE)

BackgroundThe OPTimisE intervention was developed to address uncertainty regarding the most effective physiotherapy treatment strategy for people with Lateral Elbow Tendinopathy (LET). ObjectivesTo assess the feasibility of conducting a fully-powered randomised controlled trial (RCT) evaluating whether the OPTimisE intervention is superior to usual physiotherapy treatment for adults with LET. DesignA mixed-methods multi-centred, parallel pilot and feasibility RCT, conducted in three outpatient physiotherapy departments in the UK. MethodPatients were independently randomised 1:1 in mixed blocks, stratified by site, to the OPTimisE intervention or usual care. Outcomes were assessed using pre-defined feasibility progression criteria. Results50 patients were randomised (22 Female, 28 Male), mean age 48 years (range 27–75). Consent rate was 71% (50/70), fidelity to intervention 89% (16/18), attendance rate in the OPTimisE group 82% (55/67) vs 85% (56/66) in usual care, outcome measure completion 81% (39/48) at six-month follow-up. There were no related adverse events. Patients and physiotherapists reported that the OPTimisE intervention was acceptable but suggested improvements to the trial design. 49 patients were recruited from physiotherapy referrals vs one from primary care records. Outcome measure return rates were higher when completed online (74%) compared to postal questionnaire (50%). Exploratory analysis showed improvements in both groups over time. ConclusionsIt is methodologically feasible to conduct a fully powered RCT comparing the clinical and cost-effectiveness of the OPTimisE intervention versus usual physiotherapy treatment. Considering the similar improvements observed in both groups, careful consideration is needed regarding the priority research question to be addressed in future research.

Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England

ObjectivesTo assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of...

Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial

BackgroundAcquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often fragmented across the UK, and psychological, sexual and social support are lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI.MethodsThis mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria include age > 18 years, diagnosed or suspected ABI > 3 months prior to trial entry, access to an Internet-enabled device and ability to engage with the intervention. Referrals to the study website will be made via the National Health Service (NHS), social media and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programmes. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence and usage. Secondary outcomes related to standardised measures of quality of life, sexual wellbeing and mental wellbeing. Participants and peer facilitators will be interviewed after the course to assess acceptability across both trial arms.DiscussionThis feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of the feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at the group level. These data may indicate trends in reach to particular demographic groups that can inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified if predetermined criteria are met, relating to recruitment, retention, engagement and acceptability.Trial registrationISRCTN46988394 registered on March 1, 2023.

A feasibility and pilot additive randomised control trial of attachment security priming during behavioural activation.

There is some initial evidence that attachment security priming may be useful for promoting engagement in therapy and improving clinical outcomes. This study sought to assess whether outcomes for behavioural activation delivered in routine care could be enhanced via the addition of attachment security priming. This was a pragmatic two-arm feasibility and pilot additive randomised control trial. Participants were recruited with depression deemed suitable for a behavioural activation intervention at Step 2 of a Talking Therapies for Anxiety and Depression service. Ten psychological wellbeing practitioners were trained in implementing attachment security priming. Study participants were randomised to either behavioural activation (BA) or BA plus an attachment prime. The diagrammatic prime was integrated into the depression workbook. Feasibility outcomes were training satisfaction, recruitment, willingness to participate and study attrition rates. Pilot outcomes were comparisons of clinical outcomes, attendance, drop-out and stepping-up rates. All practitioners recruited to the study, and training satisfaction was high. Of the 39 patients that were assessed for eligibility, 24 were randomised (61.53%) and there were no study drop-outs. No significant differences were found between the arms with regards to drop-out, attendance, stepping-up or clinical outcomes. Further controlled research regarding the utility of attachment security priming is warranted in larger studies that utilise manipulation checks and monitor intervention adherence.

Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial

BackgroundEvidence indicates continuous positive airway pressure (CPAP) therapy improves several important patient-centered outcomes. However, adherence to this safe and effective intervention remains poor. ObjectivesAssess nine feasibility outcomes of a nurse practitioner-led, virtually delivered motivational enhancement and device support (MENDS) intervention to improve CPAP adherence in adults with Obstructive Sleep Apnea (OSA). Secondary aims compared the changes in CPAP adherence to patient-reported outcomes, patient activation, and perceived self-efficacy. MethodsThis two-group feasibility randomized controlled trial included 29 patients newly diagnosed with OSA and prescribed CPAP therapy. The study was conducted from July 2020 through December 2021 at a midwestern sleep/pulmonary clinic. Participants were randomized to the MENDS intervention group (n=14) (30-45 minute interactive tele-discussions on weeks 2, 4, 6, and 8) or to the usual care (n=15) group. Feasibility, patient-reported outcomes, and behavioral constructs were measured at baseline and 12 weeks. CPAP adherence was measured weekly. ResultsFeasibility of the MENDS sessions was demonstrated (56 sessions offered, 52 completed remotely without technical difficulties) with minimal participant attrition and no missing CPAP data. Generalized linear mixed models showed no statistically significant time-by-group interactions on adherence or patient-reported outcomes. Higher adherence and lower CPAP apnea-hypopnea index (AHI) scores were associated with declines in pre- to post-changes in fatigue and sleep disturbance. Lower CPAP AHI scores were associated with pre- to post-decreases in PROMIS Anxiety scores (r=.532, p=.005). ConclusionThe virtual MENDS intervention was feasible. Higher CPAP adherence and lower AHI levels led to positive improvements in fatigue, sleep disturbance, and anxiety.

A feasibility randomized controlled trial testing the use of indocyanine green fluorescence image-guidance in liver surgery compared to standard liver surgery alone in reducing microscopic positive tumor margin resection rate with an embedded qualitative study: the I-FIGS study protocol

Abstract Indocyanine green fluorescence image-guidance (I-FIGS) is gaining global popularity in liver surgery for various applications. However, its true clinical value in reducing microscopic positive margins (R1-resection rate) remains uncertain. To address this, a multi-center randomized controlled trial (RCT) comparing I-FIGS with standard liver surgery is needed. However, due to a lack of essential information on potential R1 reduction rate, sample size, methodology, intervention delivery and patient experience, a feasibility RCT protocol has been developed to determine the viability of conducting a full-scale RCT. The aim of the study is to conduct a feasibility RCT (fRCT) with an embedded qualitative study to gather all the necessary information for a full-scale RCT. Adult patients undergoing elective liver surgery for colorectal liver metastasis (CRLMs), hepatocellular carcinoma (HCC) or peripheral cholangiocarcinoma will be eligible for the study. Forty patients will be randomly assigned to either the control group (standard liver surgery) or the intervention group (standard liver surgery + I-FIGS). Patients in the I-FIGS group will receive intravenous injection of 0.03–0.05 mg/kg indocyanine green (ICG) dye 2–4 hours before the surgery. Data will be collected on demographics, screening, recruitment and retention rates, adherence to study methods, intraoperative details, postoperative histology, and experiences of both surgeons and patients. Interviews will be conducted with selected patients and surgeons to explore their experiences with the intervention. The protocol has been approved by the West-Midlands-Solihull Research Ethics Committee and registered with ClinicalTrials.gov (NCT05616039). The results will be disseminated through academic publications, congresses, newsletters and other platforms.

A Live Video Dyadic Resiliency Intervention to Prevent Chronic Emotional Distress Early After Dementia Diagnoses: Protocol for a Dyadic Mixed Methods Study.

By 2030, approximately 75 million adults will be living with Alzheimer disease and related dementias (ADRDs). ADRDs produce cognitive, emotional, and behavioral changes for persons living with dementia that undermine independence and produce considerable stressors for persons living with dementia and their spousal care-partners-together called a "dyad." Clinically elevated emotional distress (ie, depression and anxiety symptoms) is common for both dyad members after ADRD diagnosis, which can become chronic and negatively impact relationship functioning, health, quality of life, and collaborative management of progressive symptoms. This study is part of a larger study that aims to develop, adapt, and establish the feasibility of Resilient Together for Alzheimer Disease and Related Dementias (RT-ADRD), a novel dyadic skills-based intervention aimed at preventing chronic emotional distress. This study aims to gather comprehensive information to develop the first iteration of RT-ADRD and inform a subsequent open pilot. Here, we describe the proposed study design and procedures. All procedures will be conducted virtually (via phone and Zoom) to minimize participant burden and gather information regarding feasibility and best practices surrounding virtual procedures for older adults. We will recruit dyads (up to n=20) from Mount Sinai Hospital (MSH) clinics within 1 month of ADRD diagnosis. Dyads will be self-referred or referred by their treating neurologists and complete screening to assess emotional distress and capacity to consent to participate in the study. Consenting dyads will then participate in a 60-minute qualitative interview using an interview guide designed to assess common challenges, unmet needs, and support preferences and to gather feedback on the proposed RT-ADRD intervention content and design. Each dyad member will then have the opportunity to participate in an optional individual interview to gather additional feedback. Finally, each dyad member will complete a brief quantitative survey remotely (by phone, tablet, or computer) via a secure platform to assess feasibility of assessment and gather preliminary data to explore associations between proposed mechanisms of change and secondary outcomes. We will conduct preliminary explorations of feasibility markers, including recruitment, screening, live video interviews, quantitative data collection, and mixed methods analyses. This study has been approved by the MSH Institutional Review Board. We anticipate that the study will be completed by late 2023. We will use results from this study to develop the first live video telehealth dyadic resiliency intervention focused on the prevention of chronic emotional distress in couples shortly after ADRD diagnoses. Our study will allow us to gather comprehensive information from dyads on important factors to address in an early prevention-focused intervention and to explore feasibility of study procedures to inform future open pilot and pilot feasibility randomized control trial investigations of RT-ADRD. PRR1-10.2196/45532.

A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper

BackgroundPeople with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures.MethodsA feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures.DiscussionThe link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area.Trial registrationThe trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228).