Cluster Randomised Feasibility Trial Research Articles

Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1

BackgroundDiabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently, referrals to diabetes inpatient specialists are usually ‘reactive’ after diabetes-related events have taken place, which are associated with an increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses, may contribute to the prevention of such diabetes-related events and result in a reduction in the risk of harm.MethodWe will conduct a cluster randomised feasibility study with process evaluation. The proactive diabetes review model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes-related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes-related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources and quality of available data.DiscussionThe aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally.Trial registrationUK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.

Move for Life an intervention for inactive adults aged 50 years and older: a cluster randomised feasibility trial.

Move for Life (MFL) is a theory-informed intervention that was developed to augment established physical activity (PA) programmes and enable inactive adults aged 50 years and older to be more active. This study examined the feasibility of MFL and sought to provide evidence of its potential for improving PA and associated health outcomes. A 3-arm cluster randomised feasibility trial compared MFL intervention, usual provision (UP) and control (CON) groups at baseline (T0), post-intervention (T1, at 8, 10 or 12- weeks) and 6-month follow up (T2). We used purposive sampling strategies to recruit participants according to characteristics of interest. Feasibility outcomes assessed recruitment, fidelity, adherence, retention and data completion rates based on pre-set criteria. Primary outcomes were accelerometer-based moderate-to-vigorous intensity PA (MVPA) and self-reported compliance with physical activity guidelines (PAGL). Secondary outcomes included light intensity PA (LiPA), standing time, sedentary time, body composition (adiposity), physical function and psychological well-being. We used linear mixed models (continuous outcomes) or generalized estimated equations (categorical outcomes) to estimate group differences over time in the study outcomes. Progression criteria for feasibility outcomes were met, and 733 individuals were recruited. Considering a 6-month period (T0-T2), while self-reported compliance with PAGL increased in MFL relative to UP and CON and in UP relative to CON, standing time decreased in MFL relative to CON and sedentary time increased in the latter compared to UP. Waist circumference decreased in MFL relative to UP and CON. MFL outperformed UP in the Timed Up and Go Test while MFL and UP increased the distance covered in the Six-Minute Walk Test compared to CON. Psychological well-being increased in MFL relative to CON (all p < 0.05). Findings show that MFL is feasible, while data are promising with regards to the potential of improving community PA programmes for adults aged 50 or more years. https://www.isrctn.com/Registration#ISRCTN11235176.

Motiv8: a study protocol for a cluster-randomised feasibility trial of a weight management intervention for adults with severe mental illness in secure forensic services

IntroductionPeople with severe mental illness have physical comorbidities which result in significant reductions in quality of life and premature mortality. Effective interventions are required that are suitable for people in secure forensic mental health services. We conducted pilot work of a multidisciplinary weight management intervention (Motiv8) which showed improvements in physical and mental health and high levels of satisfaction. We aim to test the feasibility of Motiv8 under cluster randomised conditions, with an aim to investigate the acceptability, feasibility and potential effectiveness of this intervention to supplement standard secure care.Methods and analysisA randomised waitlist-controlled feasibility trial of a lifestyle intervention (Motiv8) + TAU compared with TAU (+ Motiv8 waitlist) for adults on secure mental health units will be conducted. Thirty-two people (4 cohorts) will be recruited from secure services in Greater Manchester Mental Health NHS Foundation Trust. Participants will be randomly allocated to Motiv8 or TAU + Motiv8 waitlist. All participants will receive Motiv8 during the trial. Assessor-blinded physical/mental health and lifestyle assessments will be conducted at baseline, 10 weeks (post-intervention/waitlist), and after 12 weeks (post-waitlist intervention/follow-up). Motiv8 is a multidisciplinary intervention including exercise sessions, cooking/nutrition classes, physical health education, psychology sessions, sleep hygiene, peer support and medication review by pharmacy. A nested qualitative study will be conducted with a subsample of participants (n = 10) to explore their experiences of taking part. The analysis will focus on feasibility outcomes and tabulated success indicators of the study (e.g. Recruitment rates, retention rates, follow-up retention and response rates, attendance at sessions, the experience of involvement in the trial and delivery of the intervention, assessment of safety, development of a manualised intervention). Thematic analysis will be conducted through qualitative interviews. The analysis will aim to inform the development of a definitive trial.Ethics and disseminationThe trial has been granted ethical approval from the NHS Health Research Authority and adopted onto the UK Clinical Research Network Portfolio. Findings will be disseminated via peer-reviewed publications, professional and public networks, conferences and clinical services.Trial registrationISRCTN13539285.

The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial.

Chronic or persistent pain affects one's ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain. We aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes' feasibility and test research processes for a definitive trial. This is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation-Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention. Ethics approval was obtained in March 2023. Trial recruitment began in June 2023. The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes' selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention. ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677. DERR1-10.2196/51474.

Use of a toolbox of tailored evidence-based interventions to improve children’s physical activity and cardiorespiratory fitness in primary schools: results of the ACTIPROS cluster-randomized feasibility trial

BackgroundSchool-based physical activity (PA) promotion is usually conducted by providing one specific intervention. In contrast, the ACTIvity PROmotion via Schools (ACTIPROS) toolbox provides a set of twelve evidence-based PA interventions serving different domains of the Health Promoting Schools framework that primary schools can select according to their requirements. In this study, we tested the feasibility of the toolbox approach in primary schools.MethodsA two-arm cluster-randomized feasibility trial at primary schools (n = 5 intervention schools [IS], n = 5 control schools) located in the Federal State of Bremen, Germany, was conducted. Children’s habitual PA (GENEActiv, Activinsights Ltd.) and motor skills (Deutscher Motorik Test; DMT) were measured at the beginning (t0: Sept and Oct 2021) and at the end of the school year (t1: June and July 2022). Between Oct 2021 and July 2022, the ACTIPROS toolbox was implemented at IS. Teachers documented intervention choices and implementation within a short questionnaire (SIQ) at t1.ResultsIS successfully implemented at least one intervention of the toolbox. In total, seven out of twelve possible interventions were selected. Two schools decided to replace an intervention with another during the trial. Results of the SIQ indicated that IS tended to choose similar interventions while implementation frequency was highly different. N = 429 students from two classes per school were recruited. The mean consent rate was 75.1% (n = 322). At t0 and t1, n = 304 (94.4%) and n = 256 (79.3%) of consented children took part in the DMT, respectively. The accelerometry sample included one class per participating school. At t0 and t1, n = 166 and n = 151 devices were handed out to students and n = 133 (80.1%) and n = 106 (70.2%) valid records could be retrieved, respectively. Linear mixed models showed an intervention effect of 15.5 min (95% CI: 4.5; 26.6) in children’s daily MVPA at IS between t0 and t1 compared to controls.ConclusionsAll IS were able to implement at least one intervention from the toolbox, and unsuitable interventions were successfully replaced in a timely manner, highlighting the feasibility of implementing the ACTIPROS toolbox. Good consent rates for accelerometer and motor skills data were achieved. Results indicate a substantial increase in MVPA associated with the ACTIPROS toolbox and need to be tested in a larger sample.Trial registrationGerman Clinical Trials Register DRKS00025840.

Classroom Psychomotor Education Programme to Enhance Executive Functions: A Cluster Randomised Feasibility Trial

An increase in children exhibiting attention difficulties has created the need for more classroom-based intervention programmes. A promising link between physical education and improvement in executive functioning has been at the centre of attention. POTENTIAL constitutes a novel classroom-based psychomotor education programme to enhance students’ attention and listening skills by improving executive functions. A cluster randomised feasibility study was conducted to explore the feasibility of a definitive trial to assess POTENTIAL’s effectiveness regarding (i) recruitment and sampling procedures; (ii) compliance and fidelity; (iii) the acceptability of POTENTIAL by teachers and children; and (iv) the appropriateness of the outcome measures. Four early years classes with an inclusion unit participated: two implemented POTENTIAL and two received no intervention. Eight children in each class (n = 32) were sampled to investigate the appropriateness of the outcome measures. Teachers’ diaries were utilised to explore the acceptability of the activities and the fidelity and compliance to the implementation. The findings regarding POTENTIAL’s acceptability were positive. The recruitment targets were met, and compliance and fidelity were good. Mixed results were produced about the appropriateness of the outcome measures. Thus, the trial protocol could be scaled up in a definitive trial. This study highlights the need for more physical education programmes to support children’s executive functioning.

Mixed-methods evaluation of a group psychosocial intervention for refugee, migrant and host community women in Ecuador and Panamá: Results from the Entre Nosotras cluster randomized feasibility trial.

Community-based psychosocial interventions are key elements of mental health and psychosocial support; yet evidence regarding their effectiveness and implementation in humanitarian settings is limited. This study aimed to assess the appropriateness, acceptability, feasibility and safety of conducting a cluster randomized trial evaluating two versions of a group psychosocial intervention. Nine community clusters in Ecuador and Panamá were randomized to receive the standard version of the Entre Nosotras intervention, a community-based group psychosocial intervention co-designed with community members, or an enhanced version of Entre Nosotras that integrated a stress management component. In a sample of 225 refugees, migrants and host community women, we found that both versions were safe, acceptable and appropriate. Training lay facilitators to deliver the intervention was feasible. Challenges included slow recruitment related to delays caused by the COVID-19 pandemic, high attrition due to population mobility and other competing priorities, and mixed psychometric performance of psychosocial outcome measures. Although the intervention appeared promising, a definitive cluster randomized comparative effectiveness trial requires further adaptations to the research protocol. Within this pilot study we identified strategies to overcome these challenges that may inform adaptations. This comparative effectiveness design may be a model for identifying effective components of psychosocial interventions.

Feasibility and acceptability of NIDUS-Professional, a training and support intervention for homecare workers caring for clients living with dementia: a cluster-randomised feasibility trial protocol

IntroductionMost people living with dementia want to remain living in their own homes, and are supported to do so by family carers and homecare workers. There are concerns that homecare...

RAPID-2 study protocol: a cluster randomised feasibility trial of a midwife facilitated intervention for pregnant women with symptoms of mild to moderate anxiety

IntroductionMany women experience symptoms during pregnancy. Elevated and prolonged anxiety can have negative effects on the woman and baby. The RAPID intervention aims to provide suitable, timely support for women...

Assessing the feasibility of MOVING FORWARD, a multicentre transition intervention model across adolescent secure services in England: A cluster randomised feasibility trial

IntroductionYoung people moving from adolescent secure inpatient units to adult care in the UK present with multiple and complex needs and are more likely to experience poor transition outcomes related to enduring dependency on mental health services. However, there is lack of knowledge about the feasibility of transitional care models improving transition outcomes.ObjectivesThe MOVING FORWARD study aims to implement a new transition intervention model for young people transitioning from adolescent secure services to adult-oriented settings and test the feasibility of a future cluster trial measuring its effectiveness.MethodsThe design of the study is a three-arm feasibility, cluster randomised controlled trial comparing the MOVING FORWARD intervention against standard transition preparation in six adolescent secure services.Young people between 17-19 years, their parents/carers and key workers will be allocated in two conditions and will receive four transition preparation workshops across six months. Data will be collected at three time points: (T0) baseline, (T1) 6-12 months post-intervention, and (T2)18-24 months post-baseline.ResultsThirteen young people and 17 staff members have contributed to the intervention design through online Advisory Groups. Common identified themes included appropriateness of module content and support during delayed transitions. An intra-class correlation coefficient will be calculated to inform the power of sample size. With a sample size of 50, we will be able to estimate a drop-out rate of 80%.ConclusionsThis research will provide practitioners and policy makers with an evidence-based framework about barriers and facilitators to the proposed intervention and will enable services to reflect on quality of transitional care delivery.DisclosureNo significant relationships.

Antenatal couples\u2019 counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial

BackgroundCommon avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda.MethodsThis is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone.DiscussionThis intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples’ counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda.Trial registrationPan African Clinical Trials Registry PACTR202102794681952. Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021

Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) in home care services: a cluster randomized feasibility trial

BackgroundBehavioral and psychological symptoms of dementia (BPSD) occur frequently in people with dementia and can contribute to an increased need for help and a reduced quality of life, but also predict early institutionalization. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) might be a useful personalized approach to BPSD in people with dementia. The main objective of this feasibility trial was to explore the trial design and methods along with the patients’ and the home care staff’s acceptance of the TIME intervention before developing a definitive trial. Additionally, we wanted to explore whether TIME could be appropriate for staff in home care services in their approach towards people with dementia with anxiety and depression.MethodsThis was a 18-month feasibility trial using a parallel cluster randomized controlled design. Nine municipalities from the eastern part of Norway (clusters) — 40 people with dementia and 37 of their next of kin— were randomized to the TIME intervention or to treatment as usual. In addition, qualitative data as field notes were collected and summarized.ResultsThe staff in home care services experienced TIME as an appropriate method; in particular, the systematic approach to the patient’s BPSD was experienced as useful. However, the completion of the assessment phase was considered exhaustive and time-consuming, and some of the staff found it challenging to find time for the case conferences.ConclusionsWe consider that TIME, with some adjustments, could be useful for staff in home care services in cases where they face challenges in providing care and support to people with dementia. This feasibility trial indicates that we can move forward with a future definitive randomized controlled trial (RCT) to test the effect of TIME in people with dementia receiving home care services.Trial registrationClinicalTrial.gov identifier: SI0303150608.

CHoosing Active Role Models to INspire Girls (CHARMING): protocol for a cluster randomised feasibility trial of a school-based, community-linked programme to increase physical activity levels in 9\u201310-year-old girls

BackgroundIn the UK, there is evidence that girls’ physical activity tends to decline to a greater extent than boys as they enter adolescence. ‘Role models’ could play a vital role in inspiring girls to become or remain physically active. The CHARMING Programme is a primary school-based community linked role-model programme, co-developed in 2016, with children, parents, schools and wider stakeholders. It involves different types of physical activity delivered for 1-h each week by a community provider and peer role models (e.g. older girls from secondary schools) joining in with the sessions. The programme ultimately aims to increase and sustain physical activity levels among 9–10-year-old girls. This study aims to assess the feasibility and acceptability of the CHARMING Programme and of evaluating it using a randomised trial.MethodsThis study is a feasibility cluster randomised controlled trial, with embedded process evaluation and health economic evaluation. Approximately 90 Year 5 (i.e. 9–10-year-old) girls will be recruited across six primary schools in Mid-South Wales. Participating schools will be allocated to the programme: control on a 2:1 basis; four intervention schools will run the CHARMING Programme and two will continue with usual practice. A survey and accelerometer will be administered at baseline and repeated at 12 months. Interviews and focus groups will be conducted post-intervention delivery. The primary aim is to assess feasibility of a future randomised trial via the recruitment of schools, participants and role models; randomisation; retention; reach; data collection completion rates; programme adherence; and programme fidelity, views on intervention acceptability and programme barriers and facilitators. Secondary aims are to evaluate established physical activity outcome measures for children plus additional health economic outcomes for inclusion in a future full-scale trial.DiscussionThe results of this study will inform decisions on whether and how to proceed to a full-scale evaluation of the effectiveness and cost-effectiveness of the CHARMING Programme to improve or sustain physical activity.Trial registrationClinicalTrials.gov ISRCTN36223327. Registered March 29, 2021

A Cluster-Randomised Crossover Pilot Feasibility Study of a Multicomponent Intervention to Reduce Occupational Sedentary Behaviour in Professional Male Employees.

Professional male office employees have been identified as those most at risk of prolonged sedentary time, which is associated with many long-term adverse health conditions. The aim of the study was to assess the acceptability and feasibility of a gender-sensitive multicomponent intervention, guided by the socio-ecological model, to reduce occupational sedentary behaviour by increasing physical activity in professional men. The main elements of the intervention comprised: a Garmin watch with associated web-based platform/smartphone application, an under-desk pedal machine, and management participation and support. A cluster-randomised crossover pilot feasibility trial recruiting professional males was conducted in two workplaces. Mixed methods were used to assess the primary outcomes of recruitment, retention, and acceptability and feasibility of the intervention. Secondary outcomes included objectively measured sedentary behaviour, standing and physical activity. Focus groups were used to explore the acceptability of the intervention in a real-world setting. Twenty-two participants were recruited (mean age 42.9 years (SD 11.0)). Recruitment and retention rates were 73.3% and 95%, respectively. Overall, participants found the intervention acceptable and feasible, and expressed enjoyment of the intervention, however desk set-up issues with the pedal devices were noted. The manual recording of the pedalling bouts was overly burdensome. Preliminary data indicate that the intervention may reduce occupational sedentary behaviour and increase physical activity. This intervention should be further tested in a definitive trial following consideration of the findings of this pilot feasibility trial.

Strategies to enhance routine physical activity in care home residents: the REACH research programme including a cluster feasibility RCT

Strategies to enhance routine physical activity in care home residents: the REACH research programme including a cluster feasibility RCT

Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

The complex relationship between intimate partner violence and psychological distress warrants an integrated intervention approach. In this study we examined the relevance, acceptability, and feasibility of evaluating a multi-sectoral integrated violence- and mental health-focused intervention (Nguvu). We enrolled 311 Congolese refugee women from Nyarugusu refugee camp in Tanzania with past-year intimate partner violence and elevated psychological distress in a feasibility cluster randomized trial. Women were recruited from local women's groups that were randomized to the Nguvu intervention or usual care. Participants from women's groups randomized to Nguvu received 8 weekly sessions delivered by lay refugee incentive workers. Psychological distress, intimate partner violence, other wellbeing, and process indicators were assessed at baseline and 9-weeks post-enrollment to evaluate relevance, acceptability, and feasibility of implementing and evaluating Nguvu in refugee contexts. We found that Nguvu was relevant to the needs of refugee women affected by intimate partner violence. We found reductions in some indicators of psychological distress, but did not identify sizeable changes in partner violence over time. Overall, we found that Nguvu was acceptable and feasible. However, challenges to the research protocol included baseline imbalances between study conditions, differential intervention completion related to intimate partner violence histories, differences between Nguvu groups and facilitators, and some indication that Nguvu may be less beneficial for participants with more severe intimate partner violence profiles. We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting. A definitive cluster randomized trial requires further adaptations for recruitment and eligibility screening, randomization, and retention. ISRCTN65771265, June 27, 2016.

Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial

BackgroundCervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.MethodsWe designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.DiscussionOur trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.Trial registrationClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

Longer-term health and social care strategies for stroke survivors and their carers: the LoTS2Care research programme including cluster feasibility RCT

Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

A classroom intervention targeting working memory, attention and language skills: a cluster randomised feasibility trial

BackgroundInternational debate around the best models of speech and language therapy provision for children with language disorders has highlighted the need for research into classroom-based approaches and intervention dosage. Working memory (WM) is a cognitive skill linked to attention and language. ‘Recall to Enhance Children’s Attention, Language and Learning’ (RECALL) is a novel, 6-week, classroom-based intervention delivered by health professionals (HPs) and teachers. It is designed to target WM and enhance attention and language skills in 4–5 year olds.MethodsA cluster randomised feasibility trial was conducted to investigate aspects of the feasibility of a definitive trial to evaluate RECALL: (i) recruitment and sampling procedures; (ii) compliance and fidelity; (iii) the acceptability of RECALL to HPs and teachers; (iv) the appropriateness of the outcome measures. Six classes of 4–5 year olds participated: two received RECALL, two received an existing intervention targeting attention skills (not underpinned by WM theory), and two received education as usual (no intervention). Ten children in each class (n = 60) were sampled to assess the appropriateness of the outcome measures. Classroom observations were conducted to measure fidelity and semi-structured interviews with HPs, and teachers explored the acceptability of RECALL.ResultsThe recruitment targets were met, and all six schools completed the trial, but the sampling procedures require modification. Compliance was good (95% of RECALL sessions were delivered), but fidelity to the intervention protocol varied between 76% and 45% across the two schools. This was influenced by large class sizes, child factors, and facilitator factors, e.g., their understanding of the theory underpinning the intervention. The lack of fidelity reduced the dose (number of practice items) accessed by individual children, particularly those most at risk. There were mixed findings regarding the acceptability of RECALL and the appropriateness of the outcome measures.ConclusionsThe trial protocol could be easily scaled-up in a future definitive trial, with an amended sampling procedure. RECALL should be repackaged as a small group intervention to enhance the fidelity of its delivery and its acceptability to HPs and teachers. This study highlights the need for thorough training for professionals who deliver classroom-based interventions for children with language disorders.Trial registrationISRCTN13633886. Registered on 7 September 2018

Near patient chlamydia and gonorrhoea screening and treatment in further education/technical colleges: a cost analysis of the \u2018Test n Treat\u2019 feasibility trial

BackgroundCommunity-based screening may be one solution to increase testing and treatment of sexually transmitted infections in sexually active teenagers, but there are few data on the practicalities and cost of running such a service. We estimate the cost of running a ‘Test n Treat’ service providing rapid chlamydia (CT) and gonorrhoea (NG) testing and same day on-site CT treatment in technical colleges.MethodsProcess data from a 2016/17 cluster randomised feasibility trial were used to estimate total costs and service uptake. Pathway mapping was used to model different uptake scenarios. Participants, from six London colleges, provided self-taken genitourinary samples in the nearest toilet. Included in the study were 509 sexually active students (mean 85/college): median age 17.9 years, 49% male, 50% black ethnicity, with a baseline CT and NG prevalence of 6 and 0.5%, respectively. All participants received information about CT and NG infections at recruitment. When the Test n Treat team visited, participants were texted/emailed invitations to attend for confidential testing. Three colleges were randomly allocated the intervention, to host (non-incentivised) Test n Treat one and four months after baseline. All six colleges hosted follow-up Test n Treat seven months after baseline when students received a £10 incentive (to participate).ResultsThe mean non-incentivised daily uptake per college was 5 students (range 1 to 17), which cost £237 (range £1082 to £88) per student screened, and £4657 (range £21,281 to £1723) per CT infection detected, or £13,970 (range £63,842 to £5169) per NG infection detected.The mean incentivised daily uptake was 19 students which cost £91 per student screened, and £1408/CT infection or £7042/NG infection detected.If daily capacity for screening were achieved (49 students/day), costs including incentives would be £47 per person screened and £925/CT infection or £2774/NG infection detected.ConclusionsDelivering non-incentivised Test n Treat in technical colleges is more expensive per person screened than CT and NG screening in clinics. Targeting areas with high infection rates, combined with high, incentivised uptake could make costs comparable.Trial registrationISRCTN58038795, Assigned August 2016, registered prospectively.