Two-arm Cluster-randomized Controlled Trial Research Articles

Assessing Wolbachia-mediated Sterility for Dengue Control: Emulation of a Cluster Randomized Target Trial in Singapore.

Matings between male Aedes aegypti mosquitoes infected with wAlbB strain of Wolbachia and wildtype females yield non-viable eggs. We evaluated the efficacy of releasing wAlbB-infected Ae. aegypti male mosquitoes to suppress dengue. We specified the protocol of a two-arm cluster-randomized test-negative controlled trial (cRCT) and emulated it using a nationally representative test-negative/positive database of individuals reporting for febrile illness to any public hospital, general practitioner or polyclinic. We retrospectively built a cohort of individuals who reside in Wolbachia locations versus a comparator control group who do not reside in Wolbachia locations, using a nationally representative database of all individuals whom report for febrile illness and were tested for dengue at the Environmental Health Institute/hospital laboratories/commercial diagnostic laboratories, through general practitioner clinic, polyclinic or public/private hospital from EW1 2019-EW 262022. We emulated a constrained randomization protocol used in cRCTs to balance dengue risk between intervention and control arms in the pre-intervention period. We used the inverse-probability weighting approach to further balance the intervention and control groups using a battery of algorithmically selected sociodemographic, environmental and anthropogenic variables. Intention-to-treat analyses was conducted to estimate the risk reduction of dengue given Wolbachia exposure. Intention-to-treat analyses revealed that, compared with controls, Wolbachia releases for 3, 6, 12 or more months was associated to 47%(95%CI:25-69%), 44%(33-77%) and 61%(38-78%) protective efficacy against dengue, respectively. When exposed to 12 or more months of Wolbachia releases, protective efficacies ranged from 49%(13-72%) to 77%(60-94%) across years. The proportion of virologically confirmed dengue cases was lower overall in the intervention arm. Protective efficacies were found across all years, age and sex subgroups, with higher durations of Wolbachia exposure associated to greater risk reductions of dengue. Results demonstrated that Wolbachia-mediated sterility can strengthen dengue control in tropical cities, where dengue burden is the greatest.

Evaluation of a medical student-delivered smoking prevention program utilizing a face-aging mobile app for secondary schools in Germany: The Education Against Tobacco cluster-randomized controlled trial

BackgroundTo reduce smoking uptake in adolescents, the medical students' network Education Against Tobacco (EAT) has developed a school-based intervention involving a face-aging mobile app (Smokerface). MethodsA two-arm cluster-randomized controlled trial was conducted, evaluating the 2016 EAT intervention, which employed the mobile app Smokerface and which was delivered by medical students. Schools were randomized to intervention or control group. Surveys were conducted at baseline (pre-intervention) and at 9, 16, and 24 months post-intervention via paper & pencil questionnaires. The primary outcome was the difference in within-group changes in smoking prevalence between intervention and control group at 24 months. ResultsOverall, 144 German secondary schools comprising 11,286 pupils participated in the baseline survey, of which 100 schools participated in the baseline and at least one of the follow-up surveys, yielding 7437 pupils in the analysis sample. After 24 months, smoking prevalence was numerically lower in the intervention group compared to control group (12.9 % vs. 14.3 %); however, between-group differences in change in smoking prevalence between baseline and 24-months follow-up (OR=0.83, 95 %-CI: 0.64–1.09) were not statistically significant (p = 0.176). Intention to start smoking among baseline non-smokers declined non-significantly in the intervention group (p = 0.064), and remained essentially unchanged in the control group, but between-group differences in changes at the 24-months follow-up (OR=0.88, 0.64–1.21) were not statistically significant (p = 0.417). ConclusionWhile a trend towards beneficial effects of the intervention regarding smoking prevalence as well as intention to start smoking among baseline non-smokers was observed, our smoking prevention trial demonstrated no significant effect of the intervention.

Entomological effects of attractive targeted sugar bait station deployment in Western Zambia: vector surveillance findings from a two-arm cluster randomized phase III trial

BackgroundAttractive targeted sugar bait (ATSB) stations are a novel tool with potential to complement current approaches to malaria vector control. To assess the public health value of ATSB station deployment in areas of high coverage with standard vector control, a two-arm cluster-randomized controlled trial (cRCT) of Sarabi ATSB® stations (Westham Ltd., Hod-Hasharon, Israel) was conducted in Western Province, Zambia, a high-burden location were Anopheles funestus is the dominant vector. The trial included 70 clusters and was designed to measure the effect of ATSBs on case incidence and infection prevalence over two 7-month deployments. Reported here are results of the vector surveillance component of the study, conducted in a subset of 20 clusters and designed to provide entomological context to guide overall interpretation of trial findings.MethodsEach month, 200 paired indoor-outdoor human landing catch (HLC) and 200 paired light trap (LT) collections were conducted to monitor An. funestus parity, abundance, biting rates, sporozoite prevalence, and entomological inoculation rates (EIR).ResultsDuring the study 20,337 female An. funestus were collected, 11,229 from control and 9,108 from intervention clusters. A subset of 3,131 HLC specimens were assessed for parity: The mean non-parous proportion was 23.0% (95% CI 18.2–28.7%, total n = 1477) in the control and 21.2% (95% CI 18.8–23.9%, total n = 1654) in the intervention arm, an OR = 1.05 (95% CI 0.82–1.34; p = 0.688). A non-significant reduction in LT abundance (RR = 0.65 [95% CI 0.30–1.40, p = 0.267]) was associated with ATSB deployment. HLC rates were highly variable, but model results indicate a similar non-significant trend with a RR = 0.68 (95%CI 0.22–2.00; p = 0.479). There were no effects on sporozoite prevalence or EIR.ConclusionsAnopheles funestus parity did not differ across study arms, but ATSB deployment was associated with a non-significant 35% reduction in vector LT density, results that are consistent with the epidemiological impact reported elsewhere. Additional research is needed to better understand how to maximize the potential impact of ATSB approaches in Zambia and other contexts.Trial registration number: This trial was registered with Clinicaltrials.gov (NCT04800055, 16 March 2021).

The impacts of task shifting on the management and treatment of malnourished children in Northern Kenya: a cluster-randomized controlled trial.

Treating children with acute malnutrition can be challenging, particularly regarding access to healthcare facilities during treatment. Task shifting, a strategy of transferring specific tasks to health workers with shorter training and fewer qualifications, is being considered as an effective approach to enhancing health outcomes in primary healthcare. This study aimed to assess the effectiveness of integrating the treatment of acute malnutrition by community health volunteers into integrated community case management in two sub-counties in northern Kenya (Loima and Isiolo). We conducted a two-arm non-inferiority cluster-randomized controlled trial across 20 community health units. Participants were children aged 6-59 months with uncomplicated acute malnutrition. In the intervention group, community health volunteers used simplified tools and protocols to identify and treat eligible children at home and provided the usual integrated community case management package. In the control group, community health volunteers provided the usual integrated community case management package only (screening and referral of the malnourished children to the health facilities). The primary outcome was recovery (MUAC ≥12.5 cm for 2 consecutive weeks). Results show that children in the intervention group were more likely to recover than those in the control group [73 vs 50; risk difference (RD) = 26% (95% CI 12 to 40) and risk ratio (RR) = 2 (95% CI 1.2 to 1.9)]. The probability of defaulting was lower in the intervention group than in the control group: RD = -21% (95% CI -31 to -10) and RR = 0.3 (95% CI 0.2 to 0.5). The intervention reduced the length of stay by about 13 days, although this was not statistically significant and varied substantially by sub-county. Integrating the treatment of acute malnutrition by community health volunteers into the integrated community case management programme led to better malnutrition treatment outcomes. There is a need to integrate acute malnutrition treatment into integrated community case management and review policies to allow community health volunteers to treat uncomplicated acute malnutrition.

Universal Sexual Violence Intervention Effects in a Cluster-Randomized Trial: Moderation by Sexual Orientation.

Sexual minority (e.g., gay/lesbian, bisexual, and queer) students are more likely than their heterosexual peers to experience sexual violence (SV) during college. Interventions that prevent SV and improve SV care-seeking behaviors for sexual minority students are lacking. Giving Information for Trauma Support and Safety (GIFTSS) is an evidence-based universal SV intervention implemented by providers during college health and counseling visits. Compared to controls, GIFTSS participants reported greater self-efficacy to use SV harm reduction strategies and SV disclosure during clinical visits. However, GIFTSS' effectiveness for sexual minority participants is unknown. The current study examines whether sexual orientation moderates GIFTSS' effects on numerous SV-related outcomes (i.e., to test whether intervention effects at 4 and 12 months differed based on sexual orientation). Across 28 college campuses in Pennsylvania and West Virginia, 2,291 students participated in a two-arm cluster-randomized controlled trial. We used mixed models with two- and three-way interaction terms to test whether sexual orientation modified GIFTSS' effects at 4- and 12-month follow-up on participants': SV recognition; knowledge of and self-efficacy to enact SV harm reduction strategies; intentions to intervene; knowledge of and self-efficacy to use SV-related services; SV disclosure during visits; and recent SV exposure. Overall, 22.1% of participants were sexual minorities (n = 507). Sexual orientation moderated GIFTSS effectiveness as indicated by significant three-way interaction (p = .01) at 12-month follow-up, and knowledge of SV services decreased for heterosexual participants (β = -.23) but increased for sexual minority participants (β = .23). Our study indicates that universal provider-based education may promote greater knowledge of SV services among sexual minority than heterosexual participants, and population-specific interventions are needed that reduce sexual minority students' SV exposure, service utilization, and other critical aspects of SV prevention on university campuses.Clinical Trial Registration: Registry name: College Health Center-based Alcohol and Sexual Violence Intervention (GIFTSS), Registration number: NCT02355470, Web link: https://clinicaltrials.gov/ct2/show/NCT02355470, Deidentified individual participant data will not be made available.

Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care

IntroductionUncomplicated urinary tract infections (uUTIs) in women are common infections encountered in primary care. Evidence suggests that rapid point-of-care tests (POCTs) to detect bacteria and erythrocytes in urine at presentation...

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial

BackgroundEvidence-based parenting programmes have strong evidence in preventing and mitigating violence, but in-person programmes are challenging to deliver at scale. ParentApp is an open-source, offline-first app-based adaptation of the Parenting for Lifelong Health for Parents and Teens programme to promote playful and positive parenting, reduce risks for sexual violence victimisation, and prevent violence against adolescents. This study aims to evaluate the effectiveness and cost-effectiveness of ParentApp compared to an attention-control group.MethodsThis study is a two-arm pragmatic cluster-randomised controlled trial to test whether ParentApp reduces adolescent physical abuse, emotional abuse, and sexual violence risks and victimisation at 1 month and 12 months post-intervention. Caregivers of adolescents aged 10–17 years and their adolescent children (N = 2400 caregiver-adolescent dyads) will be recruited in urban and peri-urban communities in the Mwanza region of Tanzania. A total of 80 study clusters will be stratified and randomised (1:1) to the intervention group, who will receive ParentApp with support through a WhatsApp group, or to an attention-control group, who will receive a water, sanitation, and hygiene app. Quantitative data will be collected through outcomes questionnaires with caregivers and adolescents, administered at baseline, 4 months post-baseline, and 16 months post-baseline, as well as through routine implementation data and ParentApp engagement data. Qualitative data will be collected through individual interviews and focus groups with caregivers, adolescents, and implementing partner staff.DiscussionApp-based interventions have the potential to expand access to evidence-based parenting support, but currently lack rigorous evidence in low- and middle-income countries. This is the first known randomised control trial of a hybrid digital parenting programme to prevent the abuse of adolescents in low- and middle-income settings.Trial registrationThe trial was registered on the Open Science Framework on 14 March 2023, registration: OSF.IO/T9FXZ.

CBT-Based and eHealth-Supported Case Management for Patients with Panic Disorder or Depression in Primary Care: Results of a Proof of Concept

Abstract Evaluation of a team-based intervention in primary care that includes cognitive behavioural therapy elements and case management and was supported by eHealth components in patients with panic disorder with or without agoraphobia (PD ± AG) and/or depression. In a two-armed cluster-randomised controlled trial (cRCT), mental health conditions were assessed by the Mental Health Index (MHI-5), Patient Health Questionnaire (PHQ-9), Overall Anxiety Severity and Impairment Scale (OASIS), Panic and Agoraphobia Scale (PAS), Mobility Inventory for Agoraphobia (MIA), and Patient Assessment of Chronic Illness Care (PACIC) at baseline (T0), after 6 months (T1), and after 12 months (T2). Scores were analysed as differences from baseline using a mixed linear model with general practitioner (GP) as a random intercept and treatment, time point, and respective baseline value as fixed factors. The majority of participants (mean age 54 years, SD 12.8 years) were women (n = 40, 67.8%). We found consistent mean effects in favour of the intervention group (MHI-5 index, 6.66 [−7.38; 20.70]; PACIC, 15.92 [4.58; 27.26]; PHQ-9, −3.43 [−5.71; −1.14]; OASIS, −2.89 [−5.41; −0.37]). A cautious interpretation indicates promising effects of the intervention. Obstacles to recruitment included the workload for GPs and medical assistants (MAs), potential reservations regarding eHealth, and the onset of the COVID-19 pandemic. Trial registration: The study was registered at the German Clinical Trials Register (DRKS00016622) on February 22nd, 2019. https://drks.de/search/de/trial/DRKS00016622.

Effectiveness of the holistic primary school-based intervention MindMatters: study protocol for a cluster-randomised controlled trial

BackgroundThe prevalence of mental health problems in childhood and adolescence has increased significantly, not least due to the COVID-19 pandemic in Germany and other countries worldwide. Although holistic school interventions to promote mental health and prevent mental health problems are considered promising, there is currently uncertainty about their effectiveness due to evaluation studies with heterogeneous methodological quality. This paper presents the study protocol for the evaluation of the primary school module of MindMatters.MethodsAs part of a universal mental health intervention, the MindMatters primary school module ‘Learning Together with Emotions’ aims to promote social-emotional learning (SEL) in the classroom across five skill areas. In addition to classroom activities, the intervention includes a school development module to help primary schools create structures and processes to maintain and promote mental health. To evaluate the effectiveness of the intervention, a two-arm cluster-randomised controlled trial will be conducted, including schools implementing MindMatters over a 12-month period and a control group with no access to the intervention. Data will be collected before and 18 months after initiation of the intervention. Controlled for baseline conditions, multilevel regression analysis will be used to examine primary intervention outcomes at the pupil level (i.e. reductions in mental and behavioural problems). Further mediation and moderation analyses will examine whether proximal outcomes predict changes in mental health outcomes and whether school-level factors influence the effectiveness of the intervention.DiscussionThis study will contribute to strengthen the evidence base for holistic school (mental) health promotion interventions using a study design with high internal validity. Based on an intervention model, the results will not only provide insights into the relationship between proximal and distal outcomes, but will also allow conclusions to be drawn about how the implementation of the intervention affects its effectiveness. Finally, the findings also address the question of whether improved mental health has a positive effect on primary school pupils’ academic performance.Trial registrationGerman Clinical Trials Register DRKS00023762. Registered on 5 January 2021.

Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial

BackgroundOral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women.MethodsThe Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16–24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16–24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants’ perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention’s fidelity and cost.DiscussionEvidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings.Trial registrationClinicalTrials.gov NCT04982250. Registered on July 29, 2021.

Enhancing skin health and safety in aged care (SKINCARE trial): A cluster-randomised pragmatic trial

BackgroundOlder nursing home residents are prone to develop different skin conditions at the same time, including xerosis cutis, skin tears, pressure ulcers, incontinence-associated dermatitis or intertrigo. Guidelines and recommendations mainly address these skin conditions separately. The overall aim of this study was to measure the effects of the implementation of a skincare and prevention package. Trial designA two-arm cluster-randomised controlled trial was conducted. MethodsIn nursing homes being assigned to the intervention group, an evidence-based and structured skincare and prevention programme was implemented for six months. Nursing home residents in the control group received standard care as usual. Blinded dermatologists conducted head-to-toe skin assessments, and the researchers assessed skin barrier parameters including stratum corneum hydration and transepidermal water loss at the upper and lower extremities after three and six months. Outcomes included the cumulative incidence of incontinence-associated dermatitis, skin tears, pressure ulcers and intertrigo, and were presented as intention-to-treat and per protocol analysis. Skin dryness and resident-reported outcomes (pain, itch, quality of life) were assessed. ResultsA random sample of 17 nursing homes in the federal state of Berlin, Germany, was drawn and randomised in intervention (n = 9) and control groups (n = 8). In total, 165 participants were allocated to the intervention, and 149 participants were allocated to the control group. The cumulative incidence of skin tears (19.2 %, 95 % CI 12.8–27.8), pressure ulcers (13.6 %, 95 % CI 8.1–21.9) and intertrigo (27.0 %, 95 % CI 18.4–37.7) was lower in the intervention compared to the control group, with cumulative incidences of 27.2 % (95 % CI 19.3–36.9) for skin tears, 16.9 % (95 % CI 10.6–25.9) for pressure ulcer, and 37.8 % (95 % CI 27.5–49.4) for intertrigo. The incidence of incontinence-associated dermatitis was higher in the intervention group (26.3 %, 95 % CI 17.9–36.8) compared to the control group (23.1 %; 95 % CI 14.6–34.5). Mean skin dryness was lower in the intervention group but showed variation. The impact on pain, itch, and quality of life was trivial. ConclusionsThe present study results indicate that the implementation of tailored and evidence-based nursing routines improves skin health and safety in residential long-term care. Evidence suggests that multiple adverse skin conditions can be prevented by regular skin assessments and individually tailored skincare routines. Positive effects on skin dryness were observed, but skin physiology parameters did not indicate changes of the skin barrier function. Trial registrationThis study is registered at the German Clinical Trials Register (registration number: DRKS00015680; date of registration: January 29th, 2019) and ClinicalTrials.gov (NCT03824886; date of registration: January 31st, 2019).

Reducing Violent Discipline by Teachers: a Matched Cluster-Randomized Controlled Trial in Tanzanian Public Primary Schools

Violent discipline in schools infringes on children’s rights and is associated with harmful developmental consequences for students. This calls for effective intervention programs, particularly in countries with high prevalence of violent discipline in schools. This study tested the effectiveness of the preventative intervention Interaction Competencies with Children—for Teachers (ICC-T) in reducing violent discipline by teachers in a two-arm matched cluster-randomized controlled trial. The sample comprised teachers (n = 173, 53.7% female) and students (n = 914, 50.5% girls) from 12 public primary schools from six regions in Tanzania. Teacher physical and emotional violent discipline reported by teachers and students was assessed before and six to eight and a half months after the intervention. The schools were randomly allocated to either intervention (6; ICC-T) or control condition (6; no intervention). Teachers were not blinded. Students and research assistants conducting the follow-up assessment were blinded. A series of multivariate multilevel models revealed significant time*intervention effects on physical violent discipline reported by teachers and students and teachers’ favorable attitudes towards physical violent discipline, FDRs < .05. In addition, we found a spill-over effect on peer-to-peer violence and students’ externalizing, ps < .05. There were no significant time*intervention effects either on emotional violent discipline, FDRs > .05, teachers’ favorable attitudes towards emotional violent discipline or on student’s internalizing problems and academic performance, ps > .05. Our results provide further evidence that ICC-T may positively change teachers’ violent disciplining behavior and their attitudes towards violent discipline. ClinicalTrials.gov, NCT03893851.

Are psychosocial work factors and work-home interference associated with time to first full return-to-work after sick leave due to common mental disorders?

ObjectiveTo (1) examine the time to first full return-to-work (RTW), and (2) investigate whether psychosocial work factors and work-home interference are associated with time to first full RTW after sick leave due to common mental disorders (CMDs).MethodsThe cohort study comprised 162 employees on sick leave due to CMDs participating in a two-armed cluster-randomised controlled trial in Sweden. Baseline data consisted of a web-based questionnaire and follow-up data of repeated text messages every fourth week for 12 months. The time to first full RTW was estimated using the Kaplan–Meier Estimator. Parametric Weibull survival models with interval-censored outcomes were used to determine associations between psychosocial work factors and work-home interference with time to first full RTW. In a post hoc analysis, time-interval differences in associations for 0– ≤ 6- versus > 6–12 months were tested.ResultsDuring the 12-month follow-up, n = 131 (80.9%) reported a first full RTW. The median time to this RTW was 16 weeks (95% CI 12; 20). High psychological job demands, high emotional job demands, high work-to-home interference (WHI), and low social job support were independently associated with a longer time to first full RTW. Time-interval differences were found for job control and emotional job demands.ConclusionsPsychosocial work demands and WHI are associated with a longer time to RTW after sick leave due to CMDs. Work organisations and rehabilitation practices should include accommodations for high psychological and emotional job demands during RTW, as well as pay attention to the risk of spill-over of high job demands into employees’ private lives.

Application of the Logic Model to the School-Based Fit and Smart Adolescent Smoking Cessation Programme.

School-based smoking cessation intervention programmes are challenging to implement and evaluate. This study aimed to explain the process of developing the Fit and Smart Adolescent Smoking Cessation Programme (FSSCP). Logic model is a visual tool that helps programme planners to create an activity action plan that suits the target group to achieve programme objectives and goals. This two-arm cluster-randomised controlled trial was implemented between January 2018 and November 2018. Six schools were selected using stratified random sampling, whereby students were purposively selected and invited. The criteria of inclusion to the programme were secondary school students (aged 13 years old-17 years old) who smoked conventional cigarettes (CC) and electronic cigarettes (EC). A total of 422 students from six schools participated in this study. Three schools were designated as intervention (n = 250) and the other three as control schools (n = 172). Formative evaluation of participants in the FSSCP using the logic model showed that participants were satisfied with the overall programme (91.5%), were motivated to stop smoking (90.4%) and were prevented from relapse (89.2%). The quit rate at a 3-month follow-up was 41.8%. The logic model supported the development of the programme, with details on the processes, dissemination activities, identification of barriers, evaluation criteria and outcomes provided.

Evaluating Palin Stammering Therapy for School Children (Palin STSC 8–14): protocol for a feasibility randomised controlled trial comparing Palin STSC(8–14) with usual treatment

BackgroundHaving a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practice. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8–14: Palin Stammering Therapy for School Children (Palin STSC(8–14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8–14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised controlled trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.MethodsThis is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8–14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine the following: the recruitment and retention of therapists and families, the acceptability of the research processes and the therapeutic intervention and the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and 6 months later, including measures of stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour and peer relations, anxiety; quality of life; and economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings.DiscussionThe findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8–14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence-based intervention for school age children who stammer.Trial registrationISRCTN. ISRCTN17058884. Registered on 18 December 2019.

Evaluating a school-based intervention through routine local authority data and national school data: Challenges and opportunities.

ObjectivesThe Department for Education funded local authorities (LAs) in England to embed social workers into schools (SWIS) so that they can work more effectively with teachers, children and families. A two-arm cluster randomised-controlled trial is evaluating the effect of SWIS compared to schools without on referrals to Children’s Social Care.&#x0D; ApproachLAs collate information about all children who are referred to Children’s Social Care within their authority. A case report form has been developed by the trial team to collect school-level information on child protection enquiries, referrals, child in need assessments and numbers of days children spent in state care. Cost data are also included for an economic evaluation. LAs return a completed dataset each quarter, reporting aggregate numbers by school and year group. Data on attendance and attainment will be requested separately from the National Pupil Database (NPD) in 2023.&#x0D; ResultsQuarterly (n=6) data was supplied for 291 schools across 21 LAs. We will focus on this method of data collection and its challenges and opportunities. Relying on 21 external parties to provide all trial data in a timely manner brought risks to the collation of trial outcome data but has reduced the overall costs of data collection. LAs work with a number of different (and changing) IT systems, many of which are not compatible with each other. This, along with personnel changes in data teams, has led to delays. Receiving aggregate data limits the amount of quality control possible, therefore detailed guidance mitigated potential data input errors. Working with LAs to develop and refine these guidance materials at the outset paid dividends.&#x0D; ConclusionUsing routine LA data is a novel cost-efficient approach to collecting trial outcome data at scale. However, the disjointed and varying data architecture that exists in LAs presents practical challenges. This means we relied on good working relationships with the LAs, including regular communication and collaborative problem solving.

USing rolE-substitutioN In care homes to improve ORal health (SENIOR): a study protocol

BackgroundDental service provision in the care home sector is poor, with little emphasis on prevention. Emerging evidence suggests that the use of Dental Care Professionals (dental therapists and dental nurses) as an alternative to dentists has the potential to improve preventive advice, the provision of care and access to services within care homes. However, robust empirical evidence from definitive trials on how to successfully implement and sustain these interventions within care homes is currently lacking. The aim of the study is to determine whether Dental Care Professionals could reduce plaque levels of dentate older adults (65 + years) residing in care homes.MethodsThis protocol describes a two-arm cluster-randomised controlled trial that will be undertaken in care homes across Wales, Northern Ireland and England. In the intervention arm, the dental therapists will visit the care homes every 6 months to assess and then treat eligible residents, where necessary. All treatment will be conducted within their Scope of Practice. Dental nurses will visit the care homes every month for the first 3 months and then three-monthly afterwards to promulgate advice to improve the day-to-day prevention offered to residents by carers. The control arm will be ‘treatment as usual’.Eligible care homes (n = 40) will be randomised based on a 1:1 ratio (20 intervention and 20 control), with an average of seven residents recruited in each home resulting in an estimated sample of 280. Assessments will be undertaken at baseline, 6 months and 12 months and will include a dental examination and quality of life questionnaires. Care home staff will collect weekly information on the residents’ oral health (e.g. episodes of pain and unscheduled care). The primary outcome will be a binary classification of the mean reduction in Silness-Löe Plaque Index at 6 months. A parallel process evaluation will be undertaken to explore the intervention’s acceptability and how it could be embedded in standard practice (described in a separate paper), whilst a cost-effectiveness analysis will examine the potential long-term costs and benefits of the intervention.DiscussionThis trial will provide evidence on how to successfully implement and sustain a Dental Care Professional-led intervention within care homes to promote access and prevention.Trial registrationISRCTN16332897. Registered on 3 December 2021.

The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT)

BackgroundLong distance heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related co-morbidities, and are underserved in terms of health promotion initiatives. The purpose of this study was to evaluate the effectiveness of the multicomponent ‘Structured Health Intervention For Truckers’ (SHIFT), compared to usual care, at 6- and 16–18-month follow-up.MethodsWe conducted a two-arm cluster RCT in transport sites throughout the Midlands, UK. Outcome measures were assessed at baseline, at 6- and 16–18-month follow-up. Clusters were randomised (1:1) following baseline measurements to either the SHIFT arm or usual practice control arm. The 6-month SHIFT programme included a group-based interactive 6-h education and behaviour change session, health coach support and equipment provision (Fitbit® and resistance bands/balls to facilitate a ‘cab workout’). The primary outcome was device-assessed physical activity (mean steps/day) at 6 months. Secondary outcomes included the following: device-assessed sitting, physical activity intensity and sleep; cardiometabolic health, diet, mental wellbeing and work-related psychosocial variables. Data were analysed using mixed-effect linear regression models using a complete-case population.ResultsThree hundred eighty-two HGV drivers (mean ± SD age: 48.4 ± 9.4 years, BMI: 30.4 ± 5.1 kg/m2, 99% male) were recruited across 25 clusters (sites) and randomised into either the SHIFT (12 clusters, n = 183) or control (13 clusters, n = 199) arms. At 6 months, 209 (55%) participants provided primary outcome data. Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145–1871, p = 0.022). Favourable differences were also seen in the SHIFT group, relative to the control group, in time spent sitting (− 24 mins/day, 95% CI: − 43 to − 6), and moderate-to-vigorous physical activity (6 mins/day, 95% CI: 0.3–11). Differences were not maintained at 16–18 months. No differences were observed between groups in the other secondary outcomes at either follow-up.ConclusionsThe SHIFT programme led to a potentially clinically meaningful difference in daily steps, between trial arms, at 6 months. Whilst the longer-term impact is unclear, the programme offers potential to be incorporated into driver training courses to promote activity in this at-risk, underserved and hard-to-reach essential occupational group.Trial registrationISRCTN10483894 (date registered: 01/03/2017)

Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial

BackgroundScreening reduces incidence and mortality from colorectal cancer (CRC), yet US screening rates are low, particularly among Medicaid enrollees in rural communities. We describe a two-phase project, SMARTER CRC, designed to achieve the National Cancer Institute Cancer MoonshotSM objectives by reducing the burden of CRC on the US population. Specifically, SMARTER CRC aims to test the implementation, effectiveness, and maintenance of a mailed fecal test and patient navigation program to improve rates of CRC screening, follow-up colonoscopy, and referral to care in clinics serving rural Medicaid enrollees.MethodsPhase I activities in SMARTER CRC include a two-arm cluster-randomized controlled trial of a mailed fecal test and patient navigation program involving three Medicaid health plans and 30 rural primary care practices in Oregon and Idaho; the implementation of the program is supported by training and practice facilitation. Participating clinic units were randomized 1:1 into the intervention or usual care. The intervention combines (1) mailed fecal testing outreach supported by clinics, health plans, and vendors and (2) patient navigation for colonoscopy following an abnormal fecal test result. We will evaluate the effectiveness, implementation, and maintenance of the intervention and track adaptations to the intervention and to implementation strategies, using quantitative and qualitative methods. Our primary effectiveness outcome is receipt of any CRC screening within 6 months of enrollee identification. Our primary implementation outcome is health plan- and clinic-level rates of program delivery, by component (mailed FIT and patient navigation). Trial results will inform phase II activities to scale up the program through partnerships with health plans, primary care clinics, and regional and national organizations that serve rural primary care clinics; scale-up will include webinars, train-the-trainer workshops, and collaborative learning activities.DiscussionThis study will test the implementation, effectiveness, and scale-up of a multi-component mailed fecal testing and patient navigation program to improve CRC screening rates in rural Medicaid enrollees. Our findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings.Trial registrationRegistered at clinicaltrial.gov (NCT04890054) and at the NCI’s Clinical Trials Reporting Program (CTRP #: NCI-2021-01032) on May 11, 2021.

Effect of a workplace mobile phone-based instant messaging intervention on smoking cessation: a cluster-randomized controlled trial.

To test the effectiveness of intractive, instant messaging chat-based mobile phone support versus text-based mobile phone support integrated with brief interventions on self-reported smoking abstinence in workplaces. A two-arm parallel cluster-randomized controlled trial with follow-up to 12 months. Seventy-five companies in Hong Kong, China. Daily cigarette adult smokers (92.0% male, 90.9% not ready to quit within the next 30 days) from 75 companies (clusters). Participants were cluster-randomized to receive text-based support (TBS, n = 375; 38 clusters) or chat-based support (CBS, n = 304; 37 clusters). TBS participants received automated and fix-scheduled text messages on cessation advice and support. CBS participants received fix-scheduled text messages and additional real-time psychosocial and cessation support via instant messaging services (e.g. WhatsApp) by counsellors. Both groups received a 1-hour health talk at baseline and brief telephone counselling at 1week and 1, 3, 6 and 12 months. The primary outcome was self-reported 7-day point-prevalence abstinence at 6months post-treatment initiation. Secondary outcomes included 7-day point-prevalence abstinence at 12 months, repeated 7-day point-prevalence abstinence, smoking reduction, quit attempts and intervention engagement, defined as having read text messages and/or engaged in conversation with counsellors. By intention-to-treat assuming that dropouts were smoking, self-reported abstinence was not significantly different between the CBS and TBS groups at 6months [18.8 versus 21.6%, risk ratio (RR) = 0.87, 95% confidence interval (CI) = 0.61, 1.23, retention = 71.3%] and 12 months (21.4 versus 24.0%, RR = 0.90, 95% CI = 0.66, 1.21, retention = 70.8%). The repeated 7-day point-prevalence abstinence, smoking reduction and quit attempts were similar between the groups. The participants who were engaged in the text- and/or chat-based interventions had greater abstinence (adjusted RR = 2.91, 95% CI = 1.87, 4.52) at 6months compared with unengaged participants. Compared with a text messaging mobile phone intervention, a chat-based instant messaging mobile phone intervention did not improve smoking abstinence over 12 months in workplaces. Engagement in text-based or chat-based interventions was associated with higher quit rates compared with non-engagement.