Full-scale Trial Research Articles

Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study

BackgroundMajor depressive disorder (MDD) is a common psychiatric disorder. With systematic antidepressant treatment, 50–75% of patients have a treatment response but require 4–6 weeks to have their symptoms alleviated. Therefore, researchers anticipate the development of novel fast-acting antidepressants. Previous studies have revealed that the decrease of bio-energetic metabolism may contribute to the occurrence of depression, while our team has found adenosine triphosphate (ATP) and phosphocreatine (PCr) to be fast-acting antidepressants in the depressed-animal model. ATP and PCr have already been widely prescribed clinically as energy supplements for cells. This will be the first clinical attempt of the intravenous administration of ATP and PCr combined with orally administered fluoxetine in MDD.MethodsThis is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 42 patients will be divided randomly into three groups. Patients will receive an intravenous administration of ATP or PCr or saline twice daily combined with orally administered fluoxetine (20 mg/day) for the first 2 weeks and fluoxetine monotherapy for the following 4 weeks. Follow-up assessment will be completed at week 10. Feasibility outcomes will include percentages of patient eligibility, intention to use medication, willingness to participate, drug adherence, completion of the scheduled assessment, retention, drop-out, etc. Physical examination results, Side Effect Rating Scale, adverse events, results from blood tests, electroencephalogram, and electrocardiograph will be recorded for safety evaluation of the augmentation therapy. The trends of efficacy will be evaluated by the reduction rate of the Hamilton Depression Rating Scale, the mean change of the Clinical Global Impression Scale, and the Patients Health Questionaire-9 items.DiscussionIn our study, ATP and PCr will be given by intravenous infusion. Thus patients will be hospitalized for the initial 2 weeks for safety concern. Hospitalization will be an impact factor for the recruitment, participation, drop-out, efficacy, results, etc. The evaluation of our feasibility outcomes, study setting, safety of augmentation therapy and possible efficacy trends among groups, will facilitate a full-scale trial design and sample size calculation.Trial registrationNCT03138681. Registered on 3 May 2017. First patient: 4 May 2017.

Al-Mg-Si billets with high extrudability – state of the art and beyond

Within the alloy groups EN-AW6060 and EN-AW6063 a range of alloys termed “High Speed Alloys”. have been developed. The underlying metallurgical principles of this development are explained. Further, new technological developments and new experimental discoveries have led to a new, upcoming billet quality, “HP 6xxx”. Three different billet qualities, “Standard 6060”, “High Speed 6060” and “HP 6060” were compared in a full-scale industrial trial, and the results indicate that the improvement in extrudability of “HP 6060” over “High Speed 6060” is of the same order as the improvement of “High Speed 6060” over “Standard 6060”

Can One Drink Informal Water Alternatives Directly? Using Mobile Phone to Establish Trust in Quality

The informal water market in cities within the Global South is expanding, thanks to drought associated water shortage challenges and other socio-hydrological factors. A midst the growth is the inherent information signal asymmetry driven mainly by the vendors’ unwillingness to share the actual quality data of their source water with their customers. As a result a big mistrust environment has been created as currently; the customers have no mechanism to verify the water quality in real time. This paper aimed at developing an android application software system to fill the gap. The system is to operate the water vending business landscape as a trusted social network site (SNS) using handheld mobile phone devices. An Agile-Scrum methodology was utilized as it allows for quick changes to the system as necessary. An android platform was chosen as the initial Operating System (OS) to run the software system due to its faster global outreach capability. Specifically, Android Studio 3.4.2 IDE running on Windows 10 was deployed. And the primary languages used within the IDE were; Kotlin for the functionality and XML for the user interface (UI). Additionally, the Firebase SDK tools were used for cloud-based database functionality. The results of the prototype include; user side access and feedback exchanges, backend side supports and other added functionalities. The paper is of the strong view that since the system works on anytime-anywhere modality, then it is possible that one can drink the informal water directly. The system is recommended for full scale trial in the affected cities.

The family as a resource for improving patient and family functioning after traumatic brain injury: A descriptive nonrandomized feasibility study of a family-centered intervention

AbstractThe aim of this study was to address feasibility aspects of a multidisciplinary, family-centered rehabilitation intervention for persons with traumatic brain injury and their family. The study was done in preparation of a full-scale RCT and conducted as a collaboration between specialist and municipal health-care service, with two municipal health professionals included as collaborating partners. By applying the intervention on six persons, two families, we evaluated the attendance rate, the appropriateness of the intervention’s topics, the collaboration with the municipal health professionals, and the data collection method. Predefined success-criteria were used to evaluate feasibility. The family intervention and study procedures were evaluated as feasible. Some challenges arose and were discussed prior to commencing the full-scale trial. They concerned the logistics regarding the delivery of the intervention and making appropriate adjustments to meet the families’ unique needs and facilitate pa...

A Parent-Targeted and Mediated Video Intervention to Improve Uptake of Pain Treatment for Infants During Newborn Screening: A Pilot Randomized Controlled Trial.

Most newborns undergo newborn screening blood tests. Breastfeeding, skin-to-skin care, and sweet solutions effectively reduce pain; however, these strategies are inconsistently used. We conducted a 2-armed pilot randomized controlled trial in a mother-baby unit to examine the feasibility and acceptability of a parent-targeted and -mediated video demonstrating use of these pain-reducing strategies and to obtain preliminary effectiveness data on uptake of pain management. One hundred parent-newborn dyads were randomized to view the video or receive usual care (51 intervention and 49 control arm). Consent and attrition rates were 70% and 1%, respectively. All participants in the intervention arm received the intervention as planned and reported an intention to recommend the video and to use at least 1 pain treatment with breastfeeding or skin-to-skin care preferred over sucrose. In the intervention arm, 60% of newborns received at least 1 pain treatment compared with 67% in the control arm (absolute difference, -7%; 95% confidence interval, -26 to 12). The video was well accepted and feasible to show to parents. As there was no evidence of effect on the use of pain management, major modifications are required before launching a full-scale trial. Effective means to translate evidence-based pain knowledge is warranted.

A Real-Time Sequential Ship Roll Prediction Scheme Based on Adaptive Sliding Data Window

A ship roll prediction scheme is proposed using an adaptive sliding data window (SDW), which is designed to represent time-varying nonlinear dynamics of ship roll motion. The adjustment of SDW is realized by developing an improved fuzzy Gath-Geva (IFGG) segmentation approach, which detects the changes of system dynamics and thereby automatically adapting the scale of SDW. By virtue of the learning scheme with an adaptive SDW, the variable-structure radial basis function network is constructed sequentially to online predict ship roll dynamics. Experimental studies on online ship roll prediction are conducted on measured data from YuKun ’s full-scale sea trial. Results demonstrate the remarkable predictive accuracy of the proposed ship roll prediction model as well as the effectiveness of the IFGG-based SDW in terms of representing time-varying dynamics.

With or without you? Interaction and immersion in a virtual reality experience

This collaborative research between a team of digital technology developers and academic researchers investigates how social interaction affects visitors' experience during a virtual reality (VR) underwater seascape exploration. Prior research in immersive VR focused more on individual perceptions of immersion, interactive features and enjoyment. Analysis of focus-group discussions revealed three categories of immersion, interaction with the virtual environment (VE) and social interaction salient to satisfaction with the experience. Moderated mediation analysis of survey results from a full-scale trial (N = 234) show that the three variables had a significant role in experience satisfaction and loyalty intentions. Specifically, immersion mediates person-VE interaction effects on satisfaction and loyalty. The results contrast with previous findings from online gaming contexts, showing that social interactions decrease the impact of immersion on satisfaction and loyalty. We call for caution in the positioning and communication of VR experiences and for further research in other settings.

Process evaluation of a cluster-randomised controlled trial of multi-component weight management programme in adults with intellectual disabilities and obesity.

Providing effective weight management to adults with intellectual disabilities is necessary to challenge the high rates of obesity. The aim of this process evaluation was to explore the feasibility of conducting a full-scale clinical trial of the TAKE 5 multi-component weight management programme. The study was a 12-month pilot cluster-randomised controlled trial. Adults with intellectual disabilities and obesity were randomised to either TAKE 5, which included an energy deficit diet (EDD) or Waist Winners Too, based on health education principles. A mixed-methods process evaluation was conducted focussing on the reach, recruitment, fidelity, implementation, dose (delivered/received) and context. The study successfully recruited adults with intellectual disabilities. Both weight management programmes were delivered with high fidelity and implemented as intended. Only one weight management programme, TAKE 5, demonstrated potential efficacy in reducing body weight and body composition. The effectiveness was largely attributed to the EDD and social support from carers. The extensive process evaluation illustrated that a full-scale trial of a multi-component programme including an EDD is feasible and an acceptable approach to weight management for adults with intellectual disabilities and obesity.

Motor control exercise and patient education program for low resource rural community dwelling adults with chronic low back pain: a pilot randomized clinical trial.

This pilot randomized clinical trial assessed the feasibility of implementing motor control exercise (MCE) and patient education (PE) program for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community. Thirty patients with CLBP were recruited and randomly assigned to MCE, PE, or MCE plus PE groups. The MCE program was provided twice a week while the PE program was provided once a week all for 6 weeks. Feasibility was assessed through recruitment rate, treatment compliance, retention/dropout rate, report of adverse events, perceived helpfulness, overall satisfaction, and clinical outcome of pain (numeric pain rating scale) and functional disability (Oswestry Disability Index). Many patients were willing to participate in the study and the recruitment rate was 77%. Treatment compliance in all the three groups were >65% for supervised treatment sessions and <50% for prescribed home program. Retention rate was high and greater overall satisfaction with the interventions was reported. Compared with the baseline, all the three groups improved significantly in pain and disability (P<0.05) after 6 weeks. Pairwise comparison revealed that the MCE plus PE group was superior to the PE group for pain and to the MCE for disability (P<0.05), with large effect size. It was concluded that the designed interventions are promising and conducting a full-scale randomized clinical trial in the future is feasible to confirm the effectiveness of the interventions for the management CLBP in rural Nigeria. (Trial registration: ClinicalTrials.gov, NCT03398174)

SleepSure: a pilot randomized-controlled trial to assess the effects of eye masks and earplugs on the quality of sleep for patients in hospital

Objective: To determine the short-term effects of supplying hospital inpatients with earplugs and eye masks, preparatory to a full-scale trial. Design: A single-centre, open-label, two-arm, parallel group, randomized-controlled trial. Setting: A total of 13 medical and surgical wards in a large teaching hospital in the United Kingdom. Participants: Everyone admitted to hospital aged 18 years or older, who stayed overnight and had the mental capacity and sufficient understanding of English to give consent, the ability to complete the study questionnaire and the ability to use earplugs and eye masks unaided was considered. Interventions: The intervention group was provided with earplugs and eye masks for use the following night, and the control group received standard care. Main measures: Sleep quality assessed using the SleepSure questionnaire after the first night of using the intervention, use of earplugs and eye masks, number of falls throughout their inpatient stay, use of zopiclone during inpatient stay, length of stay and recruitment rate. Results: A total of 1600 patients were admitted; out of which, 626 (39%) were eligible and 206 (13% total, 33% eligible) recruited (intervention group, 109). The intervention group’s mean sleep quality score was 6.33 (95% confidence interval (CI): 5.89–6.77), compared with 5.09 (95% CI: 4.66–5.52) in the control group (p < 0.001). There were no differences in use of zopiclone, falls or length of stay between the groups. Of the intervention group, 91 (86%) reported using the earplugs and/or eye masks. Conclusions: The intervention seems feasible, and effective, but trial eligibility rate and rate of recruitment into the study were limited.

Due diligence required to quantify and visualise agrichemical spray deposits using dye tracers

Dye tracers allow researchers to optimise spray application equipment and spray formulations by quantifying the amount of agrichemical spray retained and/or quantifying the area covered (including the size and number of spray deposits). This paper discusses the issues involved in selecting a dye fit-for-purpose, and outlines the experimental checks required to ensure the dye will provide accurate, reliable results of spray retention and spray coverage. This is illustrated using a pilot study to identify a dye, or combination of dyes, capable of quantifying both spray retention and spray coverage on the model species Eucalyptus fastigata H. Deane & Maiden. Due diligence in selecting a dye to quantify agrichemical spray retention requires checks to ensure the dye is quantifiable, extractable from the target surface, and stable not only in the spray formulation used, but also under the prevailing environmental conditions (sunshine, temperature and humidity), and after storage on the target surface prior to extraction and analysis. To visually quantify spray coverage and/or the number and size of deposits, tests are required to ensure the dye provides clear contrast between the dye deposits and non-covered surface. Tests are also required to ensure the dye selected does not alter the physical properties of the spray. There are numerous reasons why a dye may fail to provide accurate spray deposit or coverage results, or correct results. In this study, one dye was not representative of the formulation spread (and therefore coverage). Two others could be used to visualise spray deposits but, due to UV degradation, retention was not quantifiable. A fourth dye was too difficult to visualise on the target. A fifth dye (pyranine) was a suitable candidate; it was photo-stable in dried deposits, quantifiable and could be visualised with an intense UV light source. The plant target itself presented unexpected complications; the sampling method previously employed in retention trials enabled pyranine dye to penetrate the leaves, due to moisture from the dehydrating leaf solubilising and mobilising spray dye deposits during storage. A revised sampling method, allowing the leaves to dehydrate without condensation, was required to fully recover the dye. Using the identified methodology pyranine proved to be suitable as a dual-purpose dye capable of quantifying both spray retention and spray coverage under the anticipated experimental conditions. This paper highlights the requirement for due diligence in dye selection prior to investing in a full-scale field trial. Researchers must check every stage in the experimental process of selecting dyes as deposit tracers. If not, they may fail to get results or, more likely, unwittingly publish incorrect results.

Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial

To assess the hypothesis that fluorometholone 0.1% eye drops are safe and effective as adjunctive therapy for trachomatous trichiasis (TT) surgery; determining the most promising dose. Randomized, placebo-controlled, double-masked parallel dose-ranging clinical trial. Patients undergoing upper lid TT surgery at a rural Ethiopian hospital were randomized to fluorometholone 0.1% twice daily for 4weeks, 4 times daily for 4weeks, 4 times daily for 8weeks, or matching frequency placebo in a 3:1:3:1:3:1 ratio for 1 eye. Randomization was stratified by TT severity (1-4 vs ≥5 lashes touching the globe). Safety outcomes (intraocular pressure [IOP] elevation, cataract, and other dose-limiting toxicities) and postoperative TT incidence were assessed over 1 year. Subjects randomized were 39:13:39:13:38:13 in the respective groups, and 1 subject in the 8-weeks fluorometholone group was withdrawn. Of 154 subjects, 148 (96.1%) completed 1 year's follow-up. Among 76 eyes receiving fluorometholone 4 times daily, 1 developed IOP elevation ≥ 30mm Hg (to 37mm Hg) and 1 had an allergic reaction attributed to the study drug; each resolved upon drug cessation without sequelae. No cataract or other dose-limiting toxicity events occurred. Postoperative TT within 1 year occurred in 29.3% of placebo eyes vs 17.7%, 19.6%, and 23.2% among the respective fluorometholone groups (P= .29 comparing placebo vs all active treatments combined). The results suggest fluorometholone 0.1% is likely to be safe and efficacious to reduce postoperative TT following TT surgery, and 1 drop twice daily for 4weeks is the most promising dose. Confirmation in a full-scale clinical trial is needed before programmatic implementation.

Virtual Hull Monitoring: Continuous Fatigue Assessment Without Additional Instrumentation - Technical Note

Technical Note - A novel technique to monitor hull stresses using data currently collected on most ships is explored. This technique, referred to herein as virtual hull monitoring, uses global position signals, measured or numerically-modelled wave data, and a database of calculated stress transfer functions. This enables monitoring of short-term stress states and corresponding fatigue damage accumulation for many structural locations, either onboard or at a central location, for an entire fleet. The components, benefits, and limitations of this proposed technique are discussed. Wave buoy and strain gauge measurements from a full-scale naval vessel trial are used in comparisons with hindcast wave data and the calculated stress spectra for one structural location. Close agreement between the wave data sources and corresponding stress spectra warrants further examination of virtual hull monitoring.

Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT)

BackgroundAnxiety and depression are common among patients attending cardiac rehabilitation services. Currently available pharmacological and psychological interventions have limited effectiveness in this population. There are presently no psychological interventions for anxiety and depression integrated into cardiac rehabilitation services despite emphasis in key UK National Health Service policy. A new treatment, metacognitive therapy, is highly effective at reducing anxiety and depression in mental health settings. The principal aims of the current study are (1) to evaluate the acceptability of delivering metacognitive therapy in a home-based self-help format (Home-MCT) to cardiac rehabilitation patients experiencing anxiety and depressive symptoms and conduct a feasibility trial of Home-MCT plus usual cardiac rehabilitation compared to usual cardiac rehabilitation; and (2) to inform the design and sample size for a full-scale trial.MethodsThe PATHWAY Home-MCT trial is a single-blind feasibility randomised controlled trial comparing usual cardiac rehabilitation (control) versus usual cardiac rehabilitation plus home-based self-help metacognitive therapy (intervention). Economic and qualitative evaluations will be embedded within the trial. Participants will be assessed at baseline and followed-up at 4 and 12 months. Patients who have been referred to cardiac rehabilitation programmes and have a score of ≥ 8 on the anxiety and/or depression subscales of the Hospital Anxiety and Depression Scale will be invited to take part in the study and written informed consent will be obtained. Participants will be recruited from the National Health Service in the UK. A minimum of 108 participants will be randomised to the intervention and control arms in a 1:1 ratio.DiscussionThe Home-MCT feasibility randomised controlled trial will provide evidence on the acceptability of delivering metacognitive therapy in a home-based self-help format for cardiac rehabilitation patients experiencing symptoms of anxiety and/or depression and on the feasibility and design of a full-scale trial. In addition, it will provide provisional point estimates, with appropriately wide measures of uncertainty, relating to the effectiveness and cost-effectiveness of the intervention.Trial registrationClinicalTrials.gov, NCT03129282, Submitted to Registry: 11 April 2017.

Evaluating a knowledge translation tool for parents about pediatric acute gastroenteritis: a pilot randomized trial

BackgroundPediatric acute gastroenteritis (AGE) is a common childhood illness with substantial health, family, and system impacts. Connecting parents to evidence-based patient education is key to effective decision-making and therapeutic management of AGE. Digital knowledge translation (KT) tools offer a promising approach to communicate complex health information to parents; therefore, we developed a whiteboard animation video for parents about AGE. To optimize future effectiveness evaluation of this video, the purpose of this pilot study is to assess feasibility of effectiveness outcomes and specific trial methods in four key trial domains.MethodsA single-site, parallel-arm, pilot randomized trial will be conducted. The trial will employ quantitative and qualitative methods to evaluate feasibility objectives in key scientific, process, management, and resource domains. Parents seeking care for a child with AGE in the emergency department (ED) over a 6-month period will be randomized to receive the whiteboard animation video or a sham control video. Quantitative data will be collected electronically in the ED and at home (4–10 days post-ED visit). Qualitative data will be collected via semi-structured interviews with experimental condition participants after quantitative data collection. Data will be collected to perform a sample size calculation for a full-scale trial. Scientific outcomes will include parental knowledge, decision regret, and health utilization, and estimation for these outcomes will use confidence intervals (CI) of different widths to illustrate strength of preliminary evidence. CIs will be presented alongside minimum clinically important differences (MCIDs) calculated using two methods: (1) data driven and (2) patient perspective. Descriptive statistics will be calculated to describe process, management, and resource domain outcomes. Qualitative thematic analysis will be conducted to describe additional process, management, and resource outcomes in the experimental group. Analyses will be performed using intention-to-treat.DiscussionThis pilot randomized trial will inform the design and conduct of a full-scale, effectiveness trial by gathering key data in four domains: scientific, process, management, and resource. These results will impact the emerging field of KT efforts targeting health consumers and advance the science on the best mode of patient education for acute childhood illnesses.Trial registrationclinicaltrails.gov registration number NCT03234777. Registered 31 July 2017.

Developing a Digital Marketplace for Family Planning: Pilot Randomized Encouragement Trial.

BackgroundFamily planning is an effective tool for preventing death among women who do not want to become pregnant and has been shown to improve newborn health outcomes, advance women’s empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low. The emergence of digital health tools has created new opportunities to strengthen health systems and promote behavior change. In this study, women with an unmet need for family planning in Western Kenya were randomized to receive an encouragement to try an automated investigational digital health intervention that promoted the uptake of family planning.ObjectiveThe objectives of the pilot study were to explore the feasibility of a full-scale trial—in particular, the recruitment, encouragement, and follow-up data collection procedures—and to examine the preliminary effect of the intervention on contraception uptake.MethodsThis pilot study tested the procedures for a randomized encouragement trial. We recruited 112 women with an unmet need for family planning from local markets in Western Kenya, conducted an eligibility screening, and randomized half of the women to receive an encouragement to try the investigational intervention. Four months after encouraging the treatment group, we conducted a follow-up survey with enrolled participants via short message service (SMS) text message.ResultsThe encouragement sent via SMS text messages to the treatment group led to differential rates of intervention uptake between the treatment and control groups; however, uptake by the treatment group was lower than anticipated (19/56, 33.9% vs 1/56, 1.8%, in the control group). Study attrition was also substantial. We obtained follow-up data from 44.6% (50/112) of enrolled participants. Among those in the treatment group who tried the intervention, the instrumental variables estimate of the local average treatment effect was an increase in the probability of contraceptive uptake of 41.0 percentage points (95% uncertainty interval −0.03 to 0.85).ConclusionsThis randomized encouragement design and study protocol is feasible but requires modifications to the recruitment, encouragement, and follow-up data collection procedures.Trial RegistrationClinicalTrials.gov NCT03224390; https://clinicaltrials.gov/ct2/show/NCT03224390 (Archived by WebCite at http://www.webcitation.org/70yitdJu8)

Melodic intonation therapy in post-stroke nonfluent aphasia: a randomized pilot trial

Objective: To collect data to estimate the sample size of a definitive randomized controlled trial to evaluate the effects of Melodic Intonation Therapy in post-stroke nonfluent aphasia. Design: A randomized, crossover, interventional pilot trial. Setting: Departments of Neurology and Rehabilitation from a university general hospital. Participants: Stroke survivors with post-stroke nonfluent aphasia. Interventions: Patients randomized to group 1 had treatment with Melodic Intonation Therapy first (12 sessions over six weeks) followed by no treatment; the patients in group 2 started active treatment between three and six months after their inclusion in the study, serving as waiting list controls for the first phase. Main measures: The Communicative Activity Log (CAL) questionnaire and the Boston Diagnostic Aphasia Examination (BDAE) were evaluated at baseline, and at six and 12 weeks. Results: Twenty patients were included. Four of the patients allocated to group 2 crossed over to group 1, receiving the treatment at first. Intention-to-treat analysis: after adjustment for baseline scores, the mean difference in the CAL evaluation from baseline in the treated group was 8.5 points (95% confidence interval (CI), 0.11–17.0; P = .043), with no significant change in any of the BDAE sections. Per-protocol analysis showed similar results with a clear treatment effect (P = .043) on the CAL. Conclusion: Melodic Intonation Therapy might have a positive effect on the communication skills of stroke survivors with nonfluent aphasia as measured by the CAL questionnaire. A full-scale trial with at least 27 patients per group is necessary to confirm these results.

Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

BackgroundPhysical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression.ObjectiveThe objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes.MethodsParticipants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes.ResultsOf the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference −3.6, 95% CI −6.1 to −1.1).ConclusionsIt was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures.Trial RegistrationClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa)

Presessions to the National Diabetes Prevention Program May be a Promising Strategy to Improve Attendance and Weight Loss Outcomes.

The National Diabetes Prevention Program (NDPP) is a widely disseminated lifestyle intervention. Attendance is problematic, leading to suboptimal weight loss, especially among racial/ethnic minority participants. We conducted a novel "presession" protocol to improve engagement of diverse NDPP candidates, comparing NDPP participants who attended a presession to those who did not on attendance and weight loss outcomes. Longitudinal cohort study. A safety net health-care system. A total of 1140 patients with diabetes risks (58.9% Hispanic, 19.8% non-Hispanic black, 61.8% low income). The NDPP has been delivered in a Denver, Colorado health-care system since 2013. The program included 22 to 25 sessions over 1 year. Beginning September 2016, individuals were required to attend a presession before enrollment that focused on (1) increasing risk awareness, (2) motivational interviewing to participate in the NDPP, and (3) problem-solving around engagement barriers. Duration and intensity of NDPP attendance and weight loss. Outcomes of 75 presession participants who enrolled in the NDPP were compared to 1065 prior participants using analysis of covariance and multivariable logistic regression. Presession participants stayed in the NDPP 99.8 days longer ( P < .001) and attended 14.3% more sessions ( P < .001) on average than those without a presession. Presession participants lost 2.0% more weight ( P < .001) and were 3.5 times more likely to achieve the 5% weight loss target ( P < .001). Presessions may improve NDPP outcomes for individuals from diverse backgrounds. A full-scale trial is needed to determine whether presessions reliably improve NDPP effectiveness.

The ACUTE (Ambulance CPAP: Use, Treatment effect and economics) feasibility study: a pilot randomised controlled trial of prehospital CPAP for acute respiratory failure

BackgroundAcute respiratory failure (ARF) is a common and life-threatening medical emergency. Standard prehospital management involves controlled oxygen therapy and disease-specific ancillary treatments. Continuous positive airway pressure (CPAP) is a potentially beneficial alternative treatment that could be delivered by emergency medical services. However, it is uncertain whether this treatment could work effectively in United Kingdom National Health Service (NHS) ambulance services and if it represents value for money.MethodsAn individual patient randomised controlled external pilot trial will be conducted comparing prehospital CPAP to standard oxygen therapy for ARF. Adults presenting to ambulance service clinicians will be eligible if they have respiratory distress with peripheral oxygen saturation below British Thoracic Society (BTS) target levels, despite titrated supplemental oxygen. Enrolled patients will be allocated (1:1 simple randomisation) to prehospital CPAP (O_two system) or standard oxygen therapy using identical sealed boxes. Feasibility outcomes will include incidence of recruited eligible patients, number of erroneously recruited patients and proportion of cases adhering to allocation schedule and treatment, followed up at 30 days and with complete data collection. Effectiveness outcomes will comprise survival at 30 days (definitive trial primary end point), endotracheal intubation, admission to critical care, length of hospital stay, visual analogue scale (VAS) dyspnoea score, EQ-5D-5L and health care resource use at 30 days. The cost-effectiveness of CPAP, and of conducting a definitive trial, will be evaluated by updating an existing economic model. The trial aims to recruit 120 patients over 12 months from four regional ambulance hubs within the West Midlands Ambulance Service (WMAS). This sample size will allow estimation of feasibility outcomes with a precision of < 5%. Feasibility and effectiveness outcomes will be reported descriptively for the whole trial population, and each trial arm, together with their 95% confidence intervals.DiscussionThis study will determine if it is feasible, acceptable and cost-effective to undertake a full-scale trial comparing CPAP and standard oxygen treatment, delivered by ambulance service clinicians for ARF. This will inform NHS practice and prevent inappropriate prehospital CPAP adoption on the basis of limited evidence and at a potentially substantial cost.Trial registrationISRCTN12048261. Registered on 30 August 2017. http://www.isrctn.com/ISRCTN12048261