Background: As food insecurity and healthcare costs are linked, healthcare entities (i.e., providers, healthcare systems, insurers) are increasingly interested in identifying and providing solutions to address food insecurity among their patients. Home-delivered meals are one long-standing solution to address food insecurity among homebound older adults. However, there is limited evidence about what mode of delivery is most effective in promoting community independence, reducing healthcare utilization, and improving quality of life as well as how these outcomes may vary as a function of people's preferences for how meals are delivered to them.
Methods: With extensive stakeholder input, we designed and implemented a pragmatic randomized comparative effectiveness study in which we will enroll 2300 older adults on waiting lists at home-delivered meals programs across the country and randomize them to receive for 6 months, either (1) weekday lunchtime meals delivered by a local volunteer or driver who also provides socialization and wellness checks or (2) biweekly delivery of 10 frozen meals to participants' homes. Participant data will be combined with Centers for Medicare and Medicaid Services (CMS) data to calculate post-randomization institutional vs. community days. Baseline and 3-month surveys will evaluate secondary outcomes (e.g., food insecurity, loneliness, quality of life) and exploratory outcomes (e.g., nutritional risk). To examine heterogeneity of treatment effects, we will test for interactions between the two types of meal delivery and participants' preferred mode of meal delivery as well as participants' living arrangements.
Discussion: This research will be the first to prospectively evaluate the comparative effectiveness of the two predominant meal delivery options. The knowledge generated from this research will be of value to healthcare providers, health systems, payers, community-based organizations, older adults, and their families, because it will identify the mode of meal delivery that best meets homebound older adults' needs and promotes community independence. In addition, the experience of working closely with stakeholders in designing and conducting this trial will be useful to researchers seeking to engage with stakeholders in the development and evaluation of complex social service interventions while balancing regulatory, resource, and human subjects research considerations.
Trial registration: ClinicalTrials.gov. NCT05357261 . Registered on May 02, 2022.
Background: Acute mountain sickness (AMS) is a debilitating condition that individuals may develop on ascent to high altitude. It is characterized by headache, nausea, vomiting, dizziness, and fatigue with the potential to progress to fatal disease. Although the pathophysiology of AMS remains unclear, proposed mechanisms are hypothesized to be similar to migraine. Prochlorperazine, a first-line treatment for acute migraine, has been shown to abort migraine early and thus may be effective in preventing AMS. Its action as a respiratory stimulant additionally makes it a promising novel agent for AMS prevention.
Methods: In this randomized double-blinded trial, participants will be randomized to receive oral prochlorperazine maleate or placebo for 24 h of three times daily dosing on a rapid ascent to 4348 m. Participants will be adults, aged 18, and older who are unacclimatized. Participants will remain at this elevation overnight. The Lake Louise Questionnaire will be utilized to define the primary outcome and presence of AMS and will be assessed the evening of and morning after ascent to peak altitude.
Discussion: Currently, acetazolamide is the preferred option for the chemoprophylaxis of AMS, which has been studied and utilized since the 1970s and involves potential prohibitive side effects. Other more efficacious options with more tolerable side effects are needed. Preventing AMS has the potential to limit both the morbidity and mortality associated with developing AMS and more serious diseases (notably high-altitude cerebral edema). Additionally, there is a substantial economic and environmental impact of AMS that could be prevented.
Trial registration: Clinicaltrial.gov, NCT06450899. Registered on June 2024.
Background: Eveningness chronotype-the tendency for later sleep and wake times-arises from a confluence of psychosocial, behavioral, and biological factors. With the onset and progression of puberty, many young people develop an eveningness chronotype, which remains prevalent through the transition into adulthood. Eveningness has been associated with increased risk for poorer health. While eveningness is modifiable, maintaining the necessary behavior changes can be challenging. The science on habits demonstrates that habit formation is a key mechanism for maintaining behavior change over time. Learning theory offers schedules of reinforcement that also hold promise for enhancing the maintenance of behavior change. The present study will evaluate the Habit-based Sleep Health Intervention (HABITs)-which combines the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) with the science of habits-and a text message intervention informed by learning theory to attempt to sustainably modify the contributors to eveningness among young adults (18-30 years of age).
Methods: Participants (N = 160) will be randomly allocated to HABITs and HABITs + Texts. Both interventions include HABITs which involves three 50-min sessions followed by six 30-min sessions. Alongside the latter six sessions, HABITs + Texts will concurrently receive the text message intervention. Aims 1-3 will compare HABITs + Texts to HABITs on improvements in the outcomes of (1) utilization of sleep health behaviors and habit formation, (2) sleep and circadian functioning, and (3) functioning in five health-relevant domains, in the short (post-treatment) and longer (6-month and 12-month follow-up) term. Exploratory analysis will (1) compare HABITs and HABITs + Texts on (a) if sleep health behavior habit formation mediates the effects of intervention on improvement in outcomes and (b) if intervention effects are moderated by select variables, and (2) to evaluate if HABITs (regardless of the text message intervention) is associated with an improvement in outcomes in the short and longer term.
Discussion: This study has the potential to advance knowledge on (1) the value of leveraging the science of habits and learning theory in behavior change interventions, (2) the use of a low-cost and efficient intervention for habit formation and maintenance, (3) interventions that address eveningness chronotype, and (4) processes related to behavior change during emerging adulthood.
Trial registration: Clinicaltrials.gov NCT05167695. Registered on December 22, 2021.
Background: Changes in response patterns of biological stress systems, including responses of the sympathetic nervous system (SNS) and the hypothalamus-pituitary-adrenal (HPA) axis to repeated stress, can promote the development and progression of chronic diseases via changes in downstream inflammatory processes. The aim of this project is thus to investigate, whether habituation of biological stress system activity including responses of the inflammatory system can be modified. Aiming to test for possible paths of action, a randomized controlled study with two intervention programs designed to manipulate cognitive coping strategies will be carried out. By increasing either ruminative or self-compassionate thoughts among healthy young adults, the intervention programs are expected to affect the regulation of occurring emotions as expressed by the responsiveness of biological systems during repeated stress exposure.
Methods: In this study, a total of 120 healthy adults will complete the Trier Social Stress Test (TSST) on two consecutive days. Immediately after the first stress induction, participants will be randomly assigned to two experimental conditions designed to manipulate cognitive coping strategies (rumination vs. self-compassion) or a control condition. Measures of HPA axis (salivary cortisol) and autonomic activity (salivary alpha amylase, heart rate, heart rate variability) as well as inflammatory markers (plasma interleukin(IL)-6, expression rates of pro- and anti-inflammatory cytokine genes) will be repeatedly assessed throughout the experimental sessions. Response and habituation indices of these measures will be calculated and compared between the experimental conditions and the control condition.
Discussion: The results should provide insight into whether modifying response patterns of biological stress systems could reverse a significant biological mechanism in the development of stress-related diseases.
Trial registration: German Clinical Trials Register (DKRS), DRKS00034790. Registered on August 12, 2024, https://www.drks.de/DRKS00034790 .
Background: Group A streptococci (Strep A) orStreptococcus pyogenes is a major human pathogen causing an estimated 500,000 deaths worldwide each year. Disease can range from mild pharyngitis to more severe infections, such as necrotizing fasciitis, septicemia, and toxic shock syndrome. Untreated, Strep A infection can lead to the serious post streptococcal pathologies of rheumatic fever/rheumatic heart disease and post-streptococcal glomerulonephritis. An effective vaccine against Strep A would have great benefits worldwide. Here, we test two products, J8 and p*17-both peptide derivatives of a highly conserved region in the M protein, in combination with the protein subunit K4S2 of SpyCEP, an IL-8 protease associated with neutrophil chemoattraction. Each peptide is individually conjugated to cross reacting material (CRM197), and the conjugated peptide vaccines are abbreviated as J8-K4S2 or p*17-K4S2.
Methods: This single-site phase I, two-stage clinical trial in Edmonton, Alberta, Canada, aims to recruit a total of 30 healthy volunteers, aged 18-45 years, without any evidence of pre-existing valvular heart disease. The trial is divided into the initial unblinded safety test dose stage (stage 1) and the randomized, double-blinded, controlled trial stage (stage 2). Stage 1 will recruit 10 volunteers-5 each to receive either J8-K4S2 or p*17-K4S2 in an unblinded, staggered fashion, whereby volunteers are dosed with intentional spacing of at least 2 days in between doses to monitor for any immediate side effects before dosing the next. Once all 5 volunteers have received 3 doses of the first test vaccine, a similar process will follow for the second test vaccine. Once safety is established in stage 1, we will proceed to stage 2, which will recruit 20 volunteers to our 3-arm randomized controlled trial (RCT), receiving either of the trial vaccines, J8-K4S2 or p*17-K4S2, or comparator (rabies) vaccine. All product dosing will be at 0, 3, and 6 weeks. The primary outcome is vaccine safety; the secondary outcome is immunogenicity and comparative analyses of the different vaccine regimens.
Discussion: This Strep A vaccine clinical trial aims to investigate safety and immunogenicity of two novel conjugated peptide-based vaccines, J8-KS42 and p*17-K4S2. If one or both vaccine products demonstrate favorable primary and secondary outcomes, the product(s) will move into phase II and III studies.
Trial registration: ClinicalTrials.gov Identifier: NCT04882514. Registered on 2021-05-12, https://clinicaltrials.gov/study/NCT04882514 .
Background: Performing spinal anesthesia in elderly patients with spine degeneration is challenging for novice practitioners. This stratified randomized controlled trial aims to compare the effectiveness of mixed reality-assisted spinal puncture (MRasp) with that of landmark-guided spinal puncture (LGsp) performed by novice practitioners in elderly patients.
Methods: This prospective, single-center, stratified, blocked, parallel randomized controlled trial will include 168 patients (aged ≥ 65 years) scheduled for elective surgery involving spinal anesthesia. All spinal punctures will be performed by anesthesiology interns and residents trained at Huadong Hospital. Patients will be randomly assigned to the MRasp group (n = 84) or the LGsp group (n = 84). Based on each intern/resident's experience in spinal puncture, participants will be stratified into three clusters: the primary group, intermediate group, and advanced group. The primary outcome will be the comparison of the rate of successful first-attempt needle insertion between the MRasp group and the LGsp group. Secondary outcomes will include the number of needle insertion attempts, the number of redirection attempts, the number of passes, the rate of successful first needle pass, the spinal puncture time, the total procedure time, and the incidence of perioperative complications. A stratified subgroup analysis will also be conducted for interns/residents at different experience levels.
Discussion: The findings from this trial establish the effectiveness of MRasp by novice practitioners in elderly patients. This trial may provide experimental evidence for exploring an effective visualization technology to assist in spinal puncture.
Trial registration: Chinese Clinical Trials Registry ChiCTR2300075291. Registered on August 31, 2023. https://www.chictr.org.cn/bin/project/edit?pid=189622 .
Background: Clinical decision support systems (CDSSs) enable the automated, real-time detection of situations associated with a risk of adverse drug events (ADEs). However, the effectiveness of CDSS in reducing ADEs has yet to be demonstrated. We have chosen to focus on the detection of ADE such as hyperkalemia and/or acute kidney injury (AKI), which are common among hospitalized older adults. The present study's primary objective is to use a CDSS to reduce the number of ADEs (such as AKI and/or hyperkalemia) that occur in hospitalized older adults.
Methods: This is a multicenter, stepped-wedge, cluster-randomized study involving five hospitals. Each hospital will start with a control period (i.e., routine care, during which each center's CDSS is deactivated) and then switch to an intervention period (during which the CDSS is activated). The intervention will be the use of a CDSS and a strategy for managing and transmitting alerts to clinical pharmacists. The rules concerning AKI and hyperkalemia have been drafted and reviewed by a multidisciplinary group. Each rule created in the CDSS is associated with a standardized procedure, based on a review of the literature. Older patients (aged 65 or over) admitted to a participating general medicine ward, a surgical ward, or obstetrics ward will be eligible for inclusion after the provision of verbal informed consent.
Discussion: This study will assess the effectiveness of the CDSS in reducing the incidence of AKI and hyperkalemia. The implementation of the CDSS can assist clinical pharmacists in their daily work and is expected to prevent ADEs.
Trial registration: ClinicalTrials.gov Identifier: NCT05923983. Registered February 02, 2023.
Background: Following successful treatment, displaced intra-articular calcaneal fractures (DIACFs) necessitate an extensive rehabilitation regimen, significantly influencing functional and socio-economic outcomes. Apart from surgical intervention, the implementation of a comprehensive rehabilitation protocol is crucial to optimize foot stability and functional recovery. The objective of this study is to ascertain the optimal rehabilitation protocol for patients with surgically treated DIACFs, either permissive weight bearing (PWB) or Restricted Weight Bearing, focusing on functional outcomes, health-related quality of life (HRQoL), radiographic parameters, cost-effectiveness, and incidence of complications.
Methods: Study design: A prospective multicenter randomized controlled trial.
Study population: Presence of surgically (extended lateral, sinus tarsi, or percutaneous approach) treated unilateral DIACFs (Sanders type II to IV), aged 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. N = 115 patients with DIACFs will be included.
Interventions: Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.
Primary outcome measure: Functional outcome, measured with the American Orthopaedic Foot & Ankle Society Score (AOFAS)).
Secondary outcomes: Functional outcome (Maryland Foot Score, MFS), HRQoL (EuroQol-5D, EQ-5D), differences in radiographic parameters, cost-effectiveness, and complications. Nature and extent of burden: The PWB protocol is aimed to be non-inferior to the RWB protocol. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks, and 6 months. The radiation exposure for both groups will differ from standard care (one extra CT scan of the foot will be made). Therefore, the burden for participants is considered minimal, with no significant health risks.
Discussion: This study will be the first study to define an optimal rehabilitation regime for surgically treated patients with DIACFs. The limitations of this study include the absence of patient blinding, as this is impossible in rehabilitation. Additionally, the primary outcome measure (AOFAS) has limited validity for DIACFs. However, it is the most commonly used questionnaire in the literature on DIACFs. There is an apparent need since current literature is lacking on this specific topic.
Trial registration: ClinicalTrials.gov NCT05721378, accepted on February 7, 2023.
Background: Process evaluations are increasingly integrated into randomised controlled trials (RCTs) of complex interventions to document their delivery and interactions with local systems and dynamics, helping understand observed health outcomes. Yet process evaluations often struggle to assess relevant contextual determinants, leaving much of the important role of "context" in shaping an intervention's mechanisms opaque in many studies. A lack of easily adapted data collection methods to help define and operationalise indicators of context likely contributes to this.
Methods: We present a method to help structure measures of context in process evaluations and describe its use in two very different settings. The "Context Tracker" is an innovative tool for use within trials and quasi-experiments to more systematically capture and understand key dimensions of context. It was developed in Zimbabwe as part of a cluster randomised controlled trial and then adapted for a quasi-experimental evaluation in the UK. Both studies provided harm reduction and health services for marginalised and hard-to-reach populations.
Results: We developed the Context Tracker to be both standardised (i.e. formatted and applied in the same way across study sites) and flexible enough to allow unique features to be explored in greater detail. Drawing on the Context and Implementation of Complex Interventions (CICI) and Risk Environments frameworks, we mapped 5 domains across micro, meso and macro levels in a simple table and used existing evidence and experience to predict factors likely to affect delivery of and participation in intervention components. We tracked these over time across study sites using routine programme statistics, observation and qualitative methods. The Context Tracker enables identification and comparison of facilitators and barriers to implementation, variations in engagement with interventions, and how mechanisms of action are (or are not) triggered in different settings.
Conclusions: The Context Tracker is one example of how evidence-based contextual determinants can be used to guide data collection and analysis within process evaluations. It is relevant in low- and high-income settings and applicable to both qualitative and quantitative analyses. While perhaps most useful to process evaluations of complex interventions targeting marginalised communities, the broader approach would benefit a more general research audience.
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