Contemporary Clinical Trials Communications最新文献

Osteoarthritis (OA) is a major source of chronic pain and disability, representing a significant global health concern that affects 10-15 % of individuals aged over 60, with a higher prevalence among females than males. This investigation aimed to evaluate the impact of a dietary supplement containing collagen peptides (MW 1-3 kDa) on knee OA symptoms and inflammatory biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Adults aged 30-81 years (50 % female) with grade II or III OA and a minimum pain score of 40 on the 0 to 100 visual analogue scale (VAS) were enrolled. Participants were randomly assigned to receive either 10 g of the test product (verum group) or placebo and were assessed at baseline (T0, pre-treatment) and after a six-month follow-up period (T6). Baseline characteristics were comparable between groups. At T6, the verum group exhibited significant reductions in VAS pain scores, Lequesne algofunctional index (LAI) scores, CRP levels (mg/L), and ESR (mm/h) compared to placebo (p < 0.001). No adverse effects were reported during the study, and the supplement demonstrated good tolerability and yielded satisfactory safety and acceptability. These findings suggest that the dietary supplement may serve as a complement to drug therapy for knee OA by alleviating osteoarticular pain, improving locomotor function and potentially reducing reliance on analgesic and anti-inflammatory medications. This study provides valuable insights into the efficacy and safety of collagen peptides in managing knee OA symptoms.

Background: Chronic illness research has many challenges making research recruitment difficult. Despite reports of facilitators and barriers to research recruitment challenges remain. The reporting of research strategies and their impact on recruitment and subsequent randomised control trials is not sufficient. A newly developed chronic illness research recruitment taxonomy (CIRRT) details factors and elements observed to impact recruitment around the components of Project, People, and Place. This paper aims to use the chronic illness research recruitment taxonomy to report and evaluate the recruitment strategies, impact they had on recruitment, and alterations to an eHealth feasibility study.

Methods: Retrospective mixed method approach was used to inductively code the research team meeting minutes during the recruitment period. The coding was then abductively matched to the chronic illness research recruitment taxonomy and gaps in the CIRRT noted. Dated coding data were integrated with recruitment progress to explore the impact of research recruitment strategies.

Results: Meeting minutes (n = 66) were analysed, recruitment strategies identified and matched to CIRRT. The reporting and identification of the recruitment strategies was aided by CIRRT use. By integrating the codes that aligned with CIRRT with recruitment progress was observed to be impacted by staffing and researcher visits.

Conclusions: CIRRT may be a useful tool in the evaluation and reporting of research recruitment strategies. Altering the roles of nurses involved and researcher visits to recruiting sites may positively impact on chronic illness research recruitment.

Background: Suicide is one of the leading causes of death among U.S. service members, and rates of suicide among military personnel have increased over the past two decades. To address this serious issue, effective preventive treatments are needed in settings where at-risk service members are frequently seen, such as emergency departments and inpatient psychiatric units. This study will compare the longitudinal effects of crisis response planning (CRP) and treatment as usual (TAU) on suicidal thoughts and behaviors among active duty service members seeking emergent care for suicidality at a military treatment facility.

Methods: The current study is conducted through a consortium, Augmenting Suicide Prevention Interventions for Service Members. This article details an ongoing stepped-wedge cluster randomized clinical trial that compares rates of suicidal thoughts and behaviors among service members at risk for suicide following care from CRP-trained providers versus untrained providers (i.e., TAU). Participants complete assessments at pretreatment and every 3 months up to 1 year. Primary outcomes include suicide attempts and behaviors, and suicidal ideation is a secondary outcome. Moderators of treatment effects will also be examined. The methodological development of this trial is discussed, along with clinical and ethical considerations for suicide prevention research in emergency, inpatient, and military treatment settings.

Conclusion: Providing evidence-based treatment for suicidality that addresses service members' unique needs is crucial to reduce suicide rates and facilitate mental health recovery in this population. This study aims to inform future implementation and dissemination of CRP in healthcare systems to ultimately decrease suicide among service members.

Clinical trials identifier: NCT05795764.

Background: Ulcerative colitis (UC) is a chronic non-specific inflammatory intestinal disease, categoried under "dysentery" and "intestinal bleeding" in Traditional Chinese Medicine (TCM). Jianpi Qingchang decoction (JPQC) is a combination formula specifically designed for the treatment of UC. The primary objective of this study is to examine the clinical efficacy of JPQC in individuals diagnosed with UC who exhibit both spleen deficiency and dampness-heat syndrome, along with the presence of fatigue. The investigation will focus on assessing the impact of JPQC on the gut microbiota and metabolites in these patients, aiming to elucidate the regulatory mechanism that JPQC exerts on the gut microbiota and metabolites in the context of UC-related fatigue.

Methods: In this randomized clinical trial, 140 subjects diagnosed with UC will be recruited and randomized into two groups. They will receive either JPQC combined with mesalazine or mesalazine alone for 12 weeks. Follow-up visits will be conducted every four weeks, with a post-treatment visit scheduled at 6 months. The primary outcome measures include the Inflammatory bowel disease fatigue scale(IBD-F). Secondary efficacy indicators comprise the assessment of TCM syndrome and individual syndrome efficacy before and after treatment, Modified Mayo score, Simple clinical colitis activity index (SCCAI), as well as the Inflammatory Bowel Disease Questionnaire (IBDQ) for each group. The other outcomes are the Intestinal microbial diversity and non-targeted metabonomics, which will be measured at baseline and 12 weeks after randomization.

Discussion: If effective, JPQC will provide substantial clinical evidence concerning the effectiveness and safety in the treatment of patients with UC experiencing spleen deficiency and dampness-heat syndrome accompanied by fatigue.

Trial registration: ChiCTR2300068348.

Background: Children with sickle cell anemia (SCA) in Sub-Saharan Africa are at high risk of sickle cerebrovascular injury (SCVI). Hydroxyurea, a commonly used disease-modifying therapy, may reduce SCVI resulting in potential impact on reducing stroke and cognitive dysfunction. We aim to test the impact of daily hydroxyurea therapy on these outcomes in Ugandan children with SCA. We hypothesized that hydroxyurea therapy over 36 months will prevent, stabilize or improve these complications of SCA.

Methods: The BRAIN SAFE II study is an open label, single arm trial of daily hydroxyurea in 270 children with SCA (HbSS) in Uganda, ages 3-9 years. Following baseline assessments, participants began hydroxyurea therapy and are followed according to local guidelines. Standard hydroxyurea dose is escalated to maximum tolerated dose (MTD). SCVI is assessed by cerebral arterial velocity using Doppler ultrasound, with cognitive function determined by formal neurocognitive testing (primary outcomes). Structural SCVI is assessed by magnetic resonance imaging (MRI) and angiography (MRA) in a sub-sample of 90 participants ages >5 years. At trial midpoint (18 months) and completion (36 months), outcomes of age-specific assessments will be compared to baseline, as well as biomarkers of anemia, inflammation and malnutrition (secondary outcomes) to determine their relationships to primary outcomes.

Conclusion: This trial will examine the impact of hydroxyurea on preventing or ameliorating SCA SCVI in children, assessed by reducing incident stroke, stroke risk and neurocognitive dysfunction. Trial results will provide critical insight into the role of hydroxyurea therapy on critical manifestations of SCVI in children with SCA.

Trial registration: https://clinicaltrials.gov/ct2/show/NCT04750707 (registered 11 February 2021).

Protocol version: BRAIN SAFE II Protocol Version 3.0, Mar 02, 2022.

Community engagement is increasingly considered a key component of intervention development, as it can leverage community members' knowledge, experiences, and insights to create a nuanced intervention which meets the needs, preferences, and realities of the population of interest. Community engagement exists along a spectrum from outreach to the community to partnership with community members and organizations, and all levels of community engagement can benefit from systematic documentation of community feedback and decision-making processes. This paper demonstrates how we utilized the "Framework for Reporting Adaptations and Modifications to Evidence-based Interventions" (FRAME; Wiltsey Stirman et al., 2019) model to track and report adaptations to our dementia end-of-life care planning intervention based on community engagement via a project-specific Community Advisory Board (CAB). Using FRAME, we generated a comprehensive report of the iterative changes made to our pilot intervention, including whether the change was planned, who made the decision to modify the intervention, the nature of the change, its relationship to intervention fidelity, and the reason for the change. This process ensured that we effectively integrated feedback and assistance from our CAB, increased the appropriateness of our intervention for our population of interest, established criteria to monitor intervention fidelity, and prepared our team to run a rigorous clinical trial of the revised intervention. Clinical Trial Registration Number: NCT05909189.