Contemporary clinical trials最新文献

Introduction

Ukraine has high HIV prevalence, concentrated among people who inject drugs (PWID), mostly of opioids. Maintenance on opioid agonist therapies (OAT) is the most effective evidence-based treatment for opioid use disorder. As PWID experience high morbidity and mortality from preventable and treatable non-communicable diseases, international agencies recommend integrating OAT into primary care centers (PCC).

Methods

A randomized, type-2 hybrid implementation trial was carried out to compare outcomes of OAT integration in PCC to OAT delivery at specialty treatment centers (STC) – standard-of-care. Tele-education supporting PCC providers in managing OAT, HIV, tuberculosis and non-communicable diseases along with pay-for-performance incentives were used to facilitate implementation. Consenting patients underwent 1:2 randomization to either STC or PCC. Quality health indicators (QHIs), a composite percentage of recommended primary and specialty services accessed by patients (blood/urine tests, cancer screenings, etc.), were defined as efficacy outcomes and were assessed by participant self-report at baseline and every 6 months over 24 months and electronic chart reviews after the completion of the follow-up. The primary outcome is defined as the difference in composite QHI scores at 24 months, in which a repeated measures likelihood-based mixed model with missing at random assumptions will be used. Providers at PCC completed surveys at baseline, 12 and 24 months to assess implementation outcomes including changes in stigma and attitudes towards OAT and PWID.

Preliminary results

Among the 1459 participants allocated to STC (N = 509) or PCC (N = 950), there were no differences in clinical and demographic characteristics. Self-reported prevalences were available for HIV (42 %), HCV (57 %), and prior tuberculosis (17 %). Study retention at 6, 12, 18, and 24 months was as 91 %, 85 %, 80 %, and 74 %, respectively.

Conclusion

PWID have a high prevalence of medical comorbidities and integrating OAT into primary care settings has the potential to improve the health of PWID. Findings from this study can help guide implementation of integrated care in Ukraine and throughout similar low-resource, high-burden countries in the Eastern European and Central Asian region.

Background

Following the successful completion of feasibility and acceptability studies of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS), a full-scale randomised controlled trial (RCT) evaluating its clinical and cost effectiveness will be conducted. This paper describes the design and protocol for a multi-site, parallel, single-blind, 2-arm RCT evaluating the clinical and cost effectiveness of iACT4CARERS plus treatment-as-usual (TAU) in comparison to TAU alone for reducing anxiety in family carers of people with dementia.

Methods

496 family carers aged ≥18 years, who are caring for a person with dementia, will be recruited from national healthcare services, general practices and community groups in England. Participants randomised to the intervention arm will receive iACT4CARERS over 12 weeks. Participants will complete outcome measures at baseline (0 weeks) and at 12-weeks and 24-weeks post-randomisation. The primary outcome and timepoint will be anxiety at 12 weeks. Secondary outcomes will include psychological flexibility, depression, and cost-effectiveness (cost per quality adjusted life years). Primary analyses will be by intention-to-treat and data will be analysed using linear mixed models. Fidelity and quality of implementation will be assessed and contextual factors associated with variation in outcomes identified in a process evaluation.

Conclusion

If iACT4CARERS is found to be effective and affordable, this self-help intervention, including minimal contact with minimally trained therapists, has the potential to be rolled out widely within healthcare services in the UK, reducing inequality in access to psychological services among this population.

Clinical trials registration: ISRCTN registry identifier ISRCTN45995725.

Background

Clinical drug trials are intricate, involving numerous stakeholders, substantial data, and stringent regulations. Traditional systems for recording, storing, and sharing trial data often face data integrity, transparency, security, and interoperability challenges. The utilization of blockchain technology has emerged as a transformative influence in various industries, and its potential within healthcare, particularly in clinical drug trials, is increasingly gaining recognition.

Methods

Blockchain technology presents a decentralized and immutable ledger system that holds promise in effectively addressing these challenges. As the healthcare industry continues its journey of digital transformation, the incorporation of blockchain technology for monitoring clinical drug trials represents a paradigm shift that can result in more reliable, efficient, and transparent trials.

Results and conclusion

This review explores the innovative application of blockchain technology in transforming the monitoring and management of clinical drug trials and provides a comprehensive overview of the possibilities, challenges, and future directions of blockchain-based monitoring in the context of clinical drug trials, contributing to the progress of both blockchain technology and healthcare research practices.

Background

There is evidence that chronic exercise can benefit the brain, but the effects vary markedly between studies. One potential mechanism for exercise-related benefit is the increase in systemic lactate concentration that is well-characterized to occur during exercise. Lactate is known to cross the blood brain barrier and can be used readily as a fuel for neurons. This may be particularly important in Alzheimer's Disease, which is characterized by cerebral hypometabolism. However, little is known about how whole-body lactate metabolism differs between older adults and individuals with cognitive impairment. This information is critical when considering potential differences in responses to exercise in various cognitive diagnosis groups.

Methods

Here we describe the use of a “lactate clamp” procedure to adjust blood lactate levels to approximate those achieved during exercise, but while at rest. This trial will compare lactate oxidation between cognitively healthy older adults and cognitively impaired participants. We will further evaluate the effect of acute lactate infusion on cognitive performance.

Discussion

The findings of the study described here, the Lactate for Energy and Neurocognition trial (clinicaltrials.gov # NCT05207397) will add to our understanding of systemic lactate mechanics in cognitively healthy older adults and individuals with Alzheimer's Disease. These findings will be applicable to ongoing exercise trials and to future studies aimed at modulating systemic bioenergetic function in aging and Alzheimer's Disease.

Background

Minorities living in the Southern US generally have greater incidence and prevalence of cardiometabolic diseases compared to other groups. Cardiometabolic disease prevalence and risk can be reduced by focusing on diet and lifestyle modifications. There is need for holistic and integrated care models for community-based healthcare organizations who are already working with minorities. This research aimed to select and optimize essential psychosocial and structural components to address diet behaviors among racial/ethnic minorities, and/or disadvantaged background young to middle aged adult populations in Mississippi.

Methods

Nutrition360 was guided by a community-academic team using a participatory approach and included a preparation and two optimization phases to examine different approaches to dietary interventions utilizing the multiphase optimization strategy. Each intervention arm included three different modalities to identify the most feasible delivery method. The intervention was conducted at a community-based, outpatient healthcare center located in Jackson, MS. Eligible participants were between 25 and 50 years old, residents of Jackson metropolitan area, at risk for cardiovascular disease-related premature mortality, and had internet access. Individuals who completed baseline surveys were randomly assigned to an intervention group and then to modality order. Co-primary outcomes were research participant burden and cost-effectiveness and secondary outcomes were attendance, and dietary measures.

Results

Thirty-one, African American individuals with a mean age of 40.5 years completed baseline surveys and were randomized to an intervention program.

Conclusion

The two most feasible and cost-effective interventions will be combined to further test this model's delivery in the real-world setting as part of the next optimization phase.

Registration

ClinicalTrials.gov, NCT06286618. https://clinicaltrials.gov/study/NCT06286618

Background

Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.

Methods

Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.

Results

Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.

Conclusion

The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.

Background

Misophonia is a disorder characterized by an intense emotional reaction to specific sounds, often leading to significant distress and impairment in daily functioning. Acceptance and commitment therapy (ACT) is a promising psychotherapy for treating misophonia, but has only been previously tested in case studies. This paper presents a protocol for the first randomized controlled trial (RCT) assessing the efficacy and feasibility of ACT supplemented by audiological interventions for misophonia versus progressive relaxation training (PRT).

Methods

The outlined protocol is a RCT with 60 adults with misophonia. After undergoing a comprehensive psychological and audiological evaluation, participants were randomly assigned to ACT (n = 30) or PRT (n = 30). All participants completed clinician-administered and self-report assessments at baseline, post-intervention, 3-month follow-up, and 6-month follow-up. The primary outcome was misophonia severity and impairment measured via clinical interview. Secondary outcomes included disgust, anger, sensory sensitivities, well-being, distress, and psychological flexibility.

Discussion

This paper outlines the rationale of using ACT supplemented by audiological methods for misophonia with the novel therapeutic target of enhancing psychological flexibility. The results of this randomized controlled trial will help determine if ACT is an efficacious and acceptable treatment for misophonia. This trial will also help clarify active psychological mechanisms of misophonia, and assess whether this combination of psychological and audiological services can effectively help individuals with misophonia.

Background

Nearly 2 million U.S. veterans live with co-occurring alcohol use disorder and posttraumatic stress disorder (AUD/PTSD). Extant AUD/PTSD treatments emphasize symptom reduction, sometimes overlooking psychosocial functioning improvements, and have dropout rates as high as 50 %. Additionally, current approaches to measuring psychosocial functioning are limited to self-report. This study protocol describes a 1:1 parallel, two-arm, pilot randomized controlled trial comparing Behavioral Activation (BA) psychotherapy to Relapse Prevention (RP) psychotherapy for veterans with AUD/PTSD.

Methods

Forty-six veterans with AUD/PTSD will be block-randomized to eight weekly, virtual, hour-long individual sessions of BA or RP. Clinical interview, self-report, and geospatial assessments will be administered at pre- and post-treatment. Select outcome and exploratory measures will be administered during treatment. Analyses will focus on trial feasibility, BA acceptability, and preliminary efficacy. Geospatial analyses will explore whether pre- to post-treatment changes in geospatial movement can be used to objectively measure treatment response. The study site and an independent Data and Safety Monitoring Board will monitor trial progress, safety, and quality. De-identified data from consenting participants will be submitted to a sponsor-designated data repository.

Conclusion

If successful, this trial could help to provide veterans with AUD/PTSD with a more acceptable treatment option. Positive findings would also lay groundwork for testing BA in civilians with AUD/PTSD. Finally, by incorporating novel geospatial methods and technologies, this study could potentially yield a new approach to objectively measuring AUD/PTSD recovery that could be used in other clinical trials. This study was registered in ClinicalTrials.gov (NCT06249386).

Background

Prior research demonstrates that nearly all (95 %) people with lung cancer (PwLC) report stigma, and approximately half (48 %) PwLC experience stigma during clinical encounters with oncology care providers (OCPs). When stigma is experienced in a medical context, it can have undesirable consequences including patients' delaying and underreporting of symptoms, misreporting of smoking behavior, and avoiding help-seeking such as psychosocial support and cessation counseling. Multi-level interventions are needed to prevent and mitigate lung cancer stigma. One promising intervention for reducing patient perception and experience of stigma is to train OCPs in responding empathically to patient emotions and promoting empathic communication within clinical encounters.

Methods

This paper describes the study protocol for a cluster randomized trial comparing Usual Care (waitlist control group) with Empathic Communication Skills (ECS) training (intervention group). For this study, we will recruit 16 community oncology practice sites, 9–11 OCPs per site, and 6 PwLCs per OCP.

Results

The goal of this trial is to investigate the effect of the ECS training on (a) OCP primary outcomes (communication and empathic skill uptake) and secondary outcomes (ECS training appraisal – relevance, novelty, clarity; self-efficacy, attitude towards communication with patients); and (b) patient-reported primary outcomes (lung cancer stigma), and secondary outcomes (perceived clinician empathy, satisfaction with OCP communication, psychological distress, social isolation, and appraisal of care).

Conclusion

Findings from this trial will advance understanding of the effectiveness of the ECS training intervention and inform future provider-level training interventions that may reduce lung cancer stigma and improve cancer care delivery.

ClinicalTrials.gov Identifier: NCT05456841

Randomized controlled trials commonly employ multiple endpoints to collectively assess the intended effects of the new intervention on multiple aspects of the disease. Focusing on the estimation of the global win probability (WinP), defined as the (weighted) mean of the WinPs across the endpoints that a treated participant would have a better outcome than a control participant, we propose a closed-form sample size formula incorporating pre-specified precision and assurance, with precision denoted by the lower limit of confidence interval and assurance denoted by the probability of achieving that lower limit. We make use of the equivalence of the WinP and the area under the receiver operating characteristic curve (AUC) and adapt a formula originally developed for the difference between two AUCs to handle the global WinP. Unequal variances between treatment groups are allowed. Simulation results suggest that the method performs very well. We illustrate the proposed formula using a Parkinson's disease clinical trial design example.