Contemporary clinical trials最新文献

Therapeutic inertia, the delay in the appropriate initiation and intensification of recommended therapies, is a major contributor to the lack of improvement in type 2 diabetes outcomes over the past decade. Therapeutic inertia during the period following diagnosis, when improvements in glycemic control can have lasting benefits, is often overlooked. Technology and team-based care approaches can effectively address therapeutic inertia. Here, we describe the protocol for a randomized, quality improvement trial targeting metformin-related therapeutic inertia among adults with recently diagnosed type 2 diabetes and a hemoglobin A1c <8 %. Service areas within an integrated healthcare delivery system were randomized to 1) usual care, 2) physician education on therapeutic inertia, and 3) physician education on therapeutic inertia paired with proactive outreach by a clinical pharmacist. The physician education sessions were offered to primary care providers working in the service areas randomized to Arm 2 and Arm 3, and proactive outreach by a clinical pharmacist was performed for patients of the providers in service areas randomized to Arm 3. Outcomes will be abstracted from the EHR at 6, 12, and 18 months following the physician education sessions. The primary outcome will be the proportion of patients with an HbA1c <7 % at each of the follow-up time points. Outcome abstraction and analyses will occur in late 2024. This trial seeks to rigorously evaluate care strategies that can shift stagnant type 2 diabetes outcomes. Our protocol, along with the pending results, may offer examples to other healthcare systems working to improve type 2 diabetes care.

Background: As people with cystic fibrosis (pwCF) live longer due to the breakthrough drug elexacaftor-tezacaftor-ivacaftor (ETI), they have questioned whether other CF therapies could be safely discontinued. SIMPLIFY was the first prospective, randomized trial to evaluate non-inferiority of discontinuing versus continuing two therapies. The QUEST (Qualitative Understanding of Experiences in the SIMPLIFY Trial) study was conducted to understand experiences of pwCF enrolled in SIMPLIFY, including why they joined, perceptions of randomization, decision-making around study withdrawal, and considerations for future discontinuation studies.

Methods: QUEST enrolled SIMPLIFY participants 14 years or older stable on ETI and caregivers of the 14-17 year-olds. Interviews were audio-recorded, transcribed, and coded. A phenomenological approach was used to inductively develop codes with no a priori hypotheses; identified themes were then organized around current research and recruitment literature.

Results: 114 interviews were completed (68 adults, 23 teenagers, and 23 caregivers). Among pwCF, median age was 27.8 years, 49 % were female and 80 % had participated in research before SIMPLIFY. Five themes were identified: ((Gul and Ali, 2010 [1]) Experience with SIMPLIFY randomization, CFF Patient Registry Annual Data Report [Internet] (2017) [2] Trust, CFF Patient Registry Annual Data Report [Internet] (2022) [3] Altruism, Goss et al. (2008) [4] Perceived personal benefits, and (Goss et al., 2002 [5]) Perceived risks and protocol burden.

Conclusion: QUEST findings highlight how a long-standing culture of research and thoughtful protocol design contributed to SIMPLIFY's successful recruitment and retention. This included understanding the importance of remaining in the trial despite not being randomized to their preferred treatment assignment. Using patient-centered approaches to select research questions, design a protocol to minimize participant barriers, and frame recruitment materials messaging contribute to successful research participation.

Introduction: Adolescents and young adults (AYA, 14-24 years) bear a disproportionate burden of new HIV infections in Nigeria and are more likely to have worse HIV outcomes compared to other age groups. However, little is known about their access to recommended sexual health care services, including HIV self-testing (HIVST), sexually transmitted infections (STI) testing, sexual behavior patterns, awareness and or access to pre-exposure prophylaxis (PrEP), and overall risk for HIV.

Methods: We present a baseline analysis of the 4 Youth by Youth randomized controlled trial aimed to evaluate the uptake and sustainability of crowdsourced HIVST strategies led by and for young people across 14 states in Nigeria. None of the participants had received intervention at the time of completing this self-reported behavioral survey. We conducted a descriptive analysis to summarize participants' characteristics, sexual behavior, HIV testing, STI testing, and knowledge of PrEP and use across the study sample of the AYAs. We conducted a chi-square test, and the level of significance was set at ≤0.05.

Results: A total of 1551 participants completed the baseline survey comprising males (777, 50.1 %) and females (774, 49.9 %). The majority (77 %) of the participants were students at enrollment. Very few of the participants had ever tested for syphilis, 47 (3.1 %), gonorrhea, 49 (3.2 %), chlamydia, 31 (2.0 %), and hepatitis B, 106 (6.9 %). 678 (43.8 %) of the participants reported to be sexually active at the time of enrolment into the study, of which about 38 % of them engaged in condomless sex. Paying for sex, alcohol use, and drug use are all significant sexual behaviors (p < 0.01). Only 14 (1 %) have ever used PrEP. 481 (31.4 %) have ever tested for HIV, and 104 (6.8 %) have ever used an HIV self-testing kit at baseline. 457 (38.6 %) were eligible for PrEP.

Conclusions: HIVST and STI uptake were low at baseline among the AYA in this study. Most AYAs also do not receive recommended sexual health care services, including STI testing services. This underlines the need for interventions to increase the uptake of HIV/STI prevention services among Nigerian AYA.

Background: Emerging research has examined electronic and mobile health (e/mHealth) technologies for weight loss and manage of type 2 diabetes mellitus (T2DM), but few studies have focused specifically on ways to target social support behaviors that have proven to be effective. While gamifying an mHealth behavioral weight loss intervention holds promise to promote and sustain social support, there has been very little research in this area. The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote sustained weight loss.

Objective: To describe the design of the 12-month mLife study, a randomized clinical trial, which compares the differential long-term effect of a behavioral weight loss program with and without gamification among adults with overweight or obesity.

Methods: Participants (target N = 240) in two consecutive cohorts were randomized to either the mLife+points or mLife group. The weight loss intervention for both groups included diet and physical activity (PA) recommendations, education, daily diet logging, visualization of PA and body weight readings captured with a wearable tracker and e-scale, and facilitation of social interaction among participants. The mLife+points group earned points for social support activities. Remote follow-up assessments of weight, anthropometric measures, diet (24 h dietary recalls), PA, social support provision, receipt and enjoyment, factors driving self-monitoring adherence and study compliance/responsiveness occurred at 6 and 12-months post-baseline.

Conclusion: The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.

Trial registration: This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT05176847.