Contemporary Clinical Trials Communications最新文献

Background

Methods

Conclusions

Registration

Background

Patients with advanced cancer experience many symptoms and needs requiring a Palliative Care Intervention (PCI). Identifying gaps between needs for PCIs and experienced delivery may improve health care, furthermore the association of gaps with quality indicators (QI). The multicentre Romanian (RO)-Swiss (CH) reality map study implemented a novel protocol based on needs concepts and culturally adapted quality indicators (QI).

Methods

An interactive mapping guide measuring unmet needs for PCIs monthly over six months, patient characteristics (cognition, EAPC basic data set, Cofactors) and QI (Inappropriate Anticancer Treatment, High Symptom Burden [IPOS, EQ5D], Repeated ER Admissions, Aggressive End-of-Life Care, and Quality of Death-and-Dying) were developed, applying swiss standards for quality assurance. A composite endpoint (QI, cofactors) was planned. Finally, local solutions responding to gaps were piloted.

Results

From 308 patients (RO: 262, CH: 46, age 62j [mean], 74 % ECOG PS 1&2, 81 % current anticancer treatment) baseline and first follow-up data revealed main gaps (symptom management, spiritual needs, family support), country differences (e.g. illness understanding, spiritual needs) and a significant association of the number of gaps with depression. Later data become less, and data quality on QI variable, revealing gaps in research conduct competences, resources, and applicability of over-sophisticated quality assurance tools. Nevertheless, the unmet needs data promoted local initiatives, 81 patients participated in feasibility studies. Finally, the joint experience stimulated academic developments and national integration of palliative care into oncology.

Conclusions

Pairing motivation and enthusiasm with more modest aims, feasibility testing of all outcomes and investment in research competences may disperse gaps.

Subconcussive, repetitive head impacts sustained in collision sports may negatively affect brain health. American football practices are controlled environments amenable to intervention. Engaging community members is essential for successful development, implementation, and sustainability of viable interventions. The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American football (i.e., football), using a community-engaged approach. This manuscript describes the co-design of the intervention and associated implementation plan and the study protocol for evaluating the effectiveness and feasibility of the intervention and implementation plan. In the first part of this study, focus groups with parents and coaches, and individual interviews with organizational leaders associated with two teams at the middle school level were conducted. An anonymous survey assessing beliefs and perceptions of non-concussive head impacts was given to parents, coaches, and organizational leaders within the local youth football league. Following the football season, qualitative and quantitative data describing determinants of head acceleration events in football were shared with 12 stakeholders of coaches, league and school administrators, parents, an athletic trainer, and local university player development director. Together, we co-designed COACH (COmmunities Aligned to reduce Concussion and Head impact exposure) and implementation plan using a strategic planning approach. The preliminary effectiveness and feasibility were assessed in the second part of this study. Youth football players participating on the teams in year 1 (control teams) were fitted with mouthpiece-based head kinematic sensors which measure head acceleration events (HAEs). HAEs were collected and quantified during team activities. Preliminary effectiveness of the intervention to reduce HAEs was measured among two new teams pilot testing COACH with mouthpiece-based sensors, while simultaneously monitoring implementation of the intervention. We report our study design and evaluation, and opportunities and challenges with our approach. The results will inform a future full-scale pragmatic trial to assess the implementation and effectiveness of the intervention program.

NCT04908930.

Introduction

To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator creams.

Methods

Two-armed double-blind RCT, registered in ClinicalTrials.gov Identifier: NCT06427889. With 80 % power, two-tailed significance of 2.5 % in each arm, 39 study persons is needed in each arm, total 78 persons, 98 including dropouts, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal®lipid cream), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28.

Discussion

This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes.

Background

Cardiac rehabilitation is a beneficial multidisciplinary treatment of exercise promotion, patient education, risk factor management, and psychosocial counseling for people with coronary heart disease (CHD) that is underutilized due to substantial disparities in access, referral, and participation. Empirical studies suggest that cardiac telerehabilitation (CTR) have safety and efficacy comparable to traditional in-person cardiac rehabilitation, however, older adults are under-reported with effectiveness, feasibility, and usability remains unclear.

Methods

The study randomized 43 older adults (84 % males) to the 12-week CTR intervention or standard of care. Guided by Social Cognitive Theory, participants received individualized in-person assessment and e-coaching sessions, followed by CTR usage at home. Data were collected at baseline (T0), six-week (T1), and 12-week (T2).

Results

Participants in the CTR intervention group showed significant improvement in daily steps (T1: β = 4126.58, p = 0.001; T2: β = 5285, p = 0.01) and health-promoting lifestyle profile (T1: β = 23.26, p < 0.001; T2: β = 12.18, p = 0.008) across study endpoints. Twenty participants completed the intervention, with 40 % used the website for data-uploading or experiential learning, 90 % used the pedometer for tele-monitoring. Improving awareness of rehabilitation and an action focus were considered key facilitators while physical discomforts and difficulties in using the technology were described as the main barriers.

Conclusions

The CTR is feasible, safe and effective in improving physical activity and healthy behaviors in older adults with CHD. Considering the variation in individual cardiovascular risk factors, full-scale RCT with a larger sample is needed to determine the effect of CTR on psychological symptoms, body weight and blood pressure, and quality of life.

Background

Population level physical activity generally does not meet recommended targets. Compared with private motor vehicle users, public transport users tend to be more physically active and financial incentives may encourage more public transport use, but these relationships are under-investigated. This paper describes the protocol of a randomised controlled trial that aimed to determine the effect of financially incentivising public transport use on physical activity in a regional Australian setting.

Methods

Get BusActive! is a 9.5-month single-blinded randomised controlled trial. A convenience sample of Tasmanians aged ≥15 years will be randomised to a 14-week incentive-based intervention (bus trip target attainment rewarded by bus trip credits and weekly supportive text messages) or an active control following baseline measures and will be followed up ∼24 weeks later (maintenance phase). Both groups will receive written physical activity guidelines. The primary outcome is change in accelerometer-measured steps/day from baseline to immediately post intervention phase and maintenance phase. Secondary outcomes are change in: smartcard-measured bus trips/week; measured and self-reported minutes/week of physical activity and sitting; transport-related behaviour (using one-week travel diary), perspectives (e.g. enablers/barriers) and costs; health. Linear mixed model regression will determine group differences. Participant-level process evaluation will be conducted and intervention cost to the public transport provider determined.

Conclusion

Get BusActive! will fill an important knowledge gap about the causal relationship between financially incentivised public transport use and physical activity—the findings will benefit health and transport-related decision makers.

Trial registration

ACTRN12623000613606.

Universal trial number

U1111-1292-3414.

Aim

The purpose of this secondary analysis was to describe issues related to internet connections during a virtual randomized clinical trial (v-RCT) that included family caregiver participants living in rural areas.

Background

Success of v-RCTs depends on reliable, high-quality internet access, which can be problematic in rural areas.

Methods

Interventionists documented connectivity issues and corrections made to address connectivity in a narrative note after each virtual visit with family caregivers enrolled in a v-RCT. Notes were reviewed for descriptions of the internet connection during the visit and then coded into those with and without connectivity problems. Two investigators reviewed notes and codes to assure reliability. Discrepancies in codes were discussed or arbitrated by a third investigator until consensus was reached. Analysis was completed using descriptive statistics.

Results

Of the 1003 visits reviewed, only 11 % of visits (115/1003) contained a documented problem with internet connectivity. Visits with documented connectivity problems were experienced by 27 % of participants (58/215). However, 60 % (35/58) of participants with a documented issue had a problem with only one visit. None of the participants withdrew from the v-RCT due to problems with their internet connections.

Conclusions

The findings support the effective use of virtual visits in research involving participants living in rural locations. V-RCTs provide a strategy that enables participation for individuals who may not otherwise have access to clinical trials conducted in-person in urban settings. Utilizing internet access to connect with and support people who live in rural areas is critically needed to advance clinical research.

Background

Adequate sleep plays a crucial role in maintaining physical, mental, and emotional health. On average, adults require 7–9 h of sleep per night. However, less than two-thirds of women meet this recommendation. During the coronavirus disease 2019 (COVID-19) pandemic, poor sleep quality and moderate-to-severe stress were highly prevalent among healthcare workers (HCWs), especially women. While some interventions have been proposed to address stress/burnout in HCWs, few have focused specifically on women in healthcare. Therefore, this is a protocol for a study that aims to determine the efficacy of a mind–body intervention (MBI) to improve sleep duration among women HCWs aged 40–60 years using the personalized (N-of-1) trial design.

Methods

A personalized (N-of-1) trials model will be employed to evaluate the efficacy of an MBI to improve sleep duration (primary endpoint) and explore its effects on sleep quality, physiological factors, and their relationships with participants’ perceived stress, anxiety, and depression. The series of personalized trials (n = 60) will be conducted over 16 weeks. The MBI will include mindfulness, yoga, and guided walking, delivered in two 2-week block sequences for 12 weeks, with two 2-week periods for baseline and follow-up. Participants will watch 30-min videos three times weekly and wear an activity tracker to monitor sleep and activity. They will receive daily text messages with questions about sleep quality and bi-weekly questionnaires about their stress, anxiety and depression scores, fatigue, concentration, confidence, mood, and pain levels.

Conclusion

Results from this study will inform the development of N-of-1 methodology for addressing the health and wellness needs of middle-aged women.

Background

While most pregnant individuals with methamphetamine use disorder (MUD) achieve abstinence, the postpartum period remains a vulnerable time for return to methamphetamine use (MU). Promising data from human and animal models, including three randomized controlled trials, suggest that micronized progesterone may prevent postpartum return to cocaine and nicotine use by reducing cravings. The primary objective of this study is to assess feasibility of enrollment and randomization of postpartum individuals with MUD to micronized progesterone to prevent return to MU. The secondary objectives are to evaluate safety, establish a preliminary estimate of efficacy, and characterize the association between allopregnanolone levels and methamphetamine cravings.

Methods

This is a pilot double-blind placebo randomized controlled trial. We plan to enroll 40 postpartum individuals with MUD over 24-months. Individuals, stratified by opioid use disorder (OUD), are randomized 1:1–400 mg oral micronized progesterone daily or placebo and attend weekly study sessions for 12 weeks. Feasibility is measured by achieving 80 % of enrollment goal. Safety is evaluated by side effect frequency, mental health status changes, lactation and medical complications. Efficacy is assessed by comparing proportion of participants with return to MU and time to return to MU based on self-report or urine testing between treatment and control groups. Salivary allopregnanolone levels and methamphetamine cravings are compared between the groups.

Conclusion

Study results will provide a first critical step towards potential intervention for prevention of return to MU among postpartum individuals. Completion of this trial will set the stage for a large-scale efficacy trial.