Contemporary Clinical Trials Communications最新文献

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.

Background

Post-traumatic stress disorder (PTSD) is highly prevalent in veterans and associated with impairments in family functioning, including parenting. There is a bidirectional relationship between PTSD and familial functioning such that impaired functioning is related to increases in trauma-related symptoms, and vice versa. Despite this known bidirectional association, there is currently no trauma-informed parenting intervention available for veterans within the Department of Veterans Affairs (VA). Strength at Home – Parents (SAHP) is an 8-session telehealth delivered psychotherapy group that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military veterans with PTSD symptoms. This paper describes the methods of an individually randomized group therapy trial to test the efficacy of SAHP compared to a VA treatment as usual control condition.Methods are reported using SPIRIT guidelines.

Methods

One hundred and ninety veterans with elevated PTSD symptoms and parent-child functioning problems will be randomly assigned to the SAHP intervention or a treatment-as-usual control group. Outcomes are measured at 4 timepoints including baseline. The primary outcome is parenting stress. We will also examine changes in parenting behaviors, whether treatment gains are maintained over time, and will conduct an exploratory analysis to examine results separately by gender. Secondary outcomes include symptoms of PTSD and depression, family functioning, and child psychosocial functioning.

Conclusion

Study findings will determine the efficacy of SAHP, an intervention developed for ease of use and implementation within the VA to improve parenting stress and parenting behaviors in veterans with elevated PTSD symptoms and parenting difficulties.

Background

Tobacco use represents a significant public health burden, being especially harmful for smokers with Type 2 Diabetes Mellitus (T2DM). Effective smoking cessation interventions are required for this vulnerable population. The goal is to describe a study protocol of a randomized controlled trial (RCT) aimed at analyzing the effectiveness and efficiency of a multicomponent smoking cessation intervention for T2DM smokers, including a training protocol on healthy lifestyle habits and self-management of T2DM (DiMe-SALUD2 project).

Methods

This RCT will assign participants to: (1) Control Group (n = 30), including a brief psychoeducation advice about smoking cessation; (2) Cognitive-behavioral treatment (CBT) for smoking cessation (n = 30), based on a multicomponent program implemented in group-based sessions over an eight-week period; and (3) CBT plus DiMeSALUD2 protocol (n = 30), which will develop an additional psychoeducational protocol specifically designed to improve healthy lifestyle habits. Participants will be assessed at baseline, post-treatment and several follow-ups (1-, 6- and 12-months). Primary outcomes will include smoking abstinence (24-h point prevalence abstinence at post-treatment and 7-day point prevalence at follow-ups) and smoking continuous abstinence. Secondary outcomes will include treatment retention, changes in smoking patterns and nicotine dependence, as well as the impact on T2DM clinical variables, mental health, and quality of life.

Discussion

The DiMeSALUD2 program could assist T2DM smokers in quitting tobacco use and improving their overall quality of life. This project will help incorporating improvements in routine clinical practice with T2DM patients, offering a smoking cessation program adapted to their specific needs.

Trial registration

ClinicalTrials.gov. Identifier: NCT05885659. Date of registration: June 2nd, 2023.

Chronic migraine is a debilitating headache disorder that is associated with excessive analgesic use. As the long-term use of analgesics could cause additional headaches due to medication overuse, there is a need to probe efficient nonprophylactic alternatives and migraineurs’ long-term adherence to such possible treatments. This protocol investigates the integration of neurofeedback and mindfulness which are the two common nonpharmacological therapies for migraines. We offer the use of portable EEG headbands for easy home-based data collection and consistent data access from researchers. In order to evaluate the efficacy of this recommended intervention, this is a protocol for a randomized control trial with a waitlisted group and an intervention group consisting of a daily attention task. The protocol presents important criteria which should be checked for consistency in longitudinal data collection from adults with chronic migraine.

Introduction

After injury, survivors of moderate to severe traumatic brain injury (msTBI) depend on informal family caregivers. Upwards of 77 % of family caregivers experience poor outcomes, such as adverse life changes, poor health-related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. The majority of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information to either survivors only, or to long-term caregivers, rather than to the new caregiver. This manuscript describes the protocol of an ongoing randomized control trial, Caregiver Wellness after TBI (CG-Well), developed to provide education, support, and skill-building to caregivers of adults with msTBI, beginning when the survivor is early in the clinical course.

Methods

Within two weeks of admission to the ICU, participants are randomized to CG-Well online modules (intervention group, n = 50 dyads) or information, support, and referral (ISR) e-bulletins that exist in the public domain (control group, n = 50 dyads) over the first six months after their family member's msTBI. Both groups receive regular phone calls. The primary outcome is intervention satisfaction at six months.

Results

Enrollment began in March 2022 and is projected to complete October 2024. We have enrolled approximately 70 % of participants at this time. Primary analysis completion is anticipated April 2025.

Discussion

This RCT is designed to evaluate caregiver satisfaction by addressing the need for tailored supportive care for caregivers of msTBI beginning during the ICU admission.

Trial registration

Clinicaltrials. gov Registration Number: NCT05307640.

Background

In this paper we outline the protocol for an implementation-effectiveness trial of ecofit, a multi-component mHealth intervention aimed at increasing participation in resistance and aerobic physical activity using the outdoor built environment (i.e., outdoor gyms) and social support. We have previously demonstrated the efficacy and effectiveness of the ecofit program in insufficiently active people with (or at risk of) type 2 diabetes and community-dwelling adults, respectively. The objective of this trial is to compare the effects of two implementation support models (i.e., ‘Low’ versus ‘Moderate’) on the reach (primary outcome), uptake, dose received, impact and fidelity of the ecofit program.

Research design and methods

This hybrid type III implementation-effectiveness study will be evaluated using a two-arm randomized controlled trial, including 16 outdoor gym locations in two large regional municipalities in New South Wales, Australia. Outdoor gym locations will be pair-matched, based on an established socio-economic status consensus-based index (high versus low), and randomized to the ‘Low’ (i.e., ecofit app only) or ‘Moderate’ (i.e., ecofit app, face-to-face workout sessions and QR codes) implementation support group. The primary outcome of ‘reach’ will be measured using a modified version of the ‘System for Observing Play and Recreation in Communities’, capturing outdoor gym use amongst community members.

Conclusion

This implementation-effectiveness trial will evaluate the effects of different levels of implementation support on participation in resistance-focused physical activity using mHealth and outdoor gyms across the broader community. This may guide widespread dissemination for councils (municipalities) nation-wide wanting to promote outdoor gym usage.

Trial registry

This trial was preregistered with the Australian and New Zealand Clinical Trial Registry (ACTRN12624000261516).

Background

Plantar fasciitis (PF) is one of the most common causes of plantar heel pain, and previous studies found that acupuncture is effective for relieving pain in patients with PF. Nevertheless, the impact of different sessions of electroacupuncture on PF has not been investigated through randomized, controlled trials.

Methods/design

This is a two parallel-group, assessor-blinded, randomized controlled trial, consisting of a four-week treatment phase followed by a 12-week follow-up. Eighty patients with chronic PF will be recruited and randomly allocated to receive 12 (three sessions per week; the multiple electroacupuncture weekly treatment group (group M)) or four (one session per week; single electroacupuncture weekly treatment group (group S)) sessions of electroacupuncture treatment in a 1:1 ratio. The primary outcome to be studied is the response rate, defined as a minimum of 50 % improvement in most severe pain intensity with first steps in the morning, compared with baseline. We will perform all analyses based on the intention-to-treat principle, with differences considered significant when the P value < 0.05 on a two-sided basis.

Discussion

This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of different electroacupuncture sessions (one session per week versus three sessions per week) for chronic PF. This study aims to contribute in produce up-to-date, rigorous evidence on the most effective frequency of electroacupuncture in managing chronic PF.

Trial registration Clinicaltrials.gov Identifier: NCT06284993. Registered on February 17, 2024.