Pilot and Feasibility Studies最新文献

Background: Osteoarthritis is one of the most prevalent musculoskeletal disorders. In osteoarthritis patients, physical activity has been shown to be an effective tool to improve quality of life as well as to reduce the pain associated with the disease and the development of additional comorbidities. Yet osteoarthritis patients often do not meet the level of physical activity recommended to stay in good health. The PIANISSIMO study primarily aims to test the adherence of people with hip and knee osteoarthritis to a 6-month intervention for the promotion of physical activity specific to this population using a dedicated mobile app.

Methods: The PIANISSIMO study is a longitudinal, interventional feasibility study conducted through a dedicated mobile app. A total of 151 participants with hip or knee osteoarthritis will be included. The app will collect data and deliver the intervention. Data will be collected through questionnaires (i.e. demographic data, osteoarthritis history, sport history, pain and functional capacities, app evaluation) and from Apple Health/Google Fit apps. The PIANISSIMO study will use a 6-month physical activity intervention based on the Capability, Opportunity, Motivation-Behaviour change theory. Participants will receive a text notification on a daily basis; they will be asked to set their daily steps goal for the next week, and the mobile app will deliver feedback on daily step count and whether the goal of the week has been reached. The primary outcome of this study is the adherence (i.e. connection log and rate of answered questionnaires) to the app-based physical activity intervention. Retention will be calculated as the number of drop-outs over 6 months of follow-up. Moreover, the acceptability of the app and intervention by the study participants will be evaluated through a questionnaire.

Discussion: This mobile app was designed to provide a digital solution for the promotion of physical activity in people with osteoarthritis. If the feasibility of delivering a physical activity intervention through the mobile app is confirmed, the efficiency of the tool in improving the quality of life of people with hip and knee osteoarthritis should then be properly investigated.

Trial registration: Registration number NCT06385028 ( https://clinicaltrials.gov/study/NCT06385028 ) Protocol version 1.2.

Background: The Supplemental Nutrition Assistance Program (SNAP) has financial incentive programs where recipients can purchase fruits and vegetables (F&V) at select sites for half price or less, leading to increased F&V consumption and projected savings in healthcare costs. Yet, limited awareness and uptake of these programs present barriers to widespread utilization, thus limiting potential impact.

Objective: The Veggie Vouchers intervention was designed to increase awareness and uptake of a SNAP F&V incentive program in South Carolina among families with children 2-17 years of age. The primary aim of this study was to determine intervention feasibility and acceptability among caregivers and pediatricians. Patterns of preliminary efficacy were secondarily examined for changes in diet-related outcomes.

Methods: This single-arm feasibility study leveraged social determinants of health screenings in a pediatric clinic to identify families who were eligible for a SNAP F&V incentive program. Eligible caregivers received brief education about this program from their pediatrician and an initial free trial to incentivize uptake. Free trial redemption rates were tracked, along with subsequent SNAP F&V incentive program use after the free trial ended. Surveys assessed intervention acceptability and changes in household food security, nutrition security, and children's dietary intake.

Results: Caregivers (n = 91; 100% female; 77% Black) and pediatricians (n = 37) were enrolled within 10 months. Most caregivers (70.3%) used their free trial (redeemers), with 58% of "non-redeemers" reporting transportation challenges as reasons for non-redemption. Over 91% of "redeemers" were satisfied with the amount, variety, and quality of F&V; 90.5% reported the free trial made it easier for them and their child to eat more F&V; and 18.8% utilized the SNAP F&V incentive program after the free trial ended. Most assessment time points achieved ≥ 70% survey completion rates. Pediatricians (88.9%) felt the intervention was easy to implement, and 100% reported minimal-to-no disruptions in clinic flow. Initial patterns indicated potential improvements in household food security and nutrition security throughout the intervention for "redeemers," compared to "non-redeemers".

Conclusions: Findings support the feasibility and acceptability of the Veggie Vouchers intervention, yet additional strategies should be explored in a larger randomized controlled trial to enhance sustained SNAP F&V program use.

Trial registration: ClinicalTrials.gov, NCT06593028. Retrospectively registered on September 11, 2024, https://clinicaltrials.gov/study/NCT06593028 .

Background: Together For Us (T4Us) is a newly developed and evidence-informed social identity intervention for youth sport. Drawing on theoretical underpinnings of social identity theory and previous shared leadership intervention research in sport, T4Us leverages athlete leaders to foster a shared sense of social identity within the team.

Methods: The purpose of this study was to conduct an initial feasibility study (Study 1) and a proof-of-concept evaluation (Study 2) to determine whether T4Us enhanced social identity and assessed the intervention implementation.

Results: In Study 1, five competitive youth ice hockey teams (mean age = 13.0 years) completed T4Us at midseason. Overall, athlete leaders (n = 19) and coaches (n = 4) expressed support for the acceptability and feasibility of the initial T4Us workshop in a youth sport setting, including the creation of a unique team "trademark" and the shared leadership mapping exercise. Participants also recommended possible improvements to T4Us (e.g., intervention timing and follow-up booster sessions to reinforce content). In Study 2, a total of 14 competitive youth soccer teams (mean age = 14.7 years) completed the revised T4Us at midseason. Descriptive results highlight that athletes' perceptions of social identity were higher at post-intervention in comparison with pre-intervention. Post-intervention implementation evaluation results revealed that the teams used the game plan to support the team trademark, and athlete leaders and coaches encouraged team members to act according to the team game plan (scores > 5 on a 7-point scale). Interviews with athlete leaders described the different ways in which T4Us enhanced social identity within the team.

Conclusion: Overall, the initial feasibility evidence and the proof-of-concept evaluation support the further development of T4Us, including a randomized-controlled T4Us protocol.

Background: Bronchopulmonary dysplasia (BPD) is a common morbidity affecting preterm infants' underdeveloped lungs, leading to long-term growth and neurodevelopmental issues. Despite its significance, no clinical prediction model exists for neonatologists.

Aim: To assess the feasibility of study procedures and provide descriptive data to guide a large multicentre study for developing a BPD-prediction model.

Methods: This was a single-centre feasibility observational cohort study conducted at a neonatal intensive care unit. Forty preterm infants born before 32 weeks of gestation were recruited within 18 months. Two echocardiographic scans on days 5 and 9 after birth were planned for each infant. Feasibility targets included achieving adequate recruitment and retention, ensuring at least 80% of recruited infants underwent two scans, and maintaining high-quality imaging, with at least 80% of scans analysable, particularly Tissue Doppler Imaging (TDI) and speckle tracking imaging (STI). Descriptive statistics for feasibility, demographic, clinical, and cardiac parameters of preterm infants with and without BPD are reported.

Results: Seventy-seven preterm infants were screened for eligibility between June 2022 and May 2023. The target of 40 preterm infants was achieved within 11 months. All infants had the first echo scan performed, whereas 39 (97%) had a second one performed. Majority had their echo scans performed within 24 h of the prespecified timeframe, i.e. days 5 and 9 after birth (34 (85%) of the first and 28 (69%) of the second echo scans). All the first and 39 (97%) of the second echo scans, excluding STI, were suitable for analysing the cardiac parameters. Regarding STI, 38 (95%) of the first and 34 (85%) of the second echo scans were analysable. Compared with the 27 infants without BPD, the 13 BPD-affected preterm infants had a lower gestational age (median 26 vs 30 weeks) and lower birth weight (median 1370 vs 763 g). Clinically, respiratory support was greater in the BPD group than in the non-BPD group (median 8.3 vs 3.0 for the first scan; 7.9 vs 0.0 (cmH2O or L/min) for the second echo scan).

Conclusion: Our findings demonstrate that a large multicentre study is feasible and will inform the construction of a BPD-prediction model.

Trial registration: NCT05235399.

Background: Work-related health issues, particularly those affecting mental health, are increasing, leading to significant costs for health systems and impacting individuals' ability to work. Preventive interventions using digital health applications promise to mitigate these issues by promoting mental well-being and reducing risk factors.

Objective: The study aimed to pilot the new prevention intervention "RV Fit Mental Health" which combines an intensive inpatient phase with an app-supported digital outpatient phase. The primary objectives were to understand the target group, evaluate the acceptability and feasibility of the intervention, and identify areas for optimization based on participant feedback.

Methods: A mixed-methods approach was employed, combining qualitative and quantitative data. Qualitative data were gathered from 18 participants through focus groups. Quantitative data were collected from 21 participants using various validated instruments, including the Work Ability Index (WAI), World Health Organization Quality of Life-BREF (WHOQOL-BREF), Depression Anxiety Stress Scale-21 (DASS-21), and eHealth Literacy scales. Data analysis was conducted using descriptive statistics and content analysis.

Results: Qualitative results highlighted the acceptability of the intervention and identified several challenges, including the transition between the different phases of the intervention and the diversity of participants' backgrounds and health conditions. Participants appreciated the holistic approach of combining an inpatient and app-supported outpatient phase but suggested further adjustments to enhance usability and integration into daily life. Quantitative findings indicated a heterogeneous group of participants.

Conclusions: The "RV Fit Mental Health" intervention shows promise for addressing work-related mental health issues. The initial results of the pilot study indicate feasibility and good acceptance of the intervention. However, further refinement and a larger-scale evaluation are necessary to confirm its efficacy and optimize its implementation. If successful, this approach could strengthen participation in working life and reduce mental health-related work incapacity.

Trial registration: DRKS-ID: DRKS000308188 ( https://drks.de/search/de/trial/DRKS00030818 ).

Objective: Ageing increases the risk of age-related diseases, but interventions promoting physical fitness, emotional well-being, and social participation can mitigate these risks. Urban care farming (UCF), which uses therapeutic farming in natural settings, shows promise for healthy ageing. This feasibility study assessed the feasibility of the UCF intervention by evaluating the acceptability and adherence of UCF by participants and trainers, implementation fidelity, and outcome measures.

Methods: This feasibility study used a single-arm pre-post design, which recruited 20 older adults (50-85) in Singapore for an 8-week UCF intervention in January 2024. Weekly 3-h sessions held in an estate in Central Singapore focused on farming activities such as planting, teamwork, and nutrition. Participants' recruitment, retention, satisfaction, and experiences of change were tracked alongside trainers' adherence to the intervention protocol. Outcome measures were collected at baseline and follow-up and assessed for reliability and effect sizes. Interviews were thematically analysed to provide deeper insights.

Results: Participants and trainers responded positively to the intervention. Recruitment reached 80%, with 95% participant retention post-intervention and an overall attendance rate of 88%, reflecting strong acceptance of the programme. Qualitative findings further supported these results, indicating that UCF activities fostered experiences of personal change, a sense of achievement, and community connectedness through social support and friendships. Implementation fidelity was maintained, though challenges such as unpredictable weather affected delivery and necessitated adjustments to certain curriculum components for the main trial. The assessed outcomes demonstrated reliable, moderate effect sizes for perceived stress, anxiety, and social isolation; however, the EQ-5D quality of life measure will be replaced due to its small effect size.

Conclusion: The UCF feasibility study was well received by older participants and trainers. Despite the small sample, outcomes demonstrated reliable, meaningful effects on well-being, guiding the design of the main waitlist-controlled trial.

Trial registration: Not applicable.

Background: Delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) is a severe complication linked to prolonged hospitalization, reduced functional outcomes, and increased mortality. Due to a lack of validated biomarkers, its development remains unpredictable, and its management is challenging. The glycocalyx, a glycoprotein layer on the luminal surface of endothelial cells, plays a crucial role in regulating leukocyte adhesion, thrombosis, and vascular permeability. As DCI is thought to result from microthrombosis, inflammation, and oxidative stress, the glycocalyx may be a relevant biomarker for DCI. This study aims to determine the feasibility of in vivo glycocalyx measurements in aSAH patients and to determine how these markers change over time in relation to DCI.

Methods: This prospective observational feasibility study will involve 30 aSAH patients. Glycocalyx thickness will be visualized in vivo using sidestream darkfield (SDF) imaging both sublingually and on the conjunctiva, while glycocalyx breakdown will be quantified ex vivo in blood samples. Measurements will be repeated six times during the first 2-week post-ictus. The primary outcome will be the feasibility of the in vivo glycocalyx measurements assessed as a multidimensional outcome, including technical feasibility, operational feasibility, participant experience, and measurement safety. Mixed model analysis will compare the feasibility of sublingual and conjunctival measurements including variables such as age, sex, neurological status, and patient location during measurement. Secondary outcomes will be the responsiveness of the in vivo glycocalyx measurements to DCI, compared to ex vivo glycocalyx measurements, analyzed using mixed-effects logistic regression.

Discussion: Traditionally, the search for DCI biomarkers has focused on systemic measurements of cerebrovascular breakdown products, which may vary due to metabolism and renal or hepatic clearance. In vivo assessment of the glycocalyx by SDF imaging is a minimally invasive method that allows for direct, local, and dynamic evaluation of the microcirculation. Given that the conjunctiva is vascularized by the ophthalmic artery branching off the internal carotid artery, it may better reflect cerebral microvascular changes associated with DCI. If feasible, in vivo glycocalyx measurements could serve as a valuable biomarker for monitoring DCI in aSAH patients, potentially offering superior predictive value compared to systemic measurements of glycocalyx breakdown products.

Objective: The overall objective of our research is to determine in children with septic shock whether the use of a fluid-sparing strategy results in improved clinical outcomes without an increased risk of adverse events compared to usual care. The specific objective of this pilot randomized controlled trial was to evaluate the feasibility of a definitive multicenter trial to answer our research question.

Design: Pragmatic, 2-arm, parallel group, open-label, prospective pilot randomized controlled trial including a nested biosample-based translational study.

Setting: Pediatric tertiary care center.

Patients: Children aged 29 days to <18 years of age presenting to the emergency department or admitted to an inpatient ward (including the PICU) with suspected or confirmed septic shock and a need for ongoing resuscitation.

Interventions: Fluid-sparing vs. usual care resuscitation strategy continued until shock reversal. The fluid-sparing intervention comprised instructions to restrict fluid bolus therapy in conjunction with early initiation and/or preferential use of vasoactive medication support as a strategy to spare fluid while targeting the hemodynamic goals specified in the American College of Critical Care Medicine Surviving Sepsis Guidelines. The usual care strategy did not limit the use of fluid bolus therapy.

Measurements and main results: Fifty-three were randomized to usual care (n = 27) or fluid-sparing (n = 26). Fifty-one participants were available for primary outcome analysis. Primary feasibility outcomes related to participant enrollment and protocol adherence. Enrollment rate was 1.8 (51/29); 95% confidence interval [CI]: 1.3-2.3 participants/month. Study procedures were implemented in 49/51 (96.1%), 95% CI: 86.5-99.5% participants within 1 h of randomization in a median (interquartile range [IQR]) of 8 (5, 15) minutes. The protocol required the use of an exception to consent process and consent for ongoing participation was 48/51 (94.1%), 95% CI: 83.8-98.8%. There were no serious adverse events.

Conclusions: We concluded the large multicenter SQUEEZE trial feasible to conduct.

Trial registration: ClinicalTrials.gov [NCT01973907]. Registered October 27, 2013, https://clinicaltrials.gov/study/NCT01973907 .

Purpose: This study evaluated the feasibility and initial health effects on functional, physical, and psychosocial outcomes of a community-based, 12-week high-intensity functional training (HIFT) intervention for adults with mobility disabilities.

Design and sample: A single-group, pre-post design with assessments at baseline and post-intervention. Twelve participants (75% female; 37-74 years) with mobility disabilities.

Intervention: Twelve-week, thrice-weekly community-based HIFT program.

Measures: Feasibility was assessed via recruitment, retention, and adherence. The Canadian Occupational Performance Measure (COPM) evaluated self-report physical function, while physical health outcomes comprised fitness, strength, flexibility, and weight-related assessments. Psychosocial measures included quality of life (QOL), self-efficacy, and perceived barriers. Energy expenditure via portable indirect calorimetry and exit interviews captured participant experiences.

Analysis: Feasibility was reported as percentages; descriptive statistics and effect sizes were calculated for functional, physical, and psychosocial outcomes. Thematic analysis identified themes from transcriptions.

Results: Recruitment was 51%, retention was 83%, and attendance was 77.5%, with one adverse event. Cohen's d effect sizes indicated improvements in function (d = 0.93-1.04), fitness (d = 0.65-1.59), flexibility (d = 0.36-0.64), BMI (d = 0.32), QOL (d = 1.04), self-efficacy (d = 1.03), and barriers to health behavior (d = 0.48). Participants reported high satisfaction and community support following the intervention. Energy expenditure averaged 154.65 (65.5) kcals/session and 86.13 (42) kcals during exercise.

Conclusion: A community-based HIFT program for individuals with mobility disabilities is feasible; however, the small sample size limits the ability to attribute changes to the intervention.

Clinicaltrials: GOV: HIFT for People with Mobility-Related Disabilities (Research GO); NCT05516030.

Background: When conventional oxygen therapies fail, endotracheal intubation and invasive mechanical ventilation are the current standard of care in patients with acute hypoxaemic respiratory failure. However, invasive mechanical ventilation is associated with increased hospital and intensive care length of stay, healthcare costs, and morbidity and mortality. Inhaled nitric oxide has the potential to treat hypoxaemia and potentially prevent the need for invasive mechanical ventilation.

Aims and objectives: The objective of this study is to examine the feasibility and effectiveness of high-flow oxygen and nitric oxide gas inhalation compared with high-flow oxygen alone in preventing invasive mechanical ventilation for patients with acute hypoxaemic respiratory failure.

Methods: In this pilot, randomised controlled feasibility study, 40 patients admitted to the intensive care unit with acute hypoxaemic respiratory failure will be randomised on a 1:1 ratio to receive one of two interventions: high-flow oxygen and nitric oxide gas inhalation (intervention) or high-flow oxygen alone (control) via high-flow nasal cannula. Feasibility, demographic, outcome, and safety data will be collected at several timepoints during participants' admission.

Discussion: This protocol outlines a structured method for investigating the effects of inhaled nitric oxide gas in preventing invasive mechanical ventilation for patients with acute hypoxaemic respiratory failure. Considering the risks, costs, and poorer outcomes associated with invasive mechanical ventilation, less invasive means of respiratory support warrant further investigation. The study will assist in planning a larger, multi-centre definitive trial.

Trial registration: This study is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622001411730. Registered 4th September 2022, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384881 .