Pilot and Feasibility Studies最新文献

Background: Postpartum weight retention and maternal obesity are associated with short- and long-term maternal morbidity and mortality risk. Most weight-loss interventions among postpartum individuals follow evidence-based lifestyle recommendations but have produced only modest effects and have had substantial heterogeneity. We developed a novel internet-assisted weight management intervention for postpartum people that integrates concepts for improving sleep health within a diet and physical activity-focused intervention. We describe the intervention protocol and discuss how the pilot study's findings will inform future development and evaluation.

Methods: We will recruit 40 postpartum individuals with overweight or obesity from Western Pennsylvania to participate in a single-blind, parallel-arm, randomized controlled trial design. Participants will be randomized at a 1:1 ratio to the Sleep GOALS (Goal-focused Online Access to Lifestyle Support) intervention or education control group. The Sleep GOALS intervention includes interactive lessons addressing sleep, diet, physical activity, behavioral self-monitoring tools, and a lifestyle coach to provide accountability, encouragement, and personalized support. The education control group will receive brochures from the American Academy of Sleep Medicine (e.g., sleep hygiene, sleep in women), SNAP education connection (e.g., family-friendly activities, meal planning), and the U.S. Department of Health and Human Services (e.g., physical activity promotion during and after pregnancy). Primary study outcomes include the intervention feasibility (i.e., recruitment, enrollment, attrition rates, intervention engagement) and acceptability (i.e., participant ratings of the intervention delivery, curricula, approach to behavioral self-monitoring, action plans, intervention platform, and coaching). Secondary outcomes include weight loss and retention of pregnancy and postpartum weight gain.

Discussion: Incorporating a holistic approach that addresses sleep health alongside diet and physical activity, the Sleep GOALS intervention aims to not only facilitate weight loss but also enhance overall maternal well-being. Pilot testing will help us identify and refine factors related to the conduct of the planned larger, definitive trial and estimate the change in secondary outcomes.

Trial registration: NCT05942326.

Background: Healthcare provider burnout is pervasive, imparts harm to providers and patients, increases healthcare and workforce disparities, and exacerbates physician and nursing shortages. Although burnout is primarily caused by organizational stressors, supportive and cooperative interdisciplinary teams foster psychological safety and are protective against burnout. To address the critical and unmet need for evidence-based, acceptable, and scalable interventions to improve burnout, this study will evaluate the feasibility and acceptability of the Compassion-Centered Spiritual Health Team Intervention (CCSH-TI), a novel team-based intervention delivered by healthcare chaplains embedded within the interprofessional team. Using CCSH-TI, chaplains teach mindfulness and compassion-based approaches designed to bolster compassion for self and others and to improve psychological safety and team civility.

Methods: This study will utilize a phase 1 clustered randomized, "standard of care" (SOC) controlled, and mixed-method design to examine the feasibility and acceptability of CCSH-TI. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at a National Cancer Institute-Designated Comprehensive Cancer Center will be randomized by team to CCSH-TI or to SOC. We will evaluate CCSH-TI feasibility (accrual, retention, CCSH-TI attendance) and acceptability (satisfaction, credibility, perceived benefit). Focus groups will identify contextual determinants of feasibility, acceptability, and implementation success. Prior to and after the intervention, as well as at 12-week follow-up, we will conduct 3-day ambulatory assessments: (1) ecological momentary assessments (EMA) of social connection, incivility, and burnout and (2) electronically activated recorder (EAR), a naturalistic observation method that samples ambient sound from participants' momentary environments used widely outside healthcare settings. We will develop and validate EAR behavioral codebooks tailored to the healthcare environment to quantify behavioral indices of psychological safety, incivility, and interprofessional teamwork.

Discussion: This study will provide data on the acceptability and feasibility of a chaplain-delivered team intervention for interprofessional healthcare teams working in oncology. The findings will inform the design of a future study to examine this innovative and scalable approach to increase access, equity, and inclusion of burnout prevention and mitigation among all healthcare providers. Additionally, this work will improve the scientific rigor of research on burnout by developing a novel, objective, and low-burden assessment toolkit. Name of the registry CCSH (Compassion-Centered Spiritual Health) for Teams Trial registration number NCT06722027 Date of registration December 9, 2024 URL of trial registry record https://clinicaltrials.gov/search?term=NCT06722027.

Background: Many adults living with sickle cell disease (SCD) suffer from chronic pain, turning to cannabis for relief. However, there are few studies that examine the efficacy of cannabis in treating pain associated with SCD. Prior to an efficacy study, a feasibility study is necessary to evaluate if such a study would be acceptable to patients, including those who use cannabis; if participants would be able to abstain from other cannabinoid-containing substances during the study; if masking would be feasible; and if dronabinol would prove safe.

Methods: We approached outpatients with SCD of any genotype at healthy baseline and asked about interest in such a study. If eligible enrolled participants received dronabinol or placebo for two, 2-week periods. Feasibility outcomes were acceptability (patient interest and enrollment rates), protocol adherence (completion of stud procedures), cannabinoid avoidance, and masking effectiveness. Patient-reported outcomes (PRO), laboratory markers of inflammation, and urine tests for the presence of cannabinoids were collected after each exposure period.

Results: A total of 27 patients were approached; 23 (85%) were interested, 13 (48%) signed consents, and 6 (22%) were enrolled so the study was determined to be acceptable. Patients who used unregulated cannabis and medical cannabis also found the study acceptable. All enrolled participants successfully completed all study procedures. Urine testing revealed no cannabinoid use except for study drug, so the study was determined to be feasible. While 4 out of 6 (67%) participants correctly identified their exposure assignment after the first study period, all 6 (100%) identified the exposure assignment after the second treatment period, so masking after the second period was not feasible. No serious adverse events were attributed to dronabinol.

Conclusion: In conclusion, a controlled study of dronabinol is acceptable, feasible, and safe to participants. However, a crossover design compromises participant masking. A larger, longer, controlled efficacy study without the crossover component is now being performed (NCT05519111). Trial registration NCT03978156. Date of registration: 07/26/2019.

Background: Greater time spent sedentary, particularly when accumulated in long, uninterrupted bouts, is associated with poorer cardiometabolic health and an increased risk of disease incidence and mortality. Experimental studies have indicated that regularly interrupting sedentary time during the day, and more recently, in the evening, with acute (2-5 min) bouts of activity improves postprandial metabolism in a range of adult populations. The effects of interrupting evening sitting time have yet to be explored in a free-living setting. Drawing on the Behaviour Change Wheel and participant-identified barriers and facilitators, the regular activity breaks (RAB) intervention was designed to support participants in interrupting evening prolonged sitting. This pilot and feasibility study will explore the feasibility of this intervention and its effects on 24-h movement patterns, glycemic control, and blood pressure. Results from this study will inform the development of a future effectiveness trial.

Methods: This 4-week, single-group intervention trial consists of a baseline, a 2-week intervention, and a 2-week follow-up period. A total of 20 adults, ≥ 18 years who self-report habitually sitting for at least 3 h in the evening, have a smartphone, and can ambulate unaided will be recruited to participate. The RAB intervention aims to support participants to regularly (~ every 30 min) perform short bouts (2-3 min) of activity during periods of prolonged sitting in the evening. The intervention components include (1) a structured consultation with the study coach where behaviour change techniques will be used to create an individualised plan for performing activity breaks in the evening; (2) provision of a mobile application to provide scheduled reminders and activity break videos; and (3) follow-up support in the form of phone calls performed on days 3 and 7. Feasibility will be assessed by meeting recruitment and retention targets; the acceptability of the intervention will be assessed via semi-structured interviews. Pilot outcomes include the number of activity breaks performed, impact on 24-h movement patterns (sleep duration and quality, sedentary time, and physical activity), blood pressure, interstitial glycemic response, mobile application engagement and capability, and opportunity and motivation to change evening sitting behaviour.

Discussion: Should the RAB intervention meet the criteria to be deemed feasible and acceptable, this will provide justification and information for its use in a large-scale effectiveness trial.

Trial registration: This study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR 12624000371594). Registered March 28, 2024.

Background: Stroke rehabilitation is essential, yet many stroke survivors receive insufficient therapy, particularly for arm function. The 2023 UK National Stroke Guidelines recommend ongoing rehabilitation, but resource constraints limit therapy intensity. Digital interventions, such as OnTrack-a wearable system co-designed with stroke survivors, carers and therapists-offer a scalable self-management solution for rehabilitation. This study evaluates the feasibility of implementing OnTrack within NHS stroke services and informs a future RCT.

Methods: A two-arm, parallel-group randomised feasibility trial conducted across three NHS sites. Stroke survivors (n = 30) with arm weakness within 12 months post-stroke were randomised 1:1 to receive either OnTrack plus usual care or usual care alone. The primary outcome was the recruitment rate. Secondary feasibility outcomes included retention, adherence, and intervention fidelity. Secondary clinical measures assessed arm function (MAL-14), self-efficacy (SSEQ), quality of life (EQ-5D-5L), and usability (SUS). A process evaluation explored intervention fidelity and implementation experiences. A preliminary economic evaluation examined data collection feasibility using the Client Service Receipt Inventory (CSRI) and a per-patient costing of the OnTrack intervention.

Results: Thirty participants out of a target of 42 (71.4%) were randomised, with 24/30 (80%) retained at 12 weeks. Intervention adherence was high with participants engaging with OnTrack an average of 6.3 days per week (90.7%). Fidelity of intervention delivery was modest (53.9%), highlighting areas for therapist training improvements. Trends suggested improvements in arm function and self-efficacy across groups. The preliminary economic evaluation confirmed the feasibility of data collection using CSRI, though limitations in accuracy and completeness were identified. A per-patient costing of the OnTrack intervention was achieved. Apparent cost differences between groups, identified through a preliminary cost-consequence analysis, were influenced by an unbalanced distribution of reported service use and should be interpreted with caution.

Conclusions: UPBEAT demonstrated the feasibility of delivering OnTrack in NHS stroke services, with strong retention and adherence. Findings support the potential for a future full-scale RCT, with refinements needed in recruitment procedures, therapist training, and economic data collection methods. Digital self-management tools like OnTrack may offer a scalable approach to increasing rehabilitation intensity, addressing gaps in stroke recovery pathways.

Trial registration: UPBEAT Feasibility Trial, IRAS: 323576, CPMS: 59352. Approved by London Surrey REC on 14/12/2023.

Background: Early weight bearing is frequently allowed and encouraged following fixation of hip and femoral and tibial shaft fractures, while pelvis, acetabulum, and lower extremity periarticular fractures are often prescribed 6-12 weeks of restricted weight bearing. Our objective was to perform a feasibility randomized trial of immediate versus delayed weight bearing as tolerated (WBAT) for fractures of the pelvis, acetabulum, distal femur, and proximal and distal tibia.

Methods: A parallel two-arm pilot feasibility trial was performed at one academic level I trauma center in the United States. Patients with a fracture of the pelvis, acetabulum, distal femur, proximal tibia, or distal tibia were eligible. Patients were randomized to either immediate WBAT or delayed (≥ 6 weeks) weight bearing after surgery. Our feasibility criteria included the following: (1) 25% overall enrollment (surgeon and patient agreement to participate in 50% eligible cases), (2) > 90% follow-up at 3 months), (3) 100% correct documentation of weight bearing status, and (4) 100% correct documentation of secondary outcome (reoperation).

Results: Surgeons allowed inclusion of 64/133 (48.1%) of eligible patients (by fracture type, 76% of pelvis; 43% of acetabulum; 38% of distal femur; 45% of proximal tibia (39% of tibial plateau); and 56% of distal tibia fractures). 50/64 (78%) of these patients agreed to participate in the study, for an overall enrollment of 38% (50/133). The follow-up rate was 46/50 (92%) at the 3-month follow-up. Correct documentation of postoperative weight bearing status and the secondary outcome of reoperation was achieved in all cases 50/50 (100%). There were two reoperations (one hardware failure and one wound infection) in the immediate WBAT group, and none in the delayed weight bearing group.

Conclusion: All four of the feasibility criteria were met. While we did not meet our target of 50% of patients whom surgeons were willing to randomize, we did exceed the target of 25% overall patient enrollment. This feasibility trial demonstrates that a randomized controlled trial of early versus delayed weight bearing would be feasible for certain fracture types, and these findings will be used to help design future studies in this realm.

Trial registration: ClinicalTrials.gov identifier: NCT05595148.

Background: Older Chinese adults in the UK are more likely to be physically inactive and face unique cultural and socioeconomic barriers to physical activity (PA) compared with the general population, yet they lack tailored interventions. Using findings from an evidence review and qualitative interviews, and guided by the Behaviour Change Wheel framework, we developed a culturally appropriate PA promotion package to enhance the capability, opportunity, and motivation of older Chinese adults in the UK to engage in PA.

Aim: This study aims to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) of culturally appropriate PA promotion strategies among older Chinese adults in the UK.

Methods/design: This is a two-arm pragmatic feasibility RCT. Community-dwelling individuals who self-identify as Chinese, reside in the UK, are aged 60 years and older, and do not meet the World Health Organization (WHO) PA recommendations (i.e. < 150 min moderate PA or balance/strength exercise < 2 times per week) will be recruited. Participants will be randomised to receive either the culturally appropriate PA promotion strategy package or the WHO PA recommendation leaflet. Outcome data will be collected at baseline, 12 weeks, and 18 weeks post-randomisation. Primary outcomes will include feasibility measures (e.g. recruitment, compliance, adherence, and follow-up rates), intervention acceptability (qualitative interviews), and both subjective PA levels (PA Scale for the Elderly) and objective PA levels (Realalt 3DTriSport 3D Pedometer). Secondary outcomes will include the Brief COM-B (Capability, Opportunity, Motivation-Behaviour) questionnaire, physical function assessments (Short Physical Performance Battery, SPPB), and quality of life (Control, Autonomy, Self-realisation, and Pleasure-12,CASP-12). The feasibility of the study will be evaluated based on the pre-specified progression criteria.

Discussion: This is the first study to assess the feasibility and acceptability of conducting an RCT of a culturally appropriate PA promotion strategy package among older Chinese adults in the UK. The findings from this study will inform improvements in PA promotion strategies and guide the development of a full-scale RCT, with the ultimate goal of creating culturally appropriate, sustainable interventions to improve the health and well-being of older Chinese adults in the UK.

Trial registration: The study protocol was registered on the Open Science Framework on 19 November 2024 ( https://doi.org/10.17605/OSF.IO/XQHJS ).

Background: The UK government 'Everyone In' initiative in response to COVID-19 in England saw an unprecedented number of individuals experiencing homelessness moved into temporary accommodation (TA). A limited supply of settled housing meant swift access to settled accommodation (SA) would not be possible for all. This pilot RCT pursued a unique opportunity to examine the feasibility and acceptability of randomising people experiencing homelessness (PEH) to SA or TA and the impact on COVID-19 infection and housing instability.

Methods: A pilot RCT, with embedded process and health economic evaluations. 1:1 participant randomisation to SA (intervention group) or TA (control group). Recruitment in two local authorities (LA) in England. Participants were aged 18 and over, in single-person homeless households, temporarily accommodated by the LA with recourse to public funds.

Primary outcomes: (i) LA recruitment; (ii) Participant recruitment; (iii) participant retention; (iv) LA adherence.

Secondary outcomes: (i) completeness of data collection at 3 and 6 months; (ii) data linkage: percentage of participants consenting to data linkage and successful match rate.

Results: Of 144 LAs approached, 26 showed interest in participating, two entered the trial. LA hesitancy to participate reflects an unease with trials in services where RCTs are rare. These recruitment challenges resulted in an amendment from full-scale effectiveness RCT to pilot RCT design. Fifty PEH were recruited (29% from 175 approached). Fifty-six percent of participants were retained at 6 months. Fifty percent of randomisation allocations were adhered to by LAs, identifying difficulties in LA systems not amenable to randomisation and a lack of support for randomisation amongst front-line staff. Frontline workers felt strongly that allocations should be based on their judgement. There was a high level of outcome measure completion. All participants consented to sharing identifiers for linkage to health and other data. A match rate with NHS Digital was sought but could not be reported due to procedural challenges.

Conclusions: Whilst not recommended to proceed to a full-scale RCT in its current design, considerable uncertainties remain about the effectiveness and cost effectiveness of different housing interventions on health outcomes, COVID-19 infection and housing stability for PEH.

Trial registration: ISRCTN69564614 . Registered on December 16, 2020.