Diabetes mellitus is a surgical risk factor, yet perioperative diabetes management remains debated, with inconsistent guidelines and limited consideration on the implementation of "enhanced recovery after surgery" (ERAS) programs. A detailed prospective observational multicenter study was launched to investigate perioperative risk factors and outcomes in diabetic patients undergoing modern optimized hip and knee arthroplasty within an established ERAS program. This study reports on the feasibility of launching prospective detailed observational studies as part of daily clinical practice within a multicenter collaboration, focusing on data completeness and successful recruitment.The feasibility analysis was conducted from October 1, 2022, to January 31, 2024, across eight public arthroplasty centers in Denmark, in diabetic patients undergoing elective primary total hip (THA), total knee (TKA), or unicompartmental knee (UKA) arthroplasty. Prospective data collection included antihyperglycemic medication, preoperative HbA1c, data on perioperative diabetes management, length of stay (LOS), and readmission after surgery. The cohort comprised 1007 DM patients (37.6% (n = 379) THA, 44.5% (n = 448) TKA, 17.9% (n = 180) UKA) with a mean age of 70.7years (SD 8.8), and the median age was 71 (IQR 65-77); 48% were female and 19% were insulin-treated. Data on the type of preoperative antihyperglycemic medications was available in 100% of patients. LOS was registered in 100% of patients, and 90-day follow-up was completed in 99% of patients. Preoperative HbA1c assessment increased from 68% in February 2023 to 96% in January 2024. From March 1st, 2023, data on perioperative diabetes management was available for 98% of all patients, with a total completion variation between 94 and 96% across the included parameters. The study demonstrates the feasibility of a prospective multicenter setup for detailed data collection on diabetic patients undergoing ERAS hip or knee arthroplasty. The high compliance rates of key metrics (≥ 94%) support that data completeness and quality are sufficient to proceed with the main study to assess the impact of diabetes and its management on outcomes within an ERAS program in 2000 patients, since enrollment exceeded expectations. ClinicalTrials.gov. NCT05613439. Registered on 9 January 2022, https://clinicaltrials.gov/study/NCT05613439?id=NCT05613439&rank=1.

Problematic benzodiazepine use alongside opioids contributes to drug-related deaths among people who use drugs. Clinical management varies considerably. An intervention to address the root causes of benzodiazepine use with opioids has been developed, which included maintenance prescribing of diazepam with anxiety, sleep, and pain management, harm reduction, and safety conversations. This study tested the feasibility of recruiting and retaining people in the intervention to address 'street' benzodiazepine use. Outcome measures and economic evaluation data collection were piloted to determine the feasibility of a future trial. The study tested the intervention in three sites (Grampian, Lothian and Fife) with a target of 15 patients per site. Inclusion criteria were people who were stable on opioid agonist treatment (OAT) with ongoing street benzodiazepine use. The intervention duration was 4-6months depending on the site. Validated tools were used to monitor outcomes covering: anxiety (GAD-7), depression (PHQ-9), quality of life (EQ-5D-5L), substance use recovery (SURE), and cognitive function (ACE-III). 'Street' drug use was measured through oral fluid tests and self-report. Resource use data were collected from an NHS perspective using a bespoke questionnaire to inform a future economic evaluation. After revisions to the inclusion criteria, 39 people were recruited (9 women, 30 men), mean age: 42 yrs. Almost all had diagnosed anxiety (n = 38) and depression (n = 39,); sleep problems were common (n = 34), and over half had chronic pain (n = 21). Retention was 77% at final data collection at 4-6months (n = 30). There were indications of improvement in anxiety, depression, self-reported recovery, and quality of life. Cognitive function was stable. Self-reported 'street' benzodiazepine use reduced from 100% (n = 39) at baseline to 35% at follow-up (n = 10). The economic data indicated good completion of the resource use and quality of life questionnaires, but this was dependent on the participants attending clinic appointments. Recruitment was feasible, and there were signs of clinical improvements across anxiety, depression, quality of life, and recovery measures. Findings justify a randomised controlled trial of this intervention vs. standard care of a benzodiazepine tapering dose. However, accurate, objective measurement of current 'street' drug use is required. ISRCTN number: 95130898. Registered 23/10/2023-retrospectively registered; ethical approval: approved 29/10/2021, North of Scotland Ethics Committee, ref: 21/NS/0135.

Depersonalization-derealization disorder (DDD) is characterized by feelings of "unreality" about the self and/or external world. Cognitive Behavioral Therapy adapted for DDD (CBT-f-DDD) has been effective in published clinical audits. This study aimed to provide feasibility and acceptability data. An individually randomized design of CBT-f-DDD versus Treatment as Usual (TAU) was carried out with adult DDD participants from NHS Trusts in London. The CBT-f-DDD group received individual sessions over a 6-month period from CBTtherapists. Qualitative interviews were conducted with CBT-f-DDD participants and their clinicians. Eight feasibility objectives were evaluated (recruitment, retention, resources, representativeness, acceptability of study design and intervention, preliminary responses to intervention, and health economics). Thirty participants with DDD were recruited over 13months. Only 63% completed the final assessment, so retention needs improvement. Resources were acceptable. The sample was comparable to previous studies, although younger, with a shorter duration of DDD and lower mean DDD scores. In a post-study questionnaire, no aspect of the study or treatment was rated unacceptable; however, some areas need improvement. Qualitative interviews with participants and clinicians recorded positive responses to CBT-f-DDD. Those in the CBT arm had a mean decrease of 16.9 points (SD 43.6) on the Cambridge Depersonalization Scale versus a mean decrease of 5.5 points (SD = 25.0) for the TAU arm. Health economics analyses found that CBT-f-DDD saved £153 per person. Participants reported an additional 0.08 Quality-Adjusted Life Years at low cost. This study suggests that a subsequent RCT for CBT-f-DDD is feasible and represents the first step in the process of establishing evidence-based treatments for DDD. However, refinements to the current design and delivery were indicated for a future fully powered definitive RCT of CBT-f-DDD. ISRCTN, ISRCTN97686121. Retrospectively registered 5 January 2023: https://doi.org/10.1186/ISRCTN97686121.

Telehealth has been proven to be an effective means of delivering psychotherapy, yet there is a lack of evidence in Vietnam where access to psychotherapy is limited. We conducted a study to evaluate the feasibility, acceptability, and preliminary efficacy of Tele-SSM-a mobile health-supported self-management intervention for depression in Vietnam. This was a pre-post, mixed-methods study. Adults aged between 18 and 64 years old with symptoms of depression were recruited and participated in 10 individual weekly sessions delivered remotely by mental health para-professionals. Feasibility was assessed by recruitment capacity, retention, and participant compliance; acceptability by participant satisfaction ratings and in-depth interviews; and preliminary efficacy by changes in depression, anxiety, stress, suicidal ideation, self-esteem, and perceived social support scores from baseline to endline. Seventy-five adults with depression were enrolled and 58 of those completed the intervention. Feasibility was adequate as recruitment, retention, and compliance all exceeded the predefined progression criteria. Recruitment reached 93.75% (progression criterion of ≥70%), retention was 77% (progression criterion of ≥75%), and compliance was high, with 93.1% of participants completing the intervention within the expected number of sessions (progression criterion of ≥80%). The intervention was well-accepted by participants with 96% of participants reporting satisfaction with the materials and coaching sessions. The average number of coaching calls required to deliver 10 sessions was 10.81, suggesting that the intervention may need to be implemented over 11 calls. Additional emphasis should be placed on realistic thinking and non-violent communications skills as participants reported more difficulties with these components. Exploratory pre-post analyses suggested potential improvements across depression, anxiety, stress, suicidal ideation, self-esteem, and perceived social support; however, these findings should be interpreted cautiously given that the study was not powered to assess efficacy. These results provide promising evidence for the adequate feasibility, acceptability and preliminary efficacy of Tele-SSM on depression. The intervention also has the potential to address anxiety and stress. These preliminary insights can inform the design of a future randomized hybrid effectiveness-implementation study, particularly with regard to recruitment, retention, adherence, and potential outcome trends. Clinicaltrials.gov, NCT06456775. Registered June 13, 2024 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06456775?cond=depression&intr=Tele-SSM&rank=1.

Mental health in university students is a growing concern worldwide. In Chile, previous studies have shown high rates of depressive symptoms, anxiety, and suicidal risk in this population. This study seeks to evaluate the acceptability and feasibility of a Cognitive Behavioral Therapy (CBT)-based intervention for the indicated prevention of suicidality in undergraduate students and to explore its impact on reducing suicidal ideation. A quasi-experimental before-and-after design will be used with a sample of students from a private university who present mild to moderate suicidal risk. As this is a pilot study, a sample size calculation is not required; however, we expect to recruit 18 participants, which will enable us to conduct acceptability and feasibility assessments and collect data for a larger-scale study. A follow-up will consist of repeating the initial assessment questionnaire, which will be completed 2 and 4 months after the intervention. The methodology includes an initial interview to assess inclusion and exclusion criteria, signing informed consent, and developing a safety plan with the students. Following this, six weekly sessions (three in-person and three with digital components) of 60min each will be held, focusing on emotional regulation, cognitive restructuring, and problem-solving. Trained psychologists will facilitate the intervention under the supervision of a trained psychologist or psychiatrist. To assess acceptability and satisfaction, the Client Satisfaction Questionnaire (CSQ-8) will be primarily used. To assess secondary outcomes, validated instruments will be applied, such as the Columbia Suicide Risk Scale (C-SSRS), the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, the Generalized Anxiety Disorder 7 (GAD-7) for anxiety symptoms, the Short Form-12 Health Survey (SF-12) for quality of life, the Distress Tolerance Scale (DTS) for stress tolerance, the Community Assessment of Psychic Experiences-Positive (CAPE-P15) for psychotic symptoms, the Difficulties in Emotion Regulation Scale (DERS-E) for emotional regulation, the Social Problem-Solving Inventory-Revised (SPSI-R) for problem-solving, and the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) for cognitive-behavioral skills. Reduction in suicidal ideation, satisfaction with the intervention, and program adherence will be measured. The study aims to determine whether the proposed prevention program, along with the accompanying assessments and procedures, is appropriate and feasible in a university setting. This will allow progress toward a larger randomized controlled trial. Furthermore, it is expected that students in the intervention group will experience a reduction in suicidal ideation. Clinical Trials NCT07001202, June 2nd, 2025. [https://www. gov/study/ NCT07001202].

Older adults can have limited knowledge about their specific needs for protein and energy and the importance of nutrition for physical functioning after hospital discharge. This study aimed to examine the feasibility of recruitment, technology access, and data collection procedures in an educational video aimed at improving the nutritional status of live-at-home older adults after discharge from a surgical hospital department. This seven-month single-centre, two-arm feasibility trial was conducted in a rural area in northern Norway from May 2022 to January 2023. The participants were live-at-home older adults 65years of age or older, who were recruited from three surgical departments in a non-university hospital. The participants were randomised using a free web service. The intervention group received access to a six-minute nutrition education video focusing on energy and protein-rich diets for malnourished older adults. The control group did not receive any intervention. Data were collected on the study feasibility recruitment rate (goal: 5 people every 2weeks over 28weeks), retention rate (goal: 82%), and access to the video (goal: 90%) as well as the feasibility of-collecting data on the participants' nutritional knowledge, body mass index, mid-arm circumference, triceps skinfold thickness, mid-arm muscle circumference, and hand grip strength. Forty-four participants were randomised to the intervention group (n = 24) or the control group (n = 20). The recruitment rate was, on average, 3patients every 2weeks. The overall retention rate was 68%, respectively 71% (17), in the intervention group and 65% (13) in the control group. Collecting the desired data was feasible with specific muscle strength and fat mass adjustments. No adverse events related to participation in the study were observed. Delivery of the education video was feasible. However, the study revealed methodological challenges with recruitment and access to the video that must be addressed before a full-scale trial. The results indicate that nutrition education videos can be a good source of knowledge and contribute to a better nutritional situation for older malnourished adults. Still, it is necessary to conduct a full-scale trial in the future to conclude whether, or not, the nutrition education video's is effective. This study was retrospectively registered in ClinicalTrials.gov ID NCT05860140.

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

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. 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. In Study 1, five competitive youth ice hockey teams (mean age = 13.0years) 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 = 14.7years) 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. Overall, the initial feasibility evidence and the proof-of-concept evaluation support the further development of T4Us, including a randomized-controlled T4Us protocol.

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. To assess the feasibility of study procedures and provide descriptive data to guide a large multicentre study for developing a BPD-prediction model. This was a single-centre feasibility observational cohort study conducted at a neonatal intensive care unit. Forty preterm infants born before 32weeks of gestation were recruited within 18months. 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. Seventy-seven preterm infants were screened for eligibility between June 2022 and May 2023. The target of 40 preterm infants was achieved within 11months. All infants had the first echo scan performed, whereas 39 (97%) had a second one performed. Majority had their echo scans performed within 24h 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 30weeks) and lower birth weight (median 1370 vs 763g). 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). Our findings demonstrate that a large multicentre study is feasible and will inform the construction of a BPD-prediction model. NCT05235399.

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. 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 2-17years 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. 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. Caregivers (n = 91; 100% female; 77% Black) and pediatricians (n = 37) were enrolled within 10months. 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". 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. ClinicalTrials.gov, NCT06593028. Retrospectively registered on September 11, 2024, https://clinicaltrials.gov/study/NCT06593028.