Pilot and Feasibility Studies最新文献

{"title":"Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol.","authors":"Christine Kersting, Johannes Just, Alexandra Piotrowski, Alexandra Schmidt, Neele Kufeld, Rebecca Bisplinghoff, Michaela Maas, Veronika Bencheva, Jordan Preuß, Birgitt Wiese, Klaus Weckbecker, Achim Mortsiefer, Petra Thürmann","doi":"10.1186/s40814-024-01564-7","DOIUrl":"10.1186/s40814-024-01564-7","url":null,"abstract":"<p><strong>Background: </strong>Chronic non-cancer pain (CNCP) is a common condition worldwide. The disease burden is influenced not only by pain itself, but also by psychiatric co-morbidities, which aggravate symptoms, generally negatively influence therapies, and may thereby lead to frustration, resignation, or withdrawal. A growing body of evidence suggests that sex and gender aspects influence CNCP management as the experience of pain, the emotions associated with it, and the expression of pain may differ between women and men. In addition, doctor-patient communication is known to be influenced by gender stereotypes. Despite there being evidence on such differences, current guidelines do not consider sex- and gender-sensitive approaches. In order to examine how to adequately address the diversity of the experience and processing of pain in patients of differing sex and gender, the GESCO study aims at developing and pilot testing a sex- and gender-sensitive intervention for patients with CNCP receiving long-term opioid therapy (LTOT) in primary care.</p><p><strong>Methods: </strong>The development process is designed in accordance with the first two phases of the UK Medical Research Council. Phase I will iteratively explore, develop, and pilot the intervention's modules using literature searches, interviews, and workshops involving stakeholders and experts. Phase II will pilot-test the novel intervention in a sample of 40 patients with CNCP under LTOT from ten general practices using an effectiveness-implementation hybrid design including a mixed-methods process evaluation focusing on implementation strategy criteria and a single-arm, pre-post comparison to determine preliminary effects in preparation for a larger effectiveness trial. The intervention will combine in-person educational sessions for general practitioners and tools to be used in patient care.</p><p><strong>Discussion: </strong>The intervention aims to improve CNCP management in primary care by empowering practitioners to reflect on their attitudes towards pain and stereotypes. Besides sex and gender aspects, awareness of other factors that might affect the care process, such as age, social conditions, or culture, is also promoted. The intention is to develop a comprehensive care concept for CNCP that considers aspects relevant for sex- and gender-sensitive care which are transferrable to other health care fields as well.</p><p><strong>Trial registration: </strong>German Clinical Trial Register DRKS00029980.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"132"},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rationale and design of healthy at home for COPD: an integrated remote patient monitoring and virtual pulmonary rehabilitation pilot study.","authors":"Laurel O'Connor, Stephanie Behar, Seanan Tarrant, Pamela Stamegna, Caitlin Pretz, Biqi Wang, Brandon Savage, Thomas Thomas Scornavacca, Jeanne Shirshac, Tracey Wilkie, Michael Hyder, Adrian Zai, Shaun Toomey, Marie Mullen, Kimberly Fisher, Emil Tigas, Steven Wong, David D McManus, Eric Alper, Peter K Lindenauer, Eric Dickson, John Broach, Vik Kheterpal, Apurv Soni","doi":"10.1186/s40814-024-01560-x","DOIUrl":"10.1186/s40814-024-01560-x","url":null,"abstract":"<p><p>Chronic obstructive pulmonary disease (COPD) is a common, costly, and morbid condition. Pulmonary rehabilitation, close monitoring, and early intervention during acute exacerbations of symptoms represent a comprehensive approach to improve outcomes, but the optimal means of delivering these services is uncertain. Logistical, financial, and social barriers to providing healthcare through face-to-face encounters, paired with recent developments in technology, have stimulated interest in exploring alternative models of care. The Healthy at Home study seeks to determine the feasibility of a multimodal, digitally enhanced intervention provided to participants with COPD longitudinally over 6 months. This paper details the recruitment, methods, and analysis plan for the study, which is recruiting 100 participants in its pilot phase. Participants were provided with several integrated services including a smartwatch to track physiological data, a study app to track symptoms and study instruments, access to a mobile integrated health program for acute clinical needs, and a virtual comprehensive pulmonary support service. Participants shared physiologic, demographic, and symptom reports, electronic health records, and claims data with the study team, facilitating a better understanding of their symptoms and potential care needs longitudinally. The Healthy at Home study seeks to develop a comprehensive digital phenotype of COPD by tracking and responding to multiple indices of disease behavior and facilitating early and nuanced responses to changes in participants' health status. This study is registered at Clinicaltrials.gov (NCT06000696).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"131"},"PeriodicalIF":1.5,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11520050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142522672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The development and testing of a single-arm feasibility and acceptability study of a whole foods diet intervention for adults with prediabetes and their offspring.","authors":"Nadia M Sneed, Raegan Kelley, Haley Turner, Mariann R Piano, Chloe Dagostino, Ashley Sellers, Kemberlee Bonnet, David Schlundt, Laura E Adams, William J Heerman","doi":"10.1186/s40814-024-01554-9","DOIUrl":"10.1186/s40814-024-01554-9","url":null,"abstract":"<p><strong>Background: </strong>Diet is considered a first-line treatment option for prediabetes, a condition that affects 96 million United States (U.S.) adults. Diet patterns that prioritize whole foods (e.g., Mediterranean) are currently recommended to treat prediabetes. However, no studies have tested whether a U.S.-style diet pattern that prioritizes whole foods can be used to treat prediabetes. The purpose of this study was to assess the feasibility and acceptability of a whole foods diet for adults with prediabetes and their offspring prior to conducting a larger clinical trial.</p><p><strong>Methods: </strong>A 2-week single-arm pre-post experimental controlled-feeding intervention of a 2020-2025 Dietary Guidelines for Americans adapted whole foods diet (e.g., primarily focused on foods that have undergone limited processing or refinement) was conducted in adults (25-59 years) with prediabetes and their biological offspring (6-17 years). Families received 2 weeks of menus and grocery delivery and weekly counseling by a registered dietitian. Families were invited to attend an optional focus group session. Feasibility was based on having a ≥ 50% family completion rate with ≥ 80% completion of study outcomes. Measures included adult-child anthropometrics (weight [kg], body mass index [BMI] including BMI% and Z-scores for offspring, waist circumference [cm]) and child diet quality estimated using the 2015 Healthy Eating Index (HEI) from a single random food record. Wilcoxon signed rank was used to compare differences between baseline and 2-week anthropometrics measures and offspring total HEI scores. Qualitative data were analyzed using thematic analysis to understand factors attributed to diet adherence and acceptability.</p><p><strong>Results: </strong>Eight families enrolled (n = 8 adults, n = 12 offspring), with 7 families completing the study (12% attrition) and completing 100% of study outcome measures. Adults experienced a median weight loss of - 1.0 kg from baseline to 2 weeks (79.5 kg to 78.5 kg). Offspring had a 24-point increase in total 2015 HEI scores (median difference 50 to 74). Focus group participants (n = 4 adults) reported being satisfied with the program and expressed a willingness to continue the diet despite identified barriers.</p><p><strong>Conclusions: </strong>A whole foods diet that provides dietary support was found to be feasible and acceptable for families at risk for T2D. Future studies are needed to test the effects of the diet on prediabetes outcomes, diet quality, and diet adherence in adults and families.</p><p><strong>Trial registration: </strong>NCT05483972 at ClinicalTrials.gov. Registered July 25, 2022. https://clinicaltrials.gov/study/NCT05483972?cond=prediabetes&term=whole%20foods%20&rank=1.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"130"},"PeriodicalIF":1.5,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer navigation intervention for individuals with serious mental illness reentering the community after jail incarceration: a qualitative case study.","authors":"Maji Hailemariam, Lauren M Weinstock, Rodlescia S Sneed, Brandon Taylor, Patrick W Corrigan, Jennifer E Johnson","doi":"10.1186/s40814-024-01555-8","DOIUrl":"10.1186/s40814-024-01555-8","url":null,"abstract":"<p><strong>Background: </strong>Criminal legal system-involved individuals with serious mental illness (SMI) experience more challenges accessing mental health and other community services than those without a history of criminal legal system involvement. A formative qualitative study was conducted to explore feasibility and acceptability and inform the adaptation of a mental health peer navigation intervention for individuals with SMI reentering the community after jail incarceration.</p><p><strong>Methods: </strong>In-depth qualitative interviews and focus-group discussions were conducted with mental health peer navigators (i.e., certified mental health peer support specialists, peer recovery coaches) and individuals with lived experience of SMI and criminal legal system involvement (N = 20 total). Data were analyzed using applied thematic analysis.</p><p><strong>Results: </strong>Four major themes emerged: (1) Feasibility and acceptability of peer-provided services: all participants reported that peer navigation services would be feasible and acceptable for individuals with SMI reentering the community after jail incarceration; (2) roles of peer navigators in addressing barriers to care: peers can address barriers to care experienced during community reentry and contribute towards service linkage/engagement; (3) shared identity and combating stigma: having a shared identity with peer navigators may minimize the impact of stigma and make it easier for clients with multiple marginalized identities to seek support; and (4) peer navigator skills and recommendations for the planned program: essential peer navigation skills include authenticity, reliability, active listening, advocacy, trauma-informed care, motivational interviewing, and empathy. Recommendations for the planned program include initiating services while clients are in custody, emphasizing the voluntary nature of peer support, knowing the limits of a peer navigation intervention, and offering support for peer navigators while on the job.</p><p><strong>Conclusion: </strong>Participants saw peer navigation services for individuals with SMI with criminal legal system involvement as potentially feasible and acceptable. Such programs may enhance their impact by offering supportive supervision, emphasizing the voluntary nature of the service, and acknowledging recovery as a self-directed endeavor.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"129"},"PeriodicalIF":1.5,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11494813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exercise-based telerehabilitation for the management of chronic pain in people with severe haemophilia: a mixed-methods feasibility study.","authors":"Paul McLaughlin, Pratima Chowdary, Kate Khair, Clive Smith, David Stephensen, Michael Hurley","doi":"10.1186/s40814-024-01550-z","DOIUrl":"https://doi.org/10.1186/s40814-024-01550-z","url":null,"abstract":"<p><strong>Background: </strong>Chronic pain is reported by between 30 and 71% of people with haemophilia (PWH). Exercise is shown to be effective for pain management in other arthritides, but it remains unclear if such an approach is effective or acceptable to PWH. The aim of this study was to evaluate the feasibility and acceptability of a telerehabilitation exercise intervention for PWH living with chronic pain.</p><p><strong>Methods: </strong>This was a multisite, non-randomised, pre-post feasibility design, with a nested qualitative study. People with severe haemophilia > 18 years, living with chronic pain, were recruited. The intervention comprised 12 low-impact/moderate intensity, individualised exercise sessions and 3 knowledge-sharing and discussion sessions. Primary objectives assessed according to predefined progression criteria were as follows: (a) recruitment rate (5 participants enrolled per site over 8 weeks), (b) adherence (≥ 75% participants would adhere to ≥ 75% of sessions), (c) follow-up rate (≥ 75% completion of self-reported measures), (d) fidelity (intervention delivered as described in protocol) and (e) safety (≤ 30% participants would report adverse events). Acceptability was evaluated from thematic analysis of post-intervention participant interviews. Preliminary evaluation of self-reported pain, function and quality of life (QoL) was a secondary objective. Results were reported using descriptive statistics integrated with qualitative findings.</p><p><strong>Results: </strong>Ten PWH were recruited and completed the intervention. Nine agreed to be interviewed post intervention. Attendance at individual sessions was 84.5% compared to 52.1% for the group sessions. Outcome measures were successfully completed for 100% at baseline, 70% at intervention end and 60% at 3-month follow-up. No serious adverse events were recorded. Group median values in outcome measures (pain, function, QoL) showed minimal change post intervention. Participant interviews highlighted high levels of enjoyment, confidence in continuing exercises independently and positive views of virtual delivery and condition-specific exercise.</p><p><strong>Conclusions: </strong>Recruitment rate and safety met the predefined progression criteria. Fidelity partially met the progression criteria, but the follow-up rate for self-reported measures did not. The study was acceptable to both participants and physiotherapists. Further intervention development is needed to review approaches to outcome measure collection and refine the usefulness of the knowledge-sharing sessions.</p><p><strong>Trial registration: </strong>The study was prospectively registered on 9 July 2021: International Standard Randomised Controlled Trial Number ISRCTN 17454597.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"128"},"PeriodicalIF":1.5,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11460162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142392508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating an early social communication intervention for young children with Down syndrome (ASCEND): results from a feasibility randomised control trial.","authors":"Vesna Stojanovik, Emma Pagnamenta, Sarah Sampson, Rachel Sutton, Benjamin Jones, Victoria Joffe, Kate Harvey, Elena Pizzo, Sarah Rae","doi":"10.1186/s40814-024-01551-y","DOIUrl":"10.1186/s40814-024-01551-y","url":null,"abstract":"<p><strong>Background: </strong>This paper reports the results from a feasibility trial of an early parent-delivered social communication intervention for young children with Down syndrome ('ASCEND'). The intervention focuses on developing children's early social communication skills, in particular responding to shared attention. The aim was to inform the feasibility of running a full-scale trial through National Health Service (NHS) Speech and Language Therapy (SaLT) services, to assess whether the intervention is effective in improving language skills before children with Down syndrome start school.</p><p><strong>Methods: </strong>This was a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, comparing the intervention plus standard NHS SaLT provision with standard NHS SaLT alone. We recruited 20 children with Down syndrome aged between 11 and 36 months through 3 NHS SaLT services, 19 of whom were randomised (10 - intervention group, 9 -control group). Pre- and post-intervention and 6-month follow-up assessments included language, social communication skills, adaptive behaviour, quality of life (parents and children), parental anxiety and depression. The intervention was parent delivered with parents having access to SaLT services and the research team during the intervention. Data were collected on recruitment and retention, standard care, treatment fidelity, acceptability of the intervention by the parents and speech and language therapists, feasibility of collecting health economic measures and suitability of the primary outcome measure.</p><p><strong>Results: </strong>The sample was sufficient for a feasibility study. The intervention (manual, support, materials) was positively received by the participating parents. Speech and language therapists also evaluated the acceptability of the intervention positively. Treatment fidelity which was measured by completion of weekly parent diaries and two adherence phone call was acceptable as 100% of the parent diaries were returned, over 90% of the parental diaries were completed correctly and 100% of adherence phone calls were completed. Retention was acceptable at 84% overall. The preliminary health economic data suggest that this intervention will be low cost. The sample size calculation suggests that 290 participants would need to be recruited, with 228 having a complete data set, for a full RCT.</p><p><strong>Conclusion: </strong>Based on recruitment, retention and treatment fidelity, as well as the acceptability of the intervention to parents and speech and language therapists, a full-scale trial would be feasible in order to assess the effectiveness of the intervention.</p><p><strong>Trial registration: </strong>ISRCTN13902755, registered on 25th August 2020, http://www.isrctn.com/ISRCTN13902755.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"127"},"PeriodicalIF":1.5,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11453083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142378181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of early continuous positive airway pressure in the delivery room (DR-CPAP) on neonates < 1500 g in a low-resource setting: a protocol for a pilot feasibility and acceptability randomized controlled trial.","authors":"Kathy Burgoine, John M Ssenkusu, Alice Nakiyemba, Francis Okello, Agnes Napyo, Cornelia Hagmann, Judith Namuyonga, Adam Hewitt-Smith, Muduwa Martha, Kate Loe, Abongo Grace, Amorut Denis, Julius Wandabwa, Peter Olupot-Olupot","doi":"10.1186/s40814-024-01552-x","DOIUrl":"10.1186/s40814-024-01552-x","url":null,"abstract":"<p><strong>Background: </strong>Preterm birth is the leading cause of childhood mortality, and respiratory distress syndrome is the predominant cause of these deaths. Early continuous positive airway pressure is effective in high-resource settings, reducing the rate of continuous positive airway pressure failure, and the need for mechanical ventilation and surfactant. However, most deaths in preterm infants occur in low-resource settings without access to mechanical ventilation or surfactant. We hypothesize that in such settings, early continuous positive airway pressure will reduce the rate of failure and therefore preterm mortality.</p><p><strong>Methods: </strong>This is a mixed methods feasibility and acceptability, single-center pilot randomized control trial of early continuous positive airway pressure among infants with birthweight 800-1500 g. There are two parallel arms: (i) application of continuous positive airway pressure; with optional oxygen when indicated; applied in the delivery room within 15 min of birth; transitioning to bubble continuous positive airway pressure after admission to the neonatal unit if Downes Score ≥ 4 (intervention), (ii) supplementary oxygen at delivery when indicated; transitioning to bubble continuous positive airways pressure after admission to the neonatal unit if Downes Score ≥ 4 (control). A two-stage consent process (verbal consent during labor, followed by full written consent within 24 h of birth) and a low-cost third-party allocation process for randomization will be piloted. We will use focus group discussions and key informant interviews to explore the acceptability of the intervention, two-stage consent process, and trial design. We will interview healthcare workers, mothers, and caregivers of preterm infants. Feasibility will be assessed by the proportion of infants randomized within 15 min of delivery; the proportion of infants in the intervention arm receiving CPAP within 15 min of delivery; and the proportion of infants with primary and secondary outcomes measured successfully.</p><p><strong>Discussion: </strong>This pilot trial will enhance our understanding of methods and techniques that can enable emergency neonatal research to be carried out effectively, affordably, and acceptably in low-resource settings. This mixed-methods approach will allow a comprehensive exploration of parental and healthcare worker perceptions, experiences, and acceptance of the intervention and trial design.</p><p><strong>Trial registration: </strong>The study is registered on the Pan African Clinical Trials Registry (PACTR) PACTR202208462613789. Registered 08 August 2022.  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23888 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"126"},"PeriodicalIF":1.5,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11451038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CONTACT: a non-randomised feasibility study of bluetooth-enabled wearables for contact tracing in UK care homes during the COVID-19 pandemic.","authors":"Carl A Thompson, Thomas Willis, Amanda Farrin, Adam Gordon, Amrit Dafu-O'Reilly, Catherine Noakes, Kishwer Khaliq, Andrew Kemp, Tom Hall, Chris Bojke, Karen Spilsbury","doi":"10.1186/s40814-024-01549-6","DOIUrl":"10.1186/s40814-024-01549-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth-enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes, we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention prior to a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;CONTACT was a non-randomised mixed-method feasibility study over 2 months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents), field observation of care, and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data were thematically analysed using a framework approach and Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82% (n = 178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~ 50% were replaced. Staff lost fewer devices, just 6%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but unlikely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and were amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;CONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable - at least in the context of shifting COVID-19 pandemic demands. Future research should co-design interventions and studies with care homes, focusing on successful intervention implementation as well as technical effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial reg","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"125"},"PeriodicalIF":1.5,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11445870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142366163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a feasibility multi-centre randomised controlled trial of a pre-operative two-week very low-calorie diet to reduce steatosis prior to liver resection (RESOLVE).","authors":"Helen Neilens, Victoria Allgar, Lexy Sorrell, Jade Chynoweth, Matthew Bailey, Paigan Aspinall, Angela King, Tracey Parkin, Andrew MacCormick, Somaiah Aroori","doi":"10.1186/s40814-024-01544-x","DOIUrl":"10.1186/s40814-024-01544-x","url":null,"abstract":"<p><strong>Background: </strong>Hepatic steatosis (HS) increases morbidity and mortality associated with liver surgery (LS). Furthermore, patients with HS are more likely to require a blood transfusion, which is associated with worse short and long-term outcomes. Patients with HS requiring LS receive no specific dietary treatment or advice. A very low-calorie diet (VLCD) is commonly used before gallbladder and bariatric surgery to reduce liver volumes and associated intraoperative morbidity. These diets typically provide 800-1200 kcal/day over a 2-4-week period. Limited evidence suggests that a VLCD in patients with LS may result in better outcomes.</p><p><strong>Methods: </strong>This study aims to test the feasibility of delivering a multi-centre randomised clinical trial to compare a dietary intervention (VLCD plus motivational instructions) versus treatment as usual (TAU) in people with HS having LS. This study will provide high-quality data to estimate screening rates, recruitment, randomisation, retention, and intervention adherence. The study will also determine the definitive trial's most clinically relevant primary outcome. The study will also estimate resource use and costs associated with the delivery of the intervention. Seventy-two adults ≥ 18 who are scheduled to undergo elective LS and have a magnetic resonance imaging (MRI) identified HS will be recruited. Acceptability to the dietary intervention will be evaluated with food diaries and focus groups. Clinical and patient-reported outcomes will be collected at baseline, pre- and post-surgery, day of discharge, plus 30- and 90-day follow-up.</p><p><strong>Discussion: </strong>This feasibility study will provide data on the acceptability and feasibility of a dietary intervention for patients with HS having LS. The intervention has been developed based on scientific evidence from other clinical areas and patient experience; therefore, it is safe for this patient group. Patients with experience of LS and VLCDs have advised throughout the development of the study protocol. The findings will inform the design of a future definitive study.</p><p><strong>Trial registration: </strong>ISRCTN Number 19701345. Date registered: 20/03/2023. URL: https://www.isrctn.com/ISRCTN19701345 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"124"},"PeriodicalIF":1.5,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11441117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142352065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pilot study testing a new transition of care model from hospital to the community for Hispanic/Latino adults with diabetes to reduce emergency department visits and hospital re-admissions.","authors":"Lucy Marie Alice Esteve, Blanca Iris Padilla, Ariana Pichardo-Lowden, Isa Granados, Scott Carlson, Leonor Corsino","doi":"10.1186/s40814-024-01534-z","DOIUrl":"https://doi.org/10.1186/s40814-024-01534-z","url":null,"abstract":"<p><strong>Background: </strong>Hispanic/Latino populations have the second highest prevalence of diabetes (12.5%) among ethnic minority groups in the USA. They also have higher rates of uncontrolled diabetes and diabetes-related complications. Approximately 29% of diabetes care costs are attributed to inpatient hospital care. To reduce hospital length of stay and re-admission rates for diabetes, the American Diabetes Association (ADA) recommends a \"structured discharge plan tailored to the individual patient with diabetes.\" However, limited research exists on the feasibility and applicability of a transition of care model specifically tailored for the Hispanic/Latino population.</p><p><strong>Methods: </strong>We conducted a 2-year pilot study to develop a practical, patient-centered, and culturally competent transition of care (TOC) model for Hispanic/Latino adults with diabetes discharged from the hospital to the community. Feasibility outcomes included recruitment rates, questionnaire completion rates, adherence to a 30-day post-discharge phone call, and resource needs and utilization for study implementation. Participant-centered outcomes included 30-day post-discharge emergency department (ED) visits, 30-day post-discharge unplanned re-admissions, follow-up visits within 2 weeks of discharge, and patient satisfaction with the TOC model.</p><p><strong>Results: </strong>Twelve participants were enrolled over the study period, with weekly enrollment ranging from 0 to 4 participants. Participants' average age in years was 47 (± 11.6); the majority were male (85%), and 75% had type 2 diabetes. Recruitment involved the support of 4 bilingual staff. The estimated time to review the chart, approach participants, obtain informed consent, complete questionnaires, and provide discharge instructions was approximately 2.5 h. Of the 10 participants who completed the 30-day post-discharge phone call, none had ED visits or unplanned hospital re-admissions within 30 days post-discharge, and all had a follow-up with a medical provider within 2 weeks.</p><p><strong>Conclusions: </strong>Implementing a patient-centered and culturally competent TOC model for Hispanic/Latino adults with diabetes discharged from the hospital to the community is feasible when considering key resources for success. These include a bilingual team with dedicated and funded time, alignment with existing discharge process and integration into the Electronic Medical Record (EMR) systems.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"122"},"PeriodicalIF":1.5,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11438034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142352063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}