Pilot and Feasibility Studies最新文献

{"title":"Strengthening Community Responses to Economic vulnerability (SeCuRE): a protocol of an HIV status-neutral pilot randomized clinical trial with transgender women of color in Detroit, Michigan.","authors":"Kristi Gamarel, Larissa Jennings Mayo-Wilson, Laura Jadwin-Cakmak, Lilianna Reyes, Dior' Monro, Ini-Abasi Ubong, Stephen Sullivan, Julisa Abad, Jeynce Poindexter, Harmony Harris, Chanel Riser, J Stephenson, Gabi Ortiz, Sarah M Peitzmeier, Torsten B Neilands, Tonia Poteat","doi":"10.1186/s40814-024-01558-5","DOIUrl":"10.1186/s40814-024-01558-5","url":null,"abstract":"<p><strong>Background: </strong>In the United States (US), transgender women of color experience cyclical, interlocking systems of structural and institutional oppression rooted in racism and transphobia, which fuel economic vulnerability. Together, cycles of intersecting racism, transphobia, and economic vulnerability create conditions that give rise to extreme HIV inequities among transgender women of color. Microeconomic interventions - designed to improve financial standing by increasing income generation and access to financial resources through entrepreneurship, cash transfers, and training - have the potential to address structural factors underlying HIV inequities. Over the past few years, several trans-led organizations, including the Trans Sistas of Color Project, have integrated microeconomic strategies, specifically emergency assistance, into their programming. The aim of the current study is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility and acceptability of a definitive subsequent RCT and explore initial evidence of an enhanced microeconomic intervention to increase income generation and improve HIV prevention and care continua outcomes.</p><p><strong>Methods: </strong>This is a two-arm waitlist randomized controlled trial in which transgender women of color will be randomly allocated to either usual care that includes the Trans Sistas of Color Project's existing microeconomic interventions, which includes the following: (1) US $250 in emergency assistance and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents) or the enhanced microeconomic intervention that includes usual care and will be enhanced to include the following: (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and HIV prevention and care, (2) employment-focused mentoring, and (3) an unconditional grant (US $1200) for use towards acquiring self-led or formal employment. Participants in each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. Participants will also complete qualitative exit interviews within 1 month of intervention completion for both conditions.</p><p><strong>Discussion: </strong>This study will be one of the first US-based pilot randomized clinical trials that builds upon existing community-led solutions to economic vulnerability to address HIV inequities. Findings will provide the necessary groundwork to examine intervention effectiveness in a future large-scale trial.</p><p><strong>Trials registration: </strong>NCT06212544.</p><p><strong>Protocol version: </strong>September 25, 2024, version 2.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"135"},"PeriodicalIF":1.5,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11545932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605977","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":"Feasibility of a custom-tailored, evidence-based, theory-informed, intervention to prevent burnout and reduce stress for healthcare professionals: protocol for a single-arm trial.","authors":"Marleen Schröter, Julia Berschick, Anna K Koch, Julia K Schiele, Martin Bogdanski, Melanie Steinmetz, Wiebke Stritter, Christian S Kessler, Georg Seifert","doi":"10.1186/s40814-024-01553-w","DOIUrl":"10.1186/s40814-024-01553-w","url":null,"abstract":"<p><strong>Background: </strong>Healthcare professionals face high levels of occupational stress, time pressure, workload, and poor organizational support. This makes them particularly vulnerable to burnout. The COVID-19 pandemic has further exacerbated this situation. This single-arm, multicenter, mixed-methods feasibility study pilots the LAGOM program: A tailored, evidence-based intervention to prevent burnout and reduce stress among healthcare professionals.</p><p><strong>Methods: </strong>Participants will include healthcare professionals (N = 30) working at Charité-Universitätsmedizin Berlin and Immanuel Hospital, Berlin. LAGOM focuses on support for individual behavior change and personal resources and also addresses the organizational level. The intervention´s feasibility will be evaluated through a non-randomized feasibility trial with a mixed methods process evaluation. The exploratory primary study aims are to assess the acceptability and feasibility of the (1) evaluation procedures and of the (2) intervention content and structure using study records, standardized questionnaires, protocol checklists, and diaries. Exploratory effectiveness analysis will take place as well. Further, semi-structured interviews (n = 3 to 6) and electrophysiological measurements (n = 20) will be conducted.</p><p><strong>Discussion: </strong>Custom-tailored, well-implemented multi-level interventions are needed to prevent burnout and reduce stress among healthcare professionals. Long-term strategies are warranted to sustainably implement effective programs. This feasibility study helps to refine trial procedures and content of the LAGOM program for a randomized controlled trial to evaluate the intervention's effectiveness.</p><p><strong>Trial registration: </strong>German Clinical Trials Register: DRKS00032014 , registered 17^th October 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"134"},"PeriodicalIF":1.5,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542239/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605974","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":"Magnetic resonance imaging-guided single-fraction preoperative radiotherapy for early-stage breast cancer (the RICE trial): feasibility study.","authors":"Ayyaz Qadir, Nabita Singh, Jenna Dean, Kerryn Brown, Mark Tacey, Bruce Mann, Tomas Kron, Glenn Cahoon, Eddie Lau, Andrew M Scott, Belinda Yeo, Su-Wen Loh, Sergio Uribe, Aung Aung Kywe Moe, Kerryn Ireland-Jenkins, Rosly McAuley, Leah McDermont, Wei Ming Ooi, Suat Ng, Michael Chao, Farshad Foroudi","doi":"10.1186/s40814-024-01557-6","DOIUrl":"10.1186/s40814-024-01557-6","url":null,"abstract":"<p><strong>Background: </strong>Over the past decade, the adoption of screening programs, digital mammography, and magnetic resonance imaging (MRI) has increased early-stage breast cancer diagnosis rates. Mortality rates have decreased due to early detection and improved treatments, including personalized therapies. Accelerated partial-breast irradiation (APBI) is emerging as a convenient and effective treatment for some patients, with studies exploring its preoperative use. Preoperative APBI, especially with MRI guidance, offers improved tumor targeting and potentially reduced side effects. Magnetic Resonance Imaging-Guided Single-Fraction Pre-Operative Radiotherapy for Early-Stage Breast Cancer (RICE trial) aims to assess the feasibility and efficacy of MRI-guided single-dose radiotherapy (RT) for early-stage breast cancer.</p><p><strong>Methods: </strong>The RICE study is a prospective, single-arm study evaluating single-fraction preoperative, APBI treatment for patients with early-stage breast cancer using a magnetic resonance imaging linear accelerator (MRI linac). Eligible patients enrolled in this study will have a core biopsy to confirm estrogen receptor-positive and HER2-negative sub-type. RT planning will use a planning computed tomography (CT) co-registered with a MRI with the patient in either the supine or prone position. For the diagnostic workup, [18F] fluorodeoxyglucose positron emission tomography/CT ([18F] FDG PET/CT) and [18F] fluoroestradiol positron emission tomography/CT ([18F] FES PET/CT) will be performed prior to treatment. Thirty patients will receive a single ablative RT dose of 21 Gray to the tumor. Pre-treatment and post-treatment MRI scans will be acquired at baseline and 5 weeks post-RT respectively. Breast-conserving surgery will be scheduled for 6 weeks after APBI treatment using the MRI linac. The primary study endpoint is the successful administration of a single fraction of preoperative breast RT under the guidance of an MRI linac. Secondary endpoints include evaluating the utility of MRI, [18F] FDG PET/CT, and [18F] FES PET/CT as a non-invasive method for assessing treatment response in patients undergoing single-fraction preoperative APBI.</p><p><strong>Conclusion: </strong>The RICE trial represents a significant step in breast cancer treatment, offering insights that could lead to treatment protocols with minimized RT appointments and enhanced patient outcomes.</p><p><strong>Trial registration: </strong>This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR). Registered 31st of May 2021.</p><p><strong>Registration number: </strong>ACTRN12621000659808 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"133"},"PeriodicalIF":1.5,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542258/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591461","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":"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}