Pilot and Feasibility Studies最新文献

{"title":"Breaking barriers: shaping global health futures with pilot and feasibility initiative.","authors":"Ambreen Nizar, Magdalena Janus","doi":"10.1186/s40814-024-01522-3","DOIUrl":"10.1186/s40814-024-01522-3","url":null,"abstract":"<p><p>In the dynamic landscape of global health, the journey from a new development to its implementation is often fraught with challenges. Yet, it is within the crucible of these challenges that ingenuity flourishes and barriers are transcended. It is with great anticipation and enthusiasm that we introduce our special series, \"Breaking barriers: shaping global health futures with pilot and feasibility initiatives.\" This series will delve into the evidence surrounding the challenges of conducting health-related studies across diverse regions of the world.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"97"},"PeriodicalIF":1.5,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11221009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141498684","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":"App-based telerehabilitation program for older adults on waiting list for physiotherapy after hospital discharge: a feasibility pragmatic randomized trial.","authors":"Pollyana Ruggio Tristão Borges, Rosana Ferreira Sampaio, Jane Fonseca Dias, Marisa Cotta Mancini, Juliana Melo Ocarino, Renan Alves Resende","doi":"10.1186/s40814-024-01521-4","DOIUrl":"10.1186/s40814-024-01521-4","url":null,"abstract":"<p><strong>Background: </strong>Inactivity while waiting for outpatient physiotherapy worsens the physical deconditioning of older adults after hospital discharge. Exercise programs can minimize the progression of deconditioning. In developing countries, telerehabilitation for older adults on the waiting list is still in the early stages. This study aimed to evaluate the feasibility of the study procedures of a telerehabilitation program for older adults waiting for outpatient physiotherapy after hospital discharge.</p><p><strong>Methods: </strong>This pragmatic randomized controlled trial recruited older adults (≥ 60 years) with several clinical diagnoses on the waiting list for outpatient physiotherapy in the Brazilian public health system after hospital discharge. The telerehabilitation group (n = 17) received a personalized program of multicomponent remote exercises using a smartphone app. The control group (n = 17) followed the usual waiting list. We assessed recruitment and dropout rates, safety, adherence, and satisfaction. The preliminary effects were verified on clinical outcomes.</p><p><strong>Results: </strong>We recruited 5.6 older adults monthly; dropouts were 12%. No serious adverse events were associated with the telerehabilitation program. The weekly adherence was 2.85 (1.43) days, and in 63.3% of the weeks the participants were enrolled, they performed the exercise program at least twice a week. Participants rated the telerehabilitation program as 9.71 (0.21), and the safety of remote exercises without professional supervision as 8.6 (2.2) on a 0-10 scale.</p><p><strong>Conclusions: </strong>The telerehabilitation program using a smartphone app was safe and presented high participants' satisfaction and adequate adherence, recruitment, and dropout rates. Therefore, the definitive study can be conducted with few modifications.</p><p><strong>Trial registration: </strong>Brazilian Registry of Clinical Trials (ReBEC), RBR-9243v7. Registered on 24 August 2020. https://ensaiosclinicos.gov.br/rg/RBR-9243v7 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"98"},"PeriodicalIF":1.5,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11221181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141498683","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 Helping Hand in Ukraine: feasibility and potential impact.","authors":"Solfrid Raknes, Tetiana Chorna","doi":"10.1186/s40814-024-01520-5","DOIUrl":"10.1186/s40814-024-01520-5","url":null,"abstract":"<p><strong>Background: </strong>New services are needed to prevent the mental health consequences of the war in Ukraine. Ten adolescents self-recruited to use and evaluate the Ukrainian version of the Helping Hand (HH) in Odesa, Ukraine. From April to June 2023, they participated in a 10-session group program where they played the cognitive behavioral game app, shared stories, and engaged in activities to enhance their coping skills.</p><p><strong>Methods: </strong>A mixed-method, quantitative-qualitative design was used to get insight into the feasibility and potential impact of the HH on Ukrainian adolescents' mental health and well-being during the war. A questionnaire to the adolescents assessed the feasibility of the intervention; anxiety and depression symptoms were assessed before and after the intervention by a standardized and validated adolescent-completed questionnaire. An interview with the psychologist who implemented the intervention was used to interpret the data completed by the adolescents.</p><p><strong>Results: </strong>Eight of 10 adolescents completed the HH intervention, and the psychologist found the HH helpful and culturally appropriate. The average anxiety and depression symptoms decreased from before the intervention (M = 20.4) to after (M = 15.0), showing a moderate effect size.</p><p><strong>Conclusion: </strong>The results indicated that the HH has a high potential to prevent mental health consequences in Ukraine.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"96"},"PeriodicalIF":1.5,"publicationDate":"2024-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11218384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477220","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":"Silver diamine fluoride for the management of dental caries in children in primary dental care: protocol for a feasibility study.","authors":"Laura Timms, Helen Rodd, Chris Deery, Paul Brocklehurst, Zoe Marshman","doi":"10.1186/s40814-024-01519-y","DOIUrl":"10.1186/s40814-024-01519-y","url":null,"abstract":"<p><strong>Background: </strong>Dental caries remains a significant problem in England, affecting 11% of 3-year-olds and 23% of 5-year-olds. While current approaches have been extensively investigated, their ability to (1) control pain and infection; (2) prevent hospital admissions, and (3) be implemented within the National Health Service (NHS) contractual arrangements, remains unsatisfactory. Silver diamine fluoride (SDF) is an alternative, non-invasive approach that has proven efficacy in arresting caries progression in primary teeth, principally from studies conducted outside of Europe. Its use in primary dental care in the UK is limited, despite the acknowledged need. The clinical and cost-effectiveness of SDF has not been compared to usual care in the UK. Before a pragmatic randomised controlled trial (RCT) can be conducted to compare SDF to usual care for caries management in young children, there are several uncertainties that require investigation. This study aims to establish whether such an RCT is feasible.</p><p><strong>Methods: </strong>This mixed-method parallel design study is a feasibility study with an embedded process evaluation, to compare SDF with usual treatment in primary dental care in the UK. It will be individually randomised, with 13 dentists and therapists, in 8 different dental primary care sites with a sample size of 80 child participants aged 1-8 years old. The aim will be to recruit ten participants per site with equal arm allocation. Follow-up will be for 1 year. The study will inform whether an RCT is feasible by resolving several key uncertainties. The acceptability and implementation of SDF and the research processes will be explored. Patient and Public Involvement and Engagement representatives will be involved throughout recruitment and retention strategies, participant documentation, analysis, engagement and dissemination.</p><p><strong>Discussion: </strong>The ability to conduct an RCT will be evaluated. If feasible, this RCT has the potential to evaluate the effectiveness of a non-invasive approach for the management of untreated caries in young children. A feasibility study also offers the opportunity to consider factors associated with the implementation of SDF at an early stage through a process evaluation that will inform the definitive trial and an implementation strategy for SDF by identifying relevant barriers and facilitators.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT06092151. Date: 19/10/2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"95"},"PeriodicalIF":1.5,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11194932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446725","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 laboratory-based protocol for measuring energy expenditure and accelerometer calibration in adults with intellectual disabilities.","authors":"A M McGarty, V Penpraze, P M Dall, C Haig, L Harris, C A Melville","doi":"10.1186/s40814-024-01512-5","DOIUrl":"10.1186/s40814-024-01512-5","url":null,"abstract":"<p><p>Adults with intellectual disabilities experience numerous health inequalities. Targeting unhealthy lifestyle behaviours, such as high levels of sedentary behaviour and overweight/obesity, is a priority area for improving the health and adults with intellectual disabilities and reducing inequalities. Energy expenditure is a fundamental component of numerous health behaviours and an essential component of various free-living behaviour measurements, e.g. accelerometry. However, little is known about energy expenditure in adults with intellectual disabilities and no population-specific accelerometer data interpretation methods have been calibrated. The limited research in this area suggests that adults with intellectual disabilities have a higher energy expenditure, which requires further exploration, and could have significant impacts of device calibration. However, due to the complex methods required for measuring energy expenditure, it is essential to first evaluate feasibility and develop an effective protocol. This study aims to test the feasibility of a laboratory-based protocol to enable the measurement of energy expenditure and accelerometer calibration in adults with intellectual disabilities.We aimed to recruit ten adults (≥ 18 years) with intellectual disabilities. The protocol involved a total of nine sedentary, stationary, and physical activities, e.g. sitting, lying down, standing, and treadmill walking. Each activity was for 5 min, with one 10 min lying down activity to measure resting energy expenditure. Breath by breath respiratory gas exchange and accelerometry (ActiGraph and ActivPAL) were measured during each activity. Feasibility was assessed descriptively using recruitment and outcome measurement completion rates, and participant/stakeholder feedback.Ten adults (N = 7 female) with intellectual disabilities participated in this study. The recruitment rate was 50% and 90% completed the protocol and all outcome measures. Therefore, the recruitment strategy and protocol are feasible.This study addresses a significant gap in our knowledge relating to exercise laboratory-based research for adults with intellectual disabilities The findings from this study provide essential data that can be used to inform the development of future protocols to measure energy expenditure and for accelerometer calibration in adults with intellectual disabilities.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"94"},"PeriodicalIF":1.5,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193167/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440791","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 randomized controlled trial of a telemedicine psychosocial intervention to improve symptom management in adults with long COVID: the COPE study protocol.","authors":"Lindsey M Knowles, Mehr Grewal, Sydney A Drever, Jeanne M Hoffman, Janna L Friedly, Tracy E Herring","doi":"10.1186/s40814-024-01515-2","DOIUrl":"10.1186/s40814-024-01515-2","url":null,"abstract":"<p><strong>Background: </strong>Long COVID is a serious public health concern due to its high prevalence and potentially debilitating symptoms. Symptoms may include fatigue, dyspnea, cognitive problems, insomnia, anxiety, and depression. There is currently no cure for long COVID, and the average length of recovery and proportion of patients who fully recover are still unknown. Subsequently, there is a critical need to improve function. Research in other chronic conditions suggests that psychosocial self-management interventions reduce symptom severity and interference with functioning. We describe the design of our study to examine the feasibility, acceptability, appropriateness, and preliminary efficacy of an intervention designed to improve symptom management and coping in adults with long COVID.</p><p><strong>Methods: </strong>This pilot trial (N = 50) uses a pragmatic, randomized two-group parallel design set within the University of Washington Post-COVID Rehabilitation and Recovery Clinic. The self-management intervention is a 6-week, group-based telemedicine intervention that teaches evidence-based strategies to manage common symptoms and improve stress management as well as communication and self-advocacy. The comparator is a wait-list control. Participants complete self-report measures of the primary and secondary outcomes at baseline and post-treatment/wait-list. Primary outcomes include intervention feasibility, acceptability, and appropriateness. Secondary outcomes include Patient-Reported Outcomes Measurement Information System measures of fatigue, sleep disturbance, cognitive difficulties, self-efficacy, pain interference, depression and anxiety symptoms, and a measure of long COVID symptoms and impression of change. At post-intervention, intervention participants also complete a qualitative interview to inform intervention refinement. Quantitative data will be examined using descriptive and statistical analysis including t-tests and chi-square tests to compare the intervention and wait-list groups on secondary outcomes. Qualitative data will be analyzed using the rigorous and accelerated data reduction technique (RADaR).</p><p><strong>Discussion: </strong>Results of this pilot randomized controlled trial will characterize the feasibility, acceptability, and appropriateness of the self-management intervention and inform intervention refinement necessary prior to further testing. Long COVID is a public health concern, and rehabilitation approaches that equip patients to manage symptoms may improve patient function and quality of life and reduce burden on the health care system.</p><p><strong>Trial registration: </strong>NCT05658536. December 16, 2022.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"93"},"PeriodicalIF":1.5,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11181592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420382","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":"Network of doctors for multimorbidity and diabetes - the NOMAD intervention: protocol for feasibility trial of multidisciplinary team conferences for people with diabetes and multimorbidity.","authors":"Stine Jorstad Bugge, Daniel Pilsgaard Henriksen, Per Damkier, Martin Torp Rahbek, Karoline Schousboe, Mette Juel Rothmann, Marianne Kjær Poulsen, Camilla Hansen, Subagini Nagarajah, Per Bruno Jensen, Sofie Lock Johansson, Vasiliki Panou, Ida Ransby Schneider, Charlotte Gjørup Pedersen, Jonas Dahl Andersen, Jørgen Hangaard, Ann-Dorthe Olsen Zwisler","doi":"10.1186/s40814-024-01517-0","DOIUrl":"10.1186/s40814-024-01517-0","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of diabetes and coexisting multimorbidity rises worldwide. Treatment of this patient group can be complex. Providing an evidence-based, coherent, and patient-centred treatment of patients with multimorbidity poses a challenge in healthcare systems, which are typically designed to deliver disease-specific care. We propose an intervention comprising multidisciplinary team conferences (MDTs) to address this issue. The MDT consists of medical specialists in five different specialities meeting to discuss multimorbid diabetes patients. This protocol describes a feasibility test of MDTs designed to coordinate care and improve quality of life for people with diabetes and multimorbidity.</p><p><strong>Methods: </strong>A mixed-methods one-arm feasibility test of the MDT. Feasibility will be assessed through prospectively collected data. We will explore patient perspectives through patient-reported outcomes (PROs) and assess the feasibility of electronic questionnaires. Feasibility outcomes are recruitment, PRO completion, technical difficulties, impact of MDT, and doctor preparation time. During 17 months, up to 112 participants will be recruited. We will report results narratively and by the use of descriptive statistics. The collected data will form the basis for a future large-scale randomised trial.</p><p><strong>Discussion: </strong>A multidisciplinary approach focusing on better management of diabetic patients suffering from multimorbidity may improve functional status, quality of life, and health outcomes. Multimorbidity and diabetes are highly prevalent in our healthcare system, but we lack a solid evidence-based approach to patient-centred care for these patients. This study represents the initial steps towards building such evidence. The concept can be efficiency tested in a randomised setting, if found feasible to intervention providers and receivers. If not, we will have gained experience on how to manage diabetes and multimorbidity as well as organisational aspects, which together may generate hypotheses for research on how to handle multimorbidity in the future.</p><p><strong>Administrative information: </strong>Protocol version: 01 TRIAL REGISTRATION: NCT05913726 - registration date: 21 June 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"91"},"PeriodicalIF":1.7,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327782","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":"Conducting a diabetes mellitus prevention trial in women with GDM in Pakistan: a feasibility study.","authors":"Romaina Iqbal, Sabahat Naz, Sana Sheikh, Rahat Qureshi, Shereen Bhutta, Haleema Yasmeen, Iqbal Azam, Paramjit Gill","doi":"10.1186/s40814-024-01514-3","DOIUrl":"10.1186/s40814-024-01514-3","url":null,"abstract":"<p><strong>Background: </strong>Women with gestational diabetes mellitus (GDM) are at a greater risk of developing type 2 diabetes mellitus (T2DM) than women without GDM. Despite this elevated risk, few trials on the prevention of T2DM among South Asian women with GDM have been reported. Therefore, this study aimed to assess the feasibility of conducting a diabetes prevention program on women with a history of GDM to inform the development of a contextually relevant definitive trial.</p><p><strong>Methods: </strong>Using a randomized controlled trial, women with GDM (n = 180) who delivered at the study hospitals (one public and one private teaching hospital, Karachi) with fasting blood glucose levels < 120 mg/dl at 6 weeks postpartum were randomized to the intervention (n = 88) or control arms (n = 92). Women in the intervention group received individualized home-based educational sessions from trained community health workers at 0, 1, 3, 6, and 9 months. In addition, they received short text messages, prerecorded messages, and printed educational material (calendars and pamphlets) for reinforcement. The intervention was centered on equipping women with knowledge, skills, and confidence to eat a healthy diet rich in fruits, vegetables, and low-fat dairy products and perform regular physical activity based on walking and household chores to reduce weight (up to 5% of their initial body weight). Women in the control arm received standard care. The feasibility outcomes of the study included screening, recruitment, and retention rates and in-depth interviews at 6 months post-intervention to explore women's experiences with the intervention. Descriptive analysis and thematic analysis were performed.</p><p><strong>Results: </strong>Of the 324 women screened during the antenatal care visits and after delivery, 255 (78.7%) were contactable 6 weeks postpartum, and 180 (70.6%) were eligible and randomized to intervention (n = 88) and control (n = 92) groups. Loss to follow-up in the intervention and control arms was 22.7% (n = 20/88) and 18.5% (n = 17/92), respectively. Women expressed satisfaction with home-based counseling and follow-up visits, text message reminders, and printed material in the form of a calendar through our qualitative interviews.</p><p><strong>Conclusions: </strong>Home-based lifestyle modification intervention augmented with text messages and printed material is feasible. However, to evaluate the intervention's effectiveness, a larger trial is warranted to assess its long-term impact on diabetes prevention.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN11387113 . Registered 5 December 2017-retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"92"},"PeriodicalIF":1.7,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327780","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":"Delayed cold-stored vs. room temperature stored platelet transfusions in bleeding adult cardiac surgery patients-a randomized multicentre pilot study (PLTS-1).","authors":"Justyna Bartoszko, Miki Peer, Deep Grewal, Saba Ansari, Jeannie Callum, Keyvan Karkouti","doi":"10.1186/s40814-024-01518-z","DOIUrl":"10.1186/s40814-024-01518-z","url":null,"abstract":"<p><strong>Background: </strong>Platelets stored at 1-6 °C are hypothesized to be more hemostatically active than standard room temperature platelets (RTP) stored at 20-24 °C. Recent studies suggest converting RTP to cold-stored platelets (Delayed Cold-Stored Platelets, DCSP) may be an important way of extending platelet lifespan and increasing platelet supply while also activating and priming platelets for the treatment of acute bleeding. However, there is little clinical trial data supporting the efficacy and safety of DCSP compared to standard RTP.</p><p><strong>Methods: </strong>This protocol details the design of a multicentre, two-arm, parallel-group, randomized, active-control, blinded, internal pilot trial to be conducted at two cardiac surgery centers in Canada. The study will randomize 50 adult (≥ 18 years old) patients undergoing at least moderately complex cardiac surgery with cardiopulmonary bypass and requiring platelet transfusion to receive either RTP as per standard of care (control group) or DCSP (intervention group). Patients randomized to the intervention group will receive ABO-identical, buffy-coat, pathogen-reduced, platelets in platelet additive solution maintained at 22 °C for up to 4 days then placed at 4 °C for a minimum of 24 h, with expiration at 14 days after collection. The duration of the intervention is from the termination of cardiopulmonary bypass to 24 h after, with a maximum of two doses of DCSP. Thereafter, all patients will receive RTP. The aim of this pilot is to assess the feasibility of a future RCT comparing the hemostatic effectiveness of DCSP to RTP (defined as the total number of allogeneic blood products transfused within 24 h after CPB) as well as safety. Specifically, the feasibility objectives of this pilot study are to determine (1) recruitment of ≥ 15% eligible patients per center per month); (2) appropriate platelet product available for ≥ 90% of patients randomized to the cold-stored platelet group; (3) Adherence to randomization assignment (> 90% of patients administered assigned product).</p><p><strong>Discussion: </strong>DCSP represents a promising logistical solution to address platelet supply shortages and a potentially more efficacious option for the management of active bleeding. No prospective clinical studies on this topic have been conducted. This proposed internal pilot study will assess the feasibility of a larger definitive study.</p><p><strong>Trial registration: </strong>NCT06147531 (clinicaltrials.gov).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"90"},"PeriodicalIF":1.7,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327781","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 home-based self-delivered prehabilitation intervention to proactively reduce fall risk in older adults: a pilot randomized controlled trial of transcranial direct current stimulation and motor imagery.","authors":"Clayton W Swanson, Sarah E Vial, Todd M Manini, Kimberly T Sibille, David J Clark","doi":"10.1186/s40814-024-01516-1","DOIUrl":"10.1186/s40814-024-01516-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Several changes occur in the central nervous system with increasing age that contribute toward declines in mobility. Neurorehabilitation has proven effective in improving motor function though achieving sustained behavioral and neuroplastic adaptations is more challenging. While effective, rehabilitation usually follows adverse health outcomes, such as injurious falls. This reactive intervention approach may be less beneficial than prevention interventions. Therefore, we propose the development of a prehabilitation intervention approach to address mobility problems before they lead to adverse health outcomes. This protocol article describes a pilot study to examine the feasibility and acceptability of a home-based, self-delivered prehabilitation intervention that combines motor imagery (mentally rehearsing motor actions without physical movement) and neuromodulation (transcranial direct current stimulation, tDCS; to the frontal lobes). A secondary objective is to examine preliminary evidence of improved mobility following the intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This pilot study has a double-blind randomized controlled design. Thirty-four participants aged 70-95 who self-report having experienced a fall within the prior 12 months or have a fear of falling will be recruited. Participants will be randomly assigned to either an active or sham tDCS group for the combined tDCS and motor imagery intervention. The intervention will include six 40-min sessions delivered every other day. Participants will simultaneously practice the motor imagery tasks while receiving tDCS. Those individuals assigned to the active group will receive 20 min of 2.0-mA direct current to frontal lobes, while those in the sham group will receive 30 s of stimulation to the frontal lobes. The motor imagery practice includes six instructional videos presenting different mobility tasks related to activities of daily living. Prior to and following the intervention, participants will undergo laboratory-based mobility and cognitive assessments, questionnaires, and free-living activity monitoring.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Previous studies report that home-based, self-delivered tDCS is safe and feasible for various populations, including neurotypical older adults. Additionally, research indicates that motor imagery practice can augment motor learning and performance. By assessing the feasibility (specifically, screening rate (per month), recruitment rate (per month), randomization (screen eligible who enroll), retention rate, and compliance (percent of completed intervention sessions)) and acceptability of the home-based motor imagery and tDCS intervention, this study aims to provide preliminary data for planning larger studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;This study is registered on ClinicalTrials.gov (NCT05583578). Registered October 13, 2022. https://www.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinicaltrials: &lt;/strong&gt;gov/study/NCT05583578.&lt;/","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"89"},"PeriodicalIF":1.7,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141321347","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}