Pilot and Feasibility Studies最新文献

{"title":"Feasibility and acceptability of tailored sexual assault prevention in the US Air Force.","authors":"Marni L Kan, Nichole M Scaglione, Alexander Buben, Jessica K Morgan, Kathryn E L Grimes, Colleen J Watson, Samantha Charm, Ashley N Lowe, Randall P Eckhoff, Marian Lane, Meghan K Root, Leah B Pound","doi":"10.1186/s40814-024-01565-6","DOIUrl":"10.1186/s40814-024-01565-6","url":null,"abstract":"<p><strong>Background: </strong>Sexual assault prevention is a priority for the military and is likely to be most effective when tailored to specific needs and individual experiences. Technology advances make it possible to integrate individualized programming into group education settings common to military training, but this approach is not without potential challenges. Prior to implementing and evaluating a novel prevention program, it is critical to conduct a feasibility study to assess the extent to which the program can be successfully implemented, is acceptable to participants, and can be rigorously evaluated. This paper presents the results of a large feasibility study of the Sexual Communication and Consent (SCC) program in Air Force Basic Military Training. The objectives were to understand (1) the suitability and acceptability of SCC and study procedures, (2) the research team's resources and ability to manage and implement the study and SCC, and (3) the appropriateness of the data collection procedures and outcome measures.</p><p><strong>Methods: </strong>The 26-week feasibility study involved more than 9000 trainees. At pretest, the sample was 73% male and 90% straight. Half of trainees (51%) reported not being in a romantic relationship, and 46% reported being in an exclusive romantic relationship. SCC involved 6 h of training over two sessions delivered 2 weeks apart. Sessions combined tablet-based training that was tailored to individual sexual assault risk (for revictimization, first-time victimization, or perpetration based on a screening instrument) with instructor-led classroom activities and discussion.</p><p><strong>Results: </strong>Trainee, instructor, and observer data indicated that the program was feasible, implemented with high fidelity, and acceptable to trainees. Technology and data collection procedures worked well, but time constraints led to program changes, missed content, and missing survey data. Staff time and skill requirements for SCC implementation exceeded those of standard training.</p><p><strong>Conclusions: </strong>Our results suggest that high-quality implementation of tailored sexual assault prevention training is feasible in a military environment, and they inform recommendations for program revisions, future evaluation, and sustainability.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"145"},"PeriodicalIF":1.5,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11580234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142688665","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":"Correction: Pre‑ and post‑operative voice therapy for benign vocal fold lesions: protocol for a non‑randomised, multicentre feasibility trial with embedded process evaluation.","authors":"Anna White, Paul Carding, Vicky Booth, Julian McGlashan, Jarrad Van Stan, Pip Logan, Rehab Awad","doi":"10.1186/s40814-024-01572-7","DOIUrl":"10.1186/s40814-024-01572-7","url":null,"abstract":"","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"144"},"PeriodicalIF":1.5,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11575080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142676552","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":"It is time to address fear of cancer recurrence in family caregivers: protocol for the feasibility and acceptability of a randomized pilot study of the online version of the Family Caregiver-Fear Of Recurrence Therapy (FC-FORT).","authors":"Jani Lamarche, Rinat Nissim, Jonathan Avery, Jiahui Wong, Christine Maheu, Sylvie D Lambert, Andrea M Laizner, Jennifer Jones, Mary Jane Esplen, Sophie Lebel","doi":"10.1186/s40814-024-01567-4","DOIUrl":"10.1186/s40814-024-01567-4","url":null,"abstract":"<p><strong>Background: </strong>Fear of cancer recurrence (FCR) is common, persistent, and is associated with lower quality of life, impaired functioning, and psychological distress in cancer patients. Studies suggest that family caregivers of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients and in patient-caregiver dyads. However, to date, no intervention exists to individually target family caregiver's FCR. The aims of the proposed pilot study are to (1) assess the feasibility and acceptability of the newly adapted Family Caregiver-Fear Of Recurrence Therapy (FC-FORT) intervention to inform a larger randomized control trial study, and (2) estimate the clinical significance of FC-FORT. Initial evaluation of FC-FORT revealed high user satisfaction and usability.</p><p><strong>Methods: </strong>A parallel, two-group, pilot randomized controlled trial comparing FC-FORT to a waitlist control (care as usual) will be conducted. Participant inclusion criteria are (a) women family caregivers taking care of adult cancer patients (no recurrence), (b) experiencing clinical levels of FCR, (c) access to a computer/internet connection, and (d) living in Canada. Participants (n = 36) will be recruited at Ottawa and Toronto hospitals, previous study participant pools, through social media and community partners across Canada. Participants in the intervention group will complete the FC-FORT intervention (7 consecutive weeks of virtual group therapy and homework). Participants in the control group will be offered the intervention after their participation in the study. All participants will be asked to complete questionnaire packages at baseline (T0), immediately post-intervention (7 weeks; T1) and at 3-months post-intervention (T2). Feasibility (e.g., recruitment, allocation, fidelity), acceptability (e.g., dropout, completion, satisfaction) and clinical significance of secondary outcomes will be evaluated (i.e., FCR illness uncertainty). Participants in the intervention group will be asked to complete measures of group cohesion and therapeutic alliance and take part in a semi-structured exit interview exploring their overall experience with FC-FORT.</p><p><strong>Discussion: </strong>This project will evaluate the acceptability and feasibility of the newly adapted FC-FORT to inform a larger trial.</p><p><strong>Trial registration: </strong>NCT, NCT05441384. Registered July 1st, 2022, https://classic.</p><p><strong>Clinicaltrials: </strong>gov/ct2/show/NCT05441384.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"143"},"PeriodicalIF":1.5,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11574991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142676555","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":"Qualitative study of the feasibility and acceptability of implementation, and potential mechanisms of Learning Together for Mental Health, a whole-school intervention aiming to promote mental health and wellbeing in secondary schools.","authors":"Neisha Sundaram, Oliver Lloyd-Houldey, Semina Michalopoulou, Steven Hope, Joanna Sturgess, Elizabeth Allen, Rosa Legood, Stephen Scott, Lee D Hudson, Dasha Nicholls, Deborah Christie, Russell M Viner, Chris Bonell","doi":"10.1186/s40814-024-01563-8","DOIUrl":"10.1186/s40814-024-01563-8","url":null,"abstract":"<p><strong>Background: </strong>Despite high rates of adolescent mental-health problems, there are few effective whole-school interventions to address this. Whole-school interventions offer a feasible and sustainable means of promoting mental health. We previously evaluated the Learning Together (LT) intervention which was effective in preventing bullying (primary outcome), promoting mental well-being, psychological functioning, and reducing substance use (secondary outcomes). We adapted LT to develop Learning Together for Mental Health (LTMH) with a new menu of evidence-based actions to address mental health and an enhanced SEL curriculum.</p><p><strong>Methods: </strong>We undertook a feasibility study of LTMH, a whole-school intervention featuring needs assessment, student and staff participation in decision-making via action groups selecting actions from an evidence-based menu, restorative practice, and a SEL and resilience skills curriculum between 2022 and 2023. This article examines the feasibility, acceptability, and potential mechanisms of LTMH, qualitatively, drawing on interviews and focus groups with 49 students in years 8 and 10, and 20 staff across four state secondary schools in southern England.</p><p><strong>Results: </strong>The intervention was feasible and acceptable to implement. In terms of feasibility, the SEL curriculum was the most challenging to implement and was not prioritised by schools that had existing social and emotional learning lessons. Training and external facilitation were well-rated. Some schools struggled with the resourcing and workload implications of implementing actions from the evidence-based menu. Some aspects were not clear. Some staff were not aware that the various components worked together. Needs reports were not easy to understand for all. Students were generally supportive of restorative practice and SEL lessons. Data supported a potential mechanism involving increased school belonging and developing practical knowledge and skills to manage emotions and relationships. The intervention has little potential for harm.</p><p><strong>Conclusions: </strong>The intervention is ready for phase III trial with minor adaptations. A phase III trial of effectiveness is justified.</p><p><strong>Trial registration: </strong>ISRCTN15301591 https://doi.org/10.1186/ISRCTN15301591.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"142"},"PeriodicalIF":1.5,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566735/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644297","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":"Addressing unmet social needs of children with obesity: a pilot randomized controlled trial.","authors":"Gita Wahi, Stacey Marjerrison, Simrat Gill, Kimberley Krasevich, Katherine M Morrison, Lehana Thabane","doi":"10.1186/s40814-024-01570-9","DOIUrl":"10.1186/s40814-024-01570-9","url":null,"abstract":"<p><strong>Background: </strong>Childhood obesity is an ongoing public health crisis, and recent clinical practice guidelines identify addressing the role of social inequities in the disparity of health among children with obesity as an area to address. This study aimed to assess the feasibility of a community navigation intervention in a pediatric weight management clinic.</p><p><strong>Methods: </strong>A single-center pilot randomized controlled trial (RCT) recruiting families from a tertiary hospital pediatric weight management program to evaluate the feasibility of a community navigation intervention. The primary feasibility outcomes were recruitment rates (goal to recruit 80% of the sample in 6 months), uptake of the intervention (goal > 80% of participants in the intervention group to have a visit with the navigator), and acceptability (goal > 90% of families in the intervention group complete all follow-up).</p><p><strong>Results: </strong>Eighty participants completed the social needs screening, and 42 (52.5%) participants screened positive for an unmet social need. In the first 6 months of recruitment, 18 participants were recruited out of a goal of 40 participants (the recruitment rate was 45% vs. the goal of 80% in 6 months), and complete recruitment was achieved in 12 months. Of the 21 participants randomized to the intervention arm, 20 completed the intervention (uptake of intervention was 95% vs. goal 80%). Ten participants in the intervention arm completed all four planned follow-up study visits (the acceptability of follow-up was 48% vs. the goal of 90%).</p><p><strong>Conclusion: </strong>We completed a pilot RCT of implementing a community navigator program in a pediatric weight management program. We found feasibility in the intervention's uptake but limited feasibility in recruiting participants and the acceptability of the follow-up.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT04711707, https://clinicaltrials.gov/ct2/show/NCT04711707.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"141"},"PeriodicalIF":1.5,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11562815/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626214","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 the development and piloting of a cluster randomised controlled trial for stress prevention, management, and coping mechanism among police officers in Nigeria.","authors":"Mojisola M Oluwasanu, Bibilola Oladeji, Hussain Oluwatobi, Musibau Titiloye, Adeyinka Adefolarin, Mackson O Unogu, Patrick Okafor, Olayinka Ajayi, Ezinne O Uvere, Ademola J Ajuwon","doi":"10.1186/s40814-024-01559-4","DOIUrl":"10.1186/s40814-024-01559-4","url":null,"abstract":"<p><strong>Background: </strong>Policing is a stressful occupation. Police officers are exposed to stressors that are inherent in the organization and operations of law enforcement. Similar to their counterparts around the world, many Nigeria police officers are exposed to high levels of stress, making them vulnerable to stress-related mental health conditions and other noncommunicable diseases. Despite these risks and their consequences to the health and safety of police officers and the larger society, interventions are currently not available to address this challenge in Nigeria. This pilot study aims to assess the burden of stress from a national sample of police officers and test the feasibility of an intervention for stress prevention, management, and coping mechanisms among police officers in Nigeria.</p><p><strong>Methods: </strong>This is a three-phase study: (1) a needs assessment and situational analysis using a convergent parallel, mixed-methods approach to determine the prevalence of stress and mental health burden among 1200 police officers in four randomly selected states in four geopolitical zones of the country, (2) the development of a peer-led intervention for stress prevention, management, and coping mechanism which will be tested using a cluster randomized trial among 200 police officers, and (3) the preliminary evaluation of the intervention based on knowledge about stress management and mental disorders and psychological distress and reduction in stress levels. These measures will be obtained at baseline (T0), immediate (T1), and 6-month post-intervention (T2). Feasibility will be determined based on enrollment rate, attendance, and completion of the group sessions. Multivariable linear regression models taking into account clustering effects will be used to estimate between-group differences in outcome measures.</p><p><strong>Discussion: </strong>Findings from the study will inform policy review and the development of a pragmatic intervention on stress prevention and management among police officers. This will enhance the policing role of officers, thus contributing to the safety of the communities they serve.</p><p><strong>Trial registration: </strong>PACTR Registry: PACTR202310474721238. Registered on 6 October, 2023. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25663 . Protocol version number 1.0 (date: 6 October, 2023).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"140"},"PeriodicalIF":1.5,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626227","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":"Nutritional intervention to enhance recovery after arthroscopic knee surgery in adults: a randomized controlled pilot trial.","authors":"Danielle L E Nyman, Callum J Pufahl, Olivia G V Hickey, Tanner Stokes, Craig A Simpson, Jessica C Selinger, Sunita Mathur, Ian Janssen, Lora M Giangregorio, Davide D Bardana, Chris McGlory","doi":"10.1186/s40814-024-01561-w","DOIUrl":"10.1186/s40814-024-01561-w","url":null,"abstract":"<p><strong>Background: </strong>Essential amino acid (EAA) and omega-3 fatty acid ingestion independently attenuate leg skeletal muscle disuse atrophy in uninjured persons. However, no data exist regarding the effectiveness of combined EAA and omega-3 fatty acid ingestion to mitigate skeletal muscle disuse atrophy in response to anterior cruciate ligament reconstruction (ACLR) surgery. This pilot trial will explore the feasibility of recruitment and retention of ACLR outpatients from a single center across 18 months to consume either a combination of omega-3 fatty acids and EAAs, or a placebo control, for 4 weeks before and 2 weeks after surgery.</p><p><strong>Methods: </strong>Thirty adult (≥ 18 years old) ACLR outpatients will be recruited for this single center, double-blind, two-arm randomized controlled feasibility pilot trial. Participants will consume either 5 g⋅day^-1 of omega-3 fatty acids (fish oil) and 40 g⋅day^-1 of EAAs or 5 g⋅day^-1 of a control fatty acid mixture (safflower oil) and 40 g⋅day^-1 of non-essential amino acids (NEAAs). Fatty acid supplements will be consumed 4 weeks before and for 2 weeks after ACLR surgery, whereas the EAAs and NEAAs will be consumed 1 week before and for 2 weeks after ACLR surgery. The primary outcomes are feasibility of recruitment and retention, with the goal to recruit 30 outpatients across 18 months and retain 22 participants upon completion of the study protocol following 12 weeks of data collection. These results will be reported using descriptive statistics, along with reasons and timepoints for study dropout. Secondary exploratory outcomes will be reported using inferential statistics for purposes of hypothesis generation and elucidation of mechanistic targets for future work; no inferences to clinical efficacy will be made. These outcomes include integrated rates of skeletal muscle protein synthesis, skeletal muscle protein content and expression of translation factors, skeletal muscle and erythrocyte phospholipid composition, and measures of skeletal muscle mass, strength, and power.</p><p><strong>Impact: </strong>This work will set the foundation for a future randomized controlled trial powered to detect an effect of EAA + omega-3 fatty acid intake on skeletal muscle size or function in response to ACLR surgery.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT06233825. Registered 31 January 2024. https://clinicaltrials.gov/study/NCT06233825?term=NCT06233825&rank=1.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"138"},"PeriodicalIF":1.5,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11556091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626226","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":"Comparison of 45-min nap versus no-nap during simulated night shift work on endothelial function: a randomized crossover feasibility trial.","authors":"P Daniel Patterson, Cassie J Hilditch, Sarah E Martin, David G L Roach, Matthew D Weaver, Tiffany S Okerman, David Hostler, Leonard S Weiss, Steven E Reis","doi":"10.1186/s40814-024-01569-2","DOIUrl":"10.1186/s40814-024-01569-2","url":null,"abstract":"<p><strong>Background: </strong>Night shift workers face increased risk of cardiovascular disease (CVD) compared to non-shift workers. Evidence supports on-shift napping and regular non-invasive monitoring of endothelial function for risk mitigation, yet neither strategy is widely used.</p><p><strong>Methods: </strong>We evaluated the feasibility of non-invasive assessment of peripheral arterial tone (PAT) to assess the effect of napping during simulated night shift work on endothelial function. We used a single-site, randomized crossover trial of simulated night shift work with a 45-min nap condition versus a control, no-nap condition (ClinicalTrials.gov NCT05436951).</p><p><strong>Results: </strong>The primary outcome was the number of participants with ≥ 70% of endothelial function assessments. Secondary outcomes included mean reactive hyperemia index (RHI), BP, and cognitive performance with the brief psychomotor vigilance task (PVT-B). Of the 10 consented, 9 completed both conditions. All participants exceeded feasibility benchmarks. Mean RHI did not differ by nap condition, and the delta from pre- to post measure did not differ (difference in delta =  - 0.26, 95% CI - 1.09, 0.58). Hourly PVT-B assessments from 19:00 to 07:00 h did not differ by nap condition. Compared to pre-nap measures, cognitive performance on the PVT-B was poorest at + 0 min post-nap.</p><p><strong>Conclusion: </strong>Our findings can inform larger studies evaluating the effects of night shift work and napping on endothelial function.</p><p><strong>Trial registrations: </strong>ClinicalTrials.gov (NCT05436951, registered on June 23, 2022).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"137"},"PeriodicalIF":1.5,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11555913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626223","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":"Intervention development and optimisation of a multi-component digital intervention for the monitoring and management of hypertensive pregnancy: the My Pregnancy Care Intervention.","authors":"Katherine Tucker, Frances Rose, Layla Lavallee, Cristian Roman, Lucy Goddard, Richard J McManus","doi":"10.1186/s40814-024-01562-9","DOIUrl":"10.1186/s40814-024-01562-9","url":null,"abstract":"<p><strong>Background: </strong>Hypertensive disorders of pregnancy affect around 10% of pregnancies and remain a major cause of maternal and foetal morbidity and mortality. Trials have shown that self-monitoring blood pressure during pregnancy is safe, but self-monitoring alone does not improve blood pressure control or pregnancy outcomes. This study aimed to develop and optimise a multicomponent intervention to support blood pressure monitoring, hypertension management and urine testing within current care pathways.</p><p><strong>Methods: </strong>Relevant literature, input from patient and public contributors (PPI) and stakeholder groups, and the researcher's previous experience were used to develop an initial intervention. Think-aloud interviews and focus groups with women from diverse backgrounds with lived experience of hypertension in pregnancy and healthcare professionals provided feedback on the intervention prototype (n = 29). The MRC Framework for Developing Complex Interventions guided the processes to optimise the intervention's acceptability and maximise engagement. A detailed tabulation of participants' views and logic models was produced using the COM-B model of Behaviour Change.</p><p><strong>Results: </strong>The prototype intervention was acceptable and viable to both pregnant women with experience of hypertensive pregnancy and healthcare professionals. Emerging themes centred on how the intervention could be optimised within current National Health Service care pathways and the lives of pregnant women to support behaviour change. Key target behaviours to support the intervention included increasing understanding of blood pressure management, engagement with the intervention, monitoring blood pressure and urine and taking appropriate actions based on those readings. This informed the development of recommendations involving clear action timelines for women and evidence-based guidance to support decision-making by healthcare professionals. The findings were used to produce the multi-component My Pregnancy Care intervention, consisting of a smartphone application and an information leaflet to support blood pressure self-monitoring and proteinuria self-testing, self-management of antihypertensive medication and smartphone application use.</p><p><strong>Conclusions: </strong>This research provided comprehensive insight into the needs of pregnant women with hypertension and their healthcare teams regarding self-monitoring and management of blood pressure. This supported the development of a tailored multi-component digital intervention that addresses barriers to blood pressure self-management by being user-friendly, persuasive and acceptable. It is hoped that the intervention will support the monitoring and management process, collaboration between healthcare professionals and women, clinical action and improved clinical outcomes.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"139"},"PeriodicalIF":1.5,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11556154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626224","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 Comprehensive Resilience-building psychosocial Intervention (CREST) for people with dementia in the community: a feasibility and acceptability study.","authors":"Dympna Casey, Priscilla Doyle, Niamh Gallagher, Grace O'Sullivan, Siobhán Smyth, Declan Devane, Kathy Murphy, Charlotte Clarke, Bob Woods, Rose-Marie Dröes, Gill Windle, Andrew W Murphy, Tony Foley, Fergus Timmons, Paddy Gillespie, Anna Hobbins, John Newell, Jaynal Abedin, Christine Domegan, Kate Irving, Barbara Whelan","doi":"10.1186/s40814-024-01568-3","DOIUrl":"10.1186/s40814-024-01568-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;A dementia diagnosis can lead to a decline in cognitive, social, and physical health, but people with dementia can live meaningful lives and participate actively in society with psychosocial support. This single-arm, non-randomised feasibility study explored the feasibility and acceptability of a Comprehensive REsilience-building psychoSocial intervenTion (CREST) for people with dementia, their caregivers, General Practitioners (GPs), and the public.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Nine people with dementia and their primary caregivers living in the community (n = 9 dyads) completed the CREST intervention which had three components (cognitive stimulation therapy [CST], physical exercise, and dementia education). Quantitative secondary outcomes were assessed at baseline and following the 15-week intervention; qualitative interviews were conducted during and post-intervention. All study components were assessed against pre-defined criteria, to determine the feasibility of conducting a future definitive trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment of people with dementia and their caregiver was a significant challenge and led to considerable delays to the onset and conduct of the intervention. Only 13% of eligible GP practices agreed to assist in recruitment and achieved a 6% enrolment rate; a community-based recruitment strategy proved more effective, yielding a 29% enrolment rate. However, once recruited, participants maintained high attendance and adherence to the content of each component with average adherence rates of 98% for CST, exercise sessions and caregiver education. Adherence to secondary exercise measures was lower, with home exercise diary completion at 37% and Fitbit wear adherence at 80% during the day and 67% at night. The people with dementia felt their concentration and fitness had improved over the 15-week intervention and particularly enjoyed the social aspects (e.g. group classes, exercising with partners from the community). Caregivers felt they had better knowledge and understanding following their education component and reported that the social aspects (interacting and sharing experiences with each other) were important. Overall, participants reported that the three components of the intervention were feasible and acceptable. In addition, the quantitative measures and health economic tools employed were feasible. However, the secondary elements of the exercise component (recording home exercise diaries and Fitbit use) were not considered feasible. Overall, pre-defined criteria for progression to a definitive intervention were fulfilled in terms of acceptability, retention and fidelity but not recruitment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;While overall, the CREST intervention was feasible and acceptable to participants, significant difficulties with recruitment of people with dementia and their caregiver through GP practices impacted the viability of delivering the intervention. Recru","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"136"},"PeriodicalIF":1.5,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626229","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}