Contemporary Clinical Trials Communications最新文献

{"title":"A mixed-methods study on the recruitment of patients from ethnic minority groups to clinical trials in a central London teaching hospital","authors":"Cecilia Vindrola-Padros ,&nbsp;Katie Gilchrist ,&nbsp;Stuart Braverman ,&nbsp;Rumana Omar ,&nbsp;Edward Merivale ,&nbsp;Ambar Hussenbux ,&nbsp;Sanjay Khanna ,&nbsp;Patience Renias-Zuva ,&nbsp;Nick McNally ,&nbsp;Rosamund Yu","doi":"10.1016/j.conctc.2025.101475","DOIUrl":"10.1016/j.conctc.2025.101475","url":null,"abstract":"<div><h3>Background/aims</h3><div>Additional research is needed to fully understand barriers in recruitment to clinical trials and how these might affect different ethnic groups. The aim of this study was to explore the factors acting as barriers and facilitators in the process of recruiting patients to clinical trials in a UK (central London) teaching hospital, with a particular focus on patients from ethnic minority groups, and on areas where action could be taken.</div></div><div><h3>Methods</h3><div>The study was designed as a mixed-methods study comprised of: 1) a quantitative workstream which explored variations in the ethnic and gender breakdown of people admitted to hospital relative to the demographic characteristics of patients enrolled into research studies at the hospital, and 2) a qualitative workstream which explored staff experiences of recruiting patients to clinical trials and patients’ experiences of being approached to take part in a clinical trial. The quantitative workstream provided the necessary context for the design of the qualitative workstream.</div></div><div><h3>Results</h3><div>We found that the chances of being involved in research at the hospital were lower in all ethnic minority groups and lower amongst female patients. Some of the factors acting as barriers in trial participation included patients’ perceptions of clinical research as a form of experimental medicine that might have high risks, the role of family members in decision-making processes, and language barriers (where patients might not be fluent in English and the study information is not communicated in other languages). Potential strategies to address underrepresentation included the development of accessible information about research and how patient data are used, development of study materials in multiple languages and use of interpreters during the recruitment process, support for staff in involving family members in decision-making and a greater ethnic diversity within study teams.</div></div><div><h3>Conclusions</h3><div>The under-representation of people from minority ethnic populations in clinical research remains a major challenge, impacting on the rigour and applicability of findings as well as implying some populations are missing out on the benefits of research. Study design needs to place greater emphasis on patient need and convenience and therefore to take greater account of the deterrent effect of financial and time burdens on trial participants. Recruiting sites and sponsors need to review the provision of interpreting and translation support for trials, including availability and cost to individual studies and staff confidence in reliability.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101475"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143767592","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 challenges and barriers to rural Veteran participation in clinical research within the Veterans Affairs healthcare system","authors":"Marcus R. Johnson ,&nbsp;Aliya Asghar ,&nbsp;Danielle J. Beck ,&nbsp;Tassos Kyriakides ,&nbsp;Matthew P. Vincenti ,&nbsp;Grant D. Huang","doi":"10.1016/j.conctc.2025.101466","DOIUrl":"10.1016/j.conctc.2025.101466","url":null,"abstract":"<div><div>The execution of clinical research in medical facilities that serve rural populations and/or that have lower care complexity levels has been proven to be challenging, as compared to larger healthcare institutions with higher complexity levels. Issues such as isolation, lack of organizational support and resources, difficulty with enrollment of study participants in rural settings, and challenges with identifying and retaining experienced clinical research staff serve as barriers to developing and establishing the necessary infrastructure to conduct clinical research at rural and/or smaller medical facilities. The United States (U.S.) Department of Veterans Affairs’ (VA) has the largest integrated health care system in the country and provides care to over 9 million Veterans. These considerations, combined with feedback collected from a subset of these types of (VA) Medical Centers (VAMCs) on this topic, demonstrate the need for a comprehensive enterprise-level strategy to address these challenges within the VA healthcare system. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure that has vast expertise in the conduct of multi-site clinical research within the VA and is well poised to lead this effort.</div><div>This manuscript describes the CSP “Advancing Capacity for Clinical Research through Engagement with Strategic Sites (ACCESS)” initiative. It focuses specifically on the successes, challenges, and lessons learned from the CSP ACCESS Workgroup (AW) during the development and implementation of a comprehensive pilot plan for engaging rural/lower complexity VAMCs (strategic sites) to participate in CSP clinical research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101466"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143777437","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 three-arm randomized controlled trial protocol: Effects of telephone-based, layperson-delivered wisdom-enhancement narrative therapy and empathy-focused interventions on loneliness, social, and mental health in older adults","authors":"Vivien Foong Yee Tang ,&nbsp;Da Jiang ,&nbsp;Maninder Kahlon ,&nbsp;Esther Oi-wah Chow ,&nbsp;Dannii Yuen-lan Yeung ,&nbsp;Rhonda Aubrey ,&nbsp;Kee-Lee Chou","doi":"10.1016/j.conctc.2025.101479","DOIUrl":"10.1016/j.conctc.2025.101479","url":null,"abstract":"<div><h3>Background</h3><div>Loneliness is an increasingly widespread issue among older adults globally, with significant implications on physical, social, and mental health. While various interventions exist to address this challenge, their long-term effects remain unclear. Using a 3-arm randomized controlled trial, this study aims to evaluate the efficacy of a telephone-based and layperson-delivered wisdom-enhancement narrative therapy (Tele-NT) and empathy-focused program (Tele-EP) against an active control group (ACG) in reducing loneliness.</div></div><div><h3>Methods</h3><div>282 community-dwelling lonely older adults will be recruited and randomly allocated into 1 of the 3 interventions. Older adults will receive two 30-min intervention per week, over the course of 4 weeks, delivered over the phone by a layperson. Assessments will be conducted in-person at baseline (T0), 1-month (T1), 6-month (T2), and 12-month (T3) post-intervention. The primary outcome will be assessed using the Chinese validated 6-item De Jong Gierveld Loneliness Scale and the Revised UCLA Loneliness Scale. The secondary outcomes will include sleep quality, perceived social support, and depressive symptoms. Potential mediators and moderators will also be explored. The data will be analysed using linear mixed models on an intention-to-treat basis.</div></div><div><h3>Discussion</h3><div>This RCT is effective, Tele-NT and/or Tele-EP could serve as a model for broader implementation in the community, offering practical solutions to mitigate loneliness and its associated health burdens in the aging populations.</div></div><div><h3>Trial registration</h3><div>This trial is registered with the Chinese Clinical Trial Registry; ChiCTR2300070179 on April 4, 2024.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101479"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746322","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":"Standardization of laparoscopic intraperitoneal onlay mesh repair for incisional hernia: Impact on clinical outcome and quality-of-life (LIPOM trial, NCT 02089958)","authors":"A. Hellinger ,&nbsp;F. Wotzlaw ,&nbsp;V. Fackeldey ,&nbsp;G. Pistorius ,&nbsp;M. Zdichavsky ,&nbsp;O. Stern ,&nbsp;R. Jünemann ,&nbsp;A. Buia ,&nbsp;LIPOM trial Study Group","doi":"10.1016/j.conctc.2025.101481","DOIUrl":"10.1016/j.conctc.2025.101481","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose&lt;/h3&gt;&lt;div&gt;Current available outcome data following laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia (IH) are comparable to a limited extent only because of a huge number of variability particulary in surgical technique and use of medical devices. In this prospective observational multicenter cohort study we evaluate the impact of a consensus driven standard protocol for IPOM, that is mesh fixation with absorbable tacks in double crown technique enforced by additional non-absorbable transfascial sutures at the edges of the mesh along with the use of Physiomesh™, on clinical and patient reported outcome measures.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A total of 102 consecutive patients were screened for eligibility between September 2013 and October 2014. 85 patients (IH: EHS W1: n = 39, W2: n = 46) were included into the study. Clinical examination and PROM for pain and quality of life measure (Carolina Comfort Scale, CCS) were performed at baseline, during hospital stay and at 6 weeks, 6 months and 1 year follow-up.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The follow-up rate was 87,1 % for the primary endpoint. The Kaplan-Meier estimate for freedom-of-recurrence at 1 year was 95.9 % (95 %-CI: 87.9–98.7 %), the cumulative recurrence rate at 1 year was 4.1 % (95 %-CI: 0.9–11.7 %). There was no intraoperative complication. One seroma (type I; 1/84 (1,2 %), 95 %-CI: 0–7.1 %) was diagnosed during hospital stay. 12 seroma (n = 12/74 (16,2 %), 95 %-CI: 9.4–26.4 %; n = 10 type II and n = 2 type IV) were diagnosed during follow-up requiring surgical intervention in 1 patient (1,4 %, Clavien Dindo grade IIIb). Subcutaneous hematoma were found during follow-up in 8 patients (8/75 (10.7 %); 95 %-CI: 5.3–19.9) with need for surgical intervention in 2 patients (2,7 %, Clavien Dindo grade IIIb). There were 3 superficial surgical site infections (3/74 (4,1 %); 95 %-CI: 0.9–11.7 %, Clavien-Dindo grade I) without need for reoperation. Patient reported pain as measured by numeric rating scale at baseline was 1.36 ± 1.53 and 0.35 ± 1.04 at 1 year follow-up. CCS total scores indicated a good outcome with a decrease to 2.80 ± 6.47 (Min: 0, Q1: 0, Median: 0; Q3: 3.0; Max: 38.0) at 1 year follow-up. Subscore sensation of mesh decreased from 4.01 ± 6.76 (min: 0, Q1: 0, Median: 0; Q3: 5.0; Max: 28.0) at 6 weeks to 1.67 ± 3.99 (Min: 0, Q1: 0, Median: 0; Q3: 1.0; Max: 21.0) after 6 months and 0.90 ± 2.69 (Min: 0, Q1: 0, Median: 0; Q3: 0; Max: 14.0) after 1 year follow-up. Subscores pain and movement limitation both decreased during follow-up and were significantly reduced at 1 year compared to preoperative assessment (p &lt; 0.001).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;This study showed favourable clinical and patient reported outcomes and a low rate of recurrences at 1 year follow-up after IPOM for elective IH applying a standardized surgical technique including the use of Physiomesh™. In view of the data leading to the market with","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101481"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143767593","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":"Effectiveness of electrical stimulation with conservative treatment for lower urinary tract symptoms in Parkinson's disease: A three-armed randomized controlled trial protocol","authors":"Dorien Bennink ,&nbsp;Rob A. de Bie ,&nbsp;Henk W. Elzevier ,&nbsp;Dagmar H. Hepp ,&nbsp;Gommert A. van Koeveringe ,&nbsp;Anton A. van der Plas ,&nbsp;Hein Putter ,&nbsp;Maxime T.M. Kummeling ,&nbsp;Heidi F.A. Moossdorff-Steinhauser","doi":"10.1016/j.conctc.2025.101480","DOIUrl":"10.1016/j.conctc.2025.101480","url":null,"abstract":"<div><h3>Background</h3><div>Despite the high prevalence of lower urinary tract symptoms (LUTS) in patients with Parkinson's disease (PD)—ranging from 27 % to 85 % including symptoms such as urinary urgency,- incontinence, frequency, and nocturia—evidence-based treatment options remain limited. Conservative treatments, such as bladder training, pelvic floor muscle exercises (PFME) with biofeedback and electrical stimulation, have been shown safe and effective in the general population, with minimal side effects. However, their efficacy specifically in PD patients remains unclear. Therefore this study aims to evaluate the effect of electrical stimulation with conservative treatment for LUTS in PD patients.</div></div><div><h3>Methods and analysis</h3><div>This randomized controlled trial includes three study arms. All three groups will receive conservative treatment in combination with different electrical stimulation parameters, small- and broad pulse duration and sham electrical stimulation. In total 150 PD patients with self-reported LUTS who are able to attend a pelvic physical therapy practice independently and complete online questionnaires will be enrolled. The primary outcome is the difference in international prostate symptom score (IPSS), with a range of 0–35.</div><div>A minimal important difference of 4.2 between baseline and 12 weeks of treatment will be statistical significant (p˂0.05). Secondary outcome include questionnaires evaluating bladder dysfunction, burden, and quality of life and will be collected at baseline, 12 weeks and 24 weeks and at one year. Additionally pelvic floor muscle function will be assed at baseline and after 12 weeks.</div><div>All participants receive eight sessions along with their assigned electrical stimulation treatment and conservative treatment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101480"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143777438","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":"Effect of dry needling on quadriceps muscles fatigue in taekwondo players: A protocol for a triple-blinded randomized controlled trial","authors":"Reyhaneh Aghajani ,&nbsp;Elaheh Dehghani ,&nbsp;Mohammad Saeid Khonji ,&nbsp;Soofia Naghdi ,&nbsp;Noureddin Nakhostin Ansari ,&nbsp;Jan Dommerholt ,&nbsp;Amin Nakhostin-Ansari","doi":"10.1016/j.conctc.2025.101476","DOIUrl":"10.1016/j.conctc.2025.101476","url":null,"abstract":"<div><h3>Background</h3><div>A common issue among athletes is muscle fatigue, a brief and transient reduction in the potential of skeletal muscle strength after engaging in muscular activity. A high-quality clinical investigation to evaluate the impact of dry needling (DN) on athletes’ muscle fatigue is lacking. Therefore, this study aims to examine the effect of DN on quadriceps muscle fatigue in taekwondo players.</div></div><div><h3>Methods</h3><div>A triple-blind, randomized, controlled trial will be conducted to measure changes in quadriceps muscle fatigue after DN. Eighty-eight taekwondo players who meet the eligibility criteria will be selected to receive either DN or sham needling to the quadriceps muscle after exercise. Three assessments will be performed before the exercise, after exercise fatigue, and after intervention. The outcomes measured will be isometric peak torque, single-leg hop test, and vertical jump test.</div></div><div><h3>Conclusions</h3><div>The results of this study will provide preliminary evidence regarding the effectiveness of DN in improving quadriceps muscle fatigue in taekwondo players.</div></div><div><h3>Trial registration</h3><div>IRCT20210811052141N1.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101476"},"PeriodicalIF":1.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143737804","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":"Experience of linking to the NHS diabetic eye screening programme records in the ASCEND-eye randomized trial and recommendations for improvement","authors":"Emily Sammons ,&nbsp;Louise Bowman ,&nbsp;Marion Mafham ,&nbsp;Jane Armitage","doi":"10.1016/j.conctc.2025.101474","DOIUrl":"10.1016/j.conctc.2025.101474","url":null,"abstract":"<div><h3>Background</h3><div>The ASCEND-Eye sub-study of the large, double-blind, 2x2 factorial design, placebo-controlled ASCEND trial compared the effects of aspirin and, separately, omega-3 fatty acids on diabetic retinopathy outcomes derived from NHS Diabetic Eye Screening Programmes (DESP) in England and Wales, in adults aged 40 years or older with diabetes and no pre-existing atherosclerotic cardiovascular disease. ASCEND-Eye was unprecedented in what it set out to achieve; no previous studies had successfully obtained linked DESP data for research purposes on a national scale in England and Wales before.</div></div><div><h3>Objective</h3><div>To describe our experience of linking DESP records to help other researchers wishing to use them. We explain the application process, lead times and resources required, and how these data were governed.</div></div><div><h3>Results</h3><div>The process of gaining regulatory and ethics committee approval for ASCEND-Eye through to data acquisition took four years. Several challenges were encountered, including a lack of documentation defining the governance of the NHS screening service, the absence of a single central data repository, the inherent complexity of liaising with multiple data controllers, and a lack of responsiveness to invitations to collaborate by nearly half of the DESPs in England.</div></div><div><h3>Conclusion</h3><div>Routinely collected healthcare data is a valuable source of outcome measure information in clinical trials. However, researchers frequently face barriers to accessing these datasets despite having written informed consent from trial participants to do so. We hope to encourage more NHS DESPs to take part in research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101474"},"PeriodicalIF":1.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746326","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":"An exploratory, open-label, parallel group, randomised controlled trial evaluating the effect of gene based nutritional intervention in type 2 diabetes: The protocol for NUDGE clinical trial","authors":"Savitesh Kushwaha ,&nbsp;Poonam Khanna ,&nbsp;Sanjay Kumar Bhadada ,&nbsp;Vivek Sagar ,&nbsp;Pramod Kumar Gupta ,&nbsp;Jarnail Singh Thakur ,&nbsp;Madhu Gupta ,&nbsp;Rachana Srivastava","doi":"10.1016/j.conctc.2025.101470","DOIUrl":"10.1016/j.conctc.2025.101470","url":null,"abstract":"<div><h3>Introduction</h3><div>Type 2 diabetes mellitus (T2DM) presents significant public health challenges in India, where unique genetic and phenotypic characteristics elevate susceptibility. Recent research highlights the interaction of genetic polymorphisms and dietary factors in T2DM management, forming the basis of personalised nutrition interventions. This study outlines the protocol for NUDGE clinical trial to evaluate the efficacy of gene-based dietary strategies compared to standard recommendations in T2DM management.</div></div><div><h3>Methods</h3><div>The NUDGE trial is an exploratory, open-label, parallel-group, randomised controlled clinical trial conducted across healthcare settings in Chandigarh, India. A total of 300 participants diagnosed with T2DM will be randomised into intervention and control groups. The intervention group will receive personalised diet plans based on genetic polymorphisms (<em>TCF7L2</em> and <em>PPARG</em>), anthropometric, and lifestyle data, while the control group follows standard dietary advice. Baseline and endline assessments will measure fasting blood glucose, HbA1c, anthropometric parameters, and adherence.</div></div><div><h3>Discussion</h3><div>Primary outcomes focus on changes in FBG, while secondary outcomes include weight and blood pressure. Statistical analyses will evaluate gene-diet interactions and adherence to dietary plans. The trial aims to establish evidence for precision nutrition in T2DM by leveraging gene-diet interactions to tailor interventions. Findings will provide insights into the role of personalised nutrition in improving glycemic control.</div></div><div><h3>Conclusion</h3><div>The NUDGE trial seeks to advance precision nutrition in T2DM management, paving the way for individualised dietary recommendations to mitigate disease progression and complications.</div></div><div><h3>Ctri reg no</h3><div>CTRI/2021/09/036121 Clinical Trial Registry of India.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101470"},"PeriodicalIF":1.4,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143684415","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":"Beta-testing the feasibility of a family-based financial incentives smoking cessation intervention with Alaska Native families: Phase 2 of the Aniqsaaq (to breathe) Study","authors":"Brianna N. Tranby ,&nbsp;Antonia M. Young ,&nbsp;Anne I. Roche ,&nbsp;Flora R. Lee ,&nbsp;Ashley R. Brown ,&nbsp;Barb J. Stillwater ,&nbsp;Judith J. Prochaska ,&nbsp;Diane K. King ,&nbsp;Paul A. Decker ,&nbsp;Bijan J. Borah ,&nbsp;Michael G. McDonell ,&nbsp;Timothy K. Thomas ,&nbsp;Christi A. Patten","doi":"10.1016/j.conctc.2025.101472","DOIUrl":"10.1016/j.conctc.2025.101472","url":null,"abstract":"<div><h3>Background</h3><div>Alaska Native and American Indian (ANAI) communities in Alaska have disproportionately high commercial tobacco smoking rates and face barriers to accessing cessation treatment. We beta-tested the feasibility of a remotely delivered, ANAI family-based financial incentive cessation intervention.</div></div><div><h3>Methods</h3><div>We enrolled 10 “dyads” (i.e., one adult ANAI person who smokes [PWS] and one adult family member of their choice) across Alaska into a culturally tailored 6-month intervention (NCT05209451). PWS completed expired carbon monoxide, salivary cotinine, and self-reported abstinence measures at home during six smoking status check-ins. Both dyad members received financial incentives in escalating amounts for confirmed PWS abstinence. Participants completed baseline and end-of-study surveys.</div></div><div><h3>Results</h3><div>Eight of the 10 PWS were women, their average age was 45 years (range = 34–57), and mean daily cigarettes smoked was 13 (range = 3–20). Five of the 10 family members were women, and four currently also smoked. Of the 60 check-ins possible among PWS participants, 41 (68 %) were completed; five (50 %) completed all check-ins. Despite minor difficulties with PWS internet connection, lost test kits, and delayed payment receipt, all participants were able to complete check-ins and received payments earned. Five PWS were abstinent at the final 6-month check-in, and two PWS were abstinent at all check-ins. Five PWS completed the end-of-study survey; four reported the intervention was helpful and would recommend it to others.</div></div><div><h3>Conclusion</h3><div>A family-based financial incentive intervention for smoking cessation with ANAI families appears feasible. Next, a randomized controlled trial will be conducted statewide to evaluate effectiveness and inform future implementation needs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101472"},"PeriodicalIF":1.4,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143703928","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 a digital platform and flare risk blood biomarker index on lupus: A study protocol design for evaluating self efficacy and disease management","authors":"Eldon R. Jupe ,&nbsp;Mohan Purushothaman ,&nbsp;Bruce Wang ,&nbsp;Gerald Lushington ,&nbsp;Sandeep Nair ,&nbsp;Vijay R. Nadipelli ,&nbsp;Bernard Rubin ,&nbsp;Melissa E. Munroe ,&nbsp;Jessica Crawley ,&nbsp;Sneha Nair ,&nbsp;Georg Armstrong ,&nbsp;Arif Sorathia ,&nbsp;Brett Adelman","doi":"10.1016/j.conctc.2025.101471","DOIUrl":"10.1016/j.conctc.2025.101471","url":null,"abstract":"<div><div>We report the design of a pilot study employing clinic visits and a synergized digital, health coaching, and biomarker platform (aiSLE® MGMT [Management]) aimed at improving patient self-efficacy and patient-physician interactions to mitigate heightened disease activity, curtail clinical flares, and reduce potential long-term organ damage in systemic lupus erythematosus (SLE). This 12-month study will utilize a longitudinal cross-over design. Adult participants with confirmed SLE will be recruited and appropriately consented at five community-based US rheumatology clinics. Board certified rheumatologists will perform an exam, documenting the SLE Physician Global assessment (PGA) at Baseline, 3-, 6- and 9-month visits. Blood samples will be collected for completion of a newly developed and validated Lupus Flare Risk Index (L-FRI) that predicts the risk of developing a clinical flare in the next 12 weeks. The digital component of the study will be initiated following the 3-month visit. Participants will be given a mobile study app interfaced with a smartwatch to record activity, heart rate, and sleep quality. The app will be used to administer patient-reported outcome (PRO) surveys and health coaching. In the first three months participants and their rheumatologists will be blinded to L-FRI results; all L-FRI and digital results will be available starting in month four. This prospective pilot study will assess the impact of a comprehensive disease management platform employing a novel blood biomarker test, a mobile app interfaced with a smartwatch to collect biometric data, and app-based video health coaching on self-efficacy, clinical decisions, and outcomes in SLE disease management.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101471"},"PeriodicalIF":1.4,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143684416","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}