Mobile-based program improves healthy eating of ulcerative colitis patients: A pilot study
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ABSTRACT:
SUBMITTER: Tu W
PROVIDER: S-EPMC10566283 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundTofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Patients with inflammatory bowel disease are susceptible to Clostridium difficile infection (CDI). Here, we evaluate CDI in the tofacitinib UC clinical program.MethodsEvents from 4 randomized, placebo-controlled studies (phase [P] 2 or P3 induction [NCT00787202; NCT01465763; NCT01458951], P3 maintenance [NCT01458574]) and an open-label, long-term extension (OLE) study (NCT01470612), were analyzed as 3 cohorts: Induction (P2/P3 induction), Maintenance (P3 maintenance), and Overall (patients receiving tofacitinib 5 or 10 mg twice daily [BID] in P2, P3, and OLE studies; including final data from the OLE study, as of August 24, 2020). Proportions and incidence rates (unique patients with events per 100 patient-years of exposure) of CDI were evaluated.ResultsThe overall cohort comprised 1157 patients who received ≥1 dose of tofacitinib 5 or 10 mg BID, with a total of 2814.4 patient-years of tofacitinib exposure and up to 7.8 years of treatment. A total of 82.6% of patients received predominantly tofacitinib 10 mg BID. In the induction, maintenance, and overall cohorts, 3 (2 tofacitinib treated, 1 placebo treated), 3 (all placebo treated), and 9 patients had CDI, respectively; the overall cohort incidence rate was 0.31 (95% confidence interval, 0.14-0.59). CDI were all mild-moderate in severity and resolved with treatment in 8 patients. Six of 9 patients continued tofacitinib treatment without interruption. Two patients had events reported as serious due to hospitalization. Two patients were receiving corticosteroids when the CDI occurred.ConclusionCDIs among patients with UC receiving tofacitinib were infrequent, cases were mild-moderate in severity, and most resolved with treatment.
| S-EPMC10152280 | biostudies-literature
Project description:UnlabelledCardiac rehabilitation (CR) is crucial in the management of cardiovascular disease (CVD), yet attendance is poor. Mobile technology (mHealth) offers a potential solution to increase reach of CR. This paper presents two development studies to determine mobile phone usage in adults with CVD and to evaluate the acceptability of an mHealth healthy eating CR program.MethodsCR attendees were surveyed to determine mobile phone usage rates. A second single-subject pilot study investigated perceptions of a 4-week theory-based healthy eating mHealth program and explored pre-post changes in self-efficacy.Results74 adults with CVD completed the survey (50/74 male; mean age 63 ± 10). Nearly all had mobile phones (70/74; 95%) and used the Internet (69/74; 93%), and most were interested in receiving CR by text message (57/74; 77%). 20 participants took part in the healthy eating pilot study. Participants read all/most of the text messages, and most (19/20) thought using mobile technology was a good way to deliver the program. The website was not widely used as visiting the website was reported to be time consuming. Exploratory t-tests revealed an increase in heart healthy eating self-efficacy post program, in particular the environmental self-efficacy subset (Mean = 0.62, SD = 0.74, p = 0.001).ConclusionsText messaging was seen as a simple and acceptable way to deliver nutrition information and behavior change strategies; however, future research is needed to determine the effectiveness of such programs.
| S-EPMC4251404 | biostudies-literature
Project description:Background and aimsVariation in care has been demonstrated among hospitalized patients with ulcerative colitis. Guidelines aim to reduce variation; however, it is known that the uptake of guidelines by physicians is variable. Providing patients with guidelines is a strategy that has not been extensively studied in inflammatory bowel disease (IBD). Our aim was to evaluate the impact of a patient-directed educational intervention that included treatment guidelines among hospitalized ulcerative colitis patients.MethodsWe performed a quality improvement, cluster-randomized trial at seven tertiary IBD centres. Sites were randomized to implement an educational intervention or standard care for a 6-month period between January 2017 and January 2018. The educational intervention consisted of a patient-directed video that provided a summary of inpatient management guidelines for ulcerative colitis. Primary outcome measures included the length of stay and colectomy at discharge and 6 months. Patient-reported outcomes included trust in physician and patient satisfaction at discharge and at 6 months.ResultsNinety-one patients were enrolled. No statistically significant differences in length of stay or colectomy were noted. Patients who received the intervention had higher trust in physician as measured by Trust in Physician Score at discharge (69.5 vs. 62.6, P = 0.028) and at 6 months (77.7 vs. 68, P = 0.008). Patient satisfaction as measured by the CACHE questionnaire in the intervention group was higher at discharge (72.8 vs. 67.1, P = 0.04); however, this difference was not sustained.ConclusionEmpowering patients with guidelines through an educational intervention resulted in differences in trust in physician and patient satisfaction. Further studies are needed for evaluating a strategy of engaging IBD patients to take a more active role in their care. (clinicaltrials.gov, NCT02569333).
| S-EPMC8158645 | biostudies-literature
Project description:BackgroundTotal proctocolectomy with ileal pouch-anal anastomosis (IPAA) is widely regarded as a definitive surgical option for managing ulcerative colitis (UC). Enhanced recovery programs (ERP) have shown potential in better outcomes following surgery; however, their perioperative benefits in UC patients undergoing IPAA remain insufficiently investigated.MethodsThis study included UC patients who underwent IPAA between January 2008 and September 2023 across multiple affiliated centers within the China UC Pouch Center Union. Key outcomes analyzed included postoperative complications and long-term quality of life (QOL), assessed via the comprehensive complication index (CCI) and Cleveland Global Quality of Life (CGQL) instrument.ResultsA total of 216 patients were included, with a median follow-up of 8.0 years (interquartile range, 4.0-11.0 years); 62 patients underwent comprehensive ERP. Results indicated that ERP implementation significantly lowered CCI scores (p = 0.036), reduced the incidence of severe complications (CCI > 26.2, p = 0.019), shortened hospital stays (p = 0.046), and improved long-term QOL (p < 0.001). Non-adherence to ERP emerged as an independent risk factor for severe postoperative complications (odds ratio, 3.195; 95% confidence interval, 1.332-7.664; p = 0.009) and impaired QOL (odds ratio, 3.222; 95% confidence interval, 1.462-7.101; p = 0.004).ConclusionOur study provided supporting evidence for the application of perioperative ERP in a specific homogeneous cohort of UC patients undergoing IPAA to further improve clinical outcomes for them.
| S-EPMC11825569 | biostudies-literature
Project description:BackgroundShared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of the increasing complexity of available treatment choices and their trade-offs. The use of decision aids (DA) may be effective in increasing patients' participation in UC management but their uptake has been limited due to high attrition rates and lack of a participatory approach to their design and implementation.ObjectiveThe primary aim of this study is to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim is to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care.MethodsmyAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients, and nonmedical volunteers. A qualitative pilot study to evaluate the DA, involving patients with UC facing new treatment decisions and inflammatory bowel disease clinicians, was undertaken.ResultsA total of 11 patients with UC and 15 clinicians provided feedback on myAID. Themes explored included the following: Acceptability and usability of myAID-myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM, uptake was thought to vary depending on clinicians' approaches to patient education and practice, potential to overcome time restrictions associated with outpatient clinics was identified, presentation of unbiased information enabling patients to digest information at their own pace was noted, and potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; Perceived role and usefulness of myAID-discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence, and myAID facilitated early discussion of medical versus surgical treatment options; Target population and timing of use-greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy; and Potential concerns and areas for improvement-some perceived that use of myAID may precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician and may increase resource requirements.ConclusionsThese preliminary findings suggest that patients and clinicians consider myAID as a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT, which will evaluate the clinical efficacy of myAID compared with usual care.Trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12617001246370; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001246370.
| S-EPMC7952232 | biostudies-literature
Project description:Ulcerative colitis (UC) is a chronic immune-mediated disorder, whose etiology is not fully understood and for which no effective treatment is available. Recently, research has focused on the dysbiosis of gut microbiome in UC. However, the results so far remain inconsistent and insufficient to understand the microbial component in UC pathogenesis. In this study, we determine specific changes in the gut microbial profile in Polish UC patients compared to healthy subjects for the first time. Using 16S rRNA gene-based analysis we have described the intestinal microbial community in a group of 20 individuals (10 UC patients and 10 controls). Our results after multiple hypothesis testing correction demonstrated substantially lower gut microbiome diversity in UC cases compared to the controls and considerable differences at the phylum level, as well as among 13 bacterial families and 20 bacterial genera (p < 0.05). UC samples were more abundant in Proteobacteria (8.42%), Actinobacteria (6.89%) and Candidate Division TM7 (2.88%) than those of healthy volunteers (2.57%, 2.29% and 0.012%, respectively). On the other hand, Bacteroidetes and Verrucomicrobia were presented at a lower level in UC relative to the controls (14% and 0% vs 27.97% and 4.47%, respectively). In conclusion, our results show a reduced gut microbial diversity in Polish UC patients, a reduction of taxa with an anti-inflammatory impact and an increased abundance of potentially pathogenic bacteria.
| S-EPMC7835370 | biostudies-literature
Project description:Genome-wide transcriptional profiling of colonic biopsies endoscopically acquired from the rectosigmoid area of healthy donors and UC patients.
2024-04-05 | GSE224758 | GEO
Project description:For IBD, >163 susceptibility loci have been revealed by Genome-wide association studies (GWAS). Still only 13.6% of the heritability in CD and 7.5% in UC can be explained by the loci that have been revealed (23128233). In an endeavor to pinpoint additional IBD genes and pathways involved in the disease, we have made a large scale transcriptome analysis of human pince 380 biopsies from 109 donors. We identified novel genes and protein-protein interaction networks that are strongly associated with disease and gives new insight to the pathology of both CD and UC and the resulting inflammation
2022-09-07 | GSE66407 | GEO
Project description:BackgroundTofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present integrated analyses of nonmelanoma skin cancer (NMSC) incidence in the tofacitinib UC clinical program.MethodsNonmelanoma skin cancer events were evaluated from 3 randomized, placebo-controlled studies: 2 identical, 8-week induction studies (NCT01465763, NCT01458951), a 52-week maintenance study (NCT01458574), and an open-label, long-term extension study (NCT01470612). Cohorts analyzed were: Induction, Maintenance, and Overall (patients receiving ≥1 dose of tofacitinib 5 mg or 10 mg twice daily [BID]). An independent adjudication committee reviewed potential NMSC. Proportions and incidence rates (IRs; unique patients with events per 100 patient-years of exposure) for NMSC were evaluated. A Cox proportional hazards model was used for risk factor analysis.ResultsNonmelanoma skin cancer was evaluated for 1124 patients (2576.4 patient-years of tofacitinib exposure; ≤6.8 years' treatment). In the Induction Cohort, NMSC IR was 0.00 for placebo and 1.26 for 10 mg BID. Nonmelanoma skin cancer IR was 0.97 for placebo, 0.00 for 5 mg BID and 1.91 for 10 mg BID in the Maintenance Cohort, and 0.73 (n = 19) in the Overall Cohort. No NMSC was metastatic or led to discontinuation. In the Overall Cohort, Cox regression identified prior NMSC (hazard ratio [HR], 9.09; P = 0.0001), tumor necrosis factor inhibitor (TNFi) failure (3.32; P = 0.0363), and age (HR per 10-year increase, 2.03; P = 0.0004) as significant independent NMSC risk factors.ConclusionsFor patients receiving tofacitinib, NMSC occurred infrequently. Older age, prior NMSC, and TNFi failure, which are previously reported NMSC risk factors in patients with UC, were associated with increased NMSC risk.
| S-EPMC8804509 | biostudies-literature
Project description:The etiology of the inflammatory bowel diseases, including ulcerative colitis, remains incomplete, but recent findings points to the involvement of complex host-microbial interactions. We hypothesized that an analysis of the proteins on the host-microbial interacting surface, the intestinal mucosa, could reveal novel insights into the diseases. Mucosal colonic biopsies were extracted by standard colonscopy from sigmoideum from 10 ulcerative colitis patients from non-inflammed tissue and 10 controls. The biopsies were immediately following extraction snap-frozen for protein analysis and the protein content of the biopsies was characterized by high-throughput quantative gel-free proteomics.
2015-05-26 | PXD001608 | Pride