Saint-petersburg, Pushkin, Russian Federation
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Phase
N/ASpan
184 weeksSponsor
Esbjerg Hospital - University Hospital of Southern DenmarkSvendborg
Recruiting
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Phase
4Span
213 weeksSponsor
Alimentiv Inc.Svendborg
Recruiting
ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion
Introduction: Inactivity during hospitalisation is associated with significant risk of functional decline especially in older patients. This have major impact on the individual level due to decreased wellbeing and higher level of dependency and on the society level due to increased caregiver burden following hospital discharge. This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients. Methods: ROBUST is a blinded RCT. Patients (n = 488) admitted with acute medical illness to Department of Geriatric Medicine, Odense University Hospital will be randomised to usual care and robot assisted active strength training of lower extremities twice daily (intervention group) or usual care and robot assisted passive sham training (control group) until discharge. Both groups will receive protein supplements. Inclusion criteria: ≥65 years of age, able to ambulate before hospitalisation, expected length of stay ≥2 days. Exclusion criteria: Able to ambulate without assistance during current hospitalisation, severe dementia, delirium, conditions contradicting robot training. The primary outcome, functional decline, will be assessed by Barthel-Index and 30s chair stand test. Secondary outcomes include Quality of life (EQ-5D), Geriatric Depression Scale, Fear of falling (FES-I), cognition (MMSE), qualitative interviews, falls, caregiver burden, discharge destination, readmissions, healthcare costs, sarcopenia, and mortality. Outcomes will be assessed at admission, discharge, and one- and three months follow-up. Data on comorbidity, medications, blood samples, and clinical frailty scale will be collected. Discussion: This study will investigate the effects of in-hospital robot assisted strength training on functional status in older patients with multimorbidity.
Phase
N/ASpan
134 weeksSponsor
Odense University HospitalSvendborg
Recruiting
Safety of Ibuprofen After Major Orthopaedic Surgeries
Hip and knee arthroplasty surgeries are some of the most frequently performed planned procedures in the western world. Multimodal analgesic treatment is the leading analgesic treatment principle, with NSAIDs as an essential part. Ibuprofen, the most frequently prescribed NSAID, is effective in reducing acute postoperative pain. However, ibuprofen may be associated with various serious adverse events, including death, cardiovascular morbidity, gastrointestinal ulcer, and renal impairment. The balance between beneficial and harmful effects of a short-term postoperative treatment with ibuprofen after elective hip and knee arthroplasty is unknown. Objectives: to assess the adverse events of an eight-day treatment of postoperative pain with ibuprofen in patients undergoing elective primary hip or knee arthroplasty. Intervention: the participants will be randomized in two groups: a) oral ibuprofen 400 mg 3 times daily for eight days. b) identical oral placebo 3 times daily for eight days. Design and trial size: PERISAFE is a randomized, placebo-controlled multicentre trial with centralized computer-generated allocation sequence and allocation concealment with unknown block size. Patients, investigators, assessors, caregivers, data-managers, writers of the manuscript, and statisticians will be blinded. A total of 2904 eligible patients are needed to detect or discard an effect corresponding to a relative risk reduction of 1/3 with an acceptable risk of type I error of 5 % and of type II error of 20 %, and a proportion of the composite outcome of serious adverse events of 8% in the experimental group. Sub-studies: - One-year follow-up on the composite primary outcome. - Subgroup analysis on predictors of chronic pain and opioid consumption at 90-days, and one-year after surgery. - Coherence of preoperative use of diuretics, ACE-inhibitors or Angiotensin-II-antagonists and postoperative risk of renal failure.
Phase
4Span
194 weeksSponsor
Naestved HospitalSvendborg
Recruiting
Bicarbonate for In-Hospital Cardiac Arrest
Phase
4Span
156 weeksSponsor
Lars Wiuff AndersenSvendborg
Recruiting
Motivational Feedback Following Total or Unicompartmental Knee Arthroplasty
Background: Worldwide over a million patients receive a TKA or UKA each year and in Denmark more than 10,000 TKA and UKA's are performed annually, and the lifetime risk of symptomatic osteoarthritis (OA) of the knees are 45%. Despite being considered a successful intervention, 15-25% of patients following TKA are not satisfied with their output, which to some degree may be associated with reduced daily physical activity (PA). Few scientific studies have examined how daily PA is affected by TKA and how it might affect rehabilitation. It is unknown if a focus on increased PA in everyday life after return from hospital might improve rehabilitation and patient satisfaction. The current study addresses this 'gap' in science with high-level clinical evidence, to investigate if a novel technology on motivational feed-back regarding PA can be introduced to assist patients with a better rehabilitation following TKA or UKA. Aim: The aim of this randomized controlled trial (RCT) nested in a prospective cohort is to investigate whether PA following TKA or UKA can be optimized by the use of an activity tracking device including motivational feedback in comparison with activity tracking without feedback. Furthermore, a prospective cohort will investigate the predictive value of PA level prior to TKA/UKA for the post-surgical length of stay, return to work, and quality of life. Trial design overview: Design: Randomized, blinded, two-arm, multi center trial. 150 patients scheduled for TKA or UKA will be recruited through Odense University Hospital (Svendborg and Odense) and Vejle Hospital. Patients will be randomized to 12 weeks of activity tracking and motivational feed-back by gamification for patient self-mobilization (Intervention group) or 'care-as-usual' including activity tracking without motivational feed-back (control group). Patients that are not eligible and/or willing to participate in the RCT study will be offered to participate in a prospective non-interventional cohort study where the main outcome are self-reported disability, generel health, return to work, pain medication, overall experience with TKA or UKA. SENS Motion: SENS Motion (SENS Innovation ApS, Copenhagen, Denmark) is a wireless medical accelerometer for collecting objectively PA data. SENS Motion has developed a patient app with gamification/motivational feed-back to enhance PA. SENS Motion is CE marked as a medical device. SENS Motion has no right to unpublished study data and is neither financially nor personally involved in this trial. None in the study group is related to SENS Motion. Blinding: The primary investigator will be blinded to allocation and will not participate in randomization of patients. The statistical analysis will be performed on allocation codes only and thus the data analysts will be blinded in relation to intervention allocation. Blinding to intervention of patients, surgeon, and nurses (healthcare providers) will not be possible due to the nature of the intervention. Randomizing and database: Randomization is performed internet-based using REDCap Randomize, allocated 1:1. The randomization itself takes place right after the surgery. The randomization is performed as a block randomization in blocks of 2, 4 and 6. No stratifications are applied to the randomization, and the primary investigator is blinded regarding the permuted blocking strategy. A data manager, with no clinical involvement in the trial, prepares the randomization sequence. The allocation is concealed in a password-protected computer file. Compliance: Patients in the control group will have the app installed on their smartphones without motivational feedback, solely for transferring data from the activity tracker. To prevent data loss, weekly SMS messages will remind both intervention and control groups to open their SENS app during the week. No standard for adherence in app interventions has been established previously. The implementation aims for a 70% adherence rate, indicating that the intervention group will interact with the app and obtain motivational feedback for 5 out of 7 days weekly. All patients will receive written information on how to attach the sensor, use the app (without a tablet), and use the tablet with motivational feedback. Moreover, all patients will receive a link to a YouTube video presenting the project and providing instructions on how to use the equipment. Time points Assessment will be performed at baseline two weeks prior to surgery and randomization, following the intervention (14 weeks post baseline) (the primary endpoint) and a long term follow-up at 12 months post baseline. Sample size: Sample size is estimated using total accelerometer counts per day from a previous publication on TKA patients. Between-group difference in change score of 50.500 activity counts per day representing ≈ 1/3 standard deviation and a change of ≈17% is considered clinically relevant. To achieve a statistical power of 80% (β=0.80), using a standard deviation of 101.000 counts per day pre- and post-intervention, and allowing the detection of statistically significant differences at an α level of 0.05 (two-tailed testing), a sample size of n = 62 is estimated for each group. Allowing for dropout a recruitment of 150 patients (in total) is planned. Main comparative analyses between groups will be performed by using an intention-to-treat analysis. Between-group mean differences and 95% confidence intervals will be estimated with a general linear model in which the patients baseline score is entered as a covariate and adjusted for potential baseline differences (age, sex, BMI). In addition to the intention-to-treat analysis, a per-protocol analysis will be also be conducted. Ethics: The study has been submitted to the regional Committee for Medical Research Ethics, which has assessed the project as "not subject to notification", Project-ID: S-20222000 - 171. Finally, The Danish Medicines Agency has declared no need for further permission to carry out the study. Qualitative study: A qualitative study using iterations where patients and healthcare professionals through interviews provided input for improvements of the current technology was initiated to tailor the technological maturation of the SENS App for the current patient group. Evaluation and patient involvement will be based on interviews of ten patients. Feed-back from the focus group will be implemented in an updated app-version. The first iteration was in augus t2021, the second was in feburary 2023, the last iteration is planed in september 2023.
Phase
N/ASpan
103 weeksSponsor
Odense University HospitalSvendborg
Recruiting
Healthy Volunteers
Care for Colon 2015
The Danish national colorectal cancer screening program includes all citizens aged 50-74 years, who are invited biennially to a fecal test for invisible blood in the stool. If the test is positive the citizen is invited for a colonoscopy. 90% of the test-positive undergo colonoscopy. The detected cancers are at a significant earlier stage and survival from screening detected cancer is higher. It is also expected that cancer incidence will drop due to removal of the advanced adenomas before they develop into cancer. Although initial results are positive, there is room for improvement. Additionally there are rare but serious complications to colonoscopy in the form of bleeding or bowel perforation. Through four years the investigators have tested the colon capsule endoscopy method, and find that the investigation is associated with significantly less discomfort and that the diagnostic ability to find polyps > 1 cm is better than colonoscopy.
Phase
N/ASpan
235 weeksSponsor
Odense University HospitalSvendborg
Recruiting
Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
Phase
N/ASpan
557 weeksSponsor
Odense University HospitalSvendborg
Recruiting
The Nordic IBD Treatment Strategy Trial
Phase
4Span
127 weeksSponsor
Region Örebro CountySvendborg
Recruiting
NORDTREAT Prospective Study on Inflammatory Bowel Disease
The primary aim is to identify molecular markers (e.g. in the blood and stools) for discrimination between individuals diagnosed with inflammatory bowel disease (IBD) inclusive Crohn's disease (CD), ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBD-U), and those without (non-IBD). Participants with suspected IBD at baseline, with various disease pathways, will be evaluated again using a 1-year cohort study. Diagnosis and clinical outcome will be evaluated at referral and after 1 year of observation. The secondary aims are, in addition to the molecular information, to investigate whether the inclusion of information on clinical and lifestyle factors as well as combination hereof (e.g. gene-environment interaction analyses) can improve the predictive potential of identifying IBD and distinguish the prognosis. Study design: A prospective Nordic multicenter study on prognostic factors for the diagnosis and characterization of IBD among patients referred to the hospital on suspicion of IBD. A panel of possible prognostic biomarkers for diagnostic purposes will be applied to all participants. Setting: All patients referred due to a suspicion of IBD to the departments of gastroenterology in Odense University Hospital, Svendborg Hospital, Vejle Hospital, Esbjerg Hospital and potentially Hospital of Southern Jutland, Aabenraa will be invited to take part in the study. Participants will be included from January 2022 for a 1-year period or until 800 participants in the Nordic study (up to 400 in Denmark) have been included. The follow-up period is one-year including visits and questionnaires and an additional nine years of follow-up by the use of register data. Biological material will be obtained four times for participants with IBD, at week-2/0, and 12, 26 and 52 after the diagnosis has been established. Participants where IBD is not established (non-IBD) will only have biological material obtained at baseline (that is visit -2/0) and will have a clinical interview after 52 weeks. All participants are treated according to standard clinical practice by the clinical departments. Clinical data consist of personal data, data on health and disease, lifestyle, laboratory measures, and disease activity scores including patient-reported outcome measures (PROMs), clinical assessments, and laboratory data. Each participant will fill out validated questionnaires on disease activity, quality of life, and lifestyle using electronic links. Data management: Study data registered by clinicians, study nurses and technicians will be stored in the web-based case report form (eCRF) Viedoc (Viedoc™, Uppsala, Sweden) or REDCap (Open Patient data Explorative Network (OPEN) at Odense University Hospital) for the diet questionnaire. The questionnaires are in Danish and the participants will have access to the questionnaires via an electronic link sent to their personal, electronic mailbox (REDCap) or via an investigator provided link to MyViedoc. All data will be stored in secure research storage facilities. Statistical methods: We will develop multivariable prediction models relating multiple predictors for a particular individual to the probability of or risk for the presence (diagnosis of IBD at baseline) or future occurrence (prognosis) of a particular outcome such as severe IBD within the first year. Predictors such as biomarkers are covariates, explored as prognostic factors (independent variables). The primary hypothesis is that the final biomarker will define the participant population into two groups each consisting of 50%: a biomarker positive group whereof 80% will be diagnosed with IBD and a biomarker negative group whereof 20% will be diagnosed with IBD. For a comparison of two independent binomial proportions using the likelihood ratio statistic with a Chi-square approximation with a two-sided significance level of 0.05, a total sample size of 800 assuming a ratio biomarker positivity-to-negativity of 1 to 1 has an approximate power of 100% when the proportions of being diagnosed with IBD are 0.8 and 0.2. If we assume that we will have 800 study participants, we will potentially ("rule of thumb") be able to build a statistical model with as many as 80 covariates in the multivariable model. The associations of the suspected important biomarkers with other variables will be tested with non-parametric tests: with Spearman rank correlation (rs) for continuous variables, and the Wilcoxon rank-sum test or Kruskal-Wallis test, including a Wilcoxon-type test for trend across ordered groups where appropriate, for categorical variables. In general, logistic regression models will be used with individual marker as the exposure variables and the clinical response as the outcome (dependent variable). The analyses will be adjusted simultaneously for sex, age, and prescribed targeted therapy. Potential interaction between biomarker status (positive/negative) and specific drug type will be analyzed. Covariates (biomarkers) consist of various measures within genetics, transcriptomic, microbiomes, and proteomics. Sample size considerations: Assuming that biomarker positivity constitutes 50% of the individuals enrolled at baseline, if our event rate is 10% on average, a total sample size of 800 patients (i.e. 400 biomarker positive) we will have a very good statistical power (99.7%) to detect a difference between proportions having surgery of 10% points (15% and 5%, respectively). If we decide to split the data set into two (2×400 individuals), in order to first build the model, and subsequently validate it in the second independent dataset, we will have 91.8% statistical power to detect a difference between groups. If the prognostic value of our biomarkers is not that effective separating the number of patients with severe IBD at week 52, we will still have more than 90% power to detect a difference between biomarker groups of 6% points (e.g. 10% and 4%, respectively). Another consideration is the number of events (individuals having severe IBD at week 52) per variable (EPV) considered for inclusion in the multivariable model. For logistic regression modelling the EPV should be at least ten times the number of potential prognostic variables that could be included in the model. As a consequence of this logic, our expected sample size of 800 individuals (having 80 events) will, with reasonable confidence, allow us to create a multivariable model with up to 8 covariates simultaneously. Project organization: NORDTREAT is part of a larger Nordic project (DK, SE, NO and IS) where regular meetings will be held between the partners. Collaborative research and material transfer agreements will be conducted with the national and international collaborators. In addition to the scientific reporting of results, major findings with translational implications will be communicated to health professionals, patient organizations, public health policy makers, and to the general public through various media and news activities.
Phase
N/ASpan
469 weeksSponsor
University of Southern DenmarkSvendborg
Recruiting