scholarly journals Innovative Telemonitoring Enhanced Care program for CHF (ITEC-CHF): Usability and Patient Perspectives (Preprint)

2020 ◽  
Author(s):  
Sheau Chen ◽  
Iain Edwards ◽  
Rajiv Jayasena ◽  
Hang Ding ◽  
Mohanraj Karunanithi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Care Program ◽  
Ethics Committee ◽  
Self Management ◽  
Trial Protocol ◽  
Care Providers ◽  
Trial Registry ◽  
Zealand Clinical Trial Registry ◽  
Clinical Trial Registry ◽  
Human Research Ethics

BACKGROUND Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but little is known about usability and patients’ willingness to engage with this technology. OBJECTIVE To evaluate patients’ feedback following participation in the Innovative Telemonitoring Enhanced Care program for CHF (ITEC-CHF) study. METHODS Survey feedback on the usability of ITEC-CHF was collected in participants following 6 months of telemonitoring of their body weight. Responses were provided on a five-point Likert-scale and through and open-ended questions to determine the perceived benefits and barriers to using ITEC-CHF. RESULTS 67 participants (73% male), aged 69.8 ± 12.4 completed the survey. The majority of participants agreed or strongly agreed that the ITEC-CHF program was easy to use (91%), easy to navigate (78%), useful (91%), and made them feel more confident in managing their weight (85%). Themes related to participants’ perceptions of telemonitoring included: (1) increased support for early intervention of clinical deterioration; (2) improved compliance with daily weighing; (3) a sense of reassurance; (4) improved self-care and accountability. CONCLUSIONS ITEC-CHF was rated highly on usability and was well accepted by users as part of their routine self-management activities. Participants were willing to use telemonitoring because they perceived many benefits for CHF management. CLINICALTRIAL This study complies with the Declaration of Helsinki. The clinical trial protocol was approved by the Health Human Research Ethics Committee in Victoria (HREC Reference: HREC/14/PH/27), and Western Australia (Reference: 15-081, and Reference: HR 181/2014), Australia. The trial was registered with Australian New Zealand Clinical Trial Registry (Trial ID: ACTRN 12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691). Informed consent was obtained from the participants in the trial.

Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development

2016 ◽  
Vol 27 (1) ◽  
pp. 2-9
Author(s):  
Abhishek Biswas ◽  
C V Shendkar ◽  
Bikas K Arya ◽  
PK Lenka ◽  
Ratnesh Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Device ◽  
Point Of Care ◽  
Clinical Trial Design ◽  
Trial Protocol ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration

Abstract Objective This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry- India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed. Design and Methods The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI. Conclusions Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.

scholarly journals Primary success of electrical cardioversion for new-onset atrial fibrillation and its association with clinical course in non-cardiac critically ill patients: sub-analysis of a multicenter observational study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Nozomu Shima ◽  
Kyohei Miyamoto ◽  
Seiya Kato ◽  
Takuo Yoshida ◽  
Shigehiko Uchino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Sinus Rhythm ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Icu Discharge ◽  
Primary Success ◽  
Success Group ◽  
Onset Atrial Fibrillation ◽  
New Onset

Abstract Background Electrical cardioversion (ECV) is widely used to restore sinus rhythm in critically ill adult patients with atrial fibrillation, although its prognostic value is uncertain. This study aims to elucidate the clinical meaning of successful ECV. Methods This is a sub-analysis of the AFTER-ICU study, a multicenter prospective study with a cohort of 423 adult non-cardiac patients with new-onset atrial fibrillation (AF). Patients that underwent ECV within 7 days after initial onset of AF were included in the sub-analysis. We compared intensive care unit (ICU) and overall hospital mortality, survival time within 30 days, cardiac rhythm at ICU discharge, and the length of ICU and overall hospital stay between patients whose sinus rhythm was restored immediately after the first ECV session (primary success group) and those in whom it was not restored (unsuccessful group). To find the factors related to the primary success of ECV, we also compared patient characteristics, the delivered energy, and pretreatment. Results Sixty-five patients received ECV and were included in this study. Although 35 patients (54%) had primary success, recurrence of AF occurred in 24 of these patients (69%). At ICU discharge, three patients still had AF in the unsuccessful group, but no patients in the primary success group still had AF. ICU mortality was 34% in the primary success group and 17% in the unsuccessful group (P = 0.10). Survival time within 30 days did not differ between the groups. Delivered energy and pretreatment were not associated with primary success of ECV. Conclusions The primary success rate of ECV for new-onset AF in adult non-cardiac ICU population was low, and even if it succeeded, the subsequent recurrence rate was high. Primary success of ECV did not affect the rate of mortality. Pretreatment and delivered energy were not associated with the primary success of ECV. Trial registration UMIN clinical trial registry, the Japanese clinical trial registry (registration number: UMIN000026401, March 31, 2017).

scholarly journals Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study

2021 ◽  
Author(s):  
Mayte Buchbender ◽  
Jakob Fehlhofer ◽  
Peter Proff ◽  
Tobias Möst ◽  
Jutta Ries ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Oral Cavity ◽  
Bowel Disease ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Expression Levels ◽  
Inflammatory Bowel ◽  
Group 2

Abstract Objectives Inflammatory bowel disease (IBD) has multiple impacts on soft and hard tissues in the oral cavity. The aim of this study was to analyze the expression of cytokines in biofilm samples from patients suffering from IBD and compare them to healthy patients. It was hypothesized that different cytokine expression levels and clinical associations might be drawn. Material and methods A total of 56 biofilm samples from three different patient cohorts (group 0 = healthy, HC n = 30; group 1 = Crohn’s disease, CD, n = 19; group 2 = ulcerative colitis, UC, n = 7) were examined for the expression levels of the cytokine interleukins IL-2, -6, and -10; matrix metalloproteinases 7 and 9; and surface antigens CD90/CD11a by quantitative real-time PCR and according to clinical parameters (plaque index, BOP, PD, DMFT, CAL). Relative gene expression was determined using the ∆∆CT method. Results The mean BOP values (p = 0.001) and PD (p = 0.000) were significantly higher in the CD group compared to controls. Expression of IL-10 was significantly higher in the CD (p = 0.004) and UC groups (p = 0.022). Expression of MMP-7 was significantly higher in the CD group (p = 0.032). IBD patients treated with TNF inhibitors (p = 0.007) or other immunosuppressants (p = 0.014) showed significant overexpression of IL-10 compared to controls. Conclusion Different expression levels of IL-10 and MMP-7 were detected in plaque samples from IBD patients. As only BOP was significantly increased, we conclude that no clinical impairment of periodontal tissue occurred in IBD patients. Clinical relevance With the worldwide increasing incidence of IBD, it is important to obtain insights into the effects of the disease on the oral cavity. The study was registered (01.09.2020) at the German clinical trial registry (DRKS00022956). Clinical trial registration The study is registered at the German clinical trial registry (DRKS00022956).

Effect of Nudge-Based Intervention on Adherence to Physician Visit Recommendations and Early Health Outcomes among Individuals Identified with Chronic Kidney Disease in Screens

2021 ◽  
pp. ASN.2021050664
Author(s):  
Shingo Fukuma ◽  
Shusaku Sasaki ◽  
Masataka Taguri ◽  
Rei Goto ◽  
Toshihiro Misumi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Health Outcomes ◽  
Behavioral Economics ◽  
Physician Visit ◽  
Group Versus ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Screening Programs ◽  
Early Health

BackgroundAlthough CKD screening programs have been provided in many settings, little is known as to how we can effectively translate those screening programs into improved health.MethodsWe conducted a randomized clinical trial on national health screening for CKD in Japan between April 2018 and March 2019. A total of 4011 participants in CKD screening programs aged 40–63 years were randomly assigned to two interventions or the control, with a ratio of 2:2:1, respectively: (1) the nudge-based letter that contained a message on the basis of behavioral economics, (2) the clinical letter including general information about CKD risks, and (3) the control (informed only of the screening results). The main outcome was adherence to a recommended physician visit within 6 months of the intervention. The secondary outcomes were eGFR, proteinuria, and BP 1 year after the intervention.ResultsCompared with the control group, the probability of undergoing a recommended physician visit was higher among participants who received the nudge-based letter (19.7% for the intervention group versus 15.8% for the control; difference, +3.9 percentage points [pp]; 95% CI, +0.8 to +7.0; P=0.02) and the clinical letter (19.7% versus 15.8%; difference, +3.9 pp; 95% CI, +0.8 to +7.0; P=0.02). We found no evidence that interventions were associated with improved early health outcomes.ConclusionsThe behavioral economics intervention tested in this large RCT had limited effect on changing behavior or improving health outcomes. Although the approach has promise, this study demonstrates the challenge of developing behavioral interventions that improve the effectiveness of CKD screening programs.Clinical Trial registry name and registration number: University Hospital Medical Information Network Clinical Trial Registry, UMIN000035230

scholarly journals Institutional Ethics Committee Regulations and Current Updates in India

2017 ◽  
Vol 18 (8) ◽  
pp. 738-741
Author(s):  
Amit V Mahuli ◽  
Simpy A Mahuli
Keyword(s):  
Ethics Committees ◽  
Ethics Committee ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Multiple Factors ◽  
Research Guidelines ◽  
Institutional Ethics ◽  
Controller General ◽  
Human Participants ◽  
Indian Scenario

ABSTRACT Aim The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Background Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question “what makes clinical research ethical” is significant and difficult to answer as multiple factors are involved. Review results The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. Conclusion In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. Clinical significance The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India. How to cite this article Mahuli AV, Mahuli SA, Patil S, Bhandi S. Institutional Ethics Committee Regulations and Current Updates in India. J Contemp Dent Pract 2017;18(8):738-741.

Guidance for reporting clinical trial registry records and published protocols use in systematic reviews of interventions

2019 ◽  
Author(s):  
Julia Bidonde ◽  
Jose Francisco Meneses-Echavez ◽  
Angela Jean Busch ◽  
Catherine Boden
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Systematic Reviews ◽  
Cochrane Collaboration ◽  
Subject Area ◽  
Selective Reporting ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Reporting Practices ◽  
Starting Point

Abstract Background: Transparency is a tenet of systematic reviews. Searching for clinical trial registry records and published protocols has become a mandatory standard when conducting a systematic review of interventions. However, there is no comprehensive guidance for review authors on how to report the use of registry records and published protocols in their systematic review. The objective of this study was to generate initial guidance to assist authors of systematic reviews of interventions in the reporting of registry records and published protocols in systematic reviews of interventions. Methods: We used a compilation of the procedures recommended by expert organizations (e.g., Cochrane Collaboration) related to the reporting of use of registry records and published protocols in the conduct of systematic reviews. The compilation was developed by one of the authors in this study and served as a starting point in developing the algorithm. We extracted current practice data related to registry records and published protocols from a stratified random sample of Cochrane systematic reviews of interventions published between 2015 and 2016 (n=169). We identified examples that adhered to or extended the current guidance. Based on the on the elements above, we created the algorithm to bridge gaps and improve current reporting practices. Results: Trial protocols should be used to account for all evidence in a subject area, evaluate reporting bias (i.e. selective reporting and publication bias), and determine the nature and number of ongoing or unpublished studies for planning review updates. Review authors’ terminology (e.g., ongoing, terminated) and consequent reporting in the review should reflect the phase of the trial found. Protocols should be clearly and consistently reported throughout the review (e.g. abstract, methods, results) as is done with published articles. Conclusions: Our study expands on available guidance to describe in greater detail the reporting of registry records and published protocols for review authors. We believe this is a timely investigation that will increase transparency in the reporting of trial records in systematic reviews of interventions and bring clarification to current fuzziness in terminology. We invite researchers to provide feedback on our work for its improvement and dissemination. Trial Registration: not applicable

scholarly journals Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhi-peng Xiao ◽  
ke Jin ◽  
Jie-qing Wan ◽  
Yong Lin ◽  
Yao-hua Pan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Blood Flow ◽  
Cerebral Blood Flow ◽  
Ischemic Stroke ◽  
Multimodal Imaging ◽  
Imaging Techniques ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cerebrovascular Reserve ◽  
Randomized Controlled

Abstract Background Cerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke. Methods/design This is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniques for the evaluation of CVR to improve treatment of patients with ischemic stroke. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. The patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months. Discussion Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635; Registered on 16 October 2016. All items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635.

Sign in / Sign up

Export Citation Format

Share Document