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Patient Participation clinical trials

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NCT ID: NCT04657783 Recruiting - Clinical trials for Cardiovascular Diseases

French National Cohort of People With Type 1 Diabetes

SFDT1
Start date: June 10, 2020
Phase:
Study type: Observational [Patient Registry]

Cardiovascular (CV) diseases are the most frequent type 1 diabetes (T1D) complications. A recent epidemiological study showed that patients with T1D have a two-fold CV mortality risk, even in case of good glycemic control. In addition, it has been shown that patients with T1D with no traditional CV risk factors had about a 80% higher risk of cardiovascular event compared to non-diabetic individuals. This indicates that further modifiable risk factors in relation to CV mortality remain to be identified. One of the candidates that could help to disentangle the factors associated with the increased CV mortality in T1D patients is glycemic variability which could contribute to diabetes complications. Indeed, severe hypoglycaemia, one of the most severe consequence of glycaemic variability, are associated with a higher mortality in patients with type 1 and type 2 diabetes. In order to evaluate the relation between glycemic variability, insulin therapy modalities and CV risk as well as some other questions related to health determinants of T1D, we are building up a large observational, prospective, multi-centric cohort study of patients gathering 15,000 patients with T1D, age above 6 years old, to perform the following: - Collecting clinical information - Evaluating Glycemic variability (assessed by the coefficient of variation of glucose (CV) calculated from automatically downloaded continuous glucose monitoring data (CGM) - Biobanking including plasma, DNA, urine, saliva and hair. - Collecting patients' reported outcomes through auto-questionnaires (online questionnaires). - Doing an active follow-up for a period of 10 years with an intermediate visit every 3 years. - Passive follow-up: link to national Health data system (Système National de Données de Santé, SNDS) in order to exhaustively collect health events as death, CV events and hospitalizations (including severe hypoglycemia).

NCT ID: NCT04484688 Not yet recruiting - Clinical trials for Patient Participation

Prestilol(Perindopril+Bisoprolol) in Therapy of Patients With Atrial Fibrilation

Start date: August 1, 2020
Phase:
Study type: Observational

The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of bisoprolol/perindopril in patients with permanent atrial fibrillation

NCT ID: NCT04420871 Completed - Clinical trials for Patient Participation

Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer

Start date: December 10, 2018
Phase: Phase 1
Study type: Interventional

A multicenter, randomized, open-label, three-period, and reference-replicated crossover study was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess the bioequivalence between two formulations of capecitabine.

NCT ID: NCT04288362 Completed - Diabetes Mellitus Clinical Trials

Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D)

PACE-D
Start date: March 25, 2019
Phase: N/A
Study type: Interventional

The study is a non-randomised controlled trial involving an intervention group and a control group. It aims to evaluate the effects of a patient engagement and empowerment model of collaborative care support planning on clinical outcomes of patients with diabetes mellitus as compared to usual care in the primary care setting. It also aims will be to examine the impact of the intervention on patient activation, patient and healthcare provider experience, and healthcare utilisation.

NCT ID: NCT04153266 Completed - Quality of Life Clinical Trials

Oral Epithelial Dysplasia Informational Needs Questionnaire

ODIN-Q
Start date: October 31, 2018
Phase:
Study type: Observational

Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED. Project aims: To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED. Timescale: 19 months. Clinical significance: This questionnaire can be useful in clinical practice. It could help to meet the patient's information needs and plan educational interventions for those showing unmet needs.

NCT ID: NCT03985163 Completed - Opioid-use Disorder Clinical Trials

Patient Reported Outcomes for Opioid Use Disorder

Start date: June 7, 2019
Phase:
Study type: Observational [Patient Registry]

The goal of the project is to build a clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient reported outcomes measures (PROs) to conduct opioid related research in emergency departments (EDs). 200 adult patients with a history of non-medical opioid use, opioid use disorder, or acute opioid overdose will be enrolled and will be asked to complete three PRO surveys (baseline, 3 days post ED discharge, and 30 days post discharge).

NCT ID: NCT02989090 Completed - Clinical trials for Patient Participation

Electronic Patient Notification of Remote ICD Data: Impact of Patient Engagement on Outcomes in the Merlin.Netâ„¢

ePHR-ICD-SJM
Start date: October 2014
Phase: N/A
Study type: Interventional

Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an overall improvement in the quality of care for such patients. Despite the efficacy of remote monitoring of ICDs and the satisfaction of patients and providers with the process, there is a desire from patients to have access and view ability of the data their ICD is transmitting. However, methods for making ICD device data directly available to the patients are not currently in place. This study aims to elicit the impact of standardized remote monitoring ICD data to patients through an electronic personal health record (ePHR) on patient engagement, healthcare utilization, and patient-provider communication. For this study, patients with an ICD manufactured by St. Jude Medical and that are undergoing remote monitoring through the remote management system, Merlin.netâ„¢, will receive a standardized format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview Health. The standard format for the electronic remote monitoring ICD data, as it is delivered to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider attitudes and perceptions regarding the value of the Patient Notification Summary, its impact on clinic workflow, and patient-provider communication will be collected.

NCT ID: NCT02979457 Completed - Clinical trials for Patient Participation

Degree of Worry as a Predictor for Utilization of Acute Health Care

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

The overall aim of the study is to construct a scale that systematically incorporates the callers' perspective in a "degree of worry - scale" and to explore the consequences for the actors in the system - caller, call-handler, and health care system. This will be done through four independent studies. 1. Is it possible to validate "the degree of worry" scale with the software system "Corti"? 2. Does callers' degree of worry relieve after telephone consultation? 3. Does call handlers' awareness of degree of worry affect triage outcome? 4. Is callers' degree of worry a predictor of illness severity?

NCT ID: NCT02714582 Completed - Nursing Clinical Trials

Feasibility, Appropriateness, Meaningfulness and Effectiveness of Bedside Shift Reporting

Start date: March 2016
Phase: N/A
Study type: Interventional

Hospitals face the challenge to continually improve their quality of care. In order to achieve this goal, they have to focus on both improving clinical practice and increasing the involvement of patients in the healthcare process. Both factors are equally important to quality of care. The World Health Organization highlights the role that patients and their family could play in the improvement of healthcare. Active patient participation reduces communication errors, increases patient empowerment and is associated with positive health and psychosocial outcomes. A possible strategy to improve patient participation through communication can be bedside shift report (BSR). Bedside shift report is a process where shift-to-shift report between nurses is, if approved by the patient, executed at the patient's bedside in order to improve the patient's involvement. Bedside shift report has the potential to result in more patient satisfaction, better clinical outcomes, improvement of health education and enhanced team coherence. Preliminary research indicates that BSR decreases safety incidents and adverse events and readmissions, positively influences staff satisfaction, offers beneficial financial effects by reducing nurses' overtime, and allows direct patient care to start earlier. Despite of these effects, rigorous and large-scale scientific research on this topic is lacking. Currently, the available evidence is scarce and mostly consists of single case or small-scale studies. Longitudinal results on effectiveness and sustainability of BSR are also unknown or inconclusive. There is a need for an increased number of controlled studies to evaluate the impact of BSR on patient, staff and economic outcomes and its longitudinal results. The aim of this study is four-folded: 1. The development and fine-tuning of a BSR-intervention and implementation protocol by using diagnostic interviews, co-design, and pilot studies. 2. A quantitative evaluation of BSR in comparison with care as usual on patient-related, clinical, and nurse-related outcomes. 3. A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR as a method to improve communication and patient participation with a particular interest in the experience of benefits and disadvantages by healthcare professionals and patients. 4. A process evaluation of BSR to determine the intervention fidelity and to assess the evolution of BSR over the period of the study (e.g. adaptations, consistent practice). The study design was based on the Medical Research Council-framework for developing and evaluating complex interventions. Power calculation indicates a minimum of 5 experimental wards with 35 patients should be included in the study. The hospital, the specialization of the ward and the nurse-patient ratio will be used for the matched controlled assignment.

NCT ID: NCT02615769 Completed - Lung Diseases Clinical Trials

Effect on Attendance if Including Focused Information of Spirometry in Preventive Health Checks

Start date: November 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if focused information of spirometry in the invitation to preventive health checks will increase the attendance compared with a standard invitation to preventive health checks.