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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: NCT02401919 Recruiting - Communication Clinical Trials

Basic Care Revisited_Communication for Patient Participation

BCR_C
Start date: May 2014
Phase: N/A
Study type: Interventional

COMMUNICATION - Feasibility and effectiveness 'Tell-us Cards' in hospital patients - Objective - To investigate the feasibility and effectiveness of 'Tell-us Cards' on patient participation in basic care in hospital settings. - Design - Cluster randomised controlled early trial design (Phase 2B, MRC Framework). Patients of two surgical and two medical wards (n=140) will be included in this study. Before and after the introduction of the intervention, assessments will take place in patients and nurses at these wards. - Intervention - The 'Tell-us card' is a tool to elicit patients preferences and needs in basic care. Patients are invited to write down their specific questions and concerns. The cards are handed out to patients admitted to the hospital (daily). Patients and informal caregivers are invited to use the cards to state their preferences. Nurses are instructed to use the cards as a tool in their dialogue with the patient in making care plans, during ward rounds or for discharge information sessions. - Comparison - Usual care - Primary outcome - Patient perception of participation in care (Individualized Care Scale (ICS) - Secondary - Use and content of the 'Tell-us Cards' actions taken by nurses as a consequence of what patients 'tell them' by means of the 'Tell-us Cards', Quality from the Patients' perspective (QPP), EQ-5D, and CQ satisfaction with communication & care in general