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Chronic Disease clinical trials

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NCT ID: NCT02115412 Completed - Diabetes Mellitus Clinical Trials

Validation of Medication Non-adherence Model (UK)

Start date: July 2014
Phase:
Study type: Observational

Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers. Non-adherence can be due to various forms and have multiple causes. To address this need, Philips Research has developed Medication Non-adherence model. This tool will help in developing a systemic way of assessing medication non-adherence and providing decision support for targeted intervention to healthcare professionals. The aim of this study is to validate this model with 750 chronically ill patients in UK.

NCT ID: NCT02105974 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 7, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.

NCT ID: NCT02105961 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 24, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02105948 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: April 15, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy. Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02102009 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Nutritional Supplementation in Adults With Chronic Respiratory Disease

OFOS
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.

NCT ID: NCT02100982 Completed - Chronic Disease Clinical Trials

Improving Communication About Patient Priorities in Multimorbidity

ICOM-APP
Start date: June 2015
Phase: N/A
Study type: Interventional

The goal of this study is to develop and test Customized Care, an intervention to help patients dealing with depression and/or anxiety in the context of multiple chronic conditions. Customized Care is designed to help patients communicate about important issues, such as financial and safety concerns, with their primary care providers (PCPs). The intervention will be delivered in patient waiting rooms prior to a routine follow-up visit with the PCP. Phase 1 of the project will ensure that the main components of Customized Care are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects of Customized Care on patient-PCP communication. Participants aged 40 years or older who have a diagnosis of two or more common chronic medical conditions will be recruited from primary care clinics. Patients screening positive for either depression or anxiety will be randomized to Customized Care vs. an active control. The investigators hypothesize that the Customized Care will improve patient-Primary Care-Provider communication.

NCT ID: NCT02097914 Completed - Chronic Disease Clinical Trials

Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial

SFH
Start date: March 2014
Phase: N/A
Study type: Interventional

The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited. The proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a Texas 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. The main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.

NCT ID: NCT02096731 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events

Start date: March 2014
Phase: N/A
Study type: Observational

Background: Recent observational studies have reported possible arrhythmogenic effects with long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object of a recent signal in trials of LABAs submitted for marketing approval. Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two long-acting bronchodilators as well as from monotherapy use of each of the long-acting bronchodilators. Methods: A series of population-based cohort studies, using both cohort and nested case-control analyses will be conducted using data from the United Kingdom's Clinical Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary disease (COPD) and at least two years of baseline medical history information. The high-dimensional propensity score technique will be used to match new users of each long-acting bronchodilator and new users of two bronchodilators with comparable subjects from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke, heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using time-dependent Cox proportional hazard regression models and conditional logistic regression models.

NCT ID: NCT02085161 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

NCT ID: NCT02084108 Completed - Chronic Diseases Clinical Trials

Efficacy of Integrated Care to Reduce Hospitalization and Nursing Home Placement in Community Dwelling Frail Elderly

Start date: July 2009
Phase: N/A
Study type: Interventional

Introduction: Care of frail and dependent elders with multiple chronic conditions is a major challenge for health care systems. The objective of this study is to evaluate the effect of coordinating the existing structures in the private and public sector for the care of frail and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social issues. This approach is aimed at improving the coordination, continuity, quality and efficacy of care in this population, which presents a high risk of hospitalization, emergency room visits, institutionalization and mortality. Methods: Three-year cluster randomised controlled trial. A control group receiving usual care (follow up by primary care physician and home nursing service) will be compared to an intervention group that will be provided, in addition, in-home multidimensional geriatric assessment with access to a 24h/7 day a week call service, and coordinated long-term follow-up. Survival analyses will be conducted to compare the outcomes between groups. Primary outcome: - Hospitalizations: rates of first hospitalization, number, cause and length of stay. Secondary outcomes: - Emergency room visits: rates of first visit, number and cause - Institutionalization: number of patients - Mortality: rate and number of deaths and place of death (home versus hospital)