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Chronic Disease clinical trials

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NCT ID: NCT02993887 Completed - Mindfulness Clinical Trials

Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children

Start date: February 20, 2017
Phase: N/A
Study type: Interventional

The investigators will conduct a randomized clinical trial pilot study to examine the effectiveness of a theoretically based intervention (called ReMind) encompassing two key components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness meditation delivered using a smart phone application (Stop, Breathe & Think™) with an intervention (Mind Only) that consists only of daily mindfulness meditation. Both components of the intervention have been tested separately (but not combined) and both interventions can be self-tailored, which meets the vital need for these caregivers to engage in self-management activities when it is convenient for them. The investigators will test the two arms of the intervention in 30 parents of technology-dependent children, 15 parents in each group. The investigators will collect mixed data at baseline, 3 months and 6 months after subject enrollment to describe changes in proximal and distal outcomes. The investigators aim to: 1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive factors, resourcefulness) and determine if there are different effects between ReMind and Mind Only interventions. 2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life, Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical (Physical Health Related Quality of Life), and cost outcomes between subjects in the ReMind and Mind Only arms over time. 3. Determine the moderating effects of parents' social support, demographics (age, gender, family income) and children's functional status on (a) proximal outcomes and the relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis Function, stress, cognitive factors and distal outcomes. 4. Evaluate the impact of decentering on the association between the interventions and the proximal and distal outcomes. 5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal and distal outcomes associated with each intervention.

NCT ID: NCT02972905 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2269557 to Japanese Healthy Subjects

Start date: October 2016
Phase: Phase 1
Study type: Interventional

GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI) to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557 will be administered via the ELLIPTA DPI with the addition of magnesium stearate. In each group of this study, subjects will receive a single dose of either GSK2269557 or placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session 2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700 mcg. There will be at least 10 days washout between the two dosing sessions. Follow up period will start 10 days (+-1 day) after the last dose of Session 2. A total number of 36 subjects will be enrolled for the study with 27 subjects receiving a dose strength of GSK2269557 and 9 subjects will receive each dose strength of GSK2269557. ELLIPTA is a trademark of the GSK group of companies.

NCT ID: NCT02969317 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients

Start date: February 24, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the pharmacokinetics of tiotropium + olodaterol fixed-dose combination (FDC) (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after single dose and at steady state in Chinese patients with COPD. The secondary objective is to assess the safety of tiotropium + olodaterol FDC (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Chinese patients with COPD.

NCT ID: NCT02965560 Completed - Clinical trials for Acute-On-Chronic Liver Failure

Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure

PGE2
Start date: October 10, 2016
Phase:
Study type: Observational

Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic inflammation and alleviate liver injury in mice model. However, there are no studies evaluating PGE2 as a predictor of early mortality.This study is designed to investigate whether plasma PGE2 and its receptors are associated with development of MOF and predict short-term mortality in patients with acute-on-chronic liver failure. By the way, we will also measure several other potential predictive factors (C-reactive protein,severe hyponatremia, Second infections,Diabetes mellitus,High density lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte ratio,soluable urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).

NCT ID: NCT02958683 Completed - Surgery Clinical Trials

Chest Wall Motion Analysis in Disease

CWM
Start date: July 2011
Phase:
Study type: Observational

Breathing movements, called chest wall motion, are very complex. The investigators are studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this differs with different diseases in the chest. Breathing movements may help with diagnosis, assessment of severity or assessing the impact of treatments for chest conditions. The investigators are following people who have a chest disease, measuring their chest wall motion and comparing it to their diagnosis and and how their treatment works. Chest wall motion can be measured in different ways at rest and whilst exercising. Small stickers on the chest can be used to reflect infra red light or visible squares of light can be shone onto the chest without using stickers.

NCT ID: NCT02956395 Completed - Chronic Disease Clinical Trials

Implementation of Community-based Collaborative Management of Complex Chronic Patients

Nextcare_CCP
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Background/Aims: Large scale adoption of integrated care for chronic patients constitutes a key milestone to accelerate adaptation of current healthcare systems to the evolving needs triggered by population ageing and high prevalence of chronic conditions. Lessons learnt from deployment experiences are being disseminated as "good practices". But, there is need for further assessment of implementation strategies in real world scenarios. Moreover, progresses achieved in disease-oriented integrated care cannot be automatically transferred to management of complex chronic patients (CCP). The protocol addresses five aims: 1) implementation of two integrated care interventions using a collaborative and adaptive case management (ACM) approach (i) Community-based management of CCP; and, ii) Integrated care for patients under long-term oxygen therapy (LTOT)); 2) adoption of information and communication technologies (ICT) required to support collaborative ACM; 3) to evaluate the impact of enhanced clinical health risk assessment and stratification; 5) to generate a roadmap for regional adoption of the CCP program. Methods/Design: the CCP program will be deployed in three healthcare sector of Barcelona-Esquerra (AISBE) (520 k citizens) and in two other areas of Catalonia: Badalona Serveis Assistencials (BSA) (420 k citizens) and Lleida (366 k citizens) following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for evaluation purposes. The study also addresses the steps for scale-up of integrated care in the entire Catalan region (7.5 M citizens). Observational studies with matched controls have been planned for both Community-based management of CCP (n=3.000) and for Integrated care for patients under LTOT (n=500). Moreover, clustered randomized controlled trials (RCT) are planned on top of the observational studies to test specific questions (i.e. performance of the ICT platform providing ACM functionalities). Main components of CCP program are: a) patient stratification; b) comprehensive assessment strategies; c) ICT supported adaptive Case management; d) Roadmap for regional adoption. Hypothesis: the CCP program will generate guidelines for large scale deployment of the CCP program, including transferability analysis, facilitating adoption of integrated care services for management of multi-morbidity.

NCT ID: NCT02940951 Completed - Chronic Disease Clinical Trials

Quality of Life Assessment and Practice Support System in Home Care Services for Older Adults

QPSS
Start date: March 12, 2018
Phase: N/A
Study type: Interventional

Older adults living with incurable and advancing life-limiting illness frequently desire to spend as much time as possible comfortably at home, rather than in hospital. They often have complex problems that not only affect their ability to function, but also their and their family caregivers' overall quality of life (QOL). Routine assessment of their perceived health care needs and their self-reported QOL is necessary to ensure that patients' and family caregivers' concerns are visible to home care clinicians so that they can be effectively monitored and addressed. These types of assessments involve asking people to respond to questions about their symptoms, their physical, psychological, social and existential/spiritual wellbeing, and their experiences with health care. Electronic information systems are increasingly used and recommended to facilitate such QOL assessments. However, there is a need for information about how such systems are best translated into practice improvements that ultimately may improve patient- and family-centred outcomes. This study is about the implementation of an innovative, electronic health care information and practice support system, the Quality of life Assessment and Practice Support System (QPSS), into routine care provided by home care services for older adults with life-limiting illnesses and their family caregivers. Eight home care sites in Canada are participating. At each site the investigators will first adapt the QPSS to the local context and develop a plan for its local implementation. Then home care staff will be asked to use it in practice and the investigators will evaluate the process of using the QPSS and its effect on patient and family caregiver quality of life, health, and satisfaction with care as well as the cost consequences of its integration into practice. The effect of its use will be studied in a randomized trial, which is the part of the study described in this registry. Patients and their family caregivers will be randomly assigned to 1) have their home care team use the QPSS in their care or 2) not to use it, instead receiving care as usual. The effect of using the QPSS will be measured using questionnaires completed by the participating patients and family caregivers every two months. If using the QPSS improves quality of life, health, or satisfaction with care, the last stage will explore how to scale up use of the QPSS in practice and its integration with existing health information systems.

NCT ID: NCT02936817 Completed - COPD Clinical Trials

Study to Assess the Effect of the Aerobika Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using FRI

Start date: December 2016
Phase: Phase 4
Study type: Interventional

Primary: The primary objective of this study is to evaluate the effect of the Aerobika® device on the aerosol deposition pattern of concomitant inhalation medication using FRI. Secondary: The secondary objective of this study is to evaluate the effect of the Aerobika® device on the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw), hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping using FRI.

NCT ID: NCT02926001 Completed - Obesity Clinical Trials

Evaluation of the Impact of a Sugar-Sweetened Beverage Tax in Chile

Start date: October 2011
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate formally the short term impacts of the tax policy applied to Sugar-Sweetened Beverages (SSBs) in Chile. The Impuesto Adicional a las Bebidas Analcohólicas (IABA, or "additional tax on soft drinks") in Chile was enacted in October 2014, affecting any non-alcoholic beverages to which colorants, flavourings or sweeteners have been added. For beverages above an added sugar concentration of at least 6.25 grams per 100ml (or equivalent proportion), the tax was increased from 13% to 18%, while for those below this threshold the tax was decreased to 10%, producing an 8% tax difference between these beverage groups. This impact evaluation analysis of the Chilean sugar-sweetened beverage (SSB) tax will estimate the impact of increasing the tax as well as decreasing the tax on soft drinks. The study will use household level grocery purchasing data for Chile. The purchasing records are available from October 2011 to September 2015 (three years before; and one year after the implementation of the tax in October 2014). The investigators will use a series of quasi-experimental approaches to evaluate the causal impact of the SSB tax policy on consumers' behaviour as well as on industry responses in the form of pricing and price promotion decisions.

NCT ID: NCT02925897 Completed - Chronic Illness Clinical Trials

Enhancing Self-care in the Housebound

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

The prevalence of people living with problems due to a long-term condition (LTC) such as heart disease, diabetes or arthritis in England exceeds 15 million, and the number of those with more than one LTC continues to grow (LTCs). This population consumes a large proportion of health service resources. Advancing age and LTCs increase the likelihood of becoming housebound, this has a detrimental effect on health and quality of life. Health policy advocates a health service model of empowerment and self-care. People who live with LTCs are often very knowledgeable about how to look after their health but find it difficult to adjust their. Motivational techniques have been demonstrated to facilitate behaviour change through changing the style of communication from directive to collaborative. The use of patient-centred conversational style of communication has been shown to elicit more willingness to change than professional-led directive consultations. Community nurses are in a unique position to influence housebound patients to play a greater part in caring for themselves, preventing complications in their long-term conditions and further ill health. This study intends to test the feasibility and acceptability of training community nurses in Understanding Behaviour Change, a communication technique which uses motivational interviewing to guide patients to change their behaviour. The opportunistic use of motivational techniques to create participatory relationships between patients, community nurses potentially represents an effective intervention to enable patients with LTCs to optimise the way they care for themselves. Motivational interviewing techniques have been widely demonstrated to bring about behaviour change but have not been studied in the context of changing the style of communication between housebound patients and the professionals caring for them.