View clinical trials related to Chronic Disease.
Filter by:The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis. The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home. Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.
This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model.
In the past two decades, as a result of population aging and shifts in patient needs, we have seen an increased demand for chronic disease management (CDM) delivered in the community. The Hong Kong Government introduced six nurse allied health clinics (NAHC) programme to assist the delivery of care to facilitate the increased demand on chronic disease management (CDM) in the community, which are currently being piloted within the government funded general outpatient clinics (GOPC) of the Hospital Authority (HA). These programmes are designed to enhance CDM in primary care through patient empowerment and use of multi-disciplinary nurse and allied health led teams, and aim for secondary prevention and treat-to-target for specific health conditions. This model of care has already been established in a number of countries, namely United Kingdom, Australia, Canada and United States, where multi-disciplinary allied-health clinics, nurse practitioners and nurse-led clinics have already been integrated into routine practice in primary care (Thomas, Cullum et al. 2000; Laurant, Reeves et al. 2005). The six NAHC programmes which have been developed to date address falls prevention (FP), continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. he Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme. The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the NAHC programme is achieved. Each NAHC participating clinic will be invited to complete a structured evaluation questionnaire. Anonymized data of all patients who have enrolled into the NAHC programme for more than 6 months will be included in the evaluation on the process and outcomes of care. Data on the process of care will be retrieved from the HA medical records. In-depth study of NAHC CC programme: In order to compare the outcomes over time between subjects who have and who have not participated in the NAHC Continence Care Programme, three hundred and sixty control patients who have not been enrolled into the NAHC CC programme will be selected for the comparison in the outcomes of care. Subjects will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline , 12-month and 24-month after enrollment. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and have improvement in clinical outcomes. Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service and patient reported outcomes between baseline and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4 times over a period of 5 years. In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and control group will be compared by independent sample t-test or Chi-square test. Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HA's NAHC programmes enhance the QOC of their participating patients. This information will be used to guide service planning and policy decision making.
The primary objective of the study is to identify demographic and non-spirometric clinical features predictive of the asthma-COPD overlap population. The study aims to explore and identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical profile that enable clinical differentiation from subjects with a primary diagnosis of either asthma alone (without persistent obstruction) or COPD alone (without reversibility). The study is designed as a targeted medical history survey which consists of a 41-item questionnaire, which will be administered by a qualified health care practitioner at the time a subject's medical history is taken. The questionnaire has been developed to elicit specific details of the respiratory history, including the following: bronchodilator use, disease progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of disease, symptom presentation, co morbidities and age of onset. In addition, demographic information, standard medical history, co morbidity and spirometric results will also be obtained and analyzed in conjunction with the questionnaire results. Approximately 1000 subjects are required for the study.
This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15 milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to standard of care (SoC). The primary objective of this study is to explore the therapeutic potential of losmapimod as a treatment to reduce the rate of exacerbations in the subset of participants with moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood eosinophils at screening. As secondary objectives safety, effects on lung function, quality of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be evaluated. The duration of the treatment period is variable but will be at least 26 weeks and up to a maximum of 52 weeks, with the end of study date being established once the final participant has been randomized. The purpose of the variable dosing regimen is to enable participants to remain in the study for a longer duration, as it is anticipated that this will increase the likelihood of observing exacerbation events without increasing the overall study duration. It will also enable safety data on dosing periods beyond 6 months to be generated. Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be randomized to the study. Sample size re-estimation will be performed during the course of the study to potentially increase the sample size up to a maximum of 600 participants.
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. This study will examine the impact of implementation and use of consumer health IT tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
Recent work have shown that low load, high-repetitive single limb resistance training, if compared to a control, can increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of limiting exertional symptoms. However, no comparison to another exercise regimen have been performed. In addition neither the intramuscular nor the mechanism of this exercise regimen have been investigated and represents the aim of the proposed project. We will in a prospective, assessor-blind; block randomized controlled, parallel-group trial compare single-limb to two-limb low load, high-repetitive resistance training in patients with severe and very severe COPD The research hypothesizes are: - that single-limb low-load high-repetitive resistance training will provide larger gain in the 6-min walking distance than two-limb low-load high- repetitive resistance training in patients with severe to very severe (stage III-IV) COPD. - that eight weeks of single limb training should also be associated with larger physiological (increased muscle endurance, less muscle fatigue and deoxygenation) and structural (muscle protein synthesis, fiber-type distribution and capillarization) muscle adaptations to training, lower cardio- respiratory demand, as well a greater increase in health-related quality of life in comparison to two-limbs simultaneous training. We will also compare the groups at baseline to investigate the acute effects and mechanisms of single-limb to two-limb low load, high-repetitive resistance training, a comparison that also will include healthy matched controls. The research hypothesizes are: - that involving a large muscle mass during exercise (e.g., two-limb low load, high-repetition resistance training) compared to involving a small muscle mass during training (e.g., single limb low load, high-repetition resistance training) would lead to larger restraints on the cardiorespiratory system in patients with severe to very severe COPD. Conversely, single limb interventions should produce less dyspnea and more muscle deoxygenation and fatigue than two-limb simultaneous exercise while healthy controls will be able to perform both legs/arms exercise without a central constraint, and no negative consequences on muscle fatigue or exercise stimulus.
The investigators hypothesize that an intervention, within an established patient-centered medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital utilization among medically complex children.