Trials
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Randomized Controlled Trial Multicenter Study
A cluster randomized controlled trial of the effectiveness and cost-effectiveness of intermediate care clinics for diabetes (ICCD): study protocol for a randomized controlled trial.
World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. ⋯ Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.
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Randomized Controlled Trial Multicenter Study
Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial.
Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment. ⋯ This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM.
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Randomized Controlled Trial Multicenter Study
Prevention of: self harm in British South Asian women: study protocol of an exploratory RCT of culturally adapted manual assisted Problem Solving Training (C- MAP).
Suicide is a major public health problem worldwide. In the UK suicide is the second most common cause of death in people aged 15-24 years. Self harm is one of the commonest reasons for medical admission in the UK. In the year following a suicide attempt the risk of a repeat attempt or death by suicide may be up to 100 times greater than in people who have never attempted suicide. Research evidence shows increased risk of suicide and attempted suicide among British South Asian women. There are concerns about the current service provision and its appropriateness for this community due to the low numbers that get involved with the services. Both problem solving and interpersonal forms of psychotherapy are beneficial in the treatment of patients who self harm and could potentially be helpful in this ethnic group.The paper describes the trial protocol of adapting and evaluating a culturally appropriate psychological treatment for the adult British South Asian women who self harm. ⋯ This study will test the feasibility and acceptability of the C- MAP in British South Asian women. We will be informed on whether a culturally adapted brief psychological intervention compared with treatment as usual for self-harm results in decreased hopelessness and suicidal ideation. This will also enable us to collect necessary information on recruitment, effect size, the optimal delivery method and acceptability of the intervention in preparation for a definitive RCT using repetition of self harm and cost effectiveness as primary outcome measures.
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Randomized Controlled Trial Multicenter Study
Depression care management for late-life depression in China primary care: protocol for a randomized controlled trial.
As a major public health issue in China and worldwide, late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Like other chronic diseases in elders such as hypertension and diabetes, depression is a chronic disease that the new National Health Policy of China indicates should be managed in primary care settings. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management (DCM) intervention, and examine its effectiveness on the depressive symptoms of older patients in Chinese primary care settings. ⋯ The DCM project is registered through the National Institutes of Health sponsored by clinical trials registry and has been assigned the identifier: NCT01287494.
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Randomized Controlled Trial Multicenter Study
Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial.
Several studies have showed that people with intellectual disabilities (ID) have suitable skills to undergo cognitive behavioural therapy (CBT). Case studies have reported successful use of cognitive behavioural therapy techniques (with adaptations) in people with ID. Modified cognitive behavioural therapy may be a feasible and effective approach for the treatment of depression, anxiety, and other mood disorders in ID. To date, two studies have reported group-based manaulised cognitive behavioural treatment programs for depression in people with mild ID. However, there is no individual manualised programme for anxiety or depression in people with intellectual disabilities. The aims of the study are to determine the feasibility of conducting a randomised controlled trial for CBT in people with ID. The data will inform the power calculation and other aspects of carrying out a definitive randomised controlled trial. ⋯ The broad outcome of the study will be to produce clear guidance for therapists to apply an established psychological intervention and identify how and whether it works with people with intellectual disabilities.