Abstract:
BACKGROUND:Impairments of memory are commonly reported by people with traumatic brain injuries (TBI). Such deficits are persistent, debilitating, and can severely impact quality of life. Currently, many do not routinely receive follow-up appointments for residual memory problems following discharge. METHODS/DESIGN:This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme. Three hundred and twelve people with a traumatic brain injury will be randomised from four centres. Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment, have memory problems, are 18 to 69 years of age, are able to travel to one of our centres and attend group sessions, and are able to give informed consent. Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care. Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme, which has been developed in previous pilot studies. The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems. All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation. The primary outcome is the Everyday Memory Questionnaire at 6 months. Secondary outcomes include the Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, health related quality of life, cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire, individual goal attainment, European Brain Injury Questionnaire (patient and relative versions), and the Everyday Memory Questionnaire-relative version. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme. DISCUSSION:The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI. We discuss our decision-making regarding choice of outcome measures and control group, and the unique challenges to recruiting people with memory problems to trials. TRIAL REGISTRATION:ISRCTN65792154; Date: 18 October 2012.
journal_name
Trialsjournal_title
Trialsauthors
das Nair R,Lincoln NB,Ftizsimmons D,Brain N,Montgomery A,Bradshaw L,Drummond A,Sackley C,Newby G,Thornton J,Stapleton S,Pink Adoi
10.1186/1745-6215-16-6subject
Has Abstractpub_date
2015-01-06 00:00:00pages
6issn
1745-6215pii
1745-6215-16-6journal_volume
16pub_type
杂志文章,多中心研究,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increas...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0622-4
更新日期:2015-03-22 00:00:00
abstract:BACKGROUND:AirSeal is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide (CO₂) recirculation during laparoscopic surgery. Comparison data to standard CO₂ pressure pneumoperitoneum insufflators is scarce. The aim of this study is to ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-239
更新日期:2014-06-20 00:00:00
abstract:BACKGROUND:Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is pop...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3733-5
更新日期:2019-12-02 00:00:00
abstract:BACKGROUND:Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmac...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2597-4
更新日期:2018-04-17 00:00:00
abstract:BACKGROUND:Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-29
更新日期:2014-01-21 00:00:00
abstract:BACKGROUND:Indigenous Australian youth (aged 15 to 34) have up to four times the risk of suicide compared with their non-Indigenous counterparts. Barriers to help-seeking include shame, feared loss of autonomy and negative attitudes towards healthcare providers. The use of mobile devices and apps continues to rise amon...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-396
更新日期:2013-11-20 00:00:00
abstract:BACKGROUND:Fibroblast growth factor 23 (FGF23) is associated with left ventricular hypertrophy (LVH) in patients with chronic kidney disease, and calcimimetic therapy reduces plasma concentrations of FGF23. It remains unknown whether treatment with the calcimimetic etelcalcetide (ETL) reduces LVH in patients on hemodia...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3707-7
更新日期:2019-10-24 00:00:00
abstract:BACKGROUND:The choice of antiepileptic drug for an individual should be based upon the highest quality evidence regarding potential benefits and harms of the available treatments. Systematic reviews and meta-analysis of randomised controlled trials should be a major source of evidence supporting this decision making pr...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-34
更新日期:2007-11-05 00:00:00
abstract:BACKGROUND:Graves' hyperthyroidism is an autoimmune disease causing hyperfunction of the thyroid gland. The concentration of selenium is high in the thyroid gland and two important groups of enzymes within the thyroid are selenoproteins, that is, they depend on selenium. Selenium may have beneficial effects on autoimmu...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-119
更新日期:2013-04-30 00:00:00
abstract:BACKGROUND:The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-140
更新日期:2014-04-23 00:00:00
abstract:BACKGROUND:The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1405-2
更新日期:2016-06-02 00:00:00
abstract:BACKGROUND:Diabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all admi...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-8
更新日期:2013-01-09 00:00:00
abstract:BACKGROUND:Depression is a debilitating and costly disease for our society, especially in the case of treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy in treatment-resistant unipolar and non-psychotic depression. It can be applied according to tw...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04255-9
更新日期:2020-04-05 00:00:00
abstract:BACKGROUND:Premature ejaculation (PE) is the most common sexual dysfunction among men. According to patients, the general practitioner (GP) is the appropriate professional with whom to discuss this issue. However, few patients receive the medical help needed because GPs find it difficult to talk to their patients about...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2947-2
更新日期:2018-11-12 00:00:00
abstract:BACKGROUND:There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process. One explanation for this reduced recovery is that the legal process and the associate...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-227
更新日期:2013-07-20 00:00:00
abstract:BACKGROUND:We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. METHODS/DESIGN:Eligible patients are aged 21 to 65 ye...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-121
更新日期:2012-08-01 00:00:00
abstract:BACKGROUND:Incomplete recovery from facial palsy results in social and physical disabilities, and the medical options for the sequelae of Bell's palsy are limited. Acupuncture is widely used for Bell's palsy patients in East Asia, but its efficacy is unclear. METHODS:We performed a randomized controlled trial includin...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0777-z
更新日期:2015-06-03 00:00:00
abstract:BACKGROUND:There are a large number of clinical outcome measures used to assess the effectiveness of prevention and management strategies of periodontal diseases. This heterogeneity causes difficulties when trying to synthesise data for systematic reviews or clinical guidelines, reducing their impact. Core outcome sets...
journal_title:Trials
pub_type: 共识发展会议,杂志文章,评审
doi:10.1186/s13063-017-2169-z
更新日期:2017-09-20 00:00:00
abstract:BACKGROUND:The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversi...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2305-9
更新日期:2017-12-22 00:00:00
abstract:BACKGROUND:The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the ef...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1770-x
更新日期:2017-01-19 00:00:00
abstract:BACKGROUND:The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16-18 weeks first-line chemotherapy in metastatic colorectal cancer (mCRC). METHODS:The study design is a pr...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4194-6
更新日期:2020-03-06 00:00:00
abstract:BACKGROUND:The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. METHODS:Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, a...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-1934-3
更新日期:2017-05-02 00:00:00
abstract:BACKGROUND:The clinical benefits of bioimpedance spectroscopy (BIS)-guided fluid management in patients on hemodialysis have been widely demonstrated. However, no previous reports have evaluated the effect of regular and serial BIS-guided fluid management on the residual renal function (RRF) in patients on peritoneal d...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-432
更新日期:2014-11-06 00:00:00
abstract:BACKGROUND:Older adults living in nursing homes spend the majority of their time inactive. The associated levels of chronic disease place an increasing burden on healthcare systems. Physical activity (PA) interventions delivered through exercise classes may be resource-intensive and require specialist staff. The aim of...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2848-4
更新日期:2018-08-29 00:00:00
abstract:BACKGROUND:College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guid...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04868-0
更新日期:2020-11-26 00:00:00
abstract:BACKGROUND:After major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complica...
journal_title:Trials
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1186/s13063-015-0903-y
更新日期:2015-08-28 00:00:00
abstract:BACKGROUND:Haemostasis in liver surgery remains a challenge despite improved resection techniques. Oozing from blood vessels too small to be ligated necessitate a treatment with haemostats in order to prevent complications attributed to bleeding. There is good evidence from randomised trials for the efficacy of fibrin ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-11-109
更新日期:2010-11-19 00:00:00
abstract:BACKGROUND:There has been longstanding interesting in cognitive training for older adults with cognitive impairment. In this study, we will investigate the effects of working memory training, and explore augmentation strategies that could possibly consolidate the effects in older adults with mild neurocognitive disorde...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0999-0
更新日期:2015-10-24 00:00:00
abstract:BACKGROUND:Patient-reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing-remitting conditions, such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequ...
journal_title:Trials
pub_type: 杂志文章,多中心研究
doi:10.1186/s13063-018-2962-3
更新日期:2018-10-24 00:00:00
abstract:BACKGROUND:Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-traumatic amputation of inferi...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-26
更新日期:2007-09-26 00:00:00