scholarly journals NA-CONTROL: a study protocol for a randomised controlled trial to compare specific outpatient rehabilitation that targets cerebral mechanisms through relearning motor control and uses self-management strategies to improve functional capability of the upper extremity, to usual care in patients with neuralgic amyotrophy

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Renee Lustenhouwer ◽  
Nens van Alfen ◽  
Ian G. M. Cameron ◽  
Ivan Toni ◽  
Alexander C. H. Geurts ◽  
...  
Keyword(s):  
Motor Control ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Management Strategies ◽  
Self Management ◽  
Outpatient Rehabilitation ◽  
Functional Capability ◽  
Neuralgic Amyotrophy ◽  
Randomised Controlled

scholarly journals Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00460-2020
Author(s):  
Michael G. Crooks ◽  
Jack Elkes ◽  
William Storrar ◽  
Kay Roy ◽  
Mal North ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Self Management ◽  
Open Label ◽  
Management Interventions ◽  
Randomised Controlled ◽  
The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

scholarly journals Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS)

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033520 ◽  
Author(s):  
Shilpa Patel ◽  
Felix Achana ◽  
Dawn Carnes ◽  
Sandra Eldridge ◽  
David R Ellard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Chronic Headache ◽  
Controlled Trial ◽  
Self Management ◽  
Management Support ◽  
Support Programme ◽  
Chronic Headaches ◽  
Randomised Controlled

IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.

scholarly journals Effectiveness of a brief positive skills intervention to improve psychological adjustment in patients with end-stage kidney disease newly initiated on haemodialysis: protocol for a randomised controlled trial (HED-Start)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053588
Author(s):  
Konstadina Griva ◽  
Jace Ming Xuan Chia ◽  
Zack Zhong Sheng Goh ◽  
Yen Peng Wong ◽  
Job Loei ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Usual Care ◽  
Life Skills ◽  
Controlled Trial ◽  
Self Management ◽  
End Stage Kidney Disease ◽  
Research Activities ◽  
Randomised Controlled ◽  
End Stage

IntroductionInitiation onto haemodialysis is a critical transition that entails multiple psychosocial and behavioural demands that can compound mental health burden. Interventions guided by self-management and cognitive–behavioural therapy to improve distress have been variably effective yet are resource-intensive or delivered reactively. Interventions with a focus on positive affect for patients with end-stage kidney disease are lacking. This study will seek (1) to develop a positive life skills intervention (HED-Start) combining evidence and stakeholder/user involvement and (2) evaluate the effectiveness of HED-Start to facilitate positive life skills acquisition and improve symptoms of distress and adjustment in incident haemodialysis patients.Methods and analysisThis is a single/assessor-blinded randomised controlled trial (RCT) to compare HED-Start to usual care. In designing HED-Start, semistructured interviews, a codesign workshop and an internal pilot will be undertaken, followed by a two-arm parallel RCT to evaluate the effectiveness of HED-Start. A total of 148 incident HD patients will be randomised using a 1:2 ratio into usual care versus HED-Start to be delivered in groups by trained facilitators between January 2021 and September 2022. Anxiety and depression will be the primary outcomes; secondary outcomes will be positive and negative affect, quality of life, illness perceptions, self-efficacy, self-management skills, benefit finding and resilience. Assessments will be taken at 2 weeks prerandomisation (baseline) and 3 months postrandomisation (2 weeks post-HED-Start completion). Primary analyses will use an intention-to-treat approach and compare changes in outcomes from baseline to follow-up relative to the control group using mixed-effect models.Ethics and disseminationEthics approval was obtained from Nanyang Technological University Institutional Review Board (IRB-2019-01-010). Written informed consent will be obtained before any research activities. Trial results will be disseminated via publications in peer-reviewed journals and conference presentations and will inform revision(s) in renal health services to support the transition of new patients to haemodialysis.Trial registration numberNCT04774770.

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

scholarly journals Pain self-management interventions for community-based patients with advanced cancer: a research programme including the IMPACCT RCT

2021 ◽  
Vol 9 (15) ◽  
pp. 1-92
Author(s):  
Michael I Bennett ◽  
Matthew J Allsop ◽  
Peter Allen ◽  
Christine Allmark ◽  
Bridgette M Bewick ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Cancer Pain ◽  
Usual Care ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Self Management ◽  
Work Package ◽  
Randomised Controlled

Background Each year in England and Wales, 150,000 people die from cancer, of whom 110,000 will suffer from cancer pain. Research highlights that cancer pain remains common, severe and undertreated, and may lead to hospital admissions. Objective To develop and evaluate pain self-management interventions for community-based patients with advanced cancer. Design A programme of mixed-methods intervention development work leading to a pragmatic multicentre randomised controlled trial of a multicomponent intervention for pain management compared with usual care, including an assessment of cost-effectiveness. Participants Patients, including those with metastatic solid cancer (histological, cytological or radiological evidence) and/or those receiving anti-cancer therapy with palliative intent, and health professionals involved in the delivery of community-based palliative care. Setting For the randomised controlled trial, patients were recruited from oncology outpatient clinics and were randomly allocated to intervention or control and followed up at home. Interventions The Supported Self-Management intervention comprised an educational component called Tackling Cancer Pain, and an eHealth component for routine pain assessment and monitoring called PainCheck. Main outcome measures The primary outcome was pain severity (measured using the Brief Pain Inventory). The secondary outcomes included pain interference (measured using the Brief Pain Inventory), participants’ pain knowledge and experience, and cost-effectiveness. We estimated costs and health-related quality-of-life outcomes using decision modelling and a separate within-trial economic analysis. We calculated incremental cost-effectiveness ratios per quality-adjusted life-year for the trial period. Results Work package 1 – We found barriers to and variation in the co-ordination of advanced cancer care by oncology and primary care professionals. We identified that the median time between referral to palliative care services and death for 42,758 patients in the UK was 48 days. We identified key components for self-management and developed and tested our Tackling Cancer Pain resource for acceptability. Work package 2 – Patients with advanced cancer and their health professionals recognised the benefits of an electronic system to monitor pain, but had reservations about how such a system might work in practice. We developed and tested a prototype PainCheck system. Work package 3 – We found that strong opioids were prescribed for 48% of patients in the last year of life at a median of 9 weeks before death. We delivered Medicines Use Reviews to patients, in which many medicines-related problems were identified. Work package 4 – A total of 161 oncology outpatients were randomised in our clinical trial, receiving either supported self-management (n = 80) or usual care (n = 81); their median survival from randomisation was 53 weeks. Primary and sensitivity analyses found no significant treatment differences for the primary outcome or for other secondary outcomes of pain severity or health-related quality of life. The literature-based decision modelling indicated that information and feedback interventions similar to the supported self-management intervention could be cost-effective. This model was not used to extrapolate the outcomes of the trial over a longer time horizon because the statistical analysis of the trial data found no difference between the trial arms in terms of the primary outcome measure (pain severity). The within-trial economic evaluation base-case analysis found that supported self-management reduced costs by £587 and yielded marginally higher quality-adjusted life-years (0.0018) than usual care. However, the difference in quality-adjusted life-years between the two trial arms was negligible and this was not in line with the decision model that had been developed. Our process evaluation found low fidelity of the interventions delivered by clinical professionals. Limitations In the randomised controlled trial, the low fidelity of the interventions and the challenge of the study design, which forced the usual-care arm to have earlier access to palliative care services, might explain the lack of observed benefit. Overall, 71% of participants returned outcome data at 6 or 12 weeks and so we used administrative data to estimate costs. Our decision model did not include the negative trial results from our randomised controlled trial and, therefore, may overestimate the likelihood of cost-effectiveness. Conclusions Our programme of research has revealed new insights into how patients with advanced cancer manage their pain and the challenges faced by health professionals in identifying those who need more help. Our clinical trial failed to show an added benefit of our interventions to enhance existing community palliative care support, although both the decision model and the economic evaluation of the trial indicated that supported self-management could result in lower health-care costs. Future work There is a need for further research to (1) understand and facilitate triggers that prompt earlier integration of palliative care and pain management within oncology services; (2) determine the optimal timing of technologies for self-management; and (3) examine prescriber and patient behaviour to achieve the earlier initiation and use of strong opioid treatment. Trial registration Current Controlled Trials ISRCTN18281271. Funding This project was funded by the National Institute for Health Research Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

scholarly journals NA-CONTROL: a study protocol for a randomised controlled trial that compares specific outpatient rehabilitation, that targets cerebral mechanisms through relearning motor control and uses self-management strategies to improve functional capability of the upper extremity, to usual care in patients with neuralgic amyotrophy.

2019 ◽  
Author(s):  
Renee Lustenhouwer ◽  
Nens van Alfen ◽  
Ian G. M. Cameron ◽  
Ivan Toni ◽  
Alexander C.H. Geurts ◽  
...  
Keyword(s):  
Motor Control ◽  
Upper Extremity ◽  
Controlled Trial ◽  
Management Strategies ◽  
Motor Planning ◽  
Rehabilitation Program ◽  
Neuralgic Amyotrophy ◽  
Scapular Dyskinesia ◽  
Randomised Controlled ◽  
Cerebral Mechanisms

Abstract Background: Neuralgic amyotrophy (NA) is a distinct peripheral neurological disorder of the brachial plexus with a yearly incidence of 1/1000, characterised by acute severe upper extremity pain. Weakness of the stabilising shoulder muscles in the acute phase leads to compensatory strategies and abnormal motor control of the shoulder; scapular dyskinesia. Despite peripheral nerve recovery, scapular dyskinesia often persists, leading to debilitating residual complaints including pain and fatigue. Evidence suggests that persistent scapular dyskinesia in NA may result from maladaptive cerebral neuroplasticity, altering motor planning. Currently there is no proven effective causative treatment for the residual symptoms in NA. Moreover, the role cerebral mechanisms may play in persistent scapular dyskinesia remains unclear. Methods: NA-CONTROL is a single-centre randomised controlled trial comparing specific rehabilitation to usual care in NA. The rehabilitation program combines relearning of motor control, targeting cerebral mechanisms, with self-management strategies. Fifty patients need to be included. Patients are recruited through the Radboud university medical center Nijmegen, the Netherlands. Patients with a (suspected) diagnosis of NA, with lateralized symptoms and scapular dyskinesia in the right upper extremity, who are 18 years or older and not in the acute phase can be included. The primary outcome is the Shoulder Rating Questionnaire score, which measures functional capability of the upper extremity. Secondary clinical outcomes include measures of pain, fatigue, participation, reachable workspace, muscle strength and quality of life. In addition, motor planning is assessed with first person motor imagery and functional MRI. In a sub-study the patients are compared to 25 healthy participants, to determine the involvement of cerebral mechanisms. This will enable interpretation of cerebral changes associated with the rehabilitation program and functional impairments in NA. Discussion: NA-CONTROL is the first randomised trial to investigate the effect of specific rehabilitation on residual complaints in NA. It also is the first study into the cerebral mechanisms that might underlie persistent scapular dyskinesia in NA. It thus may aid the further development of mechanism-based interventions for disturbed motor control in NA, as well as other peripheral neurological disorders. Trial Registration: Clinical Trials, NCT03441347. Registered 20 February 2018, https://clinicaltrials.gov/ct2/show/NCT03441347 Keywords: Neuralgic amyotrophy, parsonage turner syndrome, neurorehabilitation, upper extremity, scapular dyskinesia, motor control, peripheral nerve dysfunction, maladaptive neuroplasticity, physical therapy, occupational therapy

Sign in / Sign up

Export Citation Format

Share Document