scholarly journals Exercises with telephone follow-up versus usual care in people with hand osteoarthritis: a randomised controlled trial

2014 ◽  
Vol 22 ◽  
pp. S456 ◽  
Author(s):  
N. Østerås ◽  
K. Hagen ◽  
A-L. Sand-Svartrud ◽  
M. Grotle ◽  
I. Kjeken
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Hand Osteoarthritis ◽  
Randomised Controlled

scholarly journals Long-term outcome of two forms of randomised benzodiazepine discontinuation

2006 ◽  
Vol 188 (2) ◽  
pp. 188-189 ◽  
Author(s):  
R. C. Oude Voshaar ◽  
W. J. M. J. Gorgels ◽  
A. J. J. Mol ◽  
A. J. L. M. Van Balkom ◽  
J. Mulder ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

scholarly journals Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial

2013 ◽  
Vol 203 (5) ◽  
pp. 350-357 ◽  
Author(s):  
Claire Henderson ◽  
Elaine Brohan ◽  
Sarah Clement ◽  
Paul Williams ◽  
Francesca Lassman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Full Time ◽  
Randomised Controlled

BackgroundMany mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request ‘reasonable adjustments’. There have been no intervention studies to support decisionmaking about disclosure to an employer.AimsTo determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid.MethodIn this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014).ResultsWe recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement −22.7 (s.d. = 15.2) v. −11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03).ConclusionsThe observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.

scholarly journals Exercise programme with telephone follow-up for people with hand osteoarthritis – protocol for a randomised controlled trial

2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Nina Østerås ◽  
Kåre Birger Hagen ◽  
Margreth Grotle ◽  
Anne-Lene Sand-Svartrud ◽  
Petter Mowinckel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Hand Osteoarthritis ◽  
Randomised Controlled

scholarly journals Home-based pulmonary rehabilitation early after hospitalisation in COPD (early HomeBase): protocol for a randomised controlled trial

2021 ◽  
Vol 8 (1) ◽  
pp. e001107
Author(s):  
Narelle S Cox ◽  
Aroub Lahham ◽  
Christine F McDonald ◽  
Ajay Mahal ◽  
Paul O'Halloran ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Hospital Discharge ◽  
Hospital Readmission ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Control Group ◽  
Home Based ◽  
Randomised Controlled

IntroductionChronic obstructive pulmonary disease (COPD) is characterised by exacerbations of respiratory disease, frequently requiring hospital admission. Pulmonary rehabilitation can reduce the likelihood of future hospitalisation, but programme uptake is poor. This study aims to compare hospital readmission rates, clinical outcomes and costs between people with COPD who undertake a home-based programme of pulmonary rehabilitation commenced early (within 2 weeks) of hospital discharge with usual care.MethodsA multisite randomised controlled trial, powered for superiority, will be conducted in Australia. Eligible patients admitted to one of the participating sites for an exacerbation of COPD will be invited to participate. Participants will be randomised 1:1. Intervention group participants will undertake an 8-week programme of home-based pulmonary rehabilitation commencing within 2 weeks of hospital discharge. Control group participants will receive usual care and a weekly phone call for attention control. Outcomes will be measured by a blinded assessor at baseline, after the intervention (week 9–10 posthospital discharge), and at 12 months follow-up. The primary outcome is hospital readmission at 12 months follow-up.Ethics and disseminationHuman Research Ethics approval for all sites provided by Alfred Health (Project 51216). Findings will be published in peer-reviewed journals, conferences and lay publications.Trial registration numberACTRN12619001122145.

scholarly journals Acupuncture for Irritable Bowel Syndrome: 2-Year Follow-Up of a Randomised Controlled Trial

2017 ◽  
Vol 35 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Hugh MacPherson ◽  
Helen Tilbrook ◽  
Deborah Agbedjro ◽  
Hannah Buckley ◽  
Catherine Hewitt ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Point Estimate ◽  
Irritable Bowel ◽  
Randomised Controlled ◽  
Post Randomisation

Background A recent randomised controlled trial (RCT) of acupuncture as a treatment for irritable bowel syndrome (IBS) demonstrated sustained benefits over a period of 12 months post-randomisation. Aim To extend the trial follow-up to evaluate the effects of acupuncture at 24 months post-randomisation. Methods Patients in primary care with ongoing IBS were recruited to a two-arm pragmatic RCT of acupuncture for IBS. Participants were randomised to the offer of up to 10 weekly sessions of acupuncture plus usual care (n=116 patients) or to continue with usual care alone (n=117). The primary outcome was the self-reported IBS symptom severity score (IBS SSS) measured at 24 months post-randomisation. Analysis was by intention-to-treat using an unstructured multivariate linear model incorporating all repeated measures. Results The overall response rate was 61%. The adjusted difference in mean IBS SSS at 24 months was −18.28 (95% CI −40.95 to 4.40) in favour of the acupuncture arm. Differences at earlier time points estimated from the multivariate model were: −27.27 (−47.69 to −6.86) at 3 months; −23.69 (−45.17 to −2.21) at 6 months; −24.09 (−45.59 to −2.59) at 9 months; and −23.06 (−44.52 to −1.59) at 12 months. Conclusions There were no statistically significant differences between the acupuncture and usual care groups in IBS SSS at 24 months post-randomisation, and the point estimate for the mean difference was approximately 80% of the size of the statistically significant results seen at 6, 9 and 12 months. Trial registration number ISRCTN08827905.

scholarly journals Feasibility randomised controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e022746 ◽  
Author(s):  
Elizabeth A Grunfeld ◽  
Lauren Schumacher ◽  
Maria Armaou ◽  
Pernille L Woods ◽  
Pauline Rolf ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Data Collection ◽  
Return To Work ◽  
Usual Care ◽  
Controlled Trial ◽  
Full Time ◽  
Patients With Cancer ◽  
Randomised Controlled

ObjectivesEmployment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically led workbook intervention designed to support patients with cancer returning to work.DesignParallel-group randomised controlled trial with embedded qualitative interviews.SettingOncology clinics within four English National Health Service Trusts.ParticipantsPatients who had received a diagnosis of breast, gynaecological, prostate or colorectal cancer and who had been receiving treatment for a minimum of two weeks.InterventionA self-guided WorkPlan workbook designed to support patients with cancer to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual and was offered the workbook at the end of their 12-month follow-up.Outcome measuresWe assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness.ResultsThe recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomisation procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at 6-month and 12-month follow-up were 72% and 69%, respectively. At 6-month follow-up, 30% of the usual care group had returned to full-time or part-time work (including phased return to work) compared with 43% of the intervention group. At 12 months, the percentages were 47% (usual care) and 68% (intervention).ConclusionsThe findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and black and ethnic minority patients diagnosed with cancer.Trial registration numberISRCTN56342476; Pre-results.

Does MRI add value in general practice for patients with traumatic knee complaints? A 1-year randomised controlled trial

2018 ◽  
Vol 53 (20) ◽  
pp. 1285-1292 ◽  
Author(s):  
Nynke M Swart ◽  
Kim van Oudenaarde ◽  
Sita MA Bierma-Zeinstra ◽  
Hans JL Bloem ◽  
Wilbert B van den Hout ◽  
...  
Keyword(s):  
General Practice ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Primary Outcome Measure ◽  
Care Group ◽  
Randomised Controlled ◽  
Daily Function

ObjectiveTo determine whether referral to MRI by the general practitioner (GP) is non-inferior to usual care (no access to MRI by GPs) in patients with traumatic knee complaints regarding knee-related daily function.MethodsThis was a multicentre, non-inferiority randomised controlled trial with 1-year follow-up. GPs invited eligible patients during or after their consultation. Eligible patients (18–45 years) consulted a GP with knee complaints due to a trauma during the previous 6 months. Patients allocated to the MRI group received an MRI at (median) 7 (IQR 1–33) days after the baseline questionnaire. Patients in the usual care group received information on the course of knee complaints, and a referral to a physiotherapist or orthopaedic surgeon when indicated. The primary outcome measure was knee-related daily function measured with the Lysholm scale (0 to 100; 100=excellent function) over 1 year, with a non-inferiority margin of 6 points.ResultsA total of 356 patients were included and randomised to MRI (n=179) or usual care (n=177) from November 2012 to December 2015. MRI was non-inferior to usual care concerning knee-related daily function during 1-year follow-up, for the intention-to-treat (overall adjusted estimate: 0.33; 95% CI −1.73 to 2.39) and per-protocol (overall adjusted estimate: 0.06; 95% CI −2.08 to 2.19) analysis. There were no differences between both groups in the amount of patients visiting other healthcare providers.ConclusionMRI in general practice in patients with traumatic knee complaints was non-inferior to usual care regarding knee-related daily function during 1-year follow-up.Trial registration numberNTR3689.

scholarly journals Exercise and internet-based cognitive–behavioural therapy for depression: multicentre randomised controlled trial with 12-month follow-up

2016 ◽  
Vol 209 (5) ◽  
pp. 414-420 ◽  
Author(s):  
Mats Hallgren ◽  
Björg Helgadóttir ◽  
Matthew P. Herring ◽  
Zangin Zeebari ◽  
Nils Lindefors ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Depression Severity ◽  
Moderate Depression ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundEvidence-based treatment of depression continues to grow, but successful treatment and maintenance of treatment response remains limited.AimsTo compare the effectiveness of exercise, internet-based cognitive–behavioural therapy (ICBT) and usual care for depression.MethodA multicentre, three-group parallel, randomised controlled trial was conducted with assessment at 3 months (post-treatment) and 12 months (primary end-point). Outcome assessors were masked to group allocation. Computer-generated allocation was performed externally in blocks of 36 and the ratio of participants per group was 1:1:1. In total, 945 adults with mild to moderate depression aged 18–71 years were recruited from primary healthcare centres located throughout Sweden. Participants were randomly assigned to one of three 12-week interventions: supervised group exercise, clinician-supported ICBT or usual care by a physician. The primary outcome was depression severity assessed by the Montgomery–Åsberg Depression Rating Scale (MADRS).ResultsThe response rate at 12-month follow-up was 84%. Depression severity reduced significantly in all three treatment groups in a quadratic trend over time. Mean differences in MADRS score at 12 months were 12.1 (ICBT), 11.4 (exercise) and 9.7 (usual care). At the primary end-point the group × time interaction was significant for both exercise and ICBT. Effect sizes for both interventions were small to moderate.ConclusionsThe long-term treatment effects reported here suggest that prescribed exercise and clinician-supported ICBT should be considered for the treatment of mild to moderate depression in adults.

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