scholarly journals Improving recruitment of older people to clinical trials: use of the cohort multiple randomised controlled trial design

2015 ◽  
Vol 44 (4) ◽  
pp. 547-550 ◽  
Author(s):  
A. Clegg ◽  
C. Relton ◽  
J. Young ◽  
M. Witham
Keyword(s):  
Clinical Trials ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Trial Design ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people

2013 ◽  
Vol 42 (5) ◽  
pp. 633-640 ◽  
Author(s):  
A. K. Drahota ◽  
D. Ward ◽  
J. E. Udell ◽  
D. Soilemezi ◽  
R. Ogollah ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Older People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

scholarly journals Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022205 ◽  
Author(s):  
Esther Williamson ◽  
Lesley Ward ◽  
Karan Vadher ◽  
Susan J Dutton ◽  
Ben Parker ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Best Practice ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Community Dwelling ◽  
Neurogenic Claudication ◽  
Randomised Controlled

IntroductionNeurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention.Methods and analysisThis is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study.Ethics and disseminationEthical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website.Trial registration numberISRCTN12698674; Pre-results.

scholarly journals RANDOMISED CONTROLLED TRIAL TO REDUCE IN-PATIENT FALLS IN HOSPITALISED OLDER PEOPLE

2012 ◽  
Vol 18 (Suppl 1) ◽  
pp. A21.1-A21 ◽  
Author(s):  
D Kendrick ◽  
O Sahota ◽  
C Vass ◽  
A Drummond ◽  
M Grainge ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Older People ◽  
Controlled Trial ◽  
Patient Falls ◽  
Randomised Controlled
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