scholarly journals Safety in primary care (SAP-C): a randomised, controlled feasibility study in two different healthcare systems

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Caoimhe Madden ◽  
Sinéad Lydon ◽  
Margaret E. Cupples ◽  
Nigel D. Hart ◽  
Ciara Curran ◽  
...  
Keyword(s):  
Primary Care ◽  
Feasibility Study ◽  
Healthcare Systems ◽  
Randomised Controlled

scholarly journals Feasibility study to assess the delivery of a novel isometric exercise intervention for people with stage 1 hypertension in the NHS: protocol for the IsoFIT-BP study including amendments to mitigate the risk of COVID-19

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jonathan Wiles ◽  
Melanie Rees-Roberts ◽  
Jamie M. O’Driscoll ◽  
Timothy Doulton ◽  
Douglas MacInnes ◽  
...  
Keyword(s):  
Primary Care ◽  
Feasibility Study ◽  
Exercise Intervention ◽  
Isometric Exercise ◽  
Lifestyle Changes ◽  
Dietary Advice ◽  
Lifestyle Advice ◽  
Alternative Treatment Option ◽  
Randomised Controlled ◽  
Stage 1

Abstract Background Hypertension  (HTN) affects approximately 25% of the UK population and is a leading cause of mortality. Associated annual health care costs run into billions. National treatment guidance includes initial lifestyle advice, followed by anti-hypertensive medication if blood pressure (BP) remains high. However, adoption and adherence to recommended exercise guidelines, dietary advice and anti-hypertensive medication is poor. Four short bouts of isometric exercise (IE) performed 3 days per week (d/wk) at home elicits clinically significant reductions in BP in those with normal to high-normal BP. This study will determine the feasibility of delivering personalised IE to patients with stage 1 hypertension for whom lifestyle changes would be recommended before medication within NHS primary care. Methods This is a randomised controlled feasibility study. Participants were 18+ years, with stage 1 hypertension, not on anti-hypertensive medication and without significant medical contraindications. Trial arms will be standard lifestyle advice (control) or isometric wall squat exercise and standard lifestyle advice. Primary outcomes include the feasibility of healthcare professionals to deliver isometric exercise prescriptions in a primary care NHS setting and estimation of the variance of change in systolic BP. Secondary outcomes include accuracy of protocol delivery, execution of and adherence to protocol, recruitment rate, attrition, perception of intervention viability, cost, participant experience and accuracy of home BP. The study will last 18 months. Sample size of 100 participants (50 per arm) allows for 20% attrition and 6.5% incomplete data, based upon 74 (37 each arm) participants (two-sided 95% confidence interval, width of 1.33 and standard deviation of 4) completing 4 weeks. Ethical approval IRAS ID is 274676. Discussion Before the efficacy of this novel intervention to treat stage 1 hypertension can be investigated in any large randomised controlled trial, it is necessary to ascertain if it can be delivered and carried out in a NHS primary care setting. Findings could support IE viability as a prophylactic/alternative treatment option. Trial registration ISRCTN13472393, registered 18 August 2020

scholarly journals Feasibility Study To Assess The Delivery of A Novel Isometric Exercise Intervention For People With Stage 1 Hypertension In The NHS: Protocol For The Isofit-BP Study Including Amendments To Mitigate The Risk of COVID-19 

2021 ◽  
Author(s):  
Jonathan Wiles ◽  
Melanie Rees-Roberts ◽  
Jamie O’Driscoll ◽  
Timothy Doulton ◽  
Douglas McInnes ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Isometric Exercise ◽  
Lifestyle Changes ◽  
Lifestyle Advice ◽  
Alternative Treatment Option ◽  
Randomised Controlled ◽  
Stage 1

Abstract Background: Hypertension (HTN) affects approximately 25% of the UK population and is a leading cause of mortality. Associated annual health care costs run into billions. National treatment guidance includes initial lifestyle advice, followed by anti-hypertensive medication if blood pressure (BP) remains high. However, adoption and adherence to recommended exercise guidelines, dietary advice and anti-hypertensive medication is poor. Four short bouts of isometric exercise (IE) performed 3 days per week (d/wk) at home elicits clinically significant reductions in BP in those with normal to high-normal BP. This study will determine the feasibility of delivering personalised IE to patients with Stage 1 hypertension for whom lifestyle changes would be recommended before medication within NHS primary care.Methods: This is a randomised controlled feasibility study. Participants 18+ years, with Stage 1 hypertension, not on anti-hypertensive medication and without significant medical contraindications. Trial arms will be standard lifestyle advice (control) or isometric wall squat exercise and standard lifestyle advice. Primary outcomes include success of intervention delivery and change in BP. Secondary outcomes include accuracy of protocol delivery, execution of and adherence to protocol, recruitment rate, attrition, perception of intervention viability, cost, participant experience, and accuracy of home BP. The study will last 18 months. Sample size of 100 participants (50 per arm) allows for 20% attrition and 6.5% incomplete data, based upon 74 (37 each arm) participants (two-sided 95% confidence interval, width of 1.33 and standard deviation of 4) completing 4 weeks. Ethical approval IRAS ID: 274676.Discussion: Before the efficacy of this novel intervention to treat Stage 1 hypertension can be investigated in any large randomised controlled trial, it is necessary to ascertain if it can be delivered and carried out in a NHS primary care setting. Findings could support IE viability as a prophylactic / alternative treatment option.Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 13472393 registered 18 August 2020. http://www.isrctn.com/ISRCTN13472393

scholarly journals Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care

BMJ Open ◽  
2016 ◽  
Vol 6 (11) ◽  
pp. e012021 ◽  
Author(s):  
Matthew J Ridd ◽  
Kirsty Garfield ◽  
Daisy M Gaunt ◽  
Sandra Hollinghurst ◽  
Niamh M Redmond ◽  
...  
Keyword(s):  
Primary Care ◽  
Feasibility Study ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Parallel Group Trial ◽  
Group Trial

scholarly journals The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study

2016 ◽  
Vol 2 (1) ◽  
Author(s):  
Sinéad Lydon ◽  
Margaret E. Cupples ◽  
Nigel Hart ◽  
Andrew W. Murphy ◽  
Aileen Faherty ◽  
...  
Keyword(s):  
Primary Care ◽  
Feasibility Study ◽  
Study Protocol ◽  
Safety Climate ◽  
Randomised Controlled

Experiences in physical activity promotion in health care settings for primary prevention in the UK

2014 ◽  
Vol 62 (2) ◽  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Health Professionals ◽  
Controlled Trial ◽  
Full Range ◽  
Tertiary Care ◽  
Physical Activity Promotion ◽  
Community Based ◽  
Activity Promotion ◽  
Randomised Controlled

In addition to the delivery of primary care services, recent changes to the NHS in the United Kingdom have placed increasing responsibility on GPs for the commissioning of the full range of health services from prevention through to clinical interventions and rehabilitation. Whilst historically there has always been an expectation that primary care professionals were ideally placed to provide support for prevention as well as treatment, their active engagement in the promotion of physical activity has remained largely superficial. With notable exceptions where individuals have a personal interest or commitment, the majority of health professionals tend to limit themselves to peremptory non-specific advice at best, or frequently don’t broach the subject at all. There are a number of reasons for this including increasing time pressures, a general lack of knowledge, limited evidence and concerns about litigation in the event of an adverse exercise induced event. However in the 1990s there was a surge of interest in the emerging “Exercise on Prescription” model where patients could be referred to community based exercise instructors for a structured “prescription” of exercise in community leisure centres. Despite the continuing popularity of the model there remain problems particularly in getting the active support of health professionals who generally cite the same barriers as previously identified. In an attempt to overcome some of these problems Wales established a national exercise referral scheme with an associated randomised controlled trial. The scheme evaluated well and had subsequently evolved with new developments including integration with secondary and tertiary care pathways, accredited training for exercise instructors and exit routes into alternative community based exercise opportunities.

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