The effect of group-based exercise on cognitive performance and mood in seniors residing in intermediate care and self-care retirement facilities: a randomised controlled trial

2008 ◽  
Vol 43 (8) ◽  
pp. 608-614 ◽  
Author(s):  
A K Brown ◽  
T Liu-Ambrose ◽  
R Tate ◽  
S R Lord
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Performance ◽  
Controlled Trial ◽  
Self Care ◽  
Intermediate Care ◽  
Retirement Facilities ◽  
Randomised Controlled

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials

Open Heart ◽  
2019 ◽  
Vol 6 (1) ◽  
pp. e000954 ◽  
Author(s):  
Ann Hovland-Tånneryd ◽  
Michael Melin ◽  
Ewa Hägglund ◽  
Inger Hagerman ◽  
Hans E Persson
Keyword(s):  
Heart Failure ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Care ◽  
Control Group ◽  
Data Set ◽  
Pooled Data ◽  
Home Based ◽  
Randomised Controlled ◽  
Hospital Days

ObjectivesA home-based tool for heart failure (HF) patients, was evaluated in a specialist setting as a randomised controlled trial (RCT) and also in a validation cohort in a primary care setting in a clinical controlled trial (CCT). The tool provides education, symptom monitoring and titration of diuretics. The aim of this study was thus to extend validity of the previous RCT findings in order to describe applicability of the tool in clinical practice.MethodsData from both trials were analysed separately, as well as a pooled data set (n=172). Data were analysed with respect to HF related in-hospital days, self-care behaviour and system adherence, during a 6-month intervention. The analysis of in-hospital days for the pooled data was adjusted for baseline differences between the two study cohorts, relating to disease state.ResultsIn the RCT (n=72) the intervention group (IG) consisted of 32 patients and the control group (CG) of 40 patients. The risk ratio (RR) for in-hospital days was RR: 0.72, 95% CI 0.61 to 0.84, p<0.05 in favour of the IG. In the CCT (n=100) both the IG and the CG consisted of 50 patients and the IG had fewer in-hospitals days, comparable to the RCT findings with RR: 0.67; 95% CI 0.45 to 0.99; p<0.05. For the pooled data set made up of 172 patients, the groups were well balanced but with a higher prevalence of hypertension in the CG. The RR relating to in-hospital days for the pooled data set was 0.71; 95% CI 0.61 to 0.82; p<0.05 in favour of the IG. There was a statistically significant improvement in self-care by 27% and the median system adherence was 94%.ConclusionsThese analyses suggest that the evaluated tool might reduce HF related in-hospital days in the general HF population, which adds to the external validity of previous findings.Clinical Trial RegistrationNCT03655496.

Working in collaboration with young people and health professionals. A staged approach to the implementation of a randomised controlled trial

2010 ◽  
Vol 16 (6) ◽  
pp. 561-576 ◽  
Author(s):  
S. Aldiss ◽  
R.M. Taylor ◽  
L. Soanes ◽  
R. Maguire ◽  
M. Sage ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Health Professionals ◽  
Controlled Trial ◽  
Phase 1 ◽  
Self Care ◽  
Alert System ◽  
Symptom Report ◽  
Mobile Phone Technology ◽  
Randomised Controlled

ASyMS© is an Advanced Symptom Management System utilising mobile phone technology to monitor chemotherapy-related symptoms and promote self-care. It was first developed with an adult cancer population and is now being evaluated with young people through an iterative development process. ASyMS© involves patients recording and sending symptom reports to the hospital and receiving tailored self-care advice. Health professionals are alerted when severe symptoms are reported. Three phases of the ASyMS©-YG (young people) study are complete. Phase 1 involved young people identifying the symptoms to be assessed. Phase 2 involved young people testing the symptom report system, and ascertaining young people’s, parents’ and professionals’ perceptions of ASyMS©-YG. This paper reports on Phase 3, in which the system was developed further in preparation for a randomised controlled trial (RCT). Health professionals devised an alert system based on risk modelling side-effect severity, and young people and professionals developed self-care advice. A pilot study was conducted to test the alert system and study design in readiness for a definitive RCT. The contribution young people and professionals have made to this project is invaluable in evaluating the practical effectiveness of ASyMS©-YG and ensuring the intervention is acceptable and works in everyday practice.

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