P1927A European randomised controlled trial for m-health guided cardiac rehabilitation in the elderly; results of the EU-CaRE RCT study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E P De Kluiver ◽  
A E Van Der Velde ◽  
E P Meindersma ◽  
L F Prins ◽  
M Wilhelm ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
The Elderly ◽  
Lv Function ◽  
Random Factor ◽  
Index Event ◽  
The Difference ◽  
Randomised Controlled ◽  
The Eu

Abstract Introduction Knowledge about effectiveness of cardiac rehabilitation (CR) in the elderly is limited. Participation rates in supervised CR are consistently lower in the elderly and innovative interventions are needed. The EU has granted a CR study project; a randomised controlled trial conducted in 5 European countries, investigating the effectiveness of mobile telemonitoring guided CR (mCR) in elderly cardiac patients who declined regular CR. Methods Patients ≥65 years with indication for CR who declined regular CR were eligible for inclusion. Patients were randomised between regular care (without CR) and a 6-month mCR programme: dedicated programmed smartphone, heartrate monitoring (target HR zones) and coaching. The primary endpoint is the difference in VO2peak between 6-months follow-up and baseline. Results Between 2015 and 2018 179 patients were included. Baseline characteristics between groups (table 1) did not differ significantly, except for hypertension. The difference in VO2peak was significantly better in the mCR group (table 1). After correction (mixed linear model) for baseline VO2 peak (fixed factor) and centre (random factor) this difference remained significant. Mean number of registered activity sessions was 4.79 (95% CI; 4.07–5.50) per patient per week. Table 1. Baseline and primary outcome parameters Baseline Control Programme (n=90) mCR Programme (n=89) P-value Gender (m/f) 76/14 69/20 0.238 Age (mean±SD) 73.57±5.46 72.38±5.37 0.121 Diabetes 15 (16.7%) 23 (25.8%) 0.133 Hypertension 60 (66.7%) 73 (82.0%) 0.019* Hypercholesteremia 71 (78.3%) 74 (83.1%) 0.468 Normal LV-function 48/89 (53.9%) 53/89 (59.6%) 0.497 Index event (CABG/Valve/PCI/none) 0.735   Cardiac history prior to index event 48/89 (53.9%) 53/89 (59.6%) 0.702   Non cardiac comorbidity 40 (44.4%) 44 (49.4%) 0.503 Results   Baseline VO2peak (ml/kg/min) (95% CI) 19.83 (18.65–21.01) 18.78 (18.67–19.89) 0.191   Delta VO2peak at 6 months (ml/kg/min) (95% CI) 0.20 4 (−0.34–0.83) 1.62 (0.86–2.39) 0.005*   Corrected delta VO2peak at 6 months (ml/kg/min) 0.50 (−1.04–2.04) 1.65 (0.11–3.2) 0.015* *Significant. Conclusions The application of mCR in elderly patients who declined regular CR results in a better physical condition after 6 months. Compliance to mCR was excellent. Acknowledgement/Funding European Union's Horizon 2020 research and innovation programme under grant agreement number 634439, and funding from the Swiss Government.

scholarly journals A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial

2016 ◽  
Vol 23 (2_suppl) ◽  
pp. 27-40 ◽  
Author(s):  
Eva Prescott ◽  
Esther P Meindersma ◽  
Astrid E van der Velde ◽  
Jose R Gonzalez-Juanatey ◽  
Marie Christine Iliou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
The Elderly ◽  
European Study ◽  
Randomised Controlled ◽  
The Eu

scholarly journals How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043444
Author(s):  
Martine Rostadmo ◽  
Siri Lunde Strømme ◽  
Magne Nylenna ◽  
Pal Gulbrandsen ◽  
Erlend Hem ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
First Language ◽  
Review Article ◽  
Scientific Article ◽  
Potential Range ◽  
Parallel Group ◽  
The Difference ◽  
Randomised Controlled ◽  
Primary Care Medicine

IntroductionEnglish is the lingua franca of science. How well doctors understand English is therefore crucial for their understanding of scientific articles. However, only 5% of the world’s population have English as their first language.MethodsObjectives: To compare doctors’ comprehension of a scientific article when read in their first language (Norwegian) versus their second language (English). Our hypothesis was that doctors reading the article in Norwegian would comprehend the content better than those reading it in English.Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical review article in either Norwegian or English, before completing a questionnaire about the content of the article.Setting: Conference in primary care medicine in Norway, 2018.Participants: 130 native Norwegian-speaking doctors, 71 women and 59 men. One participant withdrew before responding to the questionnaire and was excluded from the analyses.Interventions: Participants were randomly assigned to read a review article in either Norwegian (n=64) or English (n=66). Reading time was limited to 7 min followed by 7 min to answer a questionnaire.Main outcome measures: Total score on questions related to the article content (potential range −9 to 20).ResultsDoctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared with 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% CI 0.03 to 2.62; p=0.046). Age was independently associated with total score, with decreased comprehension with increasing age.ConclusionThe difference in comprehension between the group who read in Norwegian and the group who read in English was statistically significant but modest, suggesting that the language gap in academia is possible to overcome.

TeleClinical Care: A randomised controlled trial of a smartphone-based model of care to support cardiac patients transitioning from hospital to the community (Preprint)

2021 ◽  
Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
James McVeigh ◽  
Andrew Mamo ◽  
Joseph Magdy ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Medication Adherence ◽  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Smartphone App ◽  
Model Of Care ◽  
Intervention Cost ◽  
Randomised Controlled

BACKGROUND This is the first randomised controlled trial (RCT) of a mobile health intervention that combines telemonitoring and educational components for both acute coronary syndrome (ACS) and heart failure (HF) inpatients to prevent readmission. OBJECTIVE Objective: To evaluate the feasibility, efficacy and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care – TCC) plus usual care in patients being discharged from hospital after an ACS or HF admission, in comparison to usual care alone. METHODS Methods: In this pilot, 2-centre RCT, a smartphone app-based model of care (TeleClinical Care – TCC) was applied at discharge. The primary endpoint was the incidence of unplanned 30-day readmissions. Secondary endpoints included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure and physical activity daily, plus usual care. The devices automatically transmitted recordings to the patient’s smartphone and then subsequently to a central server. Abnormal readings were flagged by email to a monitoring team. Control participants received usual care. RESULTS Results: 164 hospital inpatients were randomised at the time of discharge (TCC n=81, control n = 83, mean age 61.5 years, 79% male, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P = .97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 vs. 41 readmissions, P = 0.015), including cardiac readmissions (11 vs. 25, P = .025), and higher rates of cardiac rehabilitation completion (39% vs. 18%, P = .025) and medication adherence (75% vs. 50%, P = .002). The average usability rating of the app was 4.5/5. The intervention cost AUD $6,028 per cardiac readmission saved. When modelled in a mainstream clinical setting, however, enrolment of 237 patients was projected to have the same healthcare expenditure compared to usual care, and enrolment of 500 patients was projected to save approximately AUD $100,000. CONCLUSIONS Conclusion: TCC was feasible and safe for ACS and HF inpatients. The incidence of 30-day readmissions was similar, however long-term benefits were demonstrated including fewer total readmissions over 6 months, improved medication adherence and improved cardiac rehabilitation completion. CLINICALTRIAL The study was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618001547235).

scholarly journals Effects of training on quality of peer review: randomised controlled trial

BMJ ◽  
2004 ◽  
Vol 328 (7441) ◽  
pp. 673 ◽  
Author(s):  
Sara Schroter ◽  
Nick Black ◽  
Stephen Evans ◽  
James Carpenter ◽  
Fiona Godlee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Review ◽  
Controlled Trial ◽  
Control Group ◽  
Group Score ◽  
The Difference ◽  
Randomised Controlled ◽  
Quality Instrument

AbstractObjective To determine the effects of training on the quality of peer review.Design Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.Setting and participants Reviewers at a general medical journal.Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.Main outcome measures Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.Results Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).Conclusions Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed.

scholarly journals Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Gut ◽  
2020 ◽  
pp. gutjnl-2020-321585 ◽  
Author(s):  
Suzanne E Mahady ◽  
Karen L Margolis ◽  
Andrew Chan ◽  
Galina Polekhina ◽  
Robyn L Woods ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Bleeding Risk ◽  
The Elderly ◽  
Community Dwelling ◽  
Gi Bleeding ◽  
Prophylactic Use ◽  
Randomised Controlled

ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010–2017 (‘ASPirin in Reducing Events in the Elderly (ASPREE)’, n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.

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