scholarly journals Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial

Heart ◽  
2018 ◽  
pp. heartjnl-2018-313632 ◽  
Author(s):  
Gabriela Suellen da Silva Chaves ◽  
Gabriela Lima de Melo Ghisi ◽  
Sherry L Grace ◽  
Paul Oh ◽  
Antonio L Ribeiro ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Middle Income ◽  
Intention To Treat ◽  
Randomised Controlled

ObjectiveDespite the growing epidemic of cardiovascular diseases in middle-income countries, there is insufficient evidence about cardiac rehabilitation (CR) in these countries. Thus, the effects of comprehensive CR on functional capacity and risk factors were investigated in Brazil, to test the hypothesis that it results in better outcomes than exercise-only or no CR.MethodsSingle-blinded, randomised controlled trial with three parallel arms: comprehensive CR (exercise+education) versus exercise-only CR versus wait-list control. Eligible coronary patients were randomised in blocks of four with 1:1:1 concealed allocation. Participants randomised to exercise-only CR received 36 exercise classes; comprehensive CR group also received 24 educational sessions. The primary outcome was incremental shuttle walk test (ISWT) distance; secondary outcomes were cardiovascular risk factors. All outcomes were assessed at baseline and 6 months later. Analysis of covariance was performed on the basis of intention-to-treat (ITT) and per-protocol.Results115 (88.5%) patients were randomised; 93 (80.9%) were retained. There were improvements in ISWT distance from pretest to post-test with comprehensive (from 358.4±132.6 to 464.8±121.6 m; mean change=106.4; p<0.001) and exercise-only (from 391.5±118.8 to 488.1±106.3 m; mean change=96.5, p<0.001) CR, with significantly greater functional capacity with comprehensive CR versus control (ITT: mean difference=75.6±30.7 m, 95% CI 1.4 to 150.2). There were also reductions in systolic blood pressure with comprehensive CR (ITT: reduction of 6.2±17.8 mm Hg, p=0.04). There were no significant differences for other outcomes.ConclusionResults showed clinically significant improvements in functional capacity and blood pressure with CR, and significantly greater functional capacity with comprehensive CR compared with usual care.Trial registration numberNCT02575976;Results.

scholarly journals Danish Evaluation of Your Heart Forecast (DANY) - Study Protocol for a Randomised Controlled Trial on an Interactive Risk-communication Tool aimed at improving High Blood Pressure Patients’ adherence.

2019 ◽  
Author(s):  
Anders Elkær Jensen ◽  
Jens Søndergaard ◽  
Niels Kristian Kjær ◽  
Rod Jackson ◽  
Jesper Bo Nielsen
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Health Literacy ◽  
Randomised Controlled Trial ◽  
Risk Communication ◽  
Controlled Trial ◽  
Pressure Control ◽  
Communication Tool ◽  
Hypertensive Patients ◽  
Randomised Controlled

Abstract Background To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardio-vascular-disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, one third of hypertensive patients are adequately treated, with regards to national guidelines. One reason for this meagre status is low treatment adherence, and tools with documented effects for increasing patient adherence are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: “Your Heart Forecast” on blood pressure control, primary non-compliance, health literacy and patient empowerment.Methods Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. Discussion The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to Your Heart Forecast with the national databases of prescriptions and health services provided.

Randomised controlled trial of two advanced and extended cardiac rehabilitation programmes

Heart ◽  
2017 ◽  
Vol 104 (5) ◽  
pp. 430-437 ◽  
Author(s):  
Madoka Sunamura ◽  
Nienke ter Hoeve ◽  
Rita J G van den Berg-Emons ◽  
Marcel L Geleijnse ◽  
Mirjam Haverkamp ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Risk Function ◽  
Intention To Treat ◽  
Coronary Syndrome ◽  
Lifestyle Counselling ◽  
Randomised Controlled

ObjectiveThe OPTICARE (OPTImal CArdiac REhabilitation) randomised controlled trial compared two advanced and extended cardiac rehabilitation (CR) programmes to standard CR for patients with acute coronary syndrome (ACS). These programmes were designed to stimulate permanent adoption of a heart-healthy lifestyle. The primary outcome was the SCORE (Systematic COronary Risk Evaluation) 10-year cardiovascular mortality risk function at 18 months follow-up.MethodsIn total, 914 patients with ACS (age, 57 years; 81% men) were randomised to: (1) 3 months standard CR (CR-only); (2) standard CR including three additional face-to-face active lifestyle counselling sessions and extended with three group fitness training and general lifestyle counselling sessions in the first 9 months after standard CR (CR+F); or (3) standard CR extended for 9 months with five to six telephone general lifestyle counselling sessions (CR+T).ResultsIn an intention-to-treat analysis, we found no difference in the SCORE risk function at 18 months between CR+F and CR-only (3.30% vs 3.47%; p=0.48), or CR+T and CR-only (3.02% vs 3.47%; p=0.39). In a per-protocol analysis, two of three modifiable SCORE parameters favoured CR+F over CR-only: current smoking (13.4% vs 21.3%; p<0.001) and total cholesterol (3.9 vs 4.3 mmol/L; p<0.001). The smoking rate was also lower in CR+T compared with the CR-only (12.9% vs 21.3%; p<0.05).ConclusionsExtending CR with extra behavioural counselling (group sessions or individual telephone sessions) does not confer additional benefits with respect to SCORE parameters. Patients largely reach target levels for modifiable risk factors with few hospital readmissions already following standard CR.Trial registration numberClinicalTrials.gov NCT01395095; results.

scholarly journals Danish Evaluation of Your Heart Forecast (DANY) - Study Protocol for a Cluster Randomised Controlled Trial on an Interactive Risk-communication Tool aimed at improving High Blood Pressure Patients’ adherence.

2019 ◽  
Author(s):  
Anders Elkær Jensen ◽  
Jens Søndergaard ◽  
Niels Kristian Kjær ◽  
Rod Jackson ◽  
Jesper Bo Nielsen
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Pressure Control ◽  
Communication Tool ◽  
Hypertensive Patients ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardio-vascular-disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, one third of hypertensive patients are adequately treated, with regards to national guidelines. One reason for this meagre status is low treatment adherence, and tools with documented effects for increasing patient adherence are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: “Your Heart Forecast” on blood pressure control, primary non-compliance, health literacy and patient empowerment.Methods Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. Discussion The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to Your Heart Forecast with the national databases of prescriptions and health services provided.

scholarly journals Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Anders Elkær Jensen ◽  
Jens Søndergaard ◽  
Niels Kristian Kjær ◽  
Rod Jackson ◽  
Jesper Bo Nielsen
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Pressure Control ◽  
Communication Tool ◽  
Hypertensive Patients ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardiovascular disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, only one-third of hypertensive patients are adequately treated, with regards to national clinical guidelines. One reason for this problem is low treatment adherence; tools with documented effects for increasing adherence of patients are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: ‘Your Heart Forecast’ (YHF) on blood pressure control, primary non-compliance, health literacy and patient empowerment. Methods Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. Discussion The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to YHF with the national databases of prescriptions and health services provided. Trial registration Clinicaltrials.gov, NCT04058847. Registered on 16 August 2019.

Effectiveness of a family nurse‐led programme on accuracy of blood pressure self‐measurement: A randomised controlled trial

2021 ◽  
Author(s):  
Valentina Simonetti ◽  
Dania Comparcini ◽  
Marco Tomietto ◽  
Daniele Pavone ◽  
Maria Elena Flacco ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Swāsthya, an integrated chronic condition management programme for families of patients with hypertension and diabetes mellitus: a study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M D Saju ◽  
Bindiya M Varghese ◽  
Lorane Scaria ◽  
Anuja Maria Benny ◽  
Shilpa V Yohannan ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Social Cohesion ◽  
Chronic Conditions ◽  
Chronic Condition ◽  
Controlled Trial ◽  
Risk Groups ◽  
Care Model ◽  
Randomised Controlled

Abstract Background Kerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, thus compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management. This paper describes the protocol of our study that aims to examine the effectiveness and sustainability of an integrated care model for the management of chronic conditions and their risk factors through a family-based intervention. The proposed care model targets to modify systems and processes that predispose to chronic conditions by enhancing social cohesion and social networks, preventing lifestyle risks, developing iterative cognitive interventions, and engaging the family into customised treatment adherence strategies navigated by community health social workers (CHSWs). Methods A cluster randomised controlled trial (RCT) in selected participants will be conducted involving additional assessments prior to the baseline assessment. The assessment will identify and categorise patients into four risk groups, namely behavioural, social, cognitive, and multiple, based on dominant risks identified. Eligible participants will be randomly allocated (at a ratio of 1:1) into the intervention or control arm. The intervention arm will receive social, behavioural, and cognitive or multiple interventions corresponding to the identified risk groups, whereas the control arm will receive general intervention. Both the groups will be followed up at 6 months and 12 months post baseline to measure outcomes. The primary outcome will be the control of HTN and DM, and secondary outcomes include decreased depression and anxiety and improved functioning, social cohesion, and social network linkages. The sustainability and scalability of this intervention will be assessed through cost effectiveness, acceptability, and user friendliness of the integrated approach by performing a qualitative evaluation. Discussion This RCT will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by CHSWs. Such a model is not currently considered in the management of chronic conditions in Kerala. Trial registration Trial has been prospectively registered on Clinical Trial Registry of India- CTRI/2020/12/029474 on 1st December 2020.

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