Randomised controlled trial of a secondary prevention program for myocardial infarction patients ('ProActive Heart'): study protocol. Secondary prevention program for myocardial infarction patients

Background: \ud Coronary heart disease (CHD) is a significant cause of health and economic burden. Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient, provider, health system and societal-level barriers. As such, there is a need to develop innovative secondary prevention programs to address the treatment gap. Telephone-delivered care is convenient, flexible and has been shown to improve behavioural and clinical outcomes following myocardial infarction (MI). This paper presents the design of a randomised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for MI patients (ProActive Heart).\ud \ud Methods:\ud 550 adult MI patients have been recruited over a 14 month period (December 2007 to January 2009) through two Brisbane metropolitan hospitals, and randomised to an intervention or control group (n = 225 per group). The intervention commences within two weeks of hospital discharge delivered by study-trained health professionals ('health coaches') during up to 10 × 30 minute scripted telephone health coaching sessions. Participants also receive a ProActive Heart handbook and an educational resource to use during the health coaching sessions. The intervention focuses on appropriate modification of CHD risk factors, compliance with pharmacological management, and management of psychosocial issues. Data collection occurs at baseline or prior to commencement of the intervention (Time 1), six months follow-up or the completion of the intervention (Time 2), and at 12 months follow-up for longer term outcomes (Time 3). Primary outcome measures include quality of life (Short Form-36) and physical activity (Active Australia Survey). A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.\ud \ud Discussion: The results of this study will provide valuable new information about an innovative telephone-delivered cost-effective secondary prevention program for MI patients

A mobile phone-based care model for outpatient cardiac rehabilitation: the care assessment platform (CAP)

<p>Abstract</p> <p>Background</p> <p>Cardiac rehabilitation programs offer effective means to prevent recurrence of a cardiac event, but poor uptake of current programs have been reported globally. Home based models are considered as a feasible alternative to avoid various barriers related to care centre based programs. This paper sets out the study design for a clinical trial seeking to test the hypothesis that these programs can be better and more efficiently supported with novel Information and Communication Technologies (ICT).</p> <p>Methods/Design</p> <p>We have integrated mobile phones and web services into a comprehensive home- based care model for outpatient cardiac rehabilitation. Mobile phones with a built-in accelerometer sensor are used to measure physical exercise and WellnessDiary software is used to collect information on patients' physiological risk factors and other health information. Video and teleconferencing are used for mentoring sessions aiming at behavioural modifications through goal setting. The mentors use web-portal to facilitate personal goal setting and to assess the progress of each patient in the program. Educational multimedia content are stored or transferred via messaging systems to the patients phone to be viewed on demand. We have designed a randomised controlled trial to compare the health outcomes and cost efficiency of the proposed model with a traditional community based rehabilitation program. The main outcome measure is adherence to physical exercise guidelines.</p> <p>Discussion</p> <p>The study will provide evidence on using mobile phones and web services for mentoring and self management in a home-based care model targeting sustainable behavioural modifications in cardiac rehabilitation patients.</p> <p>Trial registration</p> <p>The trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with number ACTRN12609000251224.</p

Assessing the ‘active couch potato’ phenomenon in cardiac rehabilitation: rationale and study protocol

BACKGROUND: There is little evidence of whether or not those who have attended cardiac rehabilitation (CR) are meeting the physical activity guidelines recommended for secondary prevention of cardiovascular disease. In healthy individuals, there is evidence, that even if individuals are meeting the physical activity guidelines, the harmfulness of too much sedentary behaviour remains (active couch potato (ACP) phenomenon). Currently, there appears to be no evidence of the ACP phenomenon in those attending CR. The aims of the study are to examine the level of physical activity and sedentary behaviour in those with coronary heart disease (CHD) who have attended CR, and to investigate the potential independent associations between these behaviours and cardio-metabolic health, health-related quality of life, exercise capacity, anxiety and depression. METHODS: A prospective cohort study will be conducted in Australia over 12-months. Baseline data from this study will contribute to an international, multi-centre cross-sectional study (Australia, New Zealand, United States of America, South Africa, Spain, and Portugal). Adults currently enrolled in a 6-week phase II cardiac rehabilitation program with stable CHD and receiving optimal medical treatment +/− revascularisation will be recruited. Outcome measures will be taken at baseline (commence CR), 6 weeks (complete CR), 6 and 12-months. Physical activity and sedentary behaviour will be measured using accelerometry and two questionnaires (Active Australia Survey, Past-Day Adults’ Sedentary Time questionnaire). Health outcomes will include body mass index, waist-to-hip ratio, lipid profile, blood glucose level, quality-of-life (MacNew), exercise capacity (6-min walk test), anxiety and depression (Hospital Anxiety and Depression Scale). DISCUSSION: There has been limited investigation of the physical activity levels and sedentary behaviour of individuals with CHD attending CR. There are no studies assessing the relationship of these behaviours with health outcomes over the short and medium-term. As in healthy individuals, physical activity and sedentary behaviour may have independent effects on cardiovascular risk factors in people with CHD, which may contribute to recurrent cardiovascular events. If this is so, reducing sedentary behaviour may be a feasible first-line, additional and more achievable strategy to improve the health of those with CHD, alongside traditional recommendations to increase the time spent in moderate-to-vigorous intensity physical activity. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN1261500099557

A multidisciplinary group programme in rural settings for community-dwelling chronic stroke survivors and their carers: a pilot randomized controlled trial

Objectives: To explore whether a group programme for community-dwelling chronic stroke survivors and their carers is feasible in rural settings; to measure the impact of the programme on health-related quality of life and functional performance; and to determine if any benefits gained are maintained. Design: Randomized, assessor blind, cross-over, controlled trial. Setting: Rural outpatient. Subjects: Twenty-five community-dwelling, chronic stroke survivors and 17 carers of participant stroke survivors. Intervention: The intervention group undertook a once-a-week, seven-week group programme combining physical activity, education, self-management principles and a ‘healthy options’ morning tea. At completion, the control group crossed over to receive the intervention. Main measures: Stroke Impact Scale (stroke survivors), Health Impact Scale (carers), Six Minute Walk Test, Timed Up and Go, Caregiver Strain Index. Results: There were insufficient participants for results to reach statistical significance. However between-group trends favoured the intervention group in the majority of outcome measures for stroke survivors and carers. The majority of measures remained above baseline at 12 weeks post programme for stroke survivor participants. The programme was well attended. Of the seven sessions all participants attended four or more and 88% attended six or seven sessions. Conclusions: This novel programme incorporating physical activity, education and social interaction proved feasible to undertake by a stroke-specific multidisciplinary team in three rural Australian settings. This programme may improve and maintain health-related quality of life and physical functioning for chronic stroke survivors and their carers and warrants further investigation

Broadening the reach of cardiac rehabilitation to rural and remote Australia

Copyright © 2003 European Society of Cardiology. Published by Elsevier Science B. V.Background: Cardiac rehabilitation (CR) has an evidence base but traditional models may not readily apply to people living in rural and remote regions. Aim: To outline published comprehensive and non-hospital based CR models used for people discharged from hospital after a cardiac event that have potential relevance to those living in rural and remote areas in Australia. Methods: The PubMed database was searched using Medical subject headings (MeSH) terms and the key word ‘cardiac rehabilitation’ limited to clinical trials. Articles were retrieved if they included at least two components of CR and were not based in an outpatient setting. Results: No CR models specifically developed for rural and remote areas were identified. However, 14 studies were found that outlined 11 non-conventional comprehensive CR models. All provided CR in a home-based setting. Health professionals provided support via telephone contact or home visits, and via resources such as the Heart Manual. Reported outcomes from these CR programs varied: ranging from an increase in knowledge of risk factors, to improvements in physical activity, decreased risk factor profile, improved psychological and social functioning and reductions in health service costs and mortality. Conclusion: Home-based, CR models have the most substantive evidence base and, therefore the greatest potential to be developed and made accessible to eligible people living in rural and remote areas.Joanne Dollard, Jacquie Smith, David R Thompson and Simon Stewar