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Project: Program of Rehabilitative Exercise and Education to Avert Vascular Events after Non-disabling Stroke or Transient Ischemic Attack (PREVENT trial).
Principal investigators: MacKay-Lyons, Marilyn J. (Dalhousie University) and Gubitz, Gordon J. (Queen Elizabeth II Health Sciences Centre)
Co-investigators: Eskes, Gail A. (Dalhousie University); Blanchard, Chris M. (Dalhousie University); Bedard, Richard J. (Cape Breton Regional Health); MacKay, Michelle (Queen Elizabeth II Health Sciences Centre); Manley, Sarah (Queen Elizabeth II Health Sciences Centre); Firth, Wanda (Queen Elizabeth II Health Sciences Centre); Corning, Corinne (Nova Scotia Department of Health); Giacomantonio, Nicholas (Queen Elizabeth II Health Sciences Centre); Thompson, Kara (Queen Elizabeth II Health Sciences Centre); Skedgel, Chris (Queen Elizabeth II Health Sciences Centre); Maharaj, Mandat; Wightman, Howard; Marsters, David; DeWolfe, Judy M. (AVH Heart Function Clinic).
A. Statement of the health problem
Little stroke, big trouble, the theme of World Stroke Day 2008, proclaims a growing health concern about the management of non-disabling stroke (NDS) and transient ischemic attacks (TIAs or ‘mini strokes’). Traditionally, NDS and TIAs were often not treated seriously because they did not seem to result in further health problems later on. In reality, these little strokes do spell ‘big trouble.’ Despite lack of outward signs, many individuals who survive an NDS or TIA have significant blood vessel disease, and are at high risk for stroke, heart attack and death. Moreover, most survivors of NDS/TIA have multiple modifiable vascular risk factors (e.g., high blood pressure, physical inactivity, high cholesterol levels, diabetes, tobacco use, excess alcohol consumption and psychological stress). NDSs and TIAs are important warning signs that should not be overlooked, but NDS/TIA survivors are often unaware of the potential danger that they face, and the changes that need to be made to reduce future risk. The challenge is to find an effective way to change their behavior to improve their health status.
The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). Over time, we will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and keeping physically active. In addition, we will compare ability to think, extent of depression, and achievement of personal goals for healthy behaviour, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE to see if it is reasonable to use the PREVENT program in the future. The short length of the project (three years) is not enough to allow us to fully determine the potential of the PREVENT intervention to reduce the chances of having another stroke, TIA or heart attack, but we will collect information about these events for people in the PREVENT and USUAL CARE groups.
We will study how effective a comprehensive risk modification program is for people after NDS/TIA, with a goal of reducing their modifiable vascular risk factors after 12 months. 464 medically stable patients with NDS or TIA from three centres in Nova Scotia (urban and rural) will be randomly assigned to USUAL CARE (clinic visits for health assessment, counseling, and education) or a 12-week community-based program of exercise and education, plus conventional risk factor modification (PREVENT). Participants will be evaluated at baseline, 12 weeks, and at 6 and 12-month follow-up. In both groups, we will measure blood pressure, waist circumference, cholesterol levels, blood glucose levels, and smoking status at 12 months. We will also measure exercise capacity, daily physical activity (using a device called an ‘accelerometer’, which records physical movements) and exercise capacity (using a device that measures how oxygen is used by the body during exercise). We will use questionnaires to look at depression, how health decisions are made, and quality of life. Finally, health costs in both groups will be measured.
D. Innovative aspect
Our proposal is innovative in several ways. First, our own research into this area has not revealed any published research trials of the effects of a comprehensive program of exercise and education on vascular risk factor reduction in this group of patients. Second, the PREVENT intervention incorporates strategies known to facilitate and help sustain the behavioral changes needed for risk factor reduction (e.g., individual goal setting, a health passport to document test results and daily physical activity/medication use, education of condition and interventions, telephone follow-up). This has not been done before. Third, the PREVENT Trial provides an opportunity to compare the trial interventions in urban versus more rural settings in Nova Scotia, where the incidence of cardiovascular morbidity is particularly high. Fourth, although our primary outcome is the reduction of modifiable vascular risk factors, we will also measure other variables related to activity and exercise that have not previously been studied in these patients. For example, in order to obtain an accurate indication of daily physical activity, participants will wear a ‘step counter’ for one week at each assessment. Fifth, we will compare the direct health costs of the PREVENT program and usual care to see whether it will be cost-effective to use the PREVENT program after the study is over.
E. Relevance to the objectives of the initiative
Our proposed PREVENT trial is closely aligned with the objectives of the Secondary Stroke Prevention Health Services and Care Initiative (SSPHSI). At present, it is not known whether a comprehensive program of vascular risk reduction services and coordinated care (PREVENT) is better than ordinary clinical care in achieving and maintaining good levels of vascular risk reduction in survivors of NDS/TIA. Therefore, our main objective is to determine whether the timely delivery of such a program of services can improve long-term vascular risk-reduction and vascular health of patients after NDS/TIA living in urban or rural settings. We plan to use existing community-based cardiac rehabilitation programs in this study, which will help to sustain the program in the long term. PREVENT also addresses SSPHSI’s objectives of increasing interdisciplinary collaborations and research capacity by creating new and innovative linkages among 16 researchers, health care providers, and decision-makers spanning the clinical spectrum; our team extends well beyond the traditional stroke research community. If our findings demonstrate that PREVENT reduces vascular risk factors in a more cost-effective and sustainable manner than usual care, then this evidence could be used to support plans to further improve health service delivery after NDS/TIA throughout Nova Scotia and across Canada.