The survival rate in Systemic Lupus Erythematosus (SLE) exceeds 90% at 10 years but health status is severely impaired and comparable with that of advanced cardiac or respiratory diseases. Since these issues are often overlooked in clinical practice and because SLE affects primarily young women in their productive life, a specific intervention is needed to heighten health status and coping, and to reduce complications such as cardiovascular diseases (CVD) and osteoporosis.
Our primary goal is to demonstrate: 1- that a coordinated intervention, named the Health Improvement and Prevention Program (HIPP), will improve health status in SLE compared with usual care, and 2- that the same intervention will decrease significantly the number of cardiovascular risk factors and improve the flow-mediated dilatation (FMD - a non-invasive measure of endothelial health that we will use as a surrogate marker of CVD) in persons with SLE. Our secondary goals are to demonstrate that HIPP will: 1- improve bone health behaviors and prevent decrease in bone mineral density (BMD), 2- improve adherence to treatments, 3- help persons with lupus move towards wellness on the illness-wellness continuum by increasing their knowledge of lupus, and 4- be shown to be a cost-effective intervention that could become standard of care in SLE.
Our population will consist of consecutive patients with a diagnosis of SLE (revised 1997 ACR criteria) from the lupus clinics of the University of Toronto and McGill University. All those without cardiovascular disease or osteoporosis will be approached for this study. These two centres follow annually a total of close to 700 persons with SLE and offer standard HIPP services.
Our study design is a randomized prospective study of HIPP compared to usual care. As we believe that HIPP will be superior to usual care, we will crossover those in the usual care group to the HIPP group at 12 months. We will collect information for 24 months on all participants. The Health Improvement and Prevention Program is a multidisciplinary intervention that will be coordinated by a case manager nurse in close collaboration with the lupus treating team. After providing consent, each person will fill in demographic, health status, cost, SLE knowledge, coping, cardiovascular and osteoporosis risk questionnaires and will undergo a clinical evaluation to measure lupus disease activity and damage as well as a FMD and BMD. They will be randomized to HIPP or to usual care for 12 months after which the usual care group will be crossed over to HIPP. HIPP participants will be invited to attend a 4-week, 6 hour course that will cover the following four topics: 1) Knowledge of SLE, 2) Coping with a Chronic Disease, 3) Cardiovascular Disease in SLE and 4) Bone Health in SLE. Four to six weeks after entry into HIPP, there will be a second visit to the case manager during which an individualized program will be proposed to the patient. For all patients, this will include a standardized CVD prevention program. For those found to be at risk at baseline, it will also include a stress-reduction and/or a bone-health program. The case manager will follow HIPP participants individually by phone or in person according to their needs. Follow-up questionnaires on health status, cost and coping will be done by phone at 6 and 18 months; repeat clinical assessments for lupus activity and damage, questionnaires and FMD will be done at 12 and 24 months; and BMD will be repeated at 24 months.
Power and analyses. We will need to enroll 120 patients in our study to ensure 80% power to detect at least a 10% improvement in the SF-36 MCS and PCS and a 20% CVD risk reduction. Descriptive analyses, univariate and multivariate analyses will be carried out. For our primary goals, we will test whether HIPP is better than usual care in improving the SF-36 MCS, PCS and CVD risk profile. Our outcome will be change in the SF-36 MCS or PCS scores, FMD or CVD risk assessment, and our predictive variable will be HIPP. We will adjust for age, gender, and baseline SF-36 MCS and PCS, depression score, education, lupus activity and damage. Other secondary outcomes will be analysed using similar models. Cost will be calculated and cost-effectiveness analyses of HIPP will be performed.
Significance. A valid, cost-effective and comprehensive program to ameliorate the health and coping status and to prevent CVD and osteoporosis would have a high impact on the long-term health and quality of life of persons with SLE.
