Trial Information

HIPP Learning to Live Better With Lupus: The Health Improvement and Prevention Program in Systemic Lupus Erythematosus

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.