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HIPP Study Lay Summary:
Systemic lupus erythematosus (SLE) is a chronic disease in which a person's immune
system attacks their own body organs. Controlling SLE is difficult because there
are many symptoms that differ from person to person. Both SLE and the drugs used
to treat it may lead to premature cardiovascular disease or osteoporosis. In addition,
coping with having SLE can be very stressful. In our study, we are testing whether
persons with SLE benefit from our Health Improvement and Prevention Program (HIPP).
In HIPP, these persons will learn ways both to improve their coping skills and knowledge
of SLE, and to decrease their risk for cardiovascular disease and osteoporosis.
They will do this by working with a nurse who tailors a coping and risk-reduction
program to fit each person's needs. Half of the persons will begin HIPP as soon
as they enter the study (HIPP Now). The other half will receive their usual care
for one year after study entry, but will begin HIPP in the second year (HIPP Later).
At the end of the study we will compare the two groups to determine if increasing
awareness of SLE and health behaviors improves general health, coping skills, and
risk for cardiovascular disease or osteoporosis in persons with SLE.
Primary and Secondary objectives:
- To improve health status, decrease cardiovascular risk and improve endothelial function
in persons with SLE compared to usual care.
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- To improve bone health behaviors and prevent decrease in bone mineral density.
- To improve adherence to treatments.
- To help persons with Lupus move toward wellness by increasing knowledge.
- To show that HIPP is cost effective and could become standard care.
Follow ups
- Duration: 2 years
- Patients are seen yearly on average, more often if aggressive risk reduction is
required
- Patients are followed by phone monthly
- Questionnaires are mailed
Study Design:
- Randomized prospective study of HIPP compared to usual care, patients will be crossed
over at 12 months
- Data will be collected for 24 months.
- Demographic, health status, cost, SLE knowledge, coping, cardiovascular and osteoporosis
information will be collected.
- All patients will undergo clinical evaluation to measure disease activity,
- All patients have Bone Mineral Density (BMD) Tests every 2 years or yearly if on
prednisone
- All patients undergo Flow Mediated Dopplers (FMD) yearly while participating in
the study
- HIPP Now patients will attend 4 knowledge sessions, these sessions are given by
experts in their fields, covering SLE, coping with chronic disease, cardiovascular
disease in Lupus, bone health in Lupus.
- All HIPP Now patients in Toronto are seen by cardiologist for initial assessment
- HIPP Now patients will be followed by nurse coordinator and receive an individualized
risk assessment for coronary artery disease
- Telephone follow-up, smoking cessation counseling and those found at risk, stress
reduction (Mindfulness Based Stress Reduction) and or bone health program will be
provided.
- HIPP now patients will attend Cardiac Rehabilitation Program at TWH or receive a
home exercise program with regular telephone follow-up
- All HIPP Now patients receive a Lupus Health Passport, a detailed diary covering
medication history, blood and urine results, personal treatment plans, history of
previous hospital admissions and clinic visits. Passport is updated every 3 months
and results discussed with patient.
Inclusion Criteria:
- SLE according to the American College of Rheumatology (ACR) criteria
- Female, 18 years or older
- Must read and write French or English
Exclusion Criteria:
- Myocardial Infarction (MI) – heart attack
- Transient Ischemic Attack (TIA) – mini stroke
- Cerebrovascular accident (CVA) - stroke
- Other arterial occlusion, peripheral vascular disease (PVD) - blood clot in artery / vein
- Osteoporosis with fracture
- Pregnant
- Active cancer
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