HIPP Learning to Live Better With Lupus: The Health Improvement and Prevention Program in Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT00188357|
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was: Recruiting
First Posted : September 16, 2005
Last Update Posted : February 14, 2007
Several studies have shown that persons with systemic lupus erythematosus (SLE) have poor general health and a higher risk of heart attack and bone loss (osteoporosis) compared to the general population. Some of the risks associated with heart attacks and bone loss are modifiable (can be changed). For example, high blood pressure, high cholesterol, smoking, lack of exercise are risk factors associated with heart attacks that can be changed. Whereas, age and a family history of heart attacks are risk factors that can not be changed. Similarly, a diet low in calcium, smoking and lack of exercise are modifiable risk factors associated with osteoporosis; while, family history and age are not modifiable. The Health Improvement and Prevention Program (HIPP) in Systemic Lupus Erythematosus was developed to increase the general health in persons who have lupus and to help reduce the risk of heart attacks and bone loss. This intervention program gives comprehensive
information about lupus and provides tools on how to live better with lupus. The program includes visits with a nurse case manager who will work in close collaboration with the lupus team. She will work on an individual basis with each participant to develop a mutually agreed upon personalized care plan aimed at improving general health, coping skills and heart and bone health.
HIPP STUDY (Health Improvement And Prevention Program)
Dr Paul Fortin Principal Investigator
Primary and Secondary objectives:
- To improve health status, decrease cardiovascular risk and improve endothelial function in persons with SLE compared to usual care.
- 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.
Duration: 2 years
Enrollment 240 patients
- Randomized prospective study of HIPP compared to usual care, patients will be crossed over at Mth 12. Data collected for 24 mths.
- Demographic, health status, cost, SLE knowledge, coping, cardiovascular and osteoporosis information will be collected.
- All patients will undergo clinical evaluation to measure disease activity, BMD (every 2 years) and Flow mediated Doppler (every year)
- HIPP now patients will attend 4 knowledge sessions, covering SLE, coping with chronic disease, cardiovascular disease in Lupus, bone health in Lupus.
- HIPP now patients will be followed by nurse coordinator and receive an individualized risk assessment, telephone follow-up, smoking cessation counseling. For 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. All HIPP now pts will attend the Cardiac Rehabilitation program at the TWH.
SLE according to ACR, >18 yr, Female, must read and write french or english
MI, TIA, CVA, Other arterial occlusion, PVD, Osteoporosis as defined by BMD, Pregnant now, active cancer
For further information contact Study Coordinator Anne Cymet Tel # 13-2895 Pager 416-664-
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Behavioral: Education||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||360 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||HIPP Learning to Live Better With Lupus: The Health Improvement and Prevention Program in Systemic Lupus Erythematosus|
|Study Start Date :||August 2003|
- Coordinated intervention will improve health status of patients with Lupus compared with usual care
- Intervention will significantly decrease the number of cardiovascular risk factors and will improve flow mediated dilatation ( a non invasive measure of edothelial health
- Improve bone health behaviours and prevent decrease in bone mineral density
- improve adherance to treatments
- help persons with lupus move toward on the illness-wellness continuum by increasing their knowledge of Lupus
- cost effective intervention that could become standard of care in lupus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188357
|Contact: Anne Cymet, RN||416-603-5800 ext firstname.lastname@example.org|
|Contact: Carolyn Neville, BSCN||514-493-1943 ext 44718|
|University Health Network Toronto Western Division||Recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: Anne Cymet, RN 416-603-5800 ext 2895 email@example.com|
|Principal Investigator: Paul R Fortin|
|Sub-Investigator: Deborah DaCosta|
|Principal Investigator:||Paul R Fortin, MD,FRCP,MPH||University Health Network, Toronto|