HIPP Learning to Live Better With Lupus: The Health Improvement and Prevention Program in Systemic Lupus Erythematosus
2 other identifiers
interventional
360
1 country
1
Brief Summary
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 Study Design:
- 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. Inclusion Criteria: SLE according to ACR, \>18 yr, Female, must read and write french or english Exclusion Criteria: 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-
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedFebruary 14, 2007
September 1, 2005
September 9, 2005
February 13, 2007
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- SLE acording to ACR Criteria \> 18 years Female Able to read and write English or French -
You may not qualify if:
- \- History of Angina Myocardial infarction Cerebral Vascular Accident other arterial occlusions Peripheral Vascular disease Osteoporosis with documented fracture Pregnancy or intention of in next year Cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Canadian Institutes of Health Research (CIHR)collaborator
- The Arthritis Society, Canadacollaborator
Study Sites (1)
University Health Network Toronto Western Division
Toronto, Ontario, M5T 2S8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul R Fortin, MD,FRCP,MPH
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
August 1, 2003
Last Updated
February 14, 2007
Record last verified: 2005-09