Recruiting

Health Improvement Program

Sponsor:

University Health Network, Toronto

Code:

NCT00188357

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Education

Study Details

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-

Conditions

Systemic Lupus Erythematosus

Study ID

NCT00188357

Start date

Aug, 2003

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

SLE acording to ACR Criteria > 18 years Female Able to read and write English or French -

Exclusion Criteria:

- 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

Study Design

Enrollment

360 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Education

Primary outcome measure

  • Coordinated intervention will improve health status of patients with Lupus compared with usual care [ Time Frame: undefined ]
  • Intervention will significantly decrease the number of cardiovascular risk factors and will improve flow mediated dilatation ( a non invasive measure of edothelial health [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Carolyn Neville, BSCN

514-493-1943

Locations

University Health Network Toronto Western Division

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Principal Investigator:

Paul R Fortin

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 14, 2007

Last verified

Sep, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2007-02-14.