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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Arthritis Society, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188357
First received: September 9, 2005
Last updated: February 13, 2007
Last verified: September 2005
  Purpose

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-


Condition Intervention
Systemic Lupus Erythematosus
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIPP Learning to Live Better With Lupus: The Health Improvement and Prevention Program in Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 360
Study Start Date: August 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188357

Contacts
Contact: Anne Cymet, RN 416-603-5800 ext 2895 anne.cymet@uhn.on.ca
Contact: Carolyn Neville, BSCN 514-493-1943 ext 44718

Locations
Canada, Ontario
University Health Network Toronto Western Division Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Anne Cymet, RN    416-603-5800 ext 2895    anne.cymet@uhn.on.ca   
Principal Investigator: Paul R Fortin         
Sub-Investigator: Deborah DaCosta         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
The Arthritis Society, Canada
Investigators
Principal Investigator: Paul R Fortin, MD,FRCP,MPH University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188357     History of Changes
Other Study ID Numbers: 03-0605-A, 03-0084
Study First Received: September 9, 2005
Last Updated: February 13, 2007
Health Authority: Canada: The Arthritis Society

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014