Plain English Summary
Not provided at time of registration
Trial website
http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1
Contact information
Type
Scientific
Primary contact
Dr Paul R. Fortin
ORCID ID
Contact details
UHN - TWH Research Institute
Toronto Western Hospital
MP10-304
399 Bathurst Street
Toronto
Ontario
M5T 2S8
Canada
+1 416 603 6265
pfortin@uhnresearch.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00188357
Protocol/serial number
MCT-82939
Study information
Scientific title
The Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus: a randomised, cross-over, open-label efficacy study
Acronym
HIPP
Study hypothesis
1. The Health Improvement and Prevention Program (HIPP) will improve the physical component (PCS) and mental component (MCS) summary scores of the 36-item short form (SF-36) health status survey by an average of 4 points
2. HIPP will reduce the Framingham 8-year projected risk of cardiovascular disease (CVD) in persons with systemic lupus erythematosus (SLE) by 20%
3. HIPP will improve the flow mediated dilatation (FMD) of brachial arteries significantly
Ethics approval
1. Research Ethics Board of the University Health Network, Toronto approved on the 13th January 2004 (ref: 03-0605-A)
2. Research Ethics Board of McGill University approved on the 1st December 2006 (ref: 03-034)
3. Research Ethics Board of the University of Western Ontario approved on the 31st January 2008 (ref: 13732)
Study design
Randomised, cross-over, open-label efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information material can be found at http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1
Condition
Systemic lupus erythematosus
Intervention
Experimental interventions:
1. Non-drug coronary artery risk reduction in the setting of lupus measured at three months for one year followed by every six months for one year
2. Non-drug osteoporosis risk reduction in the setting of lupus measured at three months for one year followed by every six months for one year
3. Non-drug exercise in the setting of lupus measured at three months for one year followed by every six months for one year
4. Non-drug mindfulness based stress reduction in the setting of lupus measured at three months for one year followed by every six months for one year
Control intervention:
Usual care for 12 months.
Added 26/02/2009:
Secondary sponsor details:
Toronto Western Hospital (Canada)
c/o Dr. Paul Fortin
University Health Network
399 Bathurst Street
MP-10-304
Toronto, Ontario, M5T-2S8
Canada
Tel: +1 416 603 5800 ext. 6267
Fax: +1 416 603 6288
Email: pfortin@uhnresearch.ca
Contact for public queries:
Dr Ellie Aghdassi, Ph.D.
University Health Network
Toronto Western Hospital
399 Bathurst Street
MP-10-301
Toronto, Ontario, M5T-2S8
Canada
Tel: +1 416 603 5800 ext. 2822
Fax: +1 416 603 6288
Email: ellie.aghdassi@uhn.on.ca
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
36-item short form health survey physical and mental component summary scale (SF-36 PCS and MCS) scores, coronary disease risk reduction profiles and flow-mediated dilatation of the brachial artery yearly for two years.
Secondary outcome measures
1. Bone health improvement: yearly while on prednisone; every two years for all others
2. Adherence to treatment: every three months for one year and every six months for one year
Overall trial start date
01/08/2003
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria
2. 18 years or older
3. Female
4. Able to read and English or French
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
310 patients to enroll (to achieve 260 completers)
Participant exclusion criteria
1. History of angina
2. Myocardial infarct
3. Cerebral vascular accident
4. Trans-ischaemic attack
5. Peripheral vascular disease
6. Osteoporosis with fracture confirmed by radiology
7. Pregnant or planning within two years
8. Cancer (if cancer-free for five years then eligible)
Recruitment start date
01/08/2003
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Canada
Trial participating centre
UHN - TWH Research Institute
Toronto, Ontario
M5T 2S8
Canada
Sponsor information
Organisation
University Health Network (Canada)
Sponsor details
200 Elizabeth Street
Toronto
Ontario
M5G 2C4
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82939)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary