|
Welcome
|
|
20 November 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Learning to live better with lupus: the Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus |
| ISRCTN | ISRCTN03419655 |
| ClinicalTrials.gov identifier | NCT00188357 |
| Public title | Learning to live better with lupus: the Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus |
| Scientific title | |
| Acronym | HIPP |
| Serial number at source | MCT-82939 |
| 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 |
Ethics approval received from:
1. Research Ethics Board of the University Health Network, Toronto on the 13th January 2004 (ref: 03-0605-A) 2. Research Ethics Board of McGill University on the 1st December 2006 (ref: 03-034) 3. Research Ethics Board of the University of Western Ontario on the 31st January 2008 (ref: 13732) |
| Study design | Randomised, cross-over, open-label efficacy study |
| Countries of recruitment | Canada |
| Disease/condition/study domain |
Systemic lupus erythematosus
|
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/08/2003 |
| Anticipated end date | 01/12/2010 |
| Status of trial | Ongoing |
| Patient information material | Patient information material can be found at http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1. |
| Target number of participants | 310 patients to enroll (to achieve 260 completers) |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82939) |
| Trial website | http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1 |
| Publications | |
| Contact name | Dr Paul R. Fortin |
| Address |
UHN - TWH Research Institute
Toronto Western Hospital, MP10-304 399 Bathurst Street |
| City/town | Toronto, Ontario |
| Zip/Postcode | M5T 2S8 |
| Country | Canada |
| Tel | +1 416 603 6265 |
| Fax | +1 416 603 6288 |
| pfortin@uhnresearch.ca | |
| Sponsor | University Health Network (Canada) |
| Address | 200 Elizabeth Street |
| City/town | Toronto, Ontario |
| Zip/Postcode | M5G 2C4 |
| Country | Canada |
| Sponsor website: | http://www.uhn.ca/index.htm |
| Date applied | 16/06/2008 |
| Last edited | 23/06/2008 |
| Date ISRCTN assigned | 16/06/2008 |
|
|
|
| © ISRCTN | |
|
|
|
|