Learning to live better with lupus: the Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus
| ISRCTN | ISRCTN03419655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03419655 |
| ClinicalTrials.gov number | NCT00188357 |
| Secondary identifying numbers | MCT-82939 |
- Submission date
- 16/06/2008
- Registration date
- 16/06/2008
- Last edited
- 19/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul R. Fortin
Scientific
Scientific
UHN - TWH Research Institute
Toronto Western Hospital, MP10-304
399 Bathurst Street
Toronto, Ontario
M5T 2S8
Canada
| Phone | +1 416 603 6265 |
|---|---|
| pfortin@uhnresearch.ca |
Study information
| Study design | Randomised, cross-over, open-label efficacy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1 |
| Scientific title | The Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus: a randomised, cross-over, open-label efficacy study |
| Study acronym | HIPP |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2003 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 310 patients to enroll (to achieve 260 completers) |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
UHN - TWH Research Institute
Toronto, Ontario
M5T 2S8
Canada
M5T 2S8
Canada
Sponsor information
University Health Network (Canada)
University/education
University/education
200 Elizabeth Street
Toronto, Ontario
M5G 2C4
Canada
| Website | http://www.uhn.ca/index.htm |
|---|---|
"ROR" |
https://ror.org/042xt5161 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82939)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/02/2019: No publications found. Verifying results with principal investigator
