Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


A Randomized Clinical Trial of a Comprehensive Behavioral Intervention in Systemic Lupus Erythematosus Demonstrates Improvement in Mental Health but Not in Physical Health, Cardiovascular Risks or Endothelial Function At One Year.

Fortin1,  Paul R., Aghdassi2,  Ellie, Cymet2,  Anne, Morrison3,  Stacey, Su3,  Jiandong, Wynant4,  Willy, Pope5,  Janet E.

Toronto Western Hospital, Toronto, ON
McGill UHC/RVH, Montreal, QC
Montreal General Hospital, Montreal
University Health Network, Toronto, ON
The Toronto Western Hospital, Toronto, ON
McGill University, Quebec, QC
St. Joseph's Health Care, University of Western Ontario, London, ON
McGill Univ Health Center, Montreal, QC
Royal Victoria Hospital, Montreal, QC
Toronto General Hospital, Toronto, ON
Universite de Montreal endowed research chair in atherosclerosis, Quebec, QC

Background/Purpose:

The Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus (SLE) is the first randomized intervention aimed at the improvement of health status and coping while reducing risky behaviours for cardiovascular disease (CVD).

Methods:

An unblinded RCT of the HIPP intervention (HIPP NOW) compared to usual care (HIPP LATER) assessed physical (PCS) and mental (MCS) component summary scores of SF-36, the CVD risk derived from the Framingham risk score (CVD risk) and the flow mediated dilatation (FMD) of the brachial artery. Patients with no CVD were recruited from three academic centres. After providing consent, SF-36, SLEDAI, SDI as well as FMD were collected. Those randomized to HIPP NOW were administered a personalized risk modification program by a nurse (disease education, CVD risk reduction {including smoking cessation}, exercise, psychological intervention). Repeated clinical assessments and FMD were performed at one year. A cross-over of the LATER group occurred at one year and all patients will be reassessed at 2 years. We report here the one year results. Power calculations showed that 260 patients ensured 80% power to detect >=10% improvement in the SF-36 MCS and PCS and 20% in CVD risk. Between groups differences (1year - baseline) were tested, separately for each primary outcome, using t-tests and multivariable linear regressions (MLR) adjusting for baseline values and for patients' characteristics associated with the outcome.

Results:

We randomized 288 patients. There were no differences between groups for mean age (44 yrs), race (70% Caucasian), marital status (53% married), education (91% high school graduates), mean disease duration (11.3 yrs) and mean SLEDAI (4.04). The NOW group had a higher mean SDI (1.37 vs 1.00, p=0.03). Table 1 shows the results of the HIPP intervention at one year on the outcomes of PCS, MCS, CVD risk and the post-occlusive FMD change in brachial artery diameter.

 Unadjusted analysesAdjusted analyses
OutcomeD HIPP NOW (1 year-baseline)D HIPP LATER (1 year-baseline)p-valuebstudy-group in MLR (95%CI)p-value study-group in MLR
SF36-physical0.0260.6950.471-0.10 (-1.80; 1.60)0.909
SF-36 mental1.837-1.4410.008-2.67 (-4.84; -0.50)0.017
CVD risk (logit)-0.0230.0560.087+0.08 (-0.01; 0.17)0.067
FMD (% change)-0.290-0.2050.922+0.18 (-1.43; 1.79)0.828

The MCS score increased during the first year of follow-up in the HIPP NOW group by 1.84 units but decreased in the LATER group by 1.44. The resulting un-adjusted difference (p=0.008 for the 2-tailed t-test) and the adjusted difference from MLR (2.67, 95% CI: 0.50 to 4.84, p=0.017) were both statistically significant. There was a trend toward improvement in CVD risk (p= 0.087 for t-test and p=0.067 for MLR). The differences in the other primary outcomes were not significant.

Conclusion:

The HIPP intervention significantly improved the mental health but not the physical health in SLE as measured by the SF-36; other primary outcomes were not significant. Since SF-36 mental health improvement may precede changes towards healthier behaviour, this study will re-examine outcomes at two years.

To cite this abstract, please use the following information:
Fortin, Paul R., Aghdassi, Ellie, Cymet, Anne, Morrison, Stacey, Su, Jiandong, Wynant, Willy, et al; A Randomized Clinical Trial of a Comprehensive Behavioral Intervention in Systemic Lupus Erythematosus Demonstrates Improvement in Mental Health but Not in Physical Health, Cardiovascular Risks or Endothelial Function At One Year. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :2064
DOI:

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