Background/Purpose: The Health Improvement and Prevention Program (HIPP) is a behavioral intervention aimed at improving health status and coping of persons with lupus while reducing cardiovascular (CVD) risk.  Our purpose is to determine whether HIPP will improve health status, CVD risk and endothelial function at one year.

Methods: An unblinded RCT of HIPP compared to usual care assessed physical (PCS) and mental (MCS) component summary scores of SF-36, CVD risk derived from the Framingham risk score (FRS) and flow mediated dilatation (FMD) of the brachial artery.  Patients with lupus and no previous CVD were recruited.  SF-36, disease activity (SLEDAI-2K) and damage (SLICC-DI), CVD risk factors and FMD were collected at baseline.  Those randomized to the NOW group attended four educational lectures and were administered a personalized risk modification program (disease education, CVD and osteoporosis risk reduction, exercise, and a psychological intervention where warranted).  At one year, the LATER group crossed over and received HIPP while the NOW group resumed usual care.  Repeated clinical assessments and FMD were performed at one and two years.  Paired t-tests at the Bonferroni-corrected 2-tailed alpha=0.0125 were used to assess the statistical significance of the mean changes, estimated from data pooled from the first year for the NOW group pooled with the second year for the LATER group in PCS, MCS, FRS and FMD.  Additional analyses explored whether the changes observed at one year in the NOW group were sustained at two years.

Results: We randomized 288 patients; one withdrew at baseline leaving 287 for analysis.  Mean age was 44 yrs, 70% were Caucasian, 53% married, 91% high school graduates, mean disease duration was 11.3 yrs, mean SLEDAI 4.04 and mean SDI 1.17.  Two primary outcomes, the MCS and the FRS improved significantly at one year with a mean MCS score increase of 2.16 (95% CI: 0.75 to 3.58, p=0.003) and a mean FRS logit decrease of -0.06 (95% CI: -0.12 to -001, p=0.02) (Table 1).  There was no improvement in PCS or FMD.  Additional analyses at two years in the NOW group revealed that 1) the one-year benefit on MCS and FRS was lost at two years and 2) when compared to those without improvement in their MCS at one year, those with improvement in MCS did not benefit further in their PCS, FRS or FMD at two years. 

Table 1:  Differences after one year of the intervention HIPP in the NOW (1-year vs baseline) and LATER (2-year vs 1-year) groups

 

Primary outcome	PRE	POST	Mean of the differences	95% CI
SF-36 physical	40.89	40.87	-0.02	-1.11 ; 1.07
SF-36 mental	45.33	47.49	2.16	0.75 ; 3.58
Framingham logit	-5.79	-5.85	-0.06	-0.12 ; -0.01
FMD	0.117	0.109	-0.008	-0.028 ; 0.012

Conclusion: The HIPP behavioral intervention improves significantly the mental health and the Framingham risk score in lupus at one year but these are not sustained at two years. No reinforcement of the HIPP intervention was provided to patients of the NOW group in the second year.  Given the chronicity and unpredictability of lupus, such a behavioral intervention should incorporate ongoing booster sessions and evaluate their effectiveness in maintaining the one year benefits of the Health Improvement and Prevention Program.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-health-improvement-and-prevention-program-in-systemic-lupus-erythematosus-demonstrates-improvement-in-mental-health-and-framingham-risk-score-at-one-year/