Table 3. Results of the complete case analysis (IG: N = 211; CG: N = 220).
| Outcome | Group | N | T0 | T1 | Δ T0–T1 | Difference ΔIG vs. ΔCG | |
| M (SD) | M (SD) | p value*1 | ES *2 [95% CI] | ||||
| Primary outcome | |||||||
| Limitation in social participation (IMET) (0–90) (higher scores = worse) |
IG | 210 | 34.68 (19.29) | 27.34 (20.39) | 7.33 (21.05) | 0.018 | 0.23 [0.04; 0.42] |
| CG | 218 | 32.79 (18.33) | 29.87 (20.37) | 2.92 (17.31) | |||
| Secondary outcomes | |||||||
| Disease activity during the preceeding 7 days (GIBDI*3) (0–18) (higher scores = worse) |
IG | 188 | 5.55 (2.83) | 4.17 (3.07) | 1.38 (3.00) | <0.001 | 0.37 [0.16; 0.57] |
| CG | 184 | 5.32 (2.89) | 5.05 (3.22) | 0.27 (3.06) | |||
| Self-monitoring and insight (heiQ scale) (1–4) (higher scores = better) |
IG | 208 | 2.96 (0.45) | 3.21 (0.41) | 0.25 (0.41) | 0.001 | 0.33 [0.14; 0.52] |
| CG | 210 | 3.01 (0.46) | 3.13 (0.45) | 0.12 (0.38) | |||
| Constructive attitudes (heiQ scale) (1–4) (higher scores = better) |
IG | 209 | 3.12 (0.51) | 3.31 (0.52) | 0.19 (0.49) | 0.022 | 0.23 [0.04; 0.42] |
| CG | 211 | 3.13 (0.54) | 3.21 (0.57) | 0.08 (0.47) | |||
| Emotional well-being (heiQ scale) (1–4)(higher scores = worse) |
IG | 205 | 2.38 (0.66) | 2.08 (0.66) | −0.30 (0.58) | 0.003 | 0.31 [0.11; 0.50] |
| CG | 215 | 2.37 (0.66) | 2.25 (0.64) | −0.12 (0.60) | |||
| Psychological distress (PHQ-4) (0–12) (higher scores = worse) |
IG | 211 | 4.44 (2.70) | 3.29 (2.61) | 1.15 (2.69) | 0.015 | 0.24 [0.05; 0.43] |
| CG | 216 | 4.28 (2.78) | 3.75 (2.73) | 0.53 (2.58) | |||
| Vitality (SF-36, subscale) (0–100) (higher scores = better) |
IG | 209 | 35.46 (16.87) | 45.05 (20.46) | −9.59 (19.75) | 0.001 | 0.33 [0.14; 0.52] |
| CG | 218 | 36.49 (18.07) | 39.86 (20.60) | −3.37 (18.25) | |||
| Level of being informed about IBD (NRS 0–10) |
IG | 210 | 6.56 (2.43) | 7.49 (2.33) | −0.92 (2.52) | 0.042 | 0.20 [0.01; 0.39] |
| CG | 219 | 6.78 (2.41) | 7.26 (2.46) | −0.48 (2.02) | |||
| Health-related quality of life (EQ-VAS) (0–100) (higher scores = better) |
IG | 209 | 60.76 (16.57) | 67.58 (17.47) | −6.82 (18.92) | 0.003 | 0.29 [0.10; 0.48] |
| CG | 219 | 63.12 (15.98) | 64.81 (18.48) | −1.69 (16.82) | |||
| Current state of health at T1 a lot/somewhat (compared to T0) better |
IG | 209 | 122 (58.4%) | <0.001 | OR = 2.7 [1.8; 3.9] |
||
| CG | 220 | 76 (34.5%) | |||||
| Employment status at T1 Working, yes | IG | 210 | 193 (91.9%) | 0.749 | OR = 0.9 [0.4; 1.8] |
||
| CG | 220 | 204 (92.7%) | |||||
| Negative subjective employment prognosis (SPE) at T1 Score ≥ 2 |
IG | 204 | 92 (45.1%) | 0.474 | OR = 0.7 [0.5; 1.1] |
||
| CG | 214 | 104 (48.6%) | |||||
| Number of sick days taken off from work*4 in the preceeding 3 months (0–90) |
IG | 188 | 11.67 (17.87) | 10.30 (21.09) | 1.37 (26.13) | 0.329 | 0.10 [−0.10; 0.30] |
| CG | 195 | 9.72 (15.15) | 10.77 (20.86) | −1.06 (22.33) | |||
*1 Non-adjusted; for secondary outcomes, only p values ≤ 0.004 are statistically significant after Bonferroni adjustment.
*2 Cohen’s d with denominator as mean pooled SD and corrected for different group sizes; positive d value = advantage IG, negative value = advantage CG
*3 GIBDI incalculable for stoma and indeterminate colitis
*4 Only persons working at T1
IBD, inflammatory bowel disease; EQ-VAS, EuroQuol Visual Analogue Scale; ES, effect size; GIBDI, German Inflammatory Bowel Disease Activity Index; heiQ, Health Education Impact Questionnaire; IG, intervention group; IMET, index for measuring restrictions of participation (“Index zur Messung von Einschränkungen der Teilhabe”); CI, confidence interval; CG, control group; M, mean; N, number of valid values; NRS, numerical rating scale; OR, odds ratio; PHQ-4, Patient Health Questionnaire (short form with 4 items); SD, standard deviation; SF-36, short form 36 questionnaire; SPE, subjective prognostic employment scale (without pensioners); T0, baseline; T1, follow-up