Self-monitoring with home based fecal calprotectin is associated with increased medical treatment. A randomized controlled trial on patients with inflammatory bowel disease

Figures & data

Figure 1. Flow chart that show how the patients were recruited for the study.

Table 1. Questions at a telephone survey to compliers of IBD-Home.

1. Why did you enroll in the IBD-Home project?

2. What was your overall experience of the IBD-Home project like?

3. Did you find the digital application or the fecal calprotectin test kits difficult to use? If yes, which difficulties did you encounter?

4. Did you experience any positive effects of your participation in the IBD-Home project? If yes, which effects?

5. Did you experience any negative effects of your participation in the IBD-Home project? If yes, which effects?

6. Would you like to continue to participate in an a similar IBD self-monitoring model with fecal calprotectin test and digital application?

7. Do you have any ideas or input on how IBD-Home could be further developed?

Table 2. Baseline demographics and characteristics of patients at inclusion.

	IBD-Home Group	Control Group	p-Value (IBD-Home vs	IBD-Home group compliers	IBD-Home group non-compliers	p-value (Compliers vs
	(N = 84)	(N = 74)	Control)	(N = 24)	(N = 60)	Non complier)
Median age at inclusion (years)	34.9	36.9	.358	37.8	33.9	0.120
(25^th-75^th percentile)	(27.2 − 41.4)	(29.3 − 41.7)		(29.0 − 44.2)	(26.1- 40.4)
Gender: % (N)
Female	44% (37)	35.% (26)	.254	67% (16)	35% (21)	0.008
Male	56% (47)	65% (48)		33% (8)	65% (39)
Type of IBD: % (N)
Ulcerative colitis	66% (55)	62% (46)	.831	63% (15)	67% (40)	0.388
Crohns disease	31% (26)	35% (26)		29% (7)	32% (19)
Intermediate IBD	4 % (3)	3% (2)		8 % (2)	2% (1)
Montreal Classification % (N)
A1	17% (14)	12% (9)	.709	4% (1)	22% (13)	0.100
A2	80% (67)	84% (62)		92% (22)	75% (45)
A3	3% (3)	4% (3)		4% (1)	3% (2)
E1	21% (12)	24% (11)	.620	25% (4)	20% (8)	0.254
E2	25% (14)	30% (14)		35% (6)	20% (8)
E3	54% (31)	46% (21)		35% (6)	60% (25)
L1	23% (6)	12% (3)	.197	29% (2)	21% (4)	0.583
L2	58% (15)	44% (11)		42% (3)	63% (12)
L3	19% (5)	36% (9)		29% (2)	16% (3)
L4	0% (0)	8% (2)		0%	0% (0)
B1	73% (19)	76% (19)	.709	57% (4)	79% (15)	0.263
B2	23% (6)	16% (4)		29% (2)	21% (4)
B3	4% (1)	8% (2)		14% (1))	0% (0)
Perianal disease	23% (6)	38% (10)	.225	29% (2)	21% (4)	0.606
Median years from diagnosis	8.0 (4.0 − 10.0)	8.0 (5.0 − 9.0)	.822	6.3 (3.5 − 8.8)	9.0 (5.0 − 11.0)	0.076
(25^th-75^th percentile)
Treatment at inclusion % (N)
Five-ASA	63% (53)	65% (48)	.817	54% (13)	67% (40)	0.283
Steroids (not budesonide)	13% (11)	8% (6)	.313	8% (2)	15% (9)	0.500
Budesonide	3% (3)	3% (2)	>.999	8% (2)	2% (1)	0.195
Thiopurines	36% (30)	35% (26)	.939	50% (12)	30% (18)	0.084
Anti-TNF	24% (20)	16% (12)	.236	25% (6)	23% (14)	0.871
Combination of Thiopurines and Anti-TNF	12% (10)	8% (6)	.430	17% (4)	10% (6)	0.461
Vedoluzimab	0% (0)	3% (2)	.218	0% (0)	0% (0)	>0.999
Ustekinumab	1% (1)	1% (1)	>.999	0% (0)	2% (1)	>0.999
Surgery before inclusion	19% (16)	18% (13)	.810	8% (2)	23% (14)	0.136
Median fecal calprotectin^a (µg/g) 3 years before inclusion	80 (31 − 299)	52 (24 − 204)	.059	144 (25 − 425)	68 (32 − 276)	0.508
(25^th-75^th percentile)
Median CRP (mg/L)	1 (0.5 − 2)	1 (0.5 − 2)	.520	1 (0.5 − 4)	1 (0.5 − 2)	0.520
3 years before inclusion (25^th-75^th percentile)
Median Hemoglobin (g/L) 3 years before inclusion (25^th-75^th percentile)	140 (130 − 150)	139 (130 − 150)	.619	139 (131 − 147)	142 (130 − 152)	0.619

^aFecal calprotectin CALPRO®.

Table 3. Factors associated with adherence to the IBD-Home model in the patients randomized to IBD-Home. Logistic regression.

	Univariate Odds ratio (95% CI: Lower – Upper)	Multivariate Odds ratio (95% CI: Lower – Upper)
Female gender	3.72 (1.37 − 10.1)	3.52 (1.13 − 11.0)
Age at inclusion	1.047 (0.984 − 1.113)	1.055 (0.997 − 1.139)
Type of IBD^a (UC reference)	0.889 (0.316 − 2.501)	0.712 (0.214 − 2.369)
> 5 years from diagnosis	0.463 (0.176 − 1.219)	0.376 (0.114 − 1.239)
Median value of Fecal calprotectin^b> 200 µg/g three years before inclusion	1.863 (0.675 − 5.143)	2.767 (0.871 − 8.785)

^aIntermediate IBD patients classified as ulcerative colitis patients.

^bFecal calprotectin CALPRO^®.

Figure 2. The total number of Bühlmann HBFCT IBDoc^® per patient for the patients in the intervention group who were compliant to the IBD-model.

Figure 3. The total number of tests (both Bühlmann HBFCT IBDoc^® and CALPRO^®) per patient in the intervention group (IBD-home model) and in the control group.

Table 4. Healthcare interactions and change in medical treatment during study.

	IBD-Home Group (N = 84)	Control group (N = 74)	P-value (IBD-Home vs Control)	IBD-Home group compliers (N = 24)	IBD-Home group non-compliers (N = 60)	p-Value (Compliers vs non-compliers)
Median number of total health care interactions due to IBD (telephone and visits) percentile (25^th-75^thpercentile)	1 (0–4)	1 (0–2)	0.175	2.5 (1–7)	1 (0–2)	.021
Median total telephone contacts due to IBD (25^th-75^thpercentile)	0 (0–3)	0 (0–1)	0.186	2 (0–6)	0 (0–1)	.038
Median total health care visits due to IBD (25^th-75^thpercentile)	1 (0–2)	0 (0–1)	0.076	1 (0–2)	0 (0–2)	.524
Proportion of patients who received increasedmedical treatment during study % (N)	33% (28)	15%(11)	0.007	58% (14)	23% (14)	.002
Proportion of patients who received reduction in medical treatment during study % (N)	16% (13)	14% (10)	0.727	21% (5)	13% (8)	.201

Table 5. Factors associated with increased medical treatment in the IBD-Home group.

	Univariate	Multivariate
	Odds ratio (95% CI: Lower – Upper)	Odds ratio (95% CI: Lower – Upper)
Female gender	2.78 (1.1-7.1)	3.07 (0.98-9.62)
Age at inclusion	0.99 (0.94 − 1.06)	0.98 (0.91–1.05)
Compliers vs Non-compliers	4.60 (1.67 − 12.7)	3.22 (1.04 − 9.95)
Median value of Fecal calprotectin^a> 200 µg/g three years before inclusion	3.06 (1.14 − 8.20)	3.75 (1.20 − 11.6)

Logistic regression. Statistically significant values are marked in bold.

^aFecal calprotectin CALPRO®.