Randomized Controlled Trial
Copyright ©The Author(s) 2021.
World J Clin Cases. Oct 6, 2021; 9(28): 8413-8424
Published online Oct 6, 2021. doi: 10.12998/wjcc.v9.i28.8413
Table 1 Baseline characteristics in the intervention group and the control group
Characteristics
Total, n = 158
IG, n = 80
CG, n = 78
t
z
x2
P value
Caregiver characteristics
Age (yr), mean ± SD 47.4 ± 8.447.7 ± 8.647.0 ± 8.30.5200.604
Gender, n (%)0.9330.334
Male44 (27.8)25 (31.3)19 (24.4)
Female114 (72.2)55 (68.8)59 (75.6)
Work status, n (%)0.1410.932
Full-time102 (64.6)51 (63.8)51 (65.4)
Part-time24 (15.2)13 (16.3)11 (14.1)
Unemployed32 (20.3)16 (20.0)16 (20.5)
Relationship, n (%)0.2380.888
Son or daughter45 (28.5)23 (28.8)22 (28.2)
Spouse62 (39.2)30 (37.5)32 (41.0)
Others51 (32.3)27 (33.8)24 (30.8)
Education duration (yr), mean (IQR)9.0 (6.0)9.0 (6.0)9.0 (6.5)-0.2510.802
Patient characteristics
Age (yr), mean ± SD59.2 ± 10.960.6 ± 10.757.7 ± 10.91.6690.097
Gender, n (%)0.0820.774
Male25 (15.8)12 (15.0)13 (16.7)
Female133 (84.2)68 (85.0)65 (83.3)
Comorbidity, n (%)0.1180.732
Yes28 (17.7)15 (18.8)13 (16.7)
No130 (82.3)65 (81.3)65 (83.3)
Drug therapy, n (%)0.0760.783
DMARDs + GC117 (74.1)60 (75.0)57 (73.1)
DMARDs + GC + biologics41 (26.0)20 (25.0)21 (26.9)
Disease duration (yr), mean (IQR)5.5 (6.0)5.0 (5.0)6.5 (4.3)-1.8160.069
CRP (mg/L), mean ± SD18.00 ± 5.5217.74 ± 5.6518.25 ± 5.41-0.5790.563
ESR (mm/h), mean ± SD35.49 ± 5.3335.61 ± 5.2935.36 ± 5.410.2980.766
TNF-α (pg /ml), mean ± SD43.47 ± 9.5843.93 ± 9.0442.99 ± 10.150.6180.537
CDAI, mean ± SD20.00 ± 7.6319.97 ± 7.2920.04 ± 8.01-0.0600.952
SDAI, mean ± SD38.00 ± 8.7037.71 ± 8.6738.29 ± 8.78-0.4200.675
DAS28, mean ± SD4.92 ± 1.304.94 ± 1.294.89 ± 1.330.2510.802
HAQ, mean (IQR)1.12 (0.99)1.21 (0.99)1.11 (0.99)-0.4420.659
SDS, mean ± SD57.87 ± 5.5157.31 ± 4.7758.45 ± 6.15-1.3000.196
SAS, mean ± SD53.82 ± 9.6854.43 ± 8.3453.21 ± 10.910.7910.430
Table 2 Indicators of the intervention group and the control group (mean ± SD)
Indicators
IG, n = 80
CG, n = 78
Baseline
1st mo
3rd mo
6th mo
Baseline
1st mo
3rd mo
6th mo
Inflammation level
CRP (mg/L)17.74 ± 5.6515.05 ± 4.5110.83 ± 3.842.40 ± 2.0018.25 ± 5.4116.71 ± 4.4215.13 ± 3.357.93 ± 2.77
ESR (mm/h)35.61 ± 5.2931.57 ± 4.8128.03 ± 3.4223.97 ± 3.1435.36 ± 5.4132.85 ± 4.5829.81 ± 3.3628.21 ± 2.82
TNF-α (pg/mL)43.93 ± 9.0438.22 ± 8.0533.24 ± 7.9829.61 ± 6.7242.99 ± 10.1541.01 ± 9.7238.12 ± 9.1435.56 ± 8.12
Disease activity
CDAI19.97 ± 7.2920.00 ± 7.2513.90 ± 5.174.51 ± 1.9420.04 ± 8.0119.51 ± 7.9517.94 ± 6.9315.41 ± 5.26
SDAI37.71 ± 8.6735.06 ± 8.1124.73 ± 5.996.91 ± 2.4938.29 ± 8.7836.22 ± 8.2233.06 ± 7.0323.34 ± 5.24
DAS284.94 ± 1.294.56 ± 1.004.02 ± 0.783.40 ± 1.004.89 ± 1.334.94 ± 1.294.50 ± 1.254.13 ± 0.93
HAQ1.39 ± 0.641.04 ± 0.591.12 ± 0.650.36 ± 0.281.43 ± 0.701.24 ± 0.721.22 ± 0.660.91 ± 0.58
Mood disorder
SDS57.31 ± 4.7746.60 ± 5.6737.63 ± 5.1431.81 ± 9.8258.45 ± 6.1550.95 ± 6.0951.62 ± 5.7749.58 ± 6.13
SAS54.43 ± 8.3449.81 ± 7.5240.60 ± 6.3231.71 ± 8.8453.21 ± 10.9153.01 ± 10.8449.22 ± 7.3445.13 ± 9.39
Table 3 Indicators of the intervention group grouped by relationship (mean ± SD)
Indicators
Son or daughter, n = 23
Spouse, n = 30
Others, n = 27
Baseline
1st mo
3rd mo
6th mo
Baseline
1st mo
3rd mo
6th mo
Baseline
1st mo
3rd mo
6th mo
CRP (mg/L)18.90 ± 5.0315.09 ± 4.439.45 ± 4.240.98 ± 0.8520.07 ± 5.4516.27 ± 4.8312.02 ± 3.592.44 ± 1.9314.18 ± 4.6713.67 ± 3.9210.67 ± 3.433.55 ± 2.07
ESR (mm/h)36.33 ± 3.8832.46 ± 4.7728.28 ± 4.3024.45 ± 3.9238.11 ± 4.2333.13 ± 3.9727.76 ± 2.7922.57 ± 2.3432.24 ± 5.7329.08 ± 4.8528.10 ± 3.3325.12 ± 2.66
TNF-α (pg /mL)47.25 ± 9.2440.65 ± 9.0433.57 ± 9.3929.91 ± 7.7444.71 ± 7.4937.84. ± 6.4432.24 ± 6.1528.84 ± 4.6240.24 ± 9.4236.56 ± 8.5734.08 ± 8.6530.22 ± 7.84
Table 4 Indicators of the intervention group grouped by patient’s age (mean ± SD)
Indicators
Middle-aged people, n = 42
Elderly people, n = 38
Baseline
1st mo
3rd mo
6th mo
Baseline
1st mo
3rd mo
6th mo
CDAI14.48 ± 4.0414.53 ± 4.0210.07 ± 2.324.79 ± 1.8526.03 ± 4.8426.05 ± 4.7618.13 ± 1.024.21 ± 2.00
SDAI32.88 ± 6.1930.14 ± 5.5721.65 ± 4.007.44 ± 2.1143.04 ± 7.8940.49 ± 6.9428.13 ± 6.036.32 ± 2.76
DAS284.09 ± 0.753.85 ± 0.723.64 ± 0.793.49 ± 1.035.88 ± 1.085.34 ± 0.584.44 ± 0.523.30 ± 0.96
HAQ1.34 ± 0.631.12 ± 0.601.24 ± 0.660.33 ± 0.201.45 ± 0.650.95 ± 0.580.99 ± 0.620.39 ± 0.29
SDS60.90 ± 3.3148.00 ± 6.5438.50 ± 5.5730.45 ± 8.9153.34 ± 2.3545.05 ± 4.0736.66 ± 4.4933.32 ± 10.66
SAS60.90 ± 4.8155.38 ± 5.1245.55 ± 3.6029.71 ± 6.9047.26 ± 4.7343.66 ± 4.2135.13 ± 3.5233.92 ± 10.22