Control group | Control group | Control group | Intervention group | Intervention group | Intervention group | |
Outcome
|
Baseline (n=40) | Follow-up (n=35) |
P-value
|
Baseline (n=41) | Follow-up (n=36) |
P-value
|
Efficacy† n (%) |
11 (27.5%)
|
17 (48.6%)
|
<0.05*
|
13 (31.7%)
|
23 (63.9%)
|
<0.001**
|
Safety‡ Mean (SD) |
21.42 (12.16)
|
23.73 (13.24)
|
<0.001**
|
21.08 (10.59)
|
18.91 (9.44)
|
<0.001**
|
Adherence§ Mean (SD) |
6.05 (1.26)
|
5.85 (1.43)
|
>0.05
|
6.04 (1.09)
|
7.61 (0.9)
|
<0.001**
|
Satisfaction¶ Mean (SD) |
2.2 (2.76)
|
2.66 (2.68)
|
<0.05*
|
0.76 (1.4)
|
12.58 (1.4)
|
<0.0001**
|
QoL Mean (SD) |
70.88 (20.7)
|
64.63 (21.58)
|
<0.05*
|
70.75 (14.5)
|
75.09 (14.87)
|
<0.001**
|
Difference between groups at follow-up | Difference between groups at follow-up | Difference between groups at follow-up | Difference between groups at follow-up | Difference between groups at follow-up | Difference between groups at follow-up | Difference between groups at follow-up |
Outcome | Control group | Control group | Control group | Intervention group | Intervention group | P-value |
Efficacy† | 17 (48.6%) | 17 (48.6%) | 17 (48.6%) | 23 (63.9%) | 23 (63.9%) | >0.05 |
Safety‡ | 23.73 (13.24) | 23.73 (13.24) | 23.73 (13.24) | 18.91 (9.44) | 18.91 (9.44) | >0.05 |
Adherence§ | 5.85 (1.43) | 5.85 (1.43) | 5.85 (1.43) | 7.61 (0.9) | 7.61 (0.9) | <0.0001** |
satisfaction¶ | 2.66 (2.68) | 2.66 (2.68) | 2.66 (2.68) | 12.58 (1.4) | 12.58 (1.4) | <0.0001** |
QoL | 64.63 (21.58) | 64.63 (21.58) | 64.63 (21.58) | 75.09 (14.87) | 75.09 (14.87) | <0.05* |