Table 2.
Composite scores at the 3- and 6-month follow-ups (N=209).
|
|
Control (n=107), n (%) | Intervention (n=102), n (%) | Odds ratio (95% CI) | P value | Per-protocol analysis (n=85), n (%) | Odds ratio (95% CI) | P value | ||||||||||||||
| Three months | |||||||||||||||||||||
|
|
Composite score | 2.37 (1.048-5.340) | .04 |
|
2.61 (1.133-5.996) | .02 | |||||||||||||||
|
|
|
Improved | 10 (9.3) | 20 (19.6) |
|
|
18 (21.2) |
|
|
||||||||||||
|
|
|
Deteriorated or unchanged | 97 (90.7) | 82 (80.4) |
|
|
67 (78.8) |
|
|
||||||||||||
|
|
Composite scorea | .04 |
|
|
.009 | ||||||||||||||||
|
|
|
Improved | 10 (10) | 20 (20.8) |
|
|
18 (22) |
|
|
||||||||||||
|
|
|
Unchanged | 76 (76) | 67 (79.8) |
|
|
59 (72) |
|
|
||||||||||||
|
|
|
Deteriorated | 14 (14) | 9 (9.4) |
|
|
5 (6.1) |
|
|
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| Six months | |||||||||||||||||||||
|
|
Composite scoreb | 1.47 (0.795-2.730) | .22 |
|
1.82 (0.968-3.429) | .06 | |||||||||||||||
|
|
|
Improved | 25 (23.4) | 31 (31) |
|
|
30 (35.7) |
|
|
||||||||||||
|
|
|
Deteriorated or unchanged | 82 (76.6) | 69 (69) |
|
|
54 (64.3) |
|
|
||||||||||||
|
|
Composite scorec | .15 |
|
|
.03 | ||||||||||||||||
|
|
|
Improved | 25 (24) | 31 (33) |
|
|
30 (37) |
|
|
||||||||||||
|
|
|
Unchanged | 64 (61.5) | 53 (56.4) |
|
|
45 (55.6) |
|
|
||||||||||||
|
|
|
Deteriorated | 15 (14.4) | 10 (10.6) |
|
|
6 (7.4) |
|
|
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aSeven missing values in the control group, 6 missing values in the intervention group in the intention-to-treat analysis, and 3 missing values in the intervention group in the per-protocol analysis.
bTwo missing values in the intervention group in the intention-to-treat analysis, and 1 missing value in the intervention group in the per-protocol analysis.
cThree missing values in the control group, 8 missing values in the intervention group in the intention-to-treat analysis, and 4 missing values in the intervention group in the per-protocol analysis.