| Trial arm |  | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Usual care (UC) | Intervention (I) | Odds ratio (95% CI) I versus UCe | Supported implementation (SI) | Odds ratio (95% CI) SI versus UCe | All sites | Intracluster Correlation Coefficient (ICC)c | |||||
Questionnaires returned | 96 | Â | 122 | Â | Â | 88 | Â | Â | 306 | Â | Â |
Catheterised (% of returned) | 21 | 22% | 37 | 30% | Â | 18 | 20% | Â | 76 | 25% | Â |
Potential respondents for incontinence measures (% age of returned) | 75 | 78% | 85 | 70% | Â | 70 | 80% | Â | 230 | 75% | Â |
Primary outcome: presence or absence of incontinence (ICIQ-UI Short-Form question three) | Â | Â | Â | Â | 0.94 (0.46-1.94) | Â | Â | 0.62 (0.28-1.37) | Â | Â | 0 |
Continenta | 21 | 28% | 29 | 34% | Â | 16 | 23% | Â | 66 | 29% | Â |
Incontinentb | 54 | 72% | 56 | 66% | Â | 54 | 77% | Â | 164 | 71% | Â |
ICIQ-UI Short Form (UC: 75; I: 83; SI: 70; All: 228)f | Â | Â | Â | Â | 0.83 (0.49-1.38) | Â | Â | 0.89 (0.52-1.51) | Â | Â | 0 |
Never | 21 | 30% | 29 | 41% | Â | 16 | 24% | Â | 66 | 31% | Â |
About once a week or less often | 8 | 11% | 7 | 10% | Â | 11 | 16% | Â | 26 | 12% | Â |
Two or three times per week | 12 | 17% | 10 | 14% | Â | 8 | 12% | Â | 30 | 14% | Â |
About once a day | 9 | 13% | 11 | 15% | Â | 12 | 18% | Â | 32 | 15% | Â |
Several times a day | 25 | 35% | 25 | 35% | Â | 22 | 32% | Â | 72 | 34% | Â |
All the time | 0 | 0% | 1 | 1% | Â | 1 | 1% | Â | 2 | 1% | Â |
Secondary outcomes | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Incontinence Severity Index (ISI) score (UC: 75; I: 84; SI: 68; All: 227)f | Â | Â | Â | Â | 0.87 (0.48-1.57) | Â | Â | 0.84 (0.46-1.56) | Â | Â | 0 |
Median (IQR) | 4 | 0-8 | 4 | 0-8 | Â | 4 | 1-8 | Â | 4 | (0-8) | Â |
None (0) | 21 | 28% | 29 | 35% | Â | 16 | 24% | Â | 66 | 29% | Â |
Slight (1-2) | 6 | 8% | 6 | 7% | Â | 7 | 10% | Â | 19 | 8% | Â |
Moderate (3-4) | 13 | 17% | 11 | 13% | Â | 18 | 26% | Â | 42 | 19% | Â |
Severe (6-8) | 35 | 47% | 38 | 45% | Â | 27 | 40% | Â | 100 | 44% | Â |
Leicester Urinary Symptom Questionnaire | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Frequency of toilet visits during daytime (UC: 71; I: 71; SI: 68; All: 210)f | Â | Â | Â | Â | 0.43 (0.22-0.84) | Â | Â | 0.60 (0.30-1.22) | Â | Â | 0.017 |
At least every 30 minutes | 0 | 0% | 0 | 0% | Â | 0 | 0% | Â | 0 | 0% | Â |
Every hour | 0 | 0% | 0 | 0% | Â | 0 | 0% | Â | 0 | 0% | Â |
Every 90 minutes | 2 | 3% | 2 | 3% | Â | 1 | 1% | Â | 5 | 2% | Â |
Every 2 hours | 2 | 3% | 2 | 3% | Â | 10 | 15% | Â | 14 | 7% | Â |
Less often than every 2 hours | 67 | 94% | 67 | 94% | Â | 57 | 84% | Â | 191 | 91% | Â |
Types of incontinence | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Urge incontinence present (UC: 75; I: 84; SI: 68; All: 227)f | 52 | 70% | 50 | 59% | 1.35 (0.67-2.71) | 48 | 71% | 0.89 (0.41-1.91) | 150 | 66% | 0 |
Stress incontinence present (UC: 71; I: 78; SI: 57; All: 206)f | 36 | 51% | 32 | 41% | 1.01 (0.42-2.43) | 33 | 58% | 0.82 (0.34-1.61) | 101 | 49% | 0 |
EQ-5D-3 L | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Mobility (UC: 96; I: 114; SI: 88; All: 298)f | Â | Â | Â | Â | 1.27 (0.69-2.34) | Â | Â | 1.37 (0.74-2.53) | Â | Â | Â |
No problems | 13 | 14% | 10 | 9% | Â | 6 | 7% | Â | 29 | 10% | Â |
Some problems | 51 | 53% | 44 | 39% | Â | 48 | 55% | Â | 143 | 48% | Â |
Confined to bed | 32 | 33% | 60 | 53% | Â | 34 | 39% | Â | 126 | 42% | Â |
Self-care (UC: 96; I: 114; SI: 88; All: 298)f | Â | Â | Â | Â | 0.61 (0.34-1.09) | Â | Â | 0.75 (0.40-1.39) | Â | Â | 0 |
No problems | 13 | 14% | 13 | 11% | Â | 13 | 15% | Â | 39 | 13% | Â |
Some problems | 49 | 51% | 47 | 41% | Â | 36 | 41% | Â | 132 | 44% | Â |
Unable to wash or dress | 34 | 35% | 54 | 47% | Â | 39 | 44% | Â | 127 | 43% | Â |
Usual activity (UC: 96; I: 114; SI: 88; All: 298)f | Â | Â | Â | Â | 0.42 (0.22-0.81) | Â | Â | 0.79 (0.41-1.51) | Â | Â | 0 |
No problems | 6 | 6% | 5 | 4% | Â | 5 | 6% | Â | 16 | 5% | Â |
Some problems | 44 | 46% | 30 | 26% | Â | 34 | 39% | Â | 108 | 36% | Â |
Unable to perform | 46 | 48% | 79 | 69% | Â | 49 | 56% | Â | 174 | 58% | Â |
Pain or discomfort (UC: 95; I: 111; SI: 84; All: 290)f | Â | Â | Â | Â | 0.66 (0.38-1.16) | Â | Â | 0.63 (0.34-1.14) | Â | Â | 0 |
None | 62 | 65% | 58 | 52% | Â | 52 | 62% | Â | 172 | 59% | Â |
Moderate | 32 | 34% | 48 | 43% | Â | 29 | 35% | Â | 109 | 38% | Â |
Extreme | 1 | 1% | 5 | 5% | Â | 3 | 4% | Â | 9 | 3% | Â |
Anxiety or depression (UC: 95; I: 107; SI: 83; All: 285)f | Â | Â | Â | Â | 0.56 (0.33-0.95) | Â | Â | 0.86 (0.49-1.51) | Â | Â | 0 |
None | 51 | 54% | 47 | 44% | Â | 47 | 57% | Â | 145 | 51% | Â |
Moderate | 42 | 44% | 54 | 50% | Â | 33 | 40% | Â | 129 | 45% | Â |
Extreme | 2 | 2% | 6 | 6% | Â | 3 | 4% | Â | 11 | 4% | Â |
Mean (SD) incontinence Quality of lifed (UC: 53; I: 43; SI: 38; All: 134)f | 75 | (56.7-90.9) | 78.4 | (37.5-89.8) | -10.1 (-29.5-9.3) | 74.4 | (48.3-92.1) | -10.1 (-28.6-8.3) | 76 | (51.7-91.2) | 0.184 |
Median (IQR) Barthel Index (UC: 96; I: 117; SI: 88; All: 301)f | 8.5 | (3-14) | 7 | (3-11) | 0.68 (0.43-1.07) | 7.5 | (4-12) | 0.70 (0.43-1.13) | 8 | (3-12) | 0 |
Dead (UC: 118; I: 145; SI: 114; All: 377)f | 4 | 3% | 7 | 5% | 1.01 (0.43-2.39) | 6 | 5% | 0.72 (0.31-1.71) | 17 | 5% | 0.0087 |