Table 3.
Secondary endpoints at 6, 15 and 24 months post-randomisation
| Intervention (n=116) | Control (n=120) | Unadjusted analysis* | Adjusted analysis† | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No | Mean (SD) | No | Mean (SD) | Mean difference (95% CI) | P value | Least squares mean difference (95% CI) | P value | |||||||
| EQ5D—visual analogue scale | ||||||||||||||
| 6 months | 101 | 75.7 (17.0) | 112 | 72.9 (17.7) | −2.81 (−7.51 to 1.89) | 0.240 | −2.06 (−5.51 to 1.38) | 0.239 | ||||||
| 15 months | 95 | 73.8 (18.3) | 106 | 69.9 (18.1) | −3.87 (−8.94 to 1.19) | 0.133 | −2.33 (−6.88 to 2.23) | 0.315 | ||||||
| 24 months | 92 | 72.5 (19.7) | 96 | 68.1 (18.2) | −4.35 (−9.82 to 1.11) | 0.119 | −3.03 (−8.42 to 2.35) | 0.268 | ||||||
| Carers’ quality adjusted life years (QALYs) gained (cumulative) | ||||||||||||||
| 6 months | 98 | 0.45 (0.14) | 109 | 0.46 (0.15) | 0.00 (−0.035 to 0.043) | 0.83 | 0.00 (−0.01 to 0.01) | 0.69 | ||||||
| 15 months | 88 | 1.00 (0.29) | 99 | 0.99 (0.28) | −0.02 (−0.10 to 0.06) | 0.68 | −0.01 (−0.06 to 0.04) | 0.74 | ||||||
| 24 months | 84 | 1.55 (0.45) | 90 | 1.52 (0.45) | −0.03 (−0.17 to 0.11) | 0.64 | −0.015 (−0.13 to 0.10) | 0.79 | ||||||
| HADS anxiety scale | ||||||||||||||
| 6 months | 104 | 6.35 (4.46) | 113 | 6.96 (4.37) | 0.610 (−0.57 to 1.79) | 0.311 | 0.218 (−0.43 to 0.97) | 0.568 | ||||||
| 15 months | 96 | 6.55 (4.54) | 106 | 7.55 (4.47) | 1.005 (−0.25 to 2.26) | 0.115 | 0.610 (−0.33 to 1.55) | 0.200 | ||||||
| 24 months | 93 | 6.55 (4.49) | 97 | 6.97 (4.50) | 0.419 (−0.87 to 1.71) | 0.521 | −0.037 (−1.10 to 1.03) | 0.946 | ||||||
| PANAS—positive affect | ||||||||||||||
| 6 months | 103 | 30.1 (8.13) | 111 | 31.5 (8.31) | 1.40 (−0.82 to 3.62) | 0.214 | 0.922 (−0.98 to 2.83) | 0.341 | ||||||
| 15 months | 96 | 30.5 (8.22) | 106 | 30.5 (8.02) | 0.03 (−2.22 to 2.29) | 0.976 | −0.079 (−2.13 to 1.97) | 0.940 | ||||||
| 24 months | 92 | 30.1 (8.73) | 95 | 31.2 (8.34) | 1.10 (−1.36 to 3.57) | 0.378 | 1.17 (−1.26 to 3.59) | 0.344 | ||||||
| Loneliness | ||||||||||||||
| 6 months | 104 | 2.06 (2.04) | 112 | 2.21 (2.21) | 0.148 (−0.42 to 0.72) | 0.611 | 0.016 (−0.41 to 0.45) | 0.945 | ||||||
| 15 months | 96 | 2.21 (2.27) | 106 | 2.57 (2.23) | 0.358 (−0.27 to 0.98) | 0.260 | 0.320 (−0.20 to 0.84) | 0.230 | ||||||
| 24 months | 93 | 2.24 (2.39) | 97 | 2.63 (2.30) | 0.392 (−0.28 to 1.06) | 0.251 | 0.173 (−0.37 to 0.72) | 0.529 | ||||||
| Perceived support (MSPSS) | ||||||||||||||
| 6 months | 102 | 45.0 (9.02) | 113 | 45.3 (9.16) | 0.351 (−2.10 to 2.80) | 0.778 | 0.044 (−1.93 to 2.02) | 0.965 | ||||||
| 15 months | 95 | 44.0 (10.19) | 106 | 44.6 (9.88) | 0.606 (−2.19 to 3.40) | 0.669 | −0.756 (−2.89 to 1.38) | 0.486 | ||||||
| 24 months | 92 | 44.5 (10.29) | 97 | 45.4 (9.17) | 0.894 (−1.9 to 3.69) | 0.529 | −0.460 (−2.76 to 1.84) | 0.693 | ||||||
HADS=hospital anxiety and depression scale; MSPSS=multidimensional scale of perceived social support; PANAS=positive and negative affectivity scale.
*Based on two sample t test.
†Based on general linear model adjusting for baseline difference, kinship, and area (that is, stratification variables); in addition, QALYs adjusted for follow-up length.