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Table 2 Effects of the intervention on primary and secondary outcomes, intention-to-treat analyses

From: A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial

 

Intervention group

Control group

Percentage difference between groups or coefficienta

P b

Primary outcomes

Frailty c

3 months (number (%))

69 out of 108 (64%)

88 out of 117 (75%)

-11.3% (-23.3% to 0.7%)

0.07

12 months (number (%))

66 out of 107 (62%)

81 out of 106 (76%)

-14.7% (-27.0% to -2.4%)

0.02

Change from 0 to 3 months

108, 0.56 ±1.10

117, 0.39 ±0.92

-0.18 (-0.43 to 0.08)

0.17

Change from 0 to 12 months

107, 0.80 ±1.19

106, 0.41 ±1.02

-0.41 (-0.68 to -0.14)

<0.01

Mobility, Short Physical Performance Battery c

3-month mean

12-month mean

Change from 0 to 3 months

Change from 0 to 12 months

107, 5.40 ±2.32

107, 5.83 ±2.82

107, -0.15 ±1.89

107, -0.52 ±2.47

116, 5.72 ±2.30

108, 4.69 ±2.91

116, 0.01 ±1.72

108, 0.98 ±2.30

0.05 (-0.42 to 0.51)

1.44 (0.80 to 2.07)

0.85

<0.001

Mobility, lower extremity continuous summary performance score c

3-month mean

12-month mean

Change from 0 to 3 months

Change from 0 to 12 months

107, 1.72 ±0.57

107, 1.77 ±0.59

107, 0.04 ±0.49

107, 0.00 ±0.50

116, 1.80 ±0.52

108, 1.49 ±0.75

116, 0.06 ±0.38

108, 0.35 ±0.63

-0.00 (-0.12 to 0.11)

0.34 (0.19 to 0.49)

0.96

<0.001

Secondary outcomes

Barthel Index c

3-month mean

12-month mean

Change from 0 to 3 months

Changes from 0 to 12 months

108, 94.2 ±11.2

106, 89.5 ±17.5

108, 0.56 ±7.92

106, 5.56 ±14.61

117, 93.2 ±13.9

108, 86.1 ±24.7

116, -0.80 ±10.87

107, 6.14 ±20.76

-0.68 (-3.05 to 1.68)

0.67 (-4.23 to 5.56)

0.57

0.79

Geriatric Depression Scale c

3-month mean

12-month mean

Change from 0 to 3 months

Change from 0 to 12 months

108, 4.89 ±3.14

106, 4.62 ±3.33

108, -0.19 ±2.30

106, 0.11 ±2.27

117, 4.90 ±3.24

108, 4.98 ±3.16

117, 0.13 ±2.52

108, 0.02 ±2.90

0.22 (-0.37 to 0.82)

-0.18 (-0.83 to 0.47)

0.46

0.59

EQ5D VAS c

3-month mean

12-month mean

Change from 0 to 3 months

Change from 0 to 12 months

108, 60.6 ±20.1

107, 57.5 ±20.8

108, -1.81 ±15.65

107, 0.41 ±18.93

117, 60.3 ±16.9

108, 57.7 ±19.7

117, -1.96 ±16.77

108, 1.12 ±20.62

0.04 (-3.93 to 4.00)

0.30 (-4.59 to 5.18)

0.99

0.91

  1. Data presented as number, mean, ±standard deviation, unless otherwise stated. aCoefficient from a linear regression model with follow-up values as a dependent variable and baseline values as a covariate. b P values, which were derived from chi-square test or linear regression models with baseline values as a covariate, are for the differences in rate or mean between intervention and control group. cThe Geriatric Depression Scale (short form) has scores between 0 and 15 with a higher score indicating more depressive symptoms. For the Mini Mental Status Examination, higher scores indicate higher cognitive function with a maximum score of 30. The Barthel Index has scores between 0 and 100 with higher scores indicating better basic activities of daily living functioning. The Short Physical Performance Battery [7] has scores between 0 and 12, and the lower extremity continuous summary performance [15] scale has scores between 0 and 2.71; in both, better mobility function is indicated by a higher score. The EQ-5D (health-related quality of life) has scores between 5 and 15 with higher scores indicating worse health-related quality of life. The EQ-5D VAS has scores between 0 and 100 with higher scores indicating better health-related quality of life. VAS: visual analog scale.