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Table 3 Secondary study outcome measures Patient reported outcomes

From: The combined diabetes and renal control trial (C-DIRECT) - a feasibility randomised controlled trial to evaluate outcomes in multi-morbid patients with diabetes and on dialysis using a mixed methods approach

 

C-DIRECT

Control

Variable

Baseline

Follow up

Mean diff

Baseline

Follow up

Mean Diff

M (SD)

M (SD)

M (SD)

M (SD)

M (SD)

M (SD)

Problem Areas in Diabetes Scale

28.00 (21.10)

26.00 (21.72)

−2.00 (16.65)

19.01 (14.71)

23.85 (24.34)

4.84 (20.87)

Hospital Anxiety and Depression Scale

 Anxiety

3.45 (3.98)

4.10 (3.04)

0.65 (4.12)

2.83 (3.07)

3.50 (3.35)

0.67 (2.04)

 Depression

5.30 (4.12)

5.30 (4.22)

0 (3.77) ^

3.65 (2.98)

4.22 (3.88)

0.57 (3.07) ^

Kidney Disease Related Quality of Life

 Physical Functioning

32.84 (10.38)

35.00 (11.99)

2.15 (8.30)

34.63 (12.14)

37.86 (10.94)

3.22 (12.87)

 Role Limitation due to Physical Health

39.90 (12.58)

48.19 (9.03)

8.29 (11.34) *#

44.89 (10.75)

45.85 (10.16)

0.96 (9.11) *#

 Bodily Pain

44.70 (15.81)

46.74 (13.01)

2.04 (13.06)

48.10 (11.61)

47.25 (15.32)

0.85 (13.07)

 General Health

30.73 (9.19)

33.96 (6.45)

3.14 (8.64) ^

33.69 (7.66)

34.59 (8.98)

0.90 (10.01) ^

 Emotional Wellbeing

52.59 (12.10)

51.62 (13.17)

−0.98 (15.63) ^

54.79 (12.30)

49.06 (16.02)

−5.73 (15.68) ^

 Role Emotional

42.66 (16.16)

44.62 (10.65)

1.96 (15.21)

50.49 (7.56)

46.29 (12.80)

−4.19 (13.22)

 Social Functioning

46.97 (13.30)

47.99 (12.81)

1.01 (13.86)

52.36 (8.38)

49.84 (11.79)

−2.52 (8.02)

 Energy

42.92 (10.74)

48.15 (11.82)

5.23 (15.52)

47.75 (10.35)

50.43 (13.78)

2.68 (14.76)

 Physical Composite Summary

33.34 (9.95)

38.60 (8.41)

5.26 (6.58) *

33.00 (15.33)

36.47 (15.18)

3.46 (7.78) *

 Mental Composite Summary

51.60 (11.87)

51.72 (12.39)

0.11 (13.19)

63.37 (31.17)

60.15 (32.13)

−3.22 (10.79)

 Symptom List

75.42 (15.98)

76.82 (17.52)

1.40 (17.71)

80.82 (16.29)

79.62 (18.20)

−1.20 (17.50)

 Effects of Kidney Disease

81.55 (17.90)

80.89 (18.55)

−0.65 (22.66)

87.50 (12.01)

78.57 (22.24)

−8.93 (22.98)

 Burden of Kidney Disease

27.19 (20.10)

38.75 (26.02)

11.56 (27.45) *

40.36 (28.25)

45.57 (35.67)

5.21 (24.50) *

 Cognitive Function

80.67 (23.68)

81.33 (20.24)

0.67 (16.32) ^

82.50 (19.24)

80.97 (26.29)

−1.53 (24.87) ^

 Quality of Social Interaction

82.00 (19.36)

86.00 (19.09)

4.00 (19.75)

84.44 (25.23)

82.64 (18.88)

−1.81 (25.73)

 Sleep

67.25 (17.11)

69.13 (16.21)

1.88 (19.55)

62.29 (16.33)

53.85 (22.55)

−8.44 (18.98

 Social Support

80.00 (19.94)

67.50 (24.47)

−12.50 (16.99) *

81.94 (30.26)

79.86 (24.56)

− 2.08 (28.37) *

 Dialysis Staff Encouragement

81.25 (25.81)

81.25 (20.88)

0 (18.14) ^

90.63 (18.15)

89.58 (15.49)

−1.04 (22.40) ^

 Patient Satisfaction

60.00 (19.04)

65.00 (24.72)

5.00 (18.81)

56.25 (16.89)

63.20 (19.64)

6.95 (18.33)

 Kidney Disease Component Summary

67.57 (11.54)

68.37 (14.98)

0.80 (9.30) ^

72.92 (8.81)

72.73 (12.39)

−0.18 (13.12) ^

Dialysis Diet and Fluid Non-Adherence Questionnaire

 Diet

4.65 (7.01)

10.05 (11.95)

5.40 (11.07)

4.83 (7.38)

7.58 (10.86)

2.75 (12.18)

 Fluid

7.45 (11.45)

7.55 (10.12)

0.10 (7.93)

5.17 (8.18)

8.00 (10.97)

2.83 (9.80)

Summary of Diabetes Self-Care Activities Assessment

 General Diet

5.03 (2.28)

3.93 (2.84)

−1.10 (2.41)

5.17 (2.19)

4.50 (2.52)

−0.67 (2.46)

 Specific Diet

4.23 (2.04)

4.43 (1.37)

0.20 (1.74)

4.52 (1.27)

4.33 (1.07)

−0.19 (1.64)

 Exercise

2.55 (2.47)

3.40 (1.92)

0.85 (1.89)

2.52 (2.21)

2.85 (2.09)

0.33 (1.79)

 Blood Sugar Taking

2.64 (2.51)

2.56 (2.63)

−0.08 (2.05)

2.31 (2.19)

2.98 (2.39)

0.67 (1.35)

 Foot Care

2.68 (2.46)

3.26 (2.63)

0.58 (2.55)

3.10 (2.57)

3.33 (2.71)

0.23 (2.77)

Diabetes Self-Efficacy Scale Total

7.11 (1.78)

7.14 (1.67)

0.03 (1.23)

7.76 (1.71)

7.71 (1.99)

−0.06 (1.14)

Health Education Impact Questionnaire

 Positive and Active Engagement in Life

2.81 (0.49)

3.08 (0.55)

0.28 (0.51)

2.85 (0.55)

2.88 (0.70)

0.03 (0.55)

 Health Directed Behaviour

2.80 (0.73)

2.97 (0.63)

0.16 (0.59)

2.84 (0.72)

2.90 (0.61)

0.05 (0.68)

 Skills and Techniques Acquisition

3.03 (0.35)

3.14 (0.43)

0.11 (0.47)

2.99 (0.49)

3.12 (0.59)

0.14 (0.54)

 Constructive Attitudes and Approaches

2.93 (0.54)

3.17 (0.40)

0.24 (0.62) ^

3.08 (0.50)

3.26 (0.64)

0.18 (0.48) ^

 Self-Monitoring and Insight

3.16 (0.30)

3.39 (0.38)

0.23 (0.39) *

3.10 (0.28)

3.36 (0.34)

0.26 (0.35) *

 Health Service Navigation

3.17 (0.40)

3.28 (0.44)

0.11 (0.52)

3.23 (0.42)

3.44 (0.48)

0.22 (0.35)

 Social Integration and Support

2.83 (0.41)

3.13 (0.62)

0.30 (0.71)

3.00 (0.54)

3.18 (0.61)

0.19 (0.48)

 Emotional Wellbeing

2.33 (0.73)

2.38 (0.72)

0.04 (0.95)

2.22 (0.63)

2.15 (0.74)

−0.08 (0.60)

  1. *significant main effect of time observed
  2. #significant interaction effects of time and group observed
  3. ^ significant effects of ethnicity observed