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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