Table 1.
Adjusted difference in the mean of each group compared with the control group
| 6 Months | P value | 12 Months | P value | 18 Months | P value | 24 Months | P value | |
| Cognitive-attitudinal outcomes | ||||||||
| Knowledge (DIATEK): F=47.3 P<0.001; ICC PHCP=0.06; ICC subject|PHCP=0.35 | ||||||||
| PTI | – | – | 0.64 (0.17 to 1.11) | 0.007 | – | – | 0.65 (0.2 to 1.11) | 0.005 |
| PFI | – | – | −0.38 (−0.85 to 0.09) | 0.11 | – | – | −0.6 (−1.06 to −0.14) | 0.01 |
| CBI | – | – | 0.63 (0.16 to 1.11) | 0.008 | – | – | 0.34 (−0.12 to 0.8) | 0.15 |
| Empowerment (DES-SF): F=17.3 P<0.001; ICC PHCP=0.08; ICC; subject|PHCP=0.08 | ||||||||
| PTI | – | – | 1.58 (−0.59 to 3.75) | 0.15 | – | – | 3.04 (1.08 to 4.99) | 0.002 |
| PFI | – | – | 3.95 (1.9 to 6) | <0.001 | – | – | 1.84 (−0.11 to 3.79) | 0.07 |
| CBI | – | – | 3.97 (1.9 to 6.04) | <0.001 | – | – | 2.63 (0.68 to 4.58) | 0.008 |
| Behavioural outcomes | ||||||||
| Adherence dietary recommendations (MEDAS): F=25.0 P<0.001; ICC PHCP=0.03; ICC subject|PHCP=0.20 | ||||||||
| PTI | 0.22 (−0.25 to 0.69) | 0.36 | 0.71 (0.17 to 1.24) | 0.01 | 0.93 (0.46 to 1.41) | <0.001 | 0.87 (0.4 to 1.35) | <0.001 |
| PFI | −0.58 (−1.04 to −0.11) | 0.01 | −0.96 (−1.46 to −0.47) | <0.001 | 0.17 (−0.31 to 0.64) | 0.49 | 0.03 (−0.44 to 0.5) | 0.90 |
| CBI | 0.44 (−0.03 to 0.91) | 0.06 | 0.06 (−0.47 to 0.58) | 0.83 | 0.88 (0.4 to 1.35) | <0.001 | 0.7 (0.22 to 1.17) | 0.004 |
| Medication adherence (MGLS): F=14.4 P<0.001; ICC PHCP=0.04; ICC subject|PHCP=0.20 | ||||||||
| PTI | 0.09 (−0.11 to 0.3) | 0.37 | 0.09 (−0.12 to 0.3) | 0.39 | 0.13 (−0.09 to 0.34) | 0.24 | 0.16 (−0.04 to 0.36) | 0.12 |
| PFI | 0.01 (−0.2 to 0.22) | 0.90 | −0.13 (−0.34 to 0.08) | 0.24 | −0.06 (−0.26 to 0.15) | 0.58 | 0.09 (−0.11 to 0.3) | 0.39 |
| CBI | 0.03 (−0.18 to 0.24) | 0.77 | −0.19 (−0.41 to 0.03) | 0.08 | 0 (−0.21 to 0.21) | 0.98 | −0.1 (−0.31 to 0.11) | 0.36 |
| Affective outcomes | ||||||||
| Depression (BDI-II): F=53.6 P<0.001; ICC PHCP=0.05; ICC subject|PHCP=0.34 | ||||||||
| PTI | – | – | −1.91 (−3.99 to 0.17) | 0.07 | – | – | −0.76 (−2.68 to 1.16) | 0.44 |
| PFI | – | – | −2.99 (−4.99 to −1) | 0.003 | – | – | 0.37 (−1.56 to 2.3) | 0.71 |
| CBI | – | – | −3 (−5.13 to −0.87) | 0.006 | – | – | 0.23 (−1.73 to 2.19) | 0.82 |
| Anxiety (STAI-S): F=36.0 P<0.001; ICC PHCP=0.07 ICC; subject|PHCP=0.32 | ||||||||
| PTI | – | – | −2.25 (−5.75 to 1.25) | 0.21 | – | – | −2.18 (−5.54 to 1.18) | 0.20 |
| PFI | – | – | −3.47 (−6.95 to 0.02) | 0.05 | – | – | −0.39 (−3.78 to 2.99) | 0.82 |
| CBI | – | – | −5.4 (−8.99 to −1.81) | 0.003 | – | – | −0.50 (−3.9 to 2.9) | 0.77 |
| Distress (DDS2): F=14.9 P<0.001; ICC PHCP=0.05 ICC; subject|PHCP=0.25 | ||||||||
| PTI | – | – | −0.23 (−0.53 to 0.07) | 0.13 | – | – | −0.34 (−0.62 to −0.07) | 0.01 |
| PFI | – | – | −0.24 (−0.53 to 0.05) | 0.10 | – | – | −0.31 (−0.58 to −0.04) | 0.03 |
| CBI | – | – | −0.36 (−0.65 to −0.07) | 0.01 | – | – | −0.24 (−0.51 to 0.03) | 0.08 |
| Health-related quality of life and symptoms | ||||||||
| Health-related quality of life (ADDQoL-19): F=25.3 P<0.001; ICC PHCP=0.04; ICC subject|PHCP=0.34 | ||||||||
| PTI | 0.09 (−0.24 to 0.42) | 0.60 | 0.40 (0.04 to 0.76) | 0.03 | 0.39 (0.05 to 0.72) | 0.02 | 0.16 (−0.17 to 0.48) | 0.34 |
| PFI | −0.09 (−0.42 to 0.23) | 0.56 | 0.51 (0.16 to 0.86) | 0.005 | −0.02 (−0.35 to 0.31) | 0.89 | −0.06 (−0.38 to 0.26) | 0.71 |
| CBI | 0.03 (−0.3 to 0.35) | 0.88 | 0.84 (0.49 to 1.18) | <0.001 | 0.21 (−0.13 to 0.54) | 0.23 | −0.05 (−0.38 to 0.28) | 0.77 |
| Neuropathic symptom (MNSI): F=59.8 P<0.001; ICC PHCP=0.02 ICC; subject|PHCP=0.32 | ||||||||
| PTI | – | – | −0.35 (−0.8 to 0.09) | 0.12 | – | – | −0.08 (−0.49 to 0.33) | 0.70 |
| PFI | – | – | −0.42 (−0.87 to 0.03) | 0.07 | – | – | 0.35 (−0.07 to 0.78) | 0.11 |
| CBI | – | – | −0.57 (−1.04 to −0.1) | 0.02 | – | – | 0.31 (−0.12 to 0.74) | 0.16 |
The models were adjusted by the baseline value of dependent variables and time elapsed since diagnosis.
ADDQoL, Audit of Diabetes-Dependent Quality of life; BDI-II, Beck Depression Inventory II; CBI, combined intervention for patients and professionals; DDS2, Diabetes Distress Scale; DES-SF, Diabetes Empowerment Scale-Short Form; ICC, intraclass correlation coefficient; MEDAS, Mediterranean Diet Adherence Screener; MGLS, Morisky Medication Adherence Scale; MNSI, Michigan Neuropathy Screening Instrument; PFI, intervention only for healthcare professionals at primary care; PHCP, Primary Care Health Practices; PTI, intervention only for patients and family members; STAI-S, State Trait Anxiety Inventory.