Table 2 Scores on clinical outcomes of the intervention and control groups at 6 and 12 months
n (%)/mean ± SD/median (25–75 quartiles) | Baseline–0 months | RCT phase–6 months | Extension phase–12 months | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Intervention group (n = 95) | Control group (n = 98) | Intervention group (n = 95) | Control group (n = 98) | Intervention group (n = 95) | Control group (n = 98) | |||||||||||
Analyzed (n) | Analyzed (n) | Analyzed (n) | Analyzed (n) | Mean / mediana difference (95% CI) | p-value | Analyzed (n) | Analyzed (n) | Mean / mediana difference (95% CI) | p-value | |||||||
PAM sum score higher scores represent higher levels of patient activation (range 13–52) | 40.88 ± 5.48 | 57 (60) | 41.95 ± 5.08 | 64 (65.3) | 40.07 ± 5.76 | 59 (62.1) | 41.78 ± 5.38 | 59 (60.2) | 0.63 (−1.77–3.03) | 0.60 | 40.53 ± 5,36 | 47 (49.5) | 41.20 ± 5.27 | 44 (44.9) | 0.019 (−2.23–2.28) | 0.99 |
SDSCA diabetes self-care behavior in days a week (range 0–7) | ||||||||||||||||
General diet | 6.00 (4.75–7.00) | 57 (60) | 5.50 (4.75–6.75) | 57 (58.2) | 6.00 (5.00–7.00) | 59 (62.1) | 6.00 (5.00–7.00) | 57 (58.2) | − 0.08a (− 0.84–1.00) | 0.61 | 6.00 (5.00–7.00) | 46 (48.4) | 6.00 (5.00–7.00) | 43 (43.9) | 0.03 a (− 0.63–0.74) | 0.20 |
Specific diet | 5.50 (4.50–6.00) | 60 (63.2) | 6.00 (5.00–6.50) | 60 (61.2) | 5.50 (4.60–6.00) | 60 (63.2) | 5.50 (4.50–6.30) | 58 (59.2) | −0.06a (− 0.63–0.74) | 0.55 | 5.50 (4.50–6.00) | 49 (51.6) | 5.5 (5.00–6.50) | 45 (45.9) | − 0.09a (− 0.67–0.86) | 0.92 |
Exercise | 5.00 (3.00–6.00) | 59 (62.1) | 4.50 (2.90–6.00) | 62 (63.3) | 4.00 (3.00–5.40) | 60 (63.2) | 4.00 (3.00–6.00) | 57 (58.2) | 0.13a (− 1.09–0.83) | 0.17 | 4.50 (2.50–6.00) | 49 (51.6) | 5.00 (3.50–6.50) | 43 (43.9) | − 0.21a (− 1.28–1.20) | 0.21 |
Blood glucose control | 0.00 (0.00–0.50) | 59 (62.1) | 0.00 (0.00–0.50) | 62 (63.3) | 0.00 (0.00–0.50) | 61 (64.2) | 0.00 (0.00–0.50) | 59 (60.2) | 0.11a (−2.70–0.97) | 0.49 | 0.00 (0.00–0.88) | 48 (50.5) | 0.00 (0.00–0.50) | 44 (44.9) | 0.00a (− 0.06–0.06) | 0.30 |
Foot care | 1.00 (0.00–3.50) | 57 (60) | 1.00 (0.00–3.30) | 61 (62.2) | 1.00 (0.00–3.50) | 58 (61.1) | 1.75 (0.00–3.50) | 58 (59.2) | 0.31a (−2.58–0.46) | 0.78 | 1.50 (0.00–4.13) | 50 (52.6) | 1.25 (0.00–3.50) | 44 (44.9) | − 0.26a (− 1.20–2.21) | 0.04 |
Medication | 7.00 (7.00–7.00) | 58 (61.1) | 7.00 (7.00–7.00) | 59 (60.2) | 7.00 (7.00–7.00) | 56 (58.9) | 7.00 (7.00–7.00) | 55 (56.1) | −0.18 (− 0.53–0.16) | 0.30 | 7.00 (7.00–7.00) | 48 (50.5) | 7.00 (7.00–7.00) | 39 (39.8) | −0.51 (− 1.11–0.09) | 0.07 |
Smoking number of patients who smoked in the last 7 days | 7 (14.2) | 49 (51.6) | 4 (7.1) | 60 (61.2) | 9 (15.5) | 59 (62.1) | 6 (11.8) | 51 (52.0) | 0.02 (−0.06–0.10) | 0.62 | 7 (14.9) | 47 (49.5) | 4 (8.9) | 45 (45.9) | 0.06 (−0.02–0.14) | 0.16 |
EQ-5D index score higher scores represent higher levels of health-related quality of life (range 0–1) | 0.89 (0.84–1.00) | 58 (61.1) | 0.89 (0.84–1.00) | 62 (63.3) | 0.84 (0.77–1.00) | 63 (66.3) | 0.84 (0.78–1.00) | 61 (62.2) | − 0.00 (− 0.06–0.05) | 0.92 | 0.89 (0.81–1.00) | 48 (50.5) | 0.88 (0.79–1.00) | 46 (46.9) | 0.01 (− 0.68–0.09) | 0.76 |
EQ-VAS higher scores represent higher levels of health-related quality of life(range 0–100) | 80.00 (71.30–90.00) | 56 (58.9) | 80.00 (70.00–90.00) | 56 (57.1) | 80.00 (65.00–90.00) | 57 (60) | 80.00 (70.00–86.30) | 44 (55.1) | −8,11 (− 15.01– − 1.22) | 0.02 | 80.00 (70.00–90.00) | 43 (45.3) | 80.00 (79.50–90.00) | 42 (42.9) | −6.65 (− 15.27–-1.21) | 0.13 |
WHO-5 index score higher scores represent higher levels of emotional well-being (range 0–100) | 76.00 (61.00–80.00) | 56 (58.9) | 80.00 (72.00–80.00) | 57 (58.2) | 76.00 (57.00–80.00) | 56 (58.9) | 72.00 (64.00–80.00) | 55 (56.1) | −3.90a (−.07–15.87 | 0.93 | 78.00 (65.00–80.00) | 42 (44.2) | 76.00 (68.00–80.00) | 39 (39.8) | −5.21 (− 13.88–3.47) | 0.23 |