Table 2 Intervention effects on primary and secondary outcomes, self-management behaviors, and education items
Outcome | BASELINE | ENDPOINT (3 MONTHS) | |||||
|---|---|---|---|---|---|---|---|
Control (n = 39) | Intervention (n = 34) | P | Control (n = 39) | Intervention (n = 34) | P | ||
Primary Outcome | |||||||
 HbA1c (%) | 9.53 ± 2.78 | 9.78 ± 2.53 | 0.690 | 8.84 ± 2.40 | 8.73 ± 1.98 | 0.838 | |
 Change in HbA1c from baseline | Unadjusted mean | – | – | – | −0.696 | −1.053 | 0.454 |
Adjusted mean | −1.389 | −1.679 | 0.406 | ||||
 Patients that achieved at least 1% HbA1c drop | – | – | – | 6 (15.38) | 16 (47.06) | 0.003 | |
Secondary Outcomes | |||||||
 Random blood glucose (mg/dl) | 220 ± 103 | 242 ± 95 | 0.353 | 201 ± 87 | 181 ± 65 | 0.288 | |
 Weight (Kg) | 89.9 ± 17.8 | 85.9 ± 13.8 | 0.287 | 89.4 ± 18.1 | 84.6 ± 14 | 0.215 | |
 Treatment adherence (SCI), (5) | 2.23 ± 0.51 | 2.23 ± 0.53 | 0.995 | 2.52 ± 0.49 | 3.42 ± 0.48 | <0.0001 | |
 Medication adherence (Morisky), (4) | 2.74 ± 0.99 | 2.74 ± 1.19 | 0.974 | 2.74 ± 1.07 | 3.76 ± 0.55 | <0.0001 | |
 Diabetes self-efficacy (patient confidence), (5) | 2.82 ± 0.41 | 2.88 ± 0.43 | 0.576 | 2.68 ± 0.33 | 3.51 ± 0.39 | <0.0001 | |
 Patients’ confidence in HP/program, (5) | 2.44 ± 0.72 | 2.59 ± 0.74 | 0.377 | 4.03 ± 0.28 | 4.21 ± 0.48 | 0.059 | |
 Diabetes knowledge, (1) | 0.29 ± 0.20 | 0.35 ± 0.23 | 0.278 | 0.34 ± 0.21 | 0.73 ± 0.18 | <0.0001 | |
 Patients not admitted to ER/hospital in last 3 months | 34 (87.18) | 30 (88.24) | 1.000 | 35 (89.74) | 34 (100) | 0.118 | |
 Average frequency of blood glucose measurement, (5) | 2.28 ± 1.15 | 2.38 ± 0.95 | 0.688 | 3.21 ± 1.28 | 3.88 ± 0.77 | 0.007 | |
 Patients that checked blood glucose at least once a week | 6 (15.38) | 4 (11.76) | 0.742 | 26 (66.67) | 29 (85.29) | 0.065 | |
 Exercise (patients that walked at least 30 mins/day) | 18 (46.15) | 13 (38.24) | 0.495 | 20 (51.28) | 26 (76.47) | 0.026 | |
 Average rate of regular activity, (5) | 3.79 ± 1.70 | 3.76 ± 1.60 | 0.938 | 3.77 ± 1.75 | 4.74 ± 0.86 | 0.004 | |
 Patient satisfaction with follow-up & communication with HP/program, (5) | 2.27 ± 0.52 | 2.38 ± 0.52 | 0.360 | 4.03 ± 0.28 | 4.21 ± 0.48 | 0.059 | |
 General patient satisfaction with program | 100% of patients indicated general satisfaction with the program, said they would stay enrolled should the program continue, and said they would also recommend it to others. | ||||||
 Healthcare provider’s reputation | 100% of patients believed the program could improve the hospital’s reputation. | ||||||
Other Self-management behaviors | |||||||
 Smokers/patients that reduced or stopped smoking | 6(15.38) | 10(29.41) | 0.148 | 3 (50) | 8 (80) | 0.299 | |
 Patient commitment to seeing their doctors at preset times, (5) | 1.59 ± 1.19 | 1.65 ± 1.25 | 0.842 | 1.33 ± 0.93 | 2.26 ± 1.67 | 0.006 | |
 Results recording, (5) | 1.38 ± 1.02 | 1.41 ± 1.16 | 0.915 | 2.90 ± 1.94 | 4.09 ± 1.42 | 0.004 | |
 Adherence to medication times, (5) | 3.90 ± 1.21 | 3.94 ± 1.20 | 0.878 | 3.90 ± 1.23 | 4.76 ± 0.78 | 0.001 | |
 Adherence to insulin dose adjustment, (5) | 1.14 ± 0.38 | 1.50 ± 0.84 | 0.368 | 1 | 2 ± 1.53 | 0.134 | |
 Adherence to follow-up tests, (5) | 1.18 ± 0.68 | 1.21 ± 0.64 | 0.866 | 1.15 ± 0.67 | 1.74 ± 1.05 | 0.008 | |
 Patients that performed daily foot check and care | 27(69.23) | 26(76.47) | 0.489 | 31(79.49) | 34(100) | 0.006 | |
 Patients satisfied with their diabetes control | 5(12.82) | 4(11.76) | 1.000 | 8(20.51) | 14(41.18) | 0.055 | |
 Adherence to following healthy diet, (5) | 1.64 ± 1.18 | 1.76 ± 1.13 | 0.650 | 2.31 ± 1.62 | 3.35 ± 1.57 | 0.007 | |
 Adherence to carrying a strong-acting sugar, (5) | 2.10 ± 1.62 | 2.41 ± 1.84 | 0.448 | 2.41 ± 1.80 | 2.97 ± 1.88 | 0.199 | |
 Confidence in ability to know when it is necessary to see the doctor, (5) | 2.51 ± 0.64 | 2.53 ± 0.79 | 0.921 | 2.26 ± 0.50 | 3.06 ± 0.81 | <0.0001 | |
Education Items | |||||||
 Patients aware of side effects of their medications | 2(5.13) | 2(5.88) | 1.000 | 1(2.56) | 14(41.18) | <0.0001 | |
 Patients aware of diabetes complications | 13(33.33) | 16(47.06) | 0.232 | 17(43.59) | 32(94.12) | <0.0001 | |
 Patients aware of follow-up tests | 4(10.26) | 6(17.65) | 0.499 | 5(12.82) | 28(82.35) | <0.0001 | |
 Patients aware of healthy diet | 15(38.46) | 16(47.06) | 0.459 | 24(61.54) | 34(100) | <0.0001 | |
 Patients aware of physical activity benefits | 18(46.15) | 16(47.06) | 0.938 | 22(56.41) | 32(94.12) | 0.0002 | |