Background
Methods
Study aim
Study design
Setting of the study and characteristics of participants
Intervention
Data collection
Outcomes and statistical analysis
Results
Characteristics of the study population
Number of participants | Total | Female | Male | ||
---|---|---|---|---|---|
Total/ female | Proportion in % | Proportion in % | Proportion in % | p-valuea | |
Intervention group (%) | 1139/543 | 45.0 | 45.9 | 44.1 | 0.592 |
Austrian (%) | 1136/540 | 94.5 | 95.6 | 93.6 | 0.191 |
Living alone (%) | 1116/532 | 22.0 | 30.6 | 14.0 | < 0.001 |
Higher education (school leaving examination or higher) (%) | 1128/538 | 8.5 | 5.4 | 11.4 | < 0.001 |
Working fulltime (%) | 1136/541 | 14.0 | 7.0 | 20.3 | < 0.001 |
Smoker (%) | 1139/543 | 13.8 | 10.3 | 16.9 | 0.001 |
Any manifestation of coronary heart disease (%)c | 1139/543 | 14.7 | 10.1 | 18.8 | < 0.001 |
Any macrovasculardiabetic complication (%)d | 1139/543 | 24.1 | 19.5 | 28.2 | 0.001 |
Total/ female | Mean ± SD | Mean ± SD | Mean ± SD | p-valueb | |
---|---|---|---|---|---|
Age (mean years ± SD) | 1139/543 | 65.42 ± 10.28 | 66.89 ± 10.56 | 64.07 ± 9.84 | < 0.001 |
Duration of diabetes (mean years ± SD) | 1089/519 | 7.13 ± 6.76 | 7.34 ± 7.08 | 6.95 ± 6.46 | 0.349 |
HbA1c (% ± SD) | 1139/543 | 7.37 ± 1.38 | 7.39 ± 1.31 | 7.35 ± 1.44 | 0.614 |
Creatinine (µmol/l ± SD) | 1138/542 | 0.96 ± 0.36 | 0.87 ± 0.31 | 1.04 ± 0.39 | < 0.001 |
Triglycerides (mmol/l ± SD) | 1139/543 | 181.40 ± 155.71 | 168.66 ± 117.97 | 193.00 ± 182.78 | 0.143 |
Cholesterol (mmol/l ± SD) | 1139/543 | 195.75 ± 42.95 | 204.02 ± 43.62 | 188.21 ± 40.83 | < 0.001 |
HDL (mmol/l ± SD) | 1137/542 | 51.25 ± 14.35 | 55.71 ± 14.62 | 47.18 ± 12.83 | < 0.001 |
LDL (mmol/l ± SD) | 1091/530 | 110.03 ± 35.75 | 115.45 ± 37.34 | 104.91 ± 33.42 | < 0.001 |
Systolic blood pressure (mmHg ± SD) | 1139/543 | 139.41 ± 17.78 | 140.34 ± 18.16 | 138.56 ± 17.39 | 0.092 |
Diastolic blood pressure (mmHg ± SD) | 1139/543 | 82.22 ± 10.61 | 82.10 ± 10.87 | 82.34 ± 10.39 | 0.700 |
BMI (kg/m2) | 1139/543 | 29.99 ± 4.91 | 30.20 ± 5.30 | 29.81 ± 4.52 | 0.301 |
EQ-VAS | 1139/543 | 71.10 ± 18.01 | 69.24 ± 18.81 | 72.80 ± 17.09 | 0.002 |
EQ-index | 1098/519 | 0.88 ± 0.17 | 0.86 ± 0.19 | 0.90 ± 0.16 | < 0.001 |
Subgroup 1/subgroup 2 | No of participants, subgroup 1/subgroup 2 | EQ-VAS, mean [CI], subgroup 1 | EQ-VAS, mean [CI], subgroup 2 | p valuea |
---|---|---|---|---|
Overall study population | 1464 | 70.1 [69.1;71.0] | – | |
Intervention/control | 639/825 | 69.4 [68.0;70.8] | 70.6 [69.3;71.8] | 0.231 |
Female/male | 700/764 | 68.4 [67.0;69.8] | 71.6 [70.3;72.8] | 0.001 |
No manifestation of coronary heart diseaseb/ any manifestation of coronary heart disease | 1253/211 | 70.6 [69.6;71.6] | 66.6 [64.1;69.2] | 0.003 |
No macrovascular diabetic complicationc/ any macrovascular diabetic complication | 1108/356 | 71.4 [70.3;72.4] | 66.0 [64.1;68.0] | < 0.001 |
Living with a partner/ living alone | 1111/318 | 71.0 [69.9;72.0] | 66.8 [64.8;68.8] | < 0.001 |
Non Austrian/Austrian | 80/1377 | 65.1 [60.6;69.7] | 70.3 [69.4;71.3] | 0.029 |
No higher education/ higher education | 1327/117 | 69.9 [68.9;70.9] | 72.1 [68.9;75.4] | 0.202 |
Working fulltime/ not working fulltime | 1255/202 | 69.7 [68.7;70.7] | 72.4 [69.9;74.9] | 0.050 |
Outcomes—univariate analysis
Number of participants | EQ-VAS, mean difference ± SD | p value | ||||
---|---|---|---|---|---|---|
Total | 512 | 2.19 ± 17.55 | 0.005 | |||
Subgroups | Female/male | Female | Male | p valuea | p valueb | p valuec |
Female/male | 249/263 | 2.46 ± 18.46 | 1.92 ± 16.68 | 0.005 | 0.729 | < 0.001 |
Non Austrian | 10/15 | 1.50 ± 24.50 | − 0.33 ± 27.12 | 0.914 | 0.865 | 0.490 |
Austrian | 239/248 | 2.50 ± 18.23 | 2.06 ± 15.91 | 0.003 | 0.776 | 0.029 |
Living with a partner | 159/223 | 2.48 ± 17.95 | 2.25 ± 16.59 | 0.008 | 0.897 | 0.002 |
Living alone | 85/35 | 2.81 ± 19.77 | − 0.71 ± 17.94 | 0.589 | 0.364 | 0.425 |
High education (school leaving examination or higher) | 17/32 | 3.53 ± 18.18 | 3.47 ± 17.57 | 0.196 | 0.991 | 0.073 |
No higher education | 229/229 | 2.28 ± 18.61 | 1.77 ± 16.64 | 0.014 | 0.755 | 0.002 |
Not working fulltime | 227/211 | 2.30 ± 18.51 | 2.73 ± 16.15 | 0.003 | 0.796 | 0.001 |
Working fulltime | 21/52 | 3.81 ± 18.63 | − 1.37 ± 18.47 | 0.611 | 0.283 | 0.046 |
Non-smoker | 222/221 | 2.18 ± 18.09 | 2.53 ± 16.28 | 0.004 | 0.831 | < 0.001 |
Current smoker | 27/42 | 4.74 ± 21.52 | − 1.29 ± 18.54 | 0.481 | 0.220 | 0.122 |
No manifestation of coronary heart diseased | 219/216 | 2.77 ± 18.23 | 1.69 ± 17.51 | 0.010 | 0.528 | < 0.001 |
Any manifestation of coronary heart diseased | 30/47 | 0.23 ± 20.22 | 3.02 ± 12.26 | 0.381 | 0.453 | 0.410 |
No macrovascular diabetic complicatione | 189/192 | 3.06 ± 17.39 | 2.11 ± 17.16 | 0.004 | 0.592 | 0.001 |
Any macrovascular diabetic complicatione | 60/71 | 0.58 ± 21.53 | 1.42 ± 15.41 | 0.537 | 0.796 | 0.022 |
Non guideline adherence treatmentf | 130/134 | 2.22 ± 17.34 | 1.21 ± 17.44 | 0.110 | 0.636 | 0.004 |
Full guideline adherence treatmentf | 119/129 | 2.72 ± 19.68 | 2.67 ± 15.89 | 0.018 | 0.980 | 0.012 |
Outcomes—multilevel analysis
3-level null model | 2-level null model | Baseline-adjusted model | Socio-economic model | Baseline and full guideline adherence treatment model | Final model | |
---|---|---|---|---|---|---|
Fixed part
a,b
| ||||||
Constant | 72.52 (0.89)* | 72.65 (0.74)* | 35.67 (1.89)* | 40.95 (4.29)* | 48.17 (5.98)* | 48.22 (6.01)* |
Patient characteristics
| ||||||
Sex (female/male) | − 2.23 (0.96)° | − 2.29 (0.99)° | − 2.30 (0.99)° | |||
Age (mean years ± SD) | − 0.13 (0.06)° | − 0.12 (0.06)° | − 0.12 (0.06)° | |||
Austrian (yes/no) | − 2.19 (2.08) | − 2.78 (2.10) | − 2.68 (2.10) | |||
Living alone (yes/no) | 2.36 (1.15)° | 2.48 (1.17)° | 2.36 (1.17)° | |||
Higher education (school leaving examination or higher) | 0.41 (1.66) | − 0.27 (1.69) | − 0.39 (1.70) | |||
Working fulltime (yes/no) | 2.82 (1.58) | 3.51 (1.62)° | 3.44 (1.62)° | |||
Smoker (yes/no) | 0.78 (1.39) | 1.34 (1.42) | 1.20 (1.42) | |||
Any macrovascular diabetic complicationc | 2.25 (1.09)° | 2.23 (1.09)° | ||||
Duration of diabetes (year) | − 0.23 (0.07)* | − 0.22 (0.07)* | ||||
Baseline values
| ||||||
EQ-VAS | 0.52 (0.03)* | 0.50 (0.03)* | 0.48 (0.03)* | 0.48 (0.03)* | ||
Body mass index (kg/cm2) | − 0.25 (0.10)° | − 0.25 (0.10)° | ||||
DMP associated variables
| ||||||
Group assignment (Intervention or control group) | 0.61 (1.27) | 1.14 (1.35) | 1.17 (1.36) | |||
Full guideline adherence treatmentd | 0.90 (1.12) | 1.03 (1.13) | ||||
District type
| ||||||
Rural | 1.46 (1.47) | |||||
Urban | − 1.04 (1.67) | |||||
Random Part
b
| ||||||
District-level (“rural”, “urban” or “mixed”) | 1.56 (3.40) | |||||
GP-level (intervention or control group) | 15.73 (6.42) | 17.36 (6.10) | 11.99 (4.25) | 12.10 (4.37) | 11.72 (4.44) | 10.51 (4.27) |
Patient characteristics-level (sex, age, nationality, education, occupational, family and smoking status, study length) | 307.22 (13.12) | 307.12 (13.12) | 224.12 (9.64) | 221.40 (9.69) | 218.29 (9.78) | 218.47 (9.79) |
Intraclass correlation coefficient, district level | 0.0048 | |||||
Intraclass correlation coefficient, GP level | 0.0485 | 0.0535 | 0.0508 | 0.0518 | 0.0509 | 0.0459 |
− 2 Log-Likelihood | 9962.12 | 9962.42 | 9438.57 | 9127.70 | 8706.66 | 8704.46 |
Number of districts | 6 | |||||
Number of GPs | 79 | 79 | 79 | 79 | 74 | 74 |
Number of patients | 1139 | 1139 | 1139 | 1103 | 1054 | 1054 |
Interpretation based on the socio-economic model | ||||||
---|---|---|---|---|---|---|
Model | Interpretation | |||||
Socio-economic model | The following baseline variables have a significantly negative impact on the final EQ-VAS: low baseline EQ-VAS score, female sex, higher age, and living alone. In the socio-economic model the baseline EQ-VAS variable was positively (0.50) and the age variable negatively associated (− 0.13). These numbers should be interpreted as follows: a high EQ-VAS score at baseline and younger age impacts positively on final EQ-VAS The variable sex was negatively (− 2.23) associated. This means that the final EQ-VAS score is lower in woman compared to men. Participants living with a partner (variable living alone, positively associated [2.36]) have a higher final EQ-VAS score compared to those living alone |
Discussion
Main findings
Strengths and limitations
Comparison with existing literature
Implications for practice and future research
Conclusion
Key message
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The EQ-VAS increased significantly within the intervention group and the improvement was stronger in women compared to men. This effect was not present in group comparison.
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The multilevel model demonstrated that sex, age, family and work circumstances, existence of any macrovascular diabetic complication, duration of diabetes, baseline body mass index and baseline EQ-VAS significantly influence EQ-VAS at follow-up.
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Future evaluations of the impact of DMPs on HRQoL in type 2 diabetes should incorporate predictors of HRQoL such as sex, age, socioeconomic status, coronary heart disease, and macrovascular diabetes complications in their analysis.