Background
Methods
Patients
Intervention
Assessments
Clinical and registry based follow-up
Statistical analysis
No. of respondents Routine/ Structured care | Routine care | Structured care |
p-value | |
---|---|---|---|---|
Socioeconomic | ||||
Age, years | 620/761 | 65.2 (73.4; 56.2) | 65.5 (73.7; 55.6) | 0.59 |
Male gender | 620/761 | 329 (53.1) | 404 (53.1) | 0.99 |
Living alone | 606/743 | 198 (32.7) | 236 (37.6) | 0.72 |
Rural residence | 596/728 | 161 (27.0) | 153 (21.0) | 0.011 |
Basic school education only | 588/723 | 459 (78.1) | 574 (79.4) | 0.56 |
Employment status | 605/744 | 0.51 | ||
In labor market | 157 (26.0) | 208 (28.0) | ||
Out of labor marketa
| 181 (29.9) | 203 (27.3) | ||
Retired | 267 (44.1) | 333 (44.8) | ||
Medical history | ||||
Cardiovascular diseaseb
| 603/743 | 191 (31.7) | 223 (30.0) | 0.51 |
Clinical | ||||
Body mass index, kg/m2
| 619/753 | 28.7 (32.2; 26.0) | 29.4 (33.0; 26.2) | 0.21 |
Hypertensionc
| 620/761 | 458 (73.9) | 568 (74.6) | 0.75 |
Biochemical | ||||
Fasting plasma glucose, mmol/L | 620/761 | 13.8 (10.7; 17.1) | 13.6 (10.7; 16.9) | 0.44 |
HbA1c, %d
| 512/624 | 10.2 (8.7; 11.9) | 10.2 (8.6; 11.7) | 0.75 |
Total cholesterol, mmol/L | 620/740 | 6.2 (5.5; 7.2) | 6.2 (5.3; 7.1) | 0.16 |
Fasting triglycerides, mmol/L | 610/736 | 2.0 (1.4; 3.0) | 2.0 (1.4; 2.9) | 0.62 |
Serum creatinine, μmol/L | 611/740 | 88 (79; 100) | 90 (80; 101) | 0.41 |
Urinary micro- or proteinuriae
| 595/723 | 254 (42.7) | 304 (42.1) | 0.81 |
Behavioral | ||||
Sedentary (leisure-time) physical activity | 604/741 | 162 (26.8) | 210 (28.3) | 0.54 |
Current smokers | 604/742 | 208 (34.4) | 264 (35.6) | 0.66 |
Results
No. of patients without outcome at diabetes diagnosis (routine/ structured) | No. (%) of patients with outcome | Absolute risk (events per 1000 patient years) | Hazard ratio (HR)a for structured- versus routine care (=reference group) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Routine care | Structured personal care | p valueb
| Routine care | Structured personal care | p valuec
| Adjusted for age, sex and clustering | p valued
| Additionally adjusted for clinical and behavioral variablesf
| p valued
| Interaction p valuee
| ||
Educationf
Any diabetes-related endpoint | 0.11 | |||||||||||
Basic | 377/461 | 281 (74.5) | 313 (67.9) | 0.04 | 89.2 | 74.5 | 0.01 | 0.80 (0.67–0.94) | 0.008 | 0.75 (0.63–0.89) | 0.0008 | |
Higher | 108/124 | 72 (66.7) | 74 (59.7) | 0.27 | 61.5 | 53.0 | 0.31 | 0.94 (0.69–1.28) | 0.69 | 1.01 (0.73–1.40) | 0.97 | |
All-cause mortality | 0.35 | |||||||||||
Basic | 459/574 | 343 (74.7) | 410 (71.4) | 0.26 | 66.4 | 63.0 | 0.45 | 0.94 (0.81–1.08) | 0.37 | 0.90 (0.77–1.06) | 0.20 | |
Higher | 129/149 | 78 (60.5) | 84 (56.4) | 0.56 | 47.8 | 43.0 | 0.48 | 1.03 (0.78–1.37) | 0.84 | 1.06 (0.78–1.43) | 0.73 | |
Employment statusg
Any diabetes-related endpoint | 0.50 | |||||||||||
Out of labor market | 148/165 | 109 (73.7) | 106 (64.2) | 0.07 | 75.2 | 61.7 | 0.06 | 0.76 (0.58–1.01) | 0.06 | 0.73 (0.55–0.97) | 0.03 | |
In labor market | 148/192 | 90 (60.8) | 108 (56.3) | 0.38 | 51.5 | 44.4 | 0.23 | 0.87 (0.67–1.14) | 0.32 | 0.84 (0.63–1.12) | 0.23 | |
All-cause mortality | 0.87 | |||||||||||
Out of labor market | 181/203 | 116 (64.1) | 127 (62.6) | 0.75 | 50.8 | 48.1 | 0.67 | 0.94 (0.74–1.20) | 0.61 | 0.90 (0.69–1.18) | 0.44 | |
In labor market | 157/208 | 62 (39.5) | 78 (37.5) | 0.69 | 25.2 | 24.1 | 0.76 | 1.02 (0.74–1.39) | 0.92 | 0.93 (0.66–1.31) | 0.68 | |
Residence Any diabetes-related endpoint | 0.033 | |||||||||||
Rural | 137/133 | 94 (68.6) | 89 (66.9) | 0.09 | 67.1 | 77.7 | 0.24 | 1.01 (0.75–1.36) | 0.95 | 1.07 (0.77–1.48) | 0.70 | |
Urban | 353/455 | 263 (74.5) | 300 (65.9) | 0.01 | 91.0 | 67.4 | <0.0001 | 0.75 (0.63–0.88) | 0.0007 | 0.71 (0.60–0.85) | 0.0001 | |
All-cause mortality | 0.21 | |||||||||||
Rural | 161/153 | 108 (67.1) | 112 (73.2) | 0.28 | 54.0 | 64.9 | 0.14 | 1.09 (0.83–1.43) | 0.55 | 1.08 (0.83–1.42) | 0.56 | |
Urban | 435/575 | 321 (73.8) | 391 (68.0) | 0.04 | 66.8 | 58.1 | 0.05 | 0.91 (0.78–1.06) | 0.21 | 0.89 (0.75–1.05) | 0.16 | |
Civil status Any diabetes-related endpoint | 0.46 | |||||||||||
Living alone | 158/176 | 120 (76.0) | 127 (72.2) | 0.42 | 101.6 | 92.7 | 0.41 | 0.83 (0.64–1.08) | 0.16 | 0.88 (0.68–1.15) | 0.36 | |
Cohabiting | 344/426 | 244 (70.9) | 273 (64.1) | 0.04 | 74.4 | 62.4 | 0.02 | 0.83 (0.70–0.98) | 0.03 | 0.78 (0.65–0.93) | 0.007 | |
All-cause mortality | 0.32 | |||||||||||
Living alone | 198/236 | 167 (84.3) | 195 (82.6) | 0.62 | 87.5 | 85.1 | 0.80 | 0.84 (0.68–1.03) | 0.09 | 0.84 (0.68–1.03) | 0.09 | |
Cohabiting | 408/507 | 267 (65.4) | 314 (61.9) | 0.31 | 52.6 | 49.3 | 0.41 | 1.00 (0.85–1.19) | 0.98 | 0.97 (0.80–1.17) | 0.71 |
Significance (p-value)a of the modification of the intervention effect by the various socio-demographic variables | ||||
---|---|---|---|---|
Educational level: Basic vs. higher | Residence: Rural vs. urban | Employment: Out of labor market vs. in labor market | Civil status: Single vs. cohabiting | |
Patient attitudesb
| ||||
Altered habits after diagnosis | 0.22 | 0.08 | 0.50 | 0.33 |
Not full diabetes diet | 0.53 | 0.74 | 0.78 | 0.45 |
Performs home blood/urinary glucose monitoring | 0.17 | 0.89 | 0.94 | 0.88 |
For the patient in question the GP’s opinionb
| ||||
Patient’s motivation; good or very good for best possible control and treatment over past year,
| 0.34 | 0.07 | 0.19 | 0.80 |
Clinical | ||||
Body mass index | 0.29 | 0.50 | 0.15 | 0.65 |
Systolic blood pressure | 0.47 | 0.23 | 0.71 | 0.54 |
Biochemical | ||||
Hemoglobin A1c | 0.48 | 0.31 | 0.91 | 0.97 |
Total cholesterol | 0.05(↓) | 0.67 | 0.83 | 0.79 |
Serum creatinine | 0.42 | 0.05 (↓) | 0.69 | 0.22 |
Micro- or proteinuriac
| 0.81 | 0.55 | 0.47 | 0.92 |
Behavioralb
| ||||
Sedentary (leisure time) physical activity | 0.90 | 0.20 | 0.57 | 0.67 |
Current smoking | 0.44 | 0.41 | 0.56 | 0.59 |
Process of careb
| ||||
Consultations/year | 0.93 | 0.26 | 0.86 | 0.53 |
Diabetes-related consultations/year | 0.91 | 0.18 | 0.56 | 0.04 (↑) |
Ever treated at diabetic clinic | 0.95 | 0.17 | 0.87 | 0.32 |
Glucose-lowering drugsb
| 0.26 | 0.96 | 0.60 | 0.33 |
Antihypertensive drugsb
| 0.33 | 0.18 | 0.55 | 0.98 |
Lipid-lowering drugsb
| 0.82 | 0.04 (↓) | 0.40 | 0.40 |