Figure 1
CONSORT flow diagram for the HAPPY London study.
Table 1
Demographics and baseline clinical characteristics for both groups.
| Clinical Values | E-coaching group (n = 205) | SOC group (n = 197) | P value |
|---|---|---|---|
| Age (years) | 65.1(6.3) | 65.9(4.8) | 0.15 |
| Male sex, no. (%) | 127(62.0) | 126(64.0) | 0.75 |
| University education, no. (%) | 109(53) | 97(49) | 0.42 |
| Smoking history, no. (%) | |||
| Non-smoker | 104(50.7) | 80(40.6) | 0.053 |
| Ex-smoker | 86(42.0) | 101(51.3) | 0.08 |
| Light (<10 cigarettes/day) | 9(4.4) | 9(4.6) | 1 |
| Moderate (11–19) | 6(2.9) | 3(1.5) | 0.53 |
| Heavy (>20) | 0 | 4(2.0) | 0.12 |
| Ethnicity, no. (%) | |||
| White | 182(88.8) | 172(87.3) | 0.76§ |
| Asian | 20(9.8) | 14(7.1) | 0.76§ |
| Black Afro-Caribbean | 1(0.5) | 5(2.5) | 0.76§ |
| Other | 2(1.0) | 6(3.0) | 0.76§ |
| Medical History | |||
| Rheumatoid Arthritis, no. (%) | 8(3.9) | 3(1.5) | 0.25 |
| BP medication, no. (%) | 105(51.2) | 83(42.1) | 0.08 |
| Cholesterol medication, no. (%) | 98(47.8) | 84(42.6) | 0.40 |
| Diabetes, no. (%) | 35(17.1) | 22(11.2) | 0.12 |
| Atrial fibrillation, no. (%) | 9(4.4) | 11(5.6) | 0.75 |
| Family History CAD, no. (%) | 75(36.6) | 60(31) | 0.25 |
| Risk Scores | |||
| QRISK2*, 10-year risk, % | 16.5(12.7; 23.1) | 16.5(12.6; 21.1) | 0.56 |
| Framingham risk score, 10-year risk, % | 16(9) | 17.8(10) | 0.54 |
| Risk Stratification | |||
| High risk, no. (%) | 73(36) | 62(31) | 0.38 |
| QRISK2 for high risk*, 10-year risk, % | 25.7(22.2; 31.2) | 26.3(21.8; 31.2) | 0.99 |
| Mod risk (n) | 132(64) | 135(69) | 0.38 |
| QRISK2 for mod*, 10-year risk, % | 13.9(11.8; 16.2) | 13.7(11.6; 16.7) | 0.95 |
| High risk or diabetes, no. (%) | 79(39) | 67(34) | 0.4 |
| Systolic BP, mmHg | 132.5(13.3) | 132.3(14.8) | 0.88 |
| Diastolic BP, mmHg | 79.2(9.2) | 80(8.6) | 0.34 |
| Weight, Kg | 80.7(18.4) | 79.7(16) | 0.56 |
| BMI, Kg/m2 | 28.1(5.6) | 27.4(4.4) | 0.16 |
| Hip circumference, cm | 104.7(10.3) | 103.6(8.2) | 0.25 |
| Waist circumference, cm | 95.8(15.2) | 95.4(12) | 0.81 |
| Total Cholesterol, mmol/L | 4.9(1.1) | 5.1(1.1) | 0.09 |
| HDL, mmol/L | 1.6(0.5) | 1.6(0.4) | 0.95 |
| LDL, mmol/L | 2.8(1) | 2.9(1) | 0.10 |
| Triglyceride*, mmol/L | 1.1(0.8; 1.5) | 1.3(0.8; 1.5) | 0.31 |
| Glucose*, mmol/L | 5.5(5.1; 6.0) | 5.5(5.1; 5.9) | 0.71 |
| hsCRP*, mg/L | 1.2(0.7; 2.5) | 1.3(0.7; 2.4) | 0.76 |
| eGFR, mL/min/1.73 sqm | 82.9(20.1) | 81.9(17.9) | 0.58 |
| Physical activity, minutes per day | 70.8(75.6) | 64.9(91.9) | 0.48 |
| Lifestyle score, out of 10, 10 being best score | 6.9(1.3) | 6.8(1.3) | 0.22 |
| Surrogate Markers | |||
| PWV, m/s | 8.5(1.7) | 8.9(1.6) | 0.027* |
| CIMT (combined right and left), mm | 0.705(0.13) | 0.736(0.13) | 0.02* |
| Quality of Life | |||
| Self-rated health state*, best health score 100 | 80(65–90) | 80(65–90) | 0.21 |
| EQ-5D-3L VAS value*, best quality of life score 1) | 0.76(0.73; 01.0) | 0.76(0.69; 1.0) | 0.39 |
[i] Results presented as mean (SD) or *median (interquartile range), unless stated otherwise.
§ white vs. non-white.
Abbreviations: BMI, body mass index; BP, blood pressure; CAD, coronary artery disease; PWV, carotid-femoral pulse wave velocity; CIMT, carotid intima-media thickness; eGFR, estimated glomerular filtration rate; EQ-5D-3L VAS, Euroqol, 5 dimension, 3 level visual analogue scale – validated questionnaire; HDL, high-density lipoprotein cholesterol; hsCRP, high sensitivity C-reactive protein; IQR, inter quartile range; LDL, low-density lipoprotein cholesterol; Mod, moderate; pd, per day; QOL, quality of life.
Figure 2
Change in carotid-femoral pulse wave velocity over six months.
Table 2
Comparison of change over six months between intervention group and SOC group.
| Clinical Values | E-coaching group n = 194 | SOC group n = 183 | Mean difference between groups over six months (95% CI) | p-value | ||
|---|---|---|---|---|---|---|
| Follow-up | Mean change over 6 months | Follow-up | Mean change over 6 months | |||
| Primary Endpoint | ||||||
| PWV†, | 8.3 (1.4) | –0.16 | 8.6 (1.7) | –0.25 | 0.09 (–0.39; 0.22) | 0.56 |
| Secondary Endpoints | ||||||
| Systolic BP, mmHg | 129.5 (13.6) | –3.18 | 130.7 (14.7) | –1.688 | –1.5 (–4.2; 1.2) | 0.27 |
| Diastolic BP, mmHg | 76.7 (9.1) | –2.37 | 78 (8.7) | –2.076 | –0.29 (–1.6; 1.1) | 0.67 |
| Weight, kg | 78.9 (18.1) | –1.22 | 79 (15.8) | –0.763 | –0.45 (–1.0; 0.1) | 0.10 |
| BMI, kg/m2 | 27.4 (5.3) | –0.42 | 27.1 (4.4) | –0.247 | –0.17 (–0.4; 0) | 0.07 |
| Hip circumference, cm | 102.2 (9.9) | –2.19 | 101.8 (8.2) | –1.809 | –0.38 (–1.2; 0.5) | 0.37 |
| Waist circumference, cm | 92.7 (14.7) | –2.55 | 93.4 (12) | –2.048 | –0.5 (–1.5; 0.5) | 0.31 |
| Total Cholesterol, mmol/L | 4.8 (1) | –0.16 | 4.9 (1) | –0.197 | 0.04 (–0.1; 0.2) | 0.60 |
| HDL, mmol/L | 1.6 (0.5) | –0.03 | 1.6 (0.4) | –0.017 | –0.01 (–0.1; 0) | 0.64 |
| LDL, mmol/L | 2.6 (0.9) | –0.10 | 2.8 (0.9) | –0.142 | 0.04 (–0.1; 0.2) | 0.56 |
| Triglyceride, mmol/L | 1.2 (0.8) | –0.08 | 1.2 (0.6) | –0.113 | 0.03 (–0.1; 0.1) | 0.56 |
| Glucose, mmol/L | 5.6 (1.3) | –0.29 | 5.5 (1.1) | –0.266 | –0.03 (–0.2; 0.2) | 0.77 |
| HsCRP, mg/L | 2.3 (5.9) | –0.26 | 2.2 (5.4) | 0.004 | –0.27 (–1.9; 1.3) | 0.75 |
| eGFR, mL/min/1.73sqm) | 82.3 (17) | –0.64 | 83 (20.2) | 1.225 | –1.87 (–4.8; 1.1) | 0.22 |
| Alcohol per week, units | 7.9 (9.4) | –0.78 | 7.7 (8.2) | –1.081 | 0.3 (–0.7; 1.3) | 0.54 |
| Physical activity, minutes per day | 98 (145.5) | 25.10 | 74.2 (100.3) | 8.448 | 16.65 (–10.3; 43.6) | 0.23 |
| Lifestyle score, best score 10 | 7.7 (1.2) | 0.74 | 7.5 (1.3) | 0.659 | 0.08 (–0.1; 0.3) | 0.45 |
| CIMT (left and right), mm | 0.72 (0.14) | 0.014 | 0.75 (0.13) | 0.015 | 0.02 (–0.017; 0.015) | 0.91 |
| QRISK2 score, 10-year risk, % | 19.2 (8.5) | 0.14 | 18.9 (8.6) | 0.01 | 0.24 (–0.4; 0.6) | 0.63 |
| Expected QRISK2 at 6 months#, 10-year risk, % | 19.6 (8.1) | 19.3 (8.8) | ||||
| Framingham risk score, 10-year risk, % | 16.1 (8.9) | –1.23 | 16.6 (9.5) | –1.37 | 0.14 (–0.9; 1.2) | 0.79 |
| Self-rated health state (best health 100)* | 85 (75; 90) | 4.81 | 84 (69; 90) | 5.58 | –0.77 (–6.5; 4.9) | 0.79 |
| EQ-5D-3L VAS value (best value 1)* | 0.76 (0.7; 1.0) | –0.00 | 0.76 (0.70; 1.0) | 0.01 | –0.01 (–0.02; 0.05) | 0.44 |
| Total logins to study Website, n | 12.8 | 9.1 | <0.001 | |||
[i] Results presented as mean (SD) or *median (interquartile range), unless stated otherwise.
Abbreviations: BMI, body mass index; BP, blood pressure; CAD, coronary artery disease; CIMT, carotid intima-media thickness; eGFR, estimated glomerular filtration rate; EQ-5D-3L VAS, Euroqol, 5 dimension, 3 level visual analogue scale – validated questionnaire; HDL, high-density lipoprotein cholesterol; hsCRP, high sensitivity C-reactive protein; IQR, inter quartile range; LDL, low-density lipoprotein cholesterol; Mod, moderate; n, number; PWV, carotid-femoral pulse wave velocity; QOL, quality of life.
# Naturally expected due to older age only if other factors unchanged. QRISK increases with increasing age.
† Corrected when extreme outlier excluded (a single reading of 27 m/s which was very different to a subsequent visit for the same patient and compared to all other readings).