Background
Aim
Methods
Trial design
Patients
Randomisation and procedures
Conventional care and interventions
Home-sent patient information group
Problem-based learning intervention group
Outcomes
Statistical analysis
Sample size justification
Primary analysis: intention-to-treat
Results
Patients
Total n = 157 n (%), mean (SD) | PBL-group n = 79 n (%), mean (SD) | Home-sent patient information-group n = 78 n (%), mean (SD) | P- value | |
---|---|---|---|---|
Gender | ||||
Male | 122 (77.7) | 60 (75.9) | 62 (79.5) | |
Female | 35 (22.3) | 19 (24.1) | 16 (20.5) | 0.702 |
Age, years | 68.7 (8.5) | 68.5 (9.2) | 68.9 (7.7) | 0.781 |
Residential area | ||||
City | 74 (47.1) | 34 (43.0) | 40 (51.3) | |
Rural or small town | 83 (52.9) | 45 (47.0) | 38 (45.8) | 0.339 |
Education | ||||
Compulsory educationa | 84 (54.2) | 46 (58.2) | 38 (50.0) | |
Upper secondary school | 31 (20.0) | 16 (20.3) | 15 (19.7) | |
University | 38 (24.5) | 17 (21.5) | 21 (27.6) | 0.430 |
Job position | ||||
Employed | 26 (16.8) | 12 (15.2) | 14 (18.4) | |
Self-employed | 15 (9.7) | 9 (11.4) | 6 (7.9) | |
Disabled pensioner | 9 (5.8) | 5 (6.3) | 4 (5.3) | |
Retired pensioner | 104 (67.1) | 52 (65.8) | 52 (68.4) | 0.864 |
Marital status | ||||
Cohabitating | 115 (74.2) | 60 (75.9) | 55 (72.4) | |
Living alone | 40 (25.8) | 19 (24.1) | 21 (27.6) | 0.714 |
Smoking, current | 19 (12.1) | 9 (11.4) | 10 (12.8) | 0.812 |
Diabetes Mellitus | 25 (15.9) | 17 (21.5) | 8 (10.3) | 0.080 |
Hypertension | 75 (47.8) | 39 (49.4) | 36 (46.2) | 0.750 |
COPDb | 15 (9.6) | 6 (7.6) | 9 (11.5) | 0.430 |
Hyperlipidaemia | 56 (35.7) | 26 (32.9) | 30 (38.5) | 0.508 |
Angina pectoris, diagnosed before current cardiac event | 40 (25.5) | 21 (26.6) | 19 (24.4) | 0.855 |
Other comorbiditiesc | 60 (38.2) | 27 (45.0) | 33 (55.0) | 0.295 |
Affecting mobility | 17 (10.8) | 10 (12.7) | 7 (9.0) | 0.609 |
Cardiac event one year before study inclusiond | ||||
Myocardial infarction | 86 (54.8) | 45 (57.0) | 41 (52.6) | |
Other | 71 (45.2) | 34 (43.0) | 37 (47.4) | 0.632 |
Time from cardiac event to start of study group, days | 284 (74) | 282 (69) | 286 (79) | 0.749 |
CCSe | ||||
0 | 98 (70.0) | 49 (67.1) | 49 (73.1) | |
I | 27 (19.3) | 17 (23.3) | 10 (14.9) | |
II | 11 (7.9) | 6 (8.2) | 5 (7.5) | |
III | 4 (2.9) | 1 (1.4) | 3 (4.5) | 0.457 |
Primary outcomes
n = 152 | Baseline PBL-group mean (SD) n = 78 | Baseline Home-sent patient information-group mean (SD) n = 74 | One-year follow-up PBL-group mean (SD) n = 60 | One-year follow-up Home-sent patient information-group mean (SD) n = 53 | Baseline - One-year follow-up mean difference (SD) PBL group n = 60 | Baseline - One-year follow-up mean difference (SD) Home-sent patient information-group n = 53 | P-value on mean difference |
---|---|---|---|---|---|---|---|
SWE-CES-10 | |||||||
Goal achievement and overcoming barriers to goal achievement | 3.7 (0.6) | 3.8 (0.7) | 3.8 (0.7) | 3.8 (0.6) | 0.07 (0.80) | 0.03 (0.64) | .772 |
Self-knowledge | 3.8 (1.0) | 3.9 (1.0) | 3.8 (1.0) | 3.9 (0,9) | −0.15 (0.97) | − 0.11 (1.06) | .826 |
Managing stress | 3.5 (0.9) | 3.4 (0.9) | 3.7 (0.9) | 3.5 (0.8) | 0.22 (0.99) | 0.08 (0.91) | .468 |
Assessing dissatisfaction and readiness to change | 3.5 (0.7) | 3.6 (0.8) | 3.7 (0.9) | 3.5 (0.8) | 0.20 (0.84) | 0.10 (1.02) | .568 |
Total | 3.7 (0.5) | 3.7 (0.6) | 3.8 (0.7) | 3.7 (0.7) | 0.08 (0.54) | 0.03 (0.56) | .543 |
EQ5D | |||||||
Mobility | 1.21 (0.41) | 1.27 (0.44) | 1.25 (0.44) | 1.25 (0.44) | 0.05 (0.43) | 0.00 (0.33) | .489 |
Self-care | 1.01 (0.12) | 1.03 (0.16) | 1.02 (0.13) | 1.02 (0.14) | 0.00 (0.00) | 0.00 (0.19) | 1.000 |
Usual activities | 1.17 (0.38) | 1.16 (0.40) | 1.12 (0.37) | 1.11 (0.37) | −0.07 (0.41) | −0.05 (0.30) | .845 |
Pain and discomfort | 1.60 (0.64) | 1.65 (0.56) | 1.48 (0.54) | 1.56 (0.54) | −0.10 (0.57) | −0.05 (0.62) | .684 |
Anxiety/depression | 1.51 (0.58) | 1.48 (0.55) | 1.35 (0.51) | 1.33 (0.55) | −0.12 (0.55) | −0.11 (0.53) | .941 |
Self-rated health VAS | 69.36 (18.79) | 72.96 (15.94) | 74.68 (17.83)(n = 55) | 77.05 (15.51) (n = 53) | 2.40 (13.78) | 3.09 (13.00) | .788 |
Ladder of Life | |||||||
Now | 6.83 (1.98) | 6.94 (1.82) | 7.04 (1.59) (n = 57) | 7.24 (1.94) (n = 46) | 0.23 (1.40) | 0.15 (1.65) | .802 |
A year ago | 6.69 (2.45) | 6.33 (2.23) | 6.73 (1.73) | 6.51 (2.06) | 0.19 (2.84) | 0.08 (2.29) | .833 |
In future one year ahead | 7.67 (1.91) | 7.84 (1.69) | 7.60 (1.70) | 7.65 (1.99) | −0.25 (1.65) | −0.26 (1.68) | .985 |
General self-efficacy (GSES) | 31.3 (5.50) | 31.5 (4.84) | 31.1 (4.65) | 32.4 (4.51) | −0.1 (4.27) | 1.0 (3.69) | .162 |
Nutritional self-efficacy (NSES) | 14.81 (3.09) | 13.45 (3.88) | 14.33 (3.71) | 13.75 (3.39) | −0.51 (3.34) | 0.04 (3.48) | .393 |
Physical self-efficacy (PSES) | 13.81 (3.64) | 13.56 (3.92) | 13.90 (3.93) | 13.33 (4.42) | −0.07 (4.20) | −0.6 (3.90) | .502 |
Stages of change | 4.09 (1.28) | 3.88 (1.34) | 4.26 (1.18) | 4.02 (1.28) | 0.00 (0.92) | −0.02 (1.04) | .921 |
Secondary outcomes
na | Baseline PBL-group mean (SD) or n (%) | Baseline Home-sent patient information-group mean (SD) or n (%) | One-year follow-up PBL-group mean (SD) or n (%) | One-year follow-up Home-sent patient information-group mean (SD) or n (%) | Baseline - One-year follow-up mean difference (SD) or (%) PBL group | Baseline - One-year follow-up mean difference (SD) or (%) Home-sent patient information-group | P-value on mean difference | |
---|---|---|---|---|---|---|---|---|
Body weight, kg | 113 | 81.8 (13.5) | 83.3 (18.1) | 81.0 (13.0) | 84.4 (17.7) | −0.83 (4.45) | 1.14 (4.85) | 0,026 |
BMI | 101 | 26.9 (3.3) | 27.6 (5.2) | 26.7 (3.6) | 28.1 (5.0) | −0.17 (1.5) | 0.50 (1.6) | 0.033 |
Waist circumference, cm | 67 | 99 (9.8) | 101 (14) | 100 (12) | 102 (14) | 1.6 (6.6) | 1.5 (4.6) | 0.931 |
Tobacco smoking | 121 | 9 (11) | 10 (13) | 4 (5.1) | 8 (10) | 0.240b | ||
Systolic BP, mmHg | 119 | 125 (17) | 128 (18) | 134 (19) | 136 (18) | 8.5 (19) | 7.6 (17) | 0.787 |
Diastolic BP, mmHg | 118 | 72 (8.8) | 74 (10) | 75 (11) | 76 (11) | 3.4 (11) | 1.6 (11) | 0.392 |
Heart rate, b.p.m. | 76 | 63 (11) | 64 (12) | 61 (10) | 65 (14) | −2.7 (11) | 0.9 (13) | 0.202 |
Total cholesterol, mmol/L | 114 | 3.9 (0.8) | 4.0 (1.0) | 4.1 (1.1) | 3.9 (1.0) | 0.2 (1.2) | −0.1 (0.7) | 0.140 |
HDL-cholesterol, mmol/L | 112 | 1.3 (0.4) | 1.3 (0.5) | 1.4 (0.4) | 1.2 (0.4) | 0.1 (0.7) | 0.0 (0.3) | 0.038 |
LDL-cholesterol, mmol/L | 110 | 2.0 (0.6) | 2.1 (0.8) | 2.1 (0.8) | 2.1 (0.8) | 0.1 (0.9) | 0.0 (0.7) | 0.373 |
Triglycerides, mmol/L | 112 | 1.3 (0.6) | 1.3 (0.6) | 1.2 (0.8) | 1.3 (0.7) | 0.0 (0.8) | 0.0 (0.5) | 0.631 |
Fasting Glucose, mmol/L | 109 | 6.1 (1.2) | 5.9 (0.8) | 6.0 (1.4) | 6.0 (1.1) | −0.1 (1.3) | 0.1 (1.2) | 0.347 |