Background
Methods
Design
Participants - Recruitment and Assignment
Intervention
Objectives
Outcome measures
Data collection and management
Calculation of sample and effect size
Statistical methods
Ethical approval
Results
Participants' flow and characteristics
Practice factors at baseline | (n = 29) |
---|---|
Practice type | |
Single | 10 (34) |
Group practice | 19 (66) |
Location | |
rural | 14 (48) |
suburban | 5 (17) |
urban | 10 (35) |
List size (patients per quarter*) | |
0-1000 | 6 (19) |
1001-1500 | 11 (36) |
>1500 | 12 (45) |
Medical staff | (n = 31) |
No. of GPs per practice | |
1 | 10 (32) |
2 | 14 (45) |
3 | 4 (13) |
4 | 3 (10) |
No. of DAs in practice | |
1-3 | 11 (35) |
4-6 | 16 (52) |
7-11 | 4 (13) |
Mean age of in years (SD) | |
GPs | 50.6 (9.0) |
DAs | 33.3 (9.6) |
Female | |
GPs | 6 (19) |
DAs | 31(100) |
Certification of GPs since mean years (SD) | 16.3 (9.0) |
DAs work experience since mean years (SD) | 10.8 (9.1) |
Participation of GP in | |
Disease management programmes | 29 (94) |
Quality management programme | 18 (58) |
Intervention group (n = 97) | Control group (n = 100) | |
---|---|---|
Mean (SD; Range) number of patients per practice | 3.2 (1.2; 1-6) | 3.2 (1.7; 1-8) |
Practice type | ||
single | 35 (36.1) | 38 (38.0) |
group | 62 (63.9) | 62 (62.0) |
List size (patients per quarter) | ||
0-1000 | 22 (22.7) | 26 (26.0) |
1001-1500 | 25 (36.1) | 22 (22.0) |
>1500 | 40 (41.2) | 42 (42.0) |
Male sex | 69 (71.1) | 74 (74.0) |
Mean (SD) age (years) | 70.4 (10.0) | 68.9 (9.7) |
Living alone | 26 (26.3) | 27 (27.0) |
Social class*: | (n = 81) | (n = 84) |
lower, | 26 (32.1), | 25 (29.8), |
middle, | 47 (58.0), | 52 (61.9), |
upper class | 8 (9.9) | 7 (8.3) |
Participation of GP in Train the trainer-trial (GP received an) | ||
intensive educational intervention | 14 (14.4) | 18 (18.0) |
control educational intervention | 9 (9.3) | 10 (10.0) |
no educational intervention | 74 (76.3) | 72 (72.0) |
NYHA-functional class (according to GP) | ||
I | 1 (1.0) | 5 (5.0) |
II | 63 (64.9) | 67 (67.0) |
III | 33 (34.0) | 27 (27.0) |
IV | 0 | 1 (1.0) |
Mean (SD) LVEF | 35.7 (7.5) (n = 83) | 37.6 (6.7) (n = 88) |
Main cause of CHF | ||
ischemic | 46 (47.4) | 47 (47.0) |
non-ischemic | 51 (52.6) | 53 (53.0) |
Mean (SD) duration (years) of CHF | 6.2 (4.6) (n = 79) | 6.8 (6.3) (n = 74) |
Localisation of CHF | ||
Left | 61 (62.9) | 67 (67.0) |
Left and right | 33 (34.0) | 31 (31.0) |
Unknown | 3 (3.1) | 2 (2.0) |
Cardiovascular interventions | ||
PTCA/Stent (any) | 29 (29.9) | 36 (36.0) |
Bypass (any) | 21 (21.6) | 21 (21.0) |
Pacemaker (right ventricular) | 16 (16.5) | 16 (16.0) |
Pacemaker (biventricular) | 7 (7.2) | 8 (8.0) |
ICD | 11 (11.3) | 21 (21.0) |
Prosthetic heart valve (any) | 5 (5.2) | 7 (7.0) |
Reanimation/Defibrillation | 8 (8.2) | 6 (6.0) |
Medical conditions | ||
Atrial fibrillation | 25 (25.8) | 29 (29.0) |
PAD | 17 (17.5) | 17 (17.0) |
Cerebrovascular disease | 22 (22.7) | 16 (16.0) |
Asthma | 7 (7.2) | 5 (5.0) |
COPD | 25 (25.8) | 27 (27.0) |
Depression | 22 (22.7) | 17 (17.0) |
Cardiovascular risk factors | ||
Diabetes mellitus | 32 (33.0) | 35 (35.0) |
Hypertension | 78 (80.4) | 78 (78.0) |
Dyslipidemia | 63 (64.9) | 75 (75.0) |
History of infarction before 60 years | 18 (18.6) | 16 (16.0) |
Ex-/smoker (Ex: since at least 6 months) | 38/9 (39.2/9.3) | 42/14 (42.0/14.0) |
Mean number (SD) of drinks per week | 3.9 (5.5) | 4.7 (9.2) |
Creatinine-Clearance: Mean (SD) GFR (ml/min)** | 71.6 (31.4) (n = 96) | 71.6 (35.1) |
Stage of renal dysfunction | (n = 96) | |
GFR ≥ 60 ml/min** | 54 (56.2) | 57 (57.0) |
GFR 30-59 ml/min** | 39 (40.6) | 37 (37.0) |
GFR ≤ 29 ml/min** | 3 (3.1) | 6 (6.0) |
Mean (SD) level of NT-pro-BNP [Median, IQR] in pg/ml | 2222.5 (5282.2) [1010.5, 1750] (n = 94) | 1828.6 (2914.9) [930, 1712] (n = 96) |
Drugs at baseline included: | ||
ACE inhibitor or A2RA | 91 (93.8) | 95 (95.0) |
β-blocker | 70 (72.2) | 84 (84.0) |
ACE inhibitor/A2RA and β-blocker | 66 (68.0) | 80 (80.0) |
Spironolactone/Eplerenone | 32 (33.0) | 26 (26.0) |
Loop diuretics | 60 (61.9) | 59 (59.0) |
Thiazide diuretics | 34 (35.1) | 41 (41.0) |
Cardiac glycosides | 25 (25.8) | 26 (26.0) |
Statins | 57 (58.8) | 58 (58.0) |
Other lipid lowering drugs | 11 (11.3) | 14 (14.0) |
Aspirin (100-300 mg/d) | 38 (39.2) | 43 (43.0) |
Clopidogrel | 5 (5.2) | 5 (5.0) |
Phenprocoumon (Vitamin K Antagonist: equivalent to Warfarin) | 41 (42.3) | 46 (46.0) |
Interventions
Quality of life, behaviour change and quality of chronic illness care
Intervention (HICMan) group | No | Control group | No | Effect Mean Difference** (95% CI), Cohen's d | P value** | ||
---|---|---|---|---|---|---|---|
SF-36
| |||||||
physical composite score | at baseline | 36.4 (11.0) | 78 | 36.9 (10.1) | 82 | ||
at follow-up** | 38.0 (8.6) | 61 | 38.3 (8.6) | 70 | -0.3 [-3.0, 2.5], 0.04 | 0.857 | |
mental composite score | at baseline | 45.8 (11.9) | 78 | 47.6 (12.8) | 82 | ||
at follow-up** | 46.5 (9.9) | 61 | 46.6 (9.9) | 70 | -0.1 [-3.4, 3.1], 0.01 | 0.929 | |
KCCQ overall summary score | at baseline | 65.4 (22.6) | 96 | 64.7 (22.7) | 100 | ||
at follow-up** | 68.0 (16.9) | 87 | 66.3 (17.2) | 93 | 1.7 [-3.0, 6.4], 0.10 | 0.477 | |
EHFScBS*
| at baseline | 25.4 (8.4) | 65 | 25.0 (7.1) | 78 | ||
at follow-up** | 21.2 (6.4) | 65 | 24.8 (6.7) | 78 |
-3.6 [-5.7, -1.6], 0.55
|
0.001
| |
PACIC overall score | at baseline | 3.2 (0.9) | 89 | 3.2 (0.8) | 97 | ||
at follow-up** | 3.8 (0.7) | 80 | 3.3 (0.7) | 89 |
0.5 [0.3, 0.7], 0.72
|
0.000
| |
PACIC-5A overall score | at baseline | 3.2 (0.9) | 89 | 3.2 (0.9) | 97 | ||
at follow-up** | 3.8 (0.7) | 79 | 3.3 (0.7) | 89 |
0.5 [0.3, 0.8], 0.72
|
0.000
|