Background
Methods
Study design and randomisation
Inclusion and exclusion criteria
Instruments and outcomes
Intervention
Module 1: Introduction | Introduction to the concepts of the Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial and patient education |
Module 2: Heart failure | Chronic heart failure: definitions; epidemiology; clinical diagnosis; treatment guidelines; echocardiographic criteria; cardiac biomarkers—B-type natriuretic peptide (BNP) and NT-proBNP (how and when to prescribe them) Clinical symptoms: how to recognise heart failure in daily practice New York Heart Association (NYHA) stages: definitions; assessment of NYHA stages from case vignettes Suspicious clinical signs Adaptation of physical activity as a function of NYHA stage |
Module 3: Concepts of patient education | Assessment and building on patients’ existing knowledge Identification of lifestyle and dietary habits, physical activity, hobbies, leisure activities, projects and resources available to the patient Assessment of patients’ stage of change, motivation and attitude Collaboration with the patient to define achievable and measurable objectives |
Module 4: Communication | Communication skills Communication tools Motivational interviewing Lifestyle counselling based on the Five As model (ask, assess, advise, assist, and arrange) |
Module 5: Role play to simulate a patient consultation with the general practitioner | Identification and use of patients’ knowledge (clinical alarm signs, physical activity, diet and cardiovascular risk factors), values, motivation, projects and resources to involve the patient in their personal objectives Classification of these personal objectives by therapeutic priority and patient preference Use of effective communication strategies |
Module 6: Case report forms | Inclusion and exclusion criteria How to promote and present the ETIC trial to patients How to fill in the case report forms How to organise the follow-up and topics: educational booklet and educational tools (i.e. dietary leaflets, clinical alarm signs) |
Knowledge | Do you suffer from heart failure? |
Attitudes | What is ‘heart failure’ for you? |
Motivation | What do you know about heart failure? |
How do you live with this disease? | |
What impact has heart failure had on your life (personal, professional, social)? | |
What are your fears? | |
What are your expectations? | |
Clinical alarm signs | For you, what could be a clinical alarm sign of your heart failure? |
What should you do to detect clinical alarm signs? | |
Do you know what to do if you detect clinical alarm signs? | |
Physical activity | What does physical activity mean for you? |
What physical activities do you undertake? Housework? Leisure (e.g. gardening)? Transportation (e.g. walking, car)? | |
When are you breathless? (New York Heart Association assessment) | |
Regarding your habits, what would you be ready to change? | |
Diet | Where do you eat your meals? |
Who does the cooking? | |
High-salt food: what do you know about it? How much do you consume? | |
What is your point of view and what changes are you ready to make? | |
For those with a body mass index ≥30: what are your diet mistakes (snack food, overeating) or diet troubles? | |
For those with a body mass index ≤18 (adult patients) or 21 (elderly patients): what are your diet mistakes or diet troubles? |
Control
Statistical considerations
Results
Recruitment of general practitioners and patients
Baseline characteristics of general practitioners and patients
Intervention Group (n = 27) | Control Group (n = 27) | |
---|---|---|
Gender male, n (%) | 17 (63) | 20 (74.1) |
Age (years), mean (SD) | 50.2 (7.9) | 51.6 (7.3) |
Length of time in practice (years), mean (SD) | 21.9 (7.9) | 23.5 (8) |
Type of practice, n (%) | ||
Rural | 4 (14.8) | 3 (11.2) |
Suburban | 16 (59.3) | 12 (44.4) |
Urban | 7 (25.9) | 12 (44.4) |
Group practices, n (%) | 16 (59.3) | 19 (70.4) |
Trainee supervisorsa
n (%) | 19 (70.4) | 13 (48.2) |
Number of patients included, mean (SD) | 4.3 (2) | 4.8 (1.8) |
Intervention (n = 115) | Control (n = 126) |
P-value | |
---|---|---|---|
Gender male, n (%) | 69 (60) | 80 (63.5) | 0.58 |
Age (years), mean (SD) | 74.7 (10.3) | 73.5 (10.8) | 0.42 |
Chronic heart failure duration, median (IQR) | 5 (1–11) | 5 (2–10) | 0.66 |
EF mean (SD) | 50.9 (13.2) | 47.7 (15.2) | 0.16 |
HFpEF n (%) | 93 (80.9) | 94 (74.6) | 0.24 |
NYHA stage, n (%) | |||
I | 14 (12.2) | 25 (19.8) | |
II | 69 (60) | 67 (53.2) | 0.26 |
III | 32 (27.8) | 34 (27) | |
Current smoker, n (%) | 14 (12.2) | 25 (19.8) | 0.11 |
BMI kg/m2, n (%)a
| |||
< 25 | 25 (22.2) | 44 (35.8) | |
25–30 | 44 (38.9) | 52 (42.3) |
0.008
|
≥ 30 | 44 (38.9) | 27 (21.9) | |
Hypertension, n (%) | 72 (62.6) | 65 (51.6) | 0.08 |
Type 2 diabetes, n (%) | 30 (26.1) | 22 (17.5) | 0.10 |
Hypercholesterolaemia, n (%) | 50 (43.5) | 54 (42.9) | 0.92 |
COPD, n (%) | 9 (7.8) | 19 (15.1) | 0.08 |
SF-36 mental health score, mean (SD) | 60.3 (21.2) | 60.1 (21.3) | 0.89 |
SF-36 physical health score, mean (SD) | 52.1 (22.5) | 50.9 (22.1) | 0.66 |
MLHFQ score, mean (SD)b
| 29.1 (22.1) | 24.4 (21.7) | 0.07 |
<24 | 50 (52.6) | 64 (57.7) | |
24–45 | 22 (23.2) | 26 (23.4) | 0.64 |
>45 | 23 (24.2) | 21 (18.9) | |
Patient adherencec, n (%) | |||
Good adherence | 46 (44.2) | 49 (43) | |
Minor nonadherence | 56 (53.9) | 60 (52.6) | 0.67 |
Nonadherence | 2 (1.9) | 5 (4.4) | |
Intervention (n = 102) | Control (n = 121) |
P-value | |
Treatment, n (%)e
| 98 (96.1) | 117 (96.7) | 1.00 |
β-blocker | 63 (61.8) | 73 (60.3) | 0.83 |
ACE inhibitor | 51 (50) | 65 (53.7) | 0.58 |
ARB | 34 (33.3) | 29 (24) | 0.12 |
ACE inhibitor or ARBd
| 85 (83.3) | 93 (76.9) | 0.23 |
β-blocker and (ACE inhibitor or ARB) | 56 (54.9) | 60 (49.6) | 0.43 |
Thiazide diuretics | 12 (12.6) | 16 (13.2) | 0.74 |
Loop diuretics | 71 (69.6) | 78 (64.5) | 0.42 |
Thiazide diuretics or loop diuretics | 76 (74.5) | 90 (74.3) | 0.98 |
Mineralocorticoid receptor antagonists | 15 (14.7) | 21 (17.4) | 0.59 |
Digoxin | 11 (10.8) | 10 (8.3) | 0.52 |
Primary outcomes
Intervention (n = 69) | Control (n = 82) |
P-value | |
---|---|---|---|
Primary outcomes | |||
SF-36 mental health score, mean (SD) | 58 (22.1) | 58.7 (23.9) | 0.57 |
SF-36 physical health score, mean (SD) | 52.8 (23.8) | 51.6 (25.5) | 0.58 |
MLHFQ score, mean (SD) | 33.4 (22.1) | 27.2 (23.3) | 0.74 |
Secondary outcomes | |||
NYHA stage, n (%)a
| |||
I | 14 (22.6) | 21 (29.2) | |
II | 35 (56.5) | 34 (47.2) | 0.73 |
III | 12 (19.3) | 15 (20.8) | |
IV | 1 (1.6) | 2 (2.8) | |
BMI kg/m2, n (%)b
| |||
< 25 | 13 (22) | 29 (40.3) | |
25–30 | 25 (42.4) | 33 (45.8) |
0.007
|
≥ 30 | 21 (35.6) | 10 (13.9) | |
Patient adherencec, n (%) | |||
Good adherence | 23 (37.1) | 32 (42.1) | |
Minor nonadherence | 35 (56.5) | 42 (55.3) | 0.55 |
Nonadherence | 4 (6.4) | 2 (2.6) | |
Mortality, n (%) | 10/115 (8.7) | 15/126 (11.9) | 0.41 |
Total CHF decompensation/visits (%) | 65/470 (13.8) | 93/545 (17.1) | 0.16 |
Hospitalisation for CHF decompensation/visits (%) | 18/65 (27.7) | 22/93 (23.7) | 0.57 |
Hospitalisation not for CHF decompensation/visits (%) | 50/470 (10.6) | 59/545 (10.8) | 0.92 |
Hospitalisation/visits (%) | 62/470 (13.2) | 74/545 (13.6) | 0.86 |
Hospitalisation/patients (%) | 41/115 (35.7) | 54/126 (42.9) | 0.26 |
Total number of days of hospitalisation | 1037 | 867 | |
HF hospitalisation/patients (%) | 13/115 (11.3) | 17/126 (13.5) | 0.61 |
Death or hospitalisation/patients (%) | 45/115 (39.1) | 60/126 (47.6) | 0.18 |
Death or HF hospitalisation/patients (%) | 20/115 (17.3) | 28/126 (22.2) | 0.35 |
dTotal visits related to GP/patients (%) | 90/115 (78 %) | 106/126(84 %) | 0.24 |
dNumber of GP visits/patient, mean (SD) | 8.1 (5.3) | 6.4 (4.5) |
0.02
|
Total visits related to cardiologist/patients (%) | 85/115 (74 %) | 84/126 (67 %) | 0.22 |
Number of cardiologist visits/patient, mean (SD) | 3.1 (2.2) | 3.1 (2) | 0.92 |