How effective is an in-hospital heart failure self-care program in a Japanese setting? Lessons from a randomized controlled pilot study

Figures & data

Figure 1 Educational topics in the program.

Abbreviations: HF, heart failure; BNP, B-type natriuretic peptide; ACEI, angiotensin-converting-enzyme inhibitor.

Figure 2 Flowchart of study patients.

Note: Non-response patients did not send back the questionnaire even after 30 days since the day of the survey.
Abbreviation: HF, heart failure.

Table 1 Characteristics of study patients at baseline

Characteristics	Total (n=32)	Program (n=15)	Usual care (n=17)	P-value
Demographic characteristics
Sex, female	10 (31%)	3 (20%)	7 (41%)	0.27
Age, years	63±14	64±15	65±17	0.84
Marital status				0.11
Single	6 (19%)	2 (13%)	4 (24%)	–
Married	17 (53%)	11 (73%)	6 (35%)	–
Widowed/divorced	9 (28%)	2 (13%)	7 (41%)	–
Education, ≤12 years	17 (53%)	7 (47%)	10 (59%)	0.49
Employment, employed	15 (47%)	7 (47%)	8 (47%)	1.00
Living alone	14 (44%)	5 (33%)	9 (53%)	1.00
Cardiac parameters at discharge
Ischemic etiology	14 (44%)	6 (40%)	8 (47%)	0.98
Prior hospitalization for HF	15 (47%)	7 (47%)	8 (47%)	0.98
NYHA functional class, II	9 (28%)	4 (27%)	5 (29%)	0.43
BNP, pg/mL, median (Q1–Q3)	238 (146–534)	190 (131–396)	248 (183–629)	0.62
LVEF <50%	21 (66%)	9 (60%)	12 (71%)	0.53
Diabetes mellitus	13 (41%)	6 (40%)	7 (41%)	0.95
Chronic kidney disease	22 (69%)	10 (67%)	12 (71%)	1.00
Medical therapy
β-blocker	26 (81%)	13 (87%)	13 (76%)	0.66
ACEI and/or ARB	29 (91%)	14 (93%)	15 (88%)	1.00
Aldosterone blocker	20 (63%)	8 (53%)	12 (71%)	0.47
Diuretics	25 (78%)	10 (67%)	15 (88%)	0.14
Self-care-related outcomes
EHFScBS score	36.4±8.4	36.2±7.6	36.6±9.5	0.90
HF knowledge score	9.4±3.6	10.6±3.2	8.1±3.6	0.06

Notes: Chronic kidney disease was defined as estimated glomerular filtration rate <60. Values are n (%), or mean ± SD.

Abbreviations: HF, heart failure; BNP, B-type natriuretic peptide; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; ACEI, angiotensin-converting-enzyme inhibitor; ARB, angiotensin II receptor blocker; SD, standard deviation; EHFScBS, European Heart Failure Self-care Behavior Scale.

Figure 3 Impacts of the program on heart failure (HF) self-care behavior.

Notes: Data represent mean of the EHFScBS score and error bars represent standard errors of the mean (SEM). Higher score indicates poorer HF self-care (range: 12–60). Follow-up time (F=5.29, P<0.01), group (F=0.05, P=0.83), and a group-by-time interaction (F=0.44, P=0.65) by the linear mixed model. ^#P<0.05 by paired t-test (vs baseline).
Abbreviation: EHFScBS, European Heart Failure Self-Care Behavior Scale.

Table 2 Impacts of the program on heart failure self-care behavior

Heart failure self-care behavior	Heart failure self-care scores			Changes of scores from baseline						A group-by-time interaction
	At baseline			At 1 month			At 6 months
	Program (n=14)	Usual care (n=14)	P-value*	Program (n=13)	Usual care (n=9)	P-value*	Program (n=8)	Usual care (n=8)	P-value*	P-value***
1 I weigh myself every day	2.3±1.6	3.1±1.6	0.21	−1.1±0.4**	−1.7±0.7	0.41	−0.3±0.4	−0.6±0.5	0.74	0.86
2 If I am short of breath, I take it easy	2.2±1.2	2.0±1.1	0.63	−0.2±0.5	−0.2±0.6	0.93	−0.1±0.3	−0.2±0.7	0.88	0.92
3 If my shortness of breath increases, I contact a hospital, my doctor, or nurse	3.1±1.6	3.4±1.8	0.66	0.2±0.5	−1.3±0.6	0.11	−0.6±0.8	−0.6±0.9	1.00	0.53
4 If my feet/legs become more swollen than usual, I contact a hospital, my doctor, or nurse	3.8±1.3	3.9±1.4	0.89	−0.2±0.5	−1.1±0.8	0.28	−0.8±0.5	0.0±0.7	0.38	0.29
5 If I gain 2 kg in 1 week, I contact a hospital, my doctor, or nurse	4.1±1.0	4.1±1.5	0.88	−1.0±0.7	−1.1±0.6	0.86	−1.7±0.6	−0.6±0.8	0.28	0.31
6 I limit the amount of fluids I drink (not more than 1–1.5 L/day)	3.2±1.7	3.2±1.8	1.00	−1.1±0.5	−1.4±0.7	0.72	−0.9±0.5	−1.7±0.6	0.33	0.96
7 I take a rest during the day	2.8±1.4	2.8±1.8	1.00	−0.5±0.4	−0.8±0.7	0.69	−0.2±0.4	−1.1±0.7	0.25	0.39
8 If I experience increased fatigue, I contact a hospital, my doctor, or nurse	3.8±1.3	3.7±1.6	0.90	−0.1±0.5	0.1±0.7	0.80	−0.6±0.5	0.0±0.7	0.51	0.37
9 I eat a low-salt diet	3.2±1.3	3.2±1.4	1.00	−1.5±0.4**	−1.1±0.7	0.63	−1.9±0.5**	−1.3±0.7	0.53	0.75
10 I take my medication as prescribed	1.2±0.6	1.0	0.19	−0.2±0.2	0.0	0.20	−0.2±0.2	0.0	0.35	0.29
11 I get a flu shot every year	3.4±2.0	3.6±2.0	0.78	0.2±0.4	−0.2±0.2	0.43	0.1±0.8	−0.5±0.5	0.28	0.42
12 I exercise regularly	3.1±1.3	2.7±1.6	0.53	−0.5±0.2	−0.4±0.5	0.87	−0.7±0.3	−0.8±0.6	0.88	0.79

Notes: Higher score indicates poorer self-care behavior. The response to each item was scored between 1 (I completely agree) and 5 (I don’t agree at all). Values are mean ± SD at baseline and mean ± SEM in changes of scores from baseline (a negative number indicates that the self-care behavior was improved).

* Unpaired t-test (program vs usual care);

** P<0.05 by Wilcoxon signed-rank test (vs baseline);

*** P-values by linear mixed model.

Abbreviations: SEM, standard errors of the mean; SD, standard deviation.

Figure 4 Impacts of the program on heart failure knowledge.

Notes: Data represents mean of the heart failure knowledge score and error bars represent standard errors of the mean (SEM). Higher score indicates greater knowledge about heart failure (range: 0–15). Follow-up time (F=5.23, P<0.01), group (F=6.89, P=0.01), and a group-by-time interaction (F=2.47, P=0.098) by the linear mixed model. ^#P<0.05 by unpaired t-test (the intervention group vs the usual care group); ^*P<0.05 by paired t-test (vs baseline).

Table 3 Impacts of the program on heart failure (HF) knowledge

Heart failure knowledge	Heart failure knowledge scores			Changes of the scores from baseline						A group-by-time interaction
	At baseline			At 1 month			At 6 months
	Program (n=14)	Usual care (n=14)	P-value#	Program (n=13)	Usual care (n=9)	P-value#	Program (n=10)	Usual care (n=9)	P-value#	P-value***
1 Exchange of oxygen and carbon dioxide occurs in heart	0.4±0.5	0.3±0.5	0.46	−0.1±0.1	−0.3±0.2	0.14	−0.1±0.1	−0.1±0.1	0.65	0.64
2 HF is a condition in which the heart is not able to pump blood through the body in sufficient amounts	0.9±0.4	0.8±0.4	0.65	0.0±0.1	0.0	1.00	0.1±0.1	0.1±0.1	1.00	0.41
3 Difficulty in breathing and shortness of breath are symptoms of HF	0.9±0.3	0.9±0.3	1.00	0.1±0.1	0.0	0.42	0.0±0.1	0.0	1.00	0.79
4 One of the symptoms when the lungs become congested with fluid is shortness of breath	0.6±0.4	0.5±0.2	0.47	0.2±0.2	0.1±0.2	0.87	0.1±0.2	0.2±0.2	0.67	0.76
5 Some patients with severe HF become breathless when they lie flat and feel much better when they sit up	0.6±0.5	0.3±0.5	0.07	0.0±0.2	0.0	1.00	0.2±0.3	0.2±0.1	0.96	0.76
6 Short-term weight gain is one of the signs of worsening HF	0.6±0.5	0.4±0.5	0.14	0.1±0.1	0.0±0.2	0.77	0.2±0.1	0.2±0.2	0.88	0.88
7 Overwork and stress sometimes cause HF to get worse	0.8±0.5	0.6±0.3	0.24	0.2±0.1	0.1±0.2	0.84	0.0	−0.1±0.1	0.34	0.11
8 Sodium causes water retention	0.6±0.5	0.7±0.5	0.71	0.2±0.1	−0.4±0.2	<0.01	0.3±0.2	0.1±0.2	0.51	0.36
9 Diuretics remove fluids from the body	1.0	0.8±0.4	0.08	0.0	0.0±0.7	1.00	0.0	−0.1±0.1	0.34	0.38
10 HF patients are discouraged from taking medications without food	0.8±0.4	0.3±0.5	0.01	0.0	0.0	–	0.1±0.1	0.0±0.2	0.65	0.66
11 HF patients should drink more water than healthy people	0.9±0.4	0.5±0.5	0.05	0.0±0.1	0.2±0.2	0.34	0.0±0.1	0.3±0.2	0.17	0.15
12 HF patients should have a high-salt diet	0.9±0.3	0.8±0.4	0.31	0.0	0.0	–	0.1±0.1	0.2±0.2	0.56	0.21
13 Smoking is good for patients with HF because it promotes the circulation of blood	1.0	0.8±1.4	0.08	0.0	−0.1±0.1	0.24	0.0	0.0±0.1	0.34	0.41
14 HF patients should not perform exercise regardless of their severity of HF	0.4±0.5	0.4±0.5	1.00	0.4±0.1	0.0±0.2	0.15	0.3±0.2	0.4±0.8	0.56	0.59
15 HF patients should take a hot bath to promote blood circulation	0.9±0.4	0.7±0.4	0.38	−0.1±0.1	−0.1±0.1	0.16	0.1±0.2	0.1±0.1	1.00	0.52

Notes: Values are mean ± SD at baseline and mean ± SEM in changes of scores from baseline (a positive number indicates that the knowledge was improved).

# Unpaired t-test (program vs usual care);

*** P-values by linear mixed model.

Abbreviations: SEM, standard errors of the mean; SD, standard deviation.

Figure 5 Impacts of the program on heart failure hospitalization and/or cardiac death.