Adherence to self-care in patients with heart failure in the HeartCycle study

Figures & data

Table 1 Inclusion and exclusion criteria for the HeartCycle study

Inclusion criteria

• A clinical diagnosis of heart failure

ο Cause of heart failure may be for any reason other than those that are rapidly reversible (see exclusion criteria)

ο May include patients with and without a low left ventricular ejection fraction or with valve disease

• Requiring treatment with at least 40 mg/day of furosemide or equivalent (1 mg of bumetanide or 10 mg of torasemide)

• Evidence of advanced or unstable disease

ο Admission to hospital for or complicated by heart failure currently or within the previous 60 days

ο Or outpatients with persistent NYHA III/IV symptoms

• An elevated NT-proBNP value (within the 3 months prior to enrollment)

ο ≥1,000 pg/mL if in sinus rhythm, including atrio-biventricular pacing

ο ≥2,000 pg/mL if not in sinus rhythm

Exclusion criteria

• Unwilling to comply with the protocol. Patients should be willing and able to make daily measurements at home throughout Phase II

• Rapidly reversible causes of heart failure such as severe anemia (defined as the need for a blood transfusion), thyrotoxicosis, admission with rapid (>120 bpm) atrial fibrillation with good ventricular function

• Inability, in the investigators’ opinion, to operate or comply with the telehealth system, even with available support from carers and health volunteers if available

• Patients who are unable to communicate directly or indirectly in the local language (English in the United Kingdom, German in Germany, and Spanish in Spain) cannot participate

Abbreviations: NYHA, New York Heart Association; NT-proBNP, N-terminal pro b-type natriuretic peptide.

Table 2 Baseline characteristics of the study population

Total number of patients =123	n (%) or mean ± SD
Men	97 (79)
Mean age (years)	66.2±11.8
Age >70 years	49 (40)
BMI (kg/m^2)
Underweight <18.5	2 (2)
Normal 18.5–25.0	37 (30)
Overweight 25.0–30.0	45 (37)
Obese ≥30.0	39 (32)
Cardiovascular history
Myocardial infarction	58 (47)
Revascularization	52 (42)
Valve surgery	11 (9)
Co-morbidities
Cancer	16 (13)
Diabetes	53 (43)
NYHA class and symptoms
NYHA II	42 (34)
NYHA III	81 (66)
Angina	18 (15)
Peripheral edema	41 (33)

Note: Values are presented as n (%) or as mean ± SD.

Abbreviations: BMI, body mass index; NYHA, New York Heart Association.

Figure 1 The number of patients per number of months of system usage.

Figure 2 Percentage of adherent patients in the EHFScB-9 self-care behavior scale at baseline and study end (n=101).

Notes: *P<0.05, **P<0.001.
Abbreviation: EHFScB-9, 9-item European Heart Failure Self-care Behavior Scale.

Table 3 Differences between the answers at baseline and study end for self-care behaviors measured with the EHFScB-9 scale (n=101)

Self-care behavior	Number of patients showing an improvement	Number of patients remaining the same (remaining adherent)	Number of patients showing a decline	Number of patients with invalid answer(s)
Daily weighing	30	61 (61)	5	5
Fluid restriction	17	70 (68)	10	4
Low-salt diet	25	65 (62)	8	3
Medication intake	4	91 (91)	2	4
Physical activity	44	35 (28)	19	3

Notes: EHFScB-9 scores range from 1 (“I completely agree”) to 5 (“I completely disagree”). A patient shows an improvement for a behavior if the score at study end is lower than the score at baseline. A patient remains the same for a behavior if the score at study end equals the score at baseline, and remains adherent if the scores for a behavior at study end and at baseline both are 1 (“I completely agree”) or 2 (“I agree”).

Abbreviation: EHFScB-9, 9-item European Heart Failure Self-care Behavior Scale.

Table 4 Objectively measured adherence per daily task (n=120)

Daily task	Overall adherence percentage	Average adherence percentage (SD)	Percentage of patients performing daily task on ≥80% of expected days
Measure weight	91	90 (16)	88
Measure blood pressure	90	89 (17)	85
Report symptoms	68	66 (32)	50

Notes: The overall adherence is the total number of received data elements (of all patients) divided by the total number of expected data elements (of all patients). The average adherence is the average of the 120 individual adherence numbers.

Abbreviation: SD, standard deviation.

Figure 3 Number of patient-months per adherence percentage interval (total number of patient-months =1,101).

Figure 4 Average adherence over time for weight, blood pressure, and symptoms reporting. The numbers at the horizontal axis denote the number of patients who were using the system in that month. Since month M18 had only one patient, this month has been excluded from the figure.

Figure 5 Box-and-whisker plot for measuring weight. Vertical axis shows adherence. Horizontal axis shows the months and the number of patients who were using the system in that month. Month M18 has been excluded from the figure since only one patient was using the system for 18 months.

Figure 6 Box-and-whisker plot for measuring blood pressure. Vertical axis shows adherence. Horizontal axis shows the months and the number of patients who were using the system in that month. Month M18 has been excluded from the figure since only one patient was using the system for 18 months.

Figure 7 Box-and-whisker plot for symptoms reporting. Vertical axis shows adherence. Horizontal axis shows the months and the number of patients who were using the system in that month. Month M18 has been excluded from the figure since only one patient was using the system for 18 months.

Table 5 Studies reporting on HF signs and symptoms monitoring adherence using telehealth system data

	Number of months in study	Average (SD) adherence percentage			Percentage of patients monitoring at least ×% of the time
		Weight	Blood pressure	Symptoms	×	Weight	Blood pressure	Symptoms
Signs and symptoms reported separately
HeartCycle	9 (average)	89.7 (16.2)	88.6 (16.9)	66.0 (32.0)	80	87.5	84.2	50.0
Prescher et al^Citation38 (TIM-HF)	22 (average)	–	90.6 (15.1)	88.0 (15.6)	–	–	–	–
Domingo et al^Citation39 (CARME)	12	76.4 (19.6)	71.8 (22.1)	–	80	52.2	44.4	–
Ledwidge et al^Citation40	5 (average)	90.6 (13.6)	–	–	85	77.0	–	–
Lyngå et al^Citation41 (WISH)	12	75	–	–	–	–	–	–
de Lusignan et al^Citation42	12	73.7 (19.9)	89.0 (6.7)	–	–	–	–	–
Signs and symptoms reported together
Prescher et al^Citation38 (TIM-HF)	22 (average)	88.9 (21.5) [P] and 81.8 (22.8) [A]			80	87.3 [P] and 85.1 [A]
Seto et al^Citation43	6	79^*			80	66
Chaudhry et al^Citation34 (Tele-HF)	6	–			43^**	90.2 (week 1) to 55.1 (week 26)
Cleland et al^Citation44 (TEN-HMS)	16 (median)	–			80	81 [P] and 55 [A]

Notes: [P] means partial adherence (ie, at least one measurement done), [A] means absolute adherence (ie, all measurements done). The percentage 79^* has been derived from the sentence “Patients completed their required measurements on average between 5 and 6 days per week”.⁴³ The value 43^** is based on at least three calls a week (a cutoff point representing approximately half the expected usage).³⁴

Abbreviations: HF, heart failure; SD, standard deviation.

Table S1 The details corresponding to the box-and-whisker plots in Figures 5–7

Month	M1	M2	M3	M4	M5	M6	M7	M8	M9	M10	M11	M12	M13	M14	M15	M16	M17	M18
n	120	120	118	116	105	92	87	80	66	57	47	35	26	15	7	5	4	1
Weight
Max	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0
75th	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0
Median	95.5	100.0	100.0	100.0	96.8	96.8	100.0	96.7	96.8	100.0	100.0	100.0	98.4	100.0	96.8	100.0	98.3	100.0
25th	85.3	93.5	93.5	93.5	90.3	87.0	93.1	83.7	82.1	80.0	85.5	88.7	86.1	73.7	93.3	100.0	81.2	100.0
Min	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	50.0	38.5	25.0	0.0	100.0	34.8	100.0
Blood pressure
Max	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	76.7
75th	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	97.6	76.7
Median	95.1	100.0	100.0	96.8	96.7	96.8	100.0	96.7	96.7	96.8	96.7	93.5	95.2	93.3	96.7	96.8	91.9	76.7
25th	85.4	93.3	93.3	90.8	83.3	86.7	92.7	79.6	83.9	85.2	83.6	80.6	82.4	72.1	80.5	90.0	83.6	76.7
Min	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	38.7	23.1	0.0	0.0	73.3	73.3	76.7
Symptoms
Max	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	13.3
75th	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	96.8	96.8	98.4	100.0	100.0	100.0	98.4	87.5	67.5	13.3
Median	92.2	93.4	93.5	93.5	93.3	91.8	96.2	88.0	83.6	90.3	87.1	91.7	88.0	86.7	90.0	51.6	50.9	13.3
25th	66.7	66.6	75.0	74.0	64.5	60.0	60.6	47.6	45.5	40.0	62.4	48.3	47.3	20.8	26.3	20.0	35.0	13.3
Min	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	3.2	0.0	0.0	0.0	18.2	4.3	13.3

Notes: For measuring weight, blood pressure, and symptoms reporting the maximum adherence, the 75th percentile, the median, the 25th percentile, and the minimum adherence per month are shown. The number of patients per month is indicated by n.

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