# Abstract

 

## Background Self-management programs for patients with heart failure can reduce hospitalizations and mortality. However, no programs have analyzed their usefulness for patients with low literacy. We compared the efficacy of a heart failure self-management program designed for patients with low literacy versus usual care. 

## Methods We performed a 12-month randomized controlled trial. From November 2001 to April 2003, we enrolled participants aged 30--80, who had heart failure and took furosemide. Intervention patients received education on self-care emphasizing daily weight measurement, diuretic dose self-adjustment, and symptom recognition and response. Picture-based educational materials, a digital scale, and scheduled telephone follow-up were provided to reinforce adherence. Control patients received a generic heart failure brochure and usual care. Primary outcomes were combined hospitalization or death, and heart failure-related quality of life. 

## Results 123 patients (64 control, 59 intervention) participated; 41% had inadequate literacy. Patients in the intervention group had a lower rate of hospitalization or death (crude incidence rate ratio (IRR) = 0.69; CI 0.4, 1.2; adjusted IRR = 0.53; CI 0.32, 0.89). This difference was larger for patients with low literacy (IRR = 0.39; CI 0.16, 0.91) than for higher literacy (IRR = 0.56; CI 0.3, 1.04), but the interaction was not statistically significant. At 12 months, more patients in the intervention group reported monitoring weights daily (79% vs. 29%, p < 0.0001). After adjusting for baseline demographic and treatment differences, we found no difference in heart failure-related quality of life at 12 months (difference = -2; CI -5, +9). 

## Conclusion A primary care-based heart failure self-management program designed for patients with low literacy reduces the risk of hospitalizations or death. # Results 

## Patients We screened 919 patients on furosemide between November 2001 and April 2003. 127 met eligibility criteria and agreed to participate (Figure [2](#)). Of those not enrolled, 407 did not have heart failure according to their physician, 367 did not meet eligibility criteria and 27 declined to participate. Of those randomized to the control group, 1 never returned after the first visit, 1 withdrew during the study and 4 died during the study. Follow-up was completed for all of the remaining participants (98%) (Figure [3](#)). Of those randomized to the intervention group, 3 never returned after the first visit, 4 withdrew during the study and 3 died during the study. Follow-up was completed for all of the remaining participants (93%). At baseline, most characteristics were similar between the two groups (Table [1](#)). However, the control group had more participants with hypertension, fewer with diabetes, and fewer men. Of heart failure related characteristics, the control group had more participants with systolic dysfunction, and taking β-blockers. The intervention group had more participants taking ACE inhibitors or ARBs, and digoxin. Regardless of these differences, none were statistically significant. The control group did have statistically significantly higher baseline MLHF scores representing worse symptoms at baseline. 

## Hospitalization or death There were 68 hospitalizations (65) or deaths (3) in the intervention group and 111 (107 hospitalizations, 4 deaths) in the control group. The crude all-cause hospital admission or death incidence rate ratio (IRR) was 0.69 (95% CI 0.40, 1.19). After adjusting for age, gender, use of ACE inhibitor or ARB, use of a β-blocker, presence of hypertension, and baseline MLHF, intervention patients were less likely to have the outcome (IRR = 0.53; 95% CI 0.32, 0.89). 61% of patients in the control group had at least one hospitalization or died, and 42% of patients in the intervention group had at least 1 hospitalization or died (p = 0.13). 

## Cardiac hospitalization 39% of patients in the control group and 34% of patients in the intervention group had at least one hospitalization for cardiac causes (p = 0.55). The unadjusted IRR was 0.79 (95% CI 0.42, 1.5). After adjusting for baseline differences, the IRR was 0.85 (95% CI 0.44, 1.7). 

## Heart failure-related quality of life In unadjusted analysis, the control group, on average, improved 5 points on the MLHF and the intervention group improved by 1 point. The difference was not statistically significant (3.5 points, 95% CI 11, -4, p = 0.36). After adjusting for baseline differences between the groups, the difference was 2 points (95% CI 9, -5, p = 0.59) suggesting no effect on heart failure-related quality of life. 

## Other outcomes 

### Knowledge Heart failure related knowledge improved more in the intervention group than in the control group. Mean difference in score improvement was 12 percentage points (95% CI 6, 18; p < 0.001). 

### Self-efficacy Heart failure self-efficacy improved more in the intervention group than in the control group. Mean difference in score improvement was 2 points (95% CI 0.7, 3.1; p = 0.0026). 

### Self-care behavior Significantly more patients in the intervention group than in the control group reported daily weight measurement at 12 months (79% vs. 29%, p < 0.001). 

## Subgroup analyses according to literacy Twenty-four patients in each group had inadequate literacy based on the S-TOFHLA (Table [2](#)). Among these patients, there was no difference in quality of life score in unadjusted and adjusted analyses (difference = -1.6; 95% CI -15, 12); p = 0.81). For the combined outcome of hospitalization or death, the unadjusted IRR was 0.77 (95% CI 0.30, 1.94). After adjusting for baseline differences, the IRR was 0.39 (95% CI 0.16, 0.91). Seventy-five patients had marginal or adequate literacy based on the S-TOFHLA. We found no difference in quality of life score in unadjusted and adjusted analyses (difference = -4.2; 95% CI -14, 6; p = 0.40). Among patients in the higher literacy group, the unadjusted IRR for hospitalization or death was 0.65 (95% CI 0.33, 1.3). After adjusting for baseline differences, the IRR was 0.56 (95% CI 0.30, 1.04). We did not find a statistically significant effect modification between literacy and the intervention. ::::table-wrap

::: caption
Baseline characteristics.
:::

Variable Control (n = 64) Intervention (n = 59) P value

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Mean Age, years (SD) 62 (11) 63 (9) 0.37
African American, % 55 54 0.96
Male, % 41 58 0.059
Education, years (SD) 9.9 (2.6) 9.1 (3.2) 0.17
Income \<15,000/yr, % 67 69 0.60
Medicaid, % 33 34 0.90
Medicare, % 72 71 0.61
Inadequate Literacy, % 39 42 0.43
Hypertension, % 89 86 0.66
Diabetes, % 52 59 0.39
Creatinine, mg/dl 1.3 1.2 0.19
Time with heart failure, mean years (SD) 7 (8) 6 (9) 0.75
NYHA class, % 0.66
II 47 53\
III 51 40\
IV 2 7\
Systolic dysfunction, % 44 39 0.73
Medications, %\
ACEI or ARB 69 78 0.25
β-blocker 72 54 0.04
Digoxin 19 25 0.39
Knowledge, mean percent 57 55 0.67
Self-efficacy, mean score 22 22 0.64
Daily weight measurement, % 15 13 0.64
HFQOL score, mean score (range 0--105) 57 45 0.0028

NYHA: New York Heart Association; ACEI: Angiotensin Converting Enzyme
Inhibitor; HFQOL: Heart Failure-Related Quality of Life:::: ::::table-wrap
::: caption
Baseline characteristics for the subgroup with low literacy.
:::

Variable Control (n = 24) Intervention (n = 24) P value

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Mean Age, years (SD) 65 (10) 68 (8) 0.38
African American, % 71 71 1.0
Male, % 46 71 0.079
Education, years (SD) 8.6 (2.9) 6.3 (2.9) 0.009
Income \<15,000/yr, % 83 88 0.33
Medicaid, % 45 45 1.0
Medicare, % 75 79 0.73
Inadequate Literacy, % 39 42 0.43
Hypertension, % 92 83 0.38
Diabetes, % 63 71 0.54
Creatinine, mg/dl 1.4 1.3 0.43
Time with heart failure, mean years (SD) 7 (7) 8 (11) 0.63
NYHA class, % 0.55
II 58 50\
III 42 46\
IV 0 4\
Systolic dysfunction, % 38 42 0.55
Medications, %\
ACEI or ARB, % 83 79 0.14
b-blocker, % 71 42 0.04
Digoxin, % 17 21 0.39
Knowledge, mean percent 46 49 0.40
Self-efficacy, mean score 21 21 0.78
Daily weight measurement, % 17 4 0.16
HFQOL score, mean score (range 0--105) 51.9 42 0.11

NYHA: New York Heart Association; ACEI: Angiotensin Converting Enzyme
Inhibitor; HFQOL: Heart Failure-Related Quality of Life::::


Extracted trial result:
Outcome: Hospitalization or death (binary)
Intervention: Follow-up and thorough education on self-care
Comparator: Standard information about self-care
Intervention events: 25
Intervention group size: 59
Comparator events: 39
Comparator group size: 64
Notes: Used percentage found in table to calculate actual number for binary variable.