Both the prevalence and incidence of heart failure (HF) have increased significantly worldwide in recent years.1 Although there have been substantial advances in medical and device therapy for HF, readmission after hospitalization for HF is common.2 After hospitalization for HF, 15-day readmission rates have been estimated at 13% and 30-day readmisson rates at approximately 25%.3 High readmission rate is identified as 1 of potential indicators of poor self-care among HF patients.3
To achieve positive clinical outcomes, self-management programs have emerged as a comprehensive approach for HF patients.4 There is growing evidence of the effectiveness of such programs; however, not all clinical trials have demonstrated improved outcomes.5 Experts have recognized that adherence to complex medical regimens and the need to modify lifestyle, along with the presence of multiple chronic conditions, might be overwhelming for HF patients. All of these factors may have contributed to the ineffectiveness of some self-management programs.4 Because of impaired cognition, excessive daytime sleepiness, depression, and poor family functioning, only 10.3% HF patients in a recent study were expert in HF self-care.6 A self-management intervention among Chinese HF population also indicated that those who were older and with poor literacy did not benefit as much as expected from a self-management strategy.7 Poor outcomes of HF self-management programs indicate that improved outcomes might be achieved by increasing patients’ adherence to self-care skills.8
Neurohumoral systems, which help to maintain circulatory homeostasis, become maladaptive and contribute to disease progression in HF patients.9 Daily body weighing, the traditional method to assess for systemic congestion, remains the fundamental aid during home-based monitoring for HF patients.9 Daily weight monitoring is frequently recommended as a part of HF self-management to prevent exacerbations,10 and a previous study found that significant weight gain was observed up to 4 days before HF event.11 The research of Jones et al12 indicated that adherence to weight monitoring was associated with lower odds of HF-related emergency visits or hospitalizations.
Our previous study indicated, however, that about 87% HF patients did not weigh themselves regularly.13 Interestingly, among those who had New York Heart Association (NYHA) class III HF, optimal weight monitoring was associated with more HF-related hospitalizations.13 A possible explanation for the result might be that these HF patients had optimal adherence to symptom monitoring yet lacked the coping skills to manage HF events, so they reported higher HF-hospitalization rate. According to Bui and Fonarow,14 monitoring alone, without follow-up and provision of feedback to HF patients, is unlikely to be an effective solution to prevent HF-related readmissions.
We hypothesized that a weight management (WM) intervention would be effective in improving HF patients’ prognosis. Weight management is a simplified self-management program that focuses on the goal of maintenance of a stable body weight and provides skills on self-adjustment of diuretics and salt and fluid intake on the basis of body weight fluctuation.15 We performed a randomized controlled trial comparing our WM intervention to usual care among a Chinese HF population with NYHA class III to test whether this intervention could increase weight monitoring adherence, reduce HF-related rehospitalization, and improve patients’ cardiac function.
Study Design and Study Population
This was a randomized controlled study. From June 2011 to August 2012, patients were recruited from the Cardiovascular Department of The First Affiliated Hospital of Soochow University. To be eligible, patients had to (1) have a clinical diagnosis of chronic HF consistent with Framingham criteria16 and (2) be NYHA class III at enrollment according to the NYHA classification system.17 Patients were not eligible if they (1) refused to participate; (2) had cognitive or psychological impairment; (3) had unstable angina, myocardial infarction, or cardiac surgery within the past 3 months; or (4) had lung disease, renal disease, or a severe comorbidity. Approval to conduct the study was obtained from the ethics committee of the First Affiliated Hospital of Soochow University.
Two researchers were responsible for data collection, intervention, and follow-up telephone visits. The researchers received a 1-hour training session for data collection and patients’ education at the beginning of the study. Upon obtaining informed consent, the rights to withdraw and to confidentiality were presented. Baseline information, including demographics, medical history, and current medicines, were collected, and a questionnaire measuring patients’ WM ability was administered. Patients were then randomized to the control or the intervention group. All participants continued to receive usual care after discharge. In addition, patients in the intervention group were given a booklet on WM, a weight diary, and 1-on-1 education, which took about 45 minutes, by 1 researcher on the day before discharge. The intervention group also received scheduled telephone visiting once every week in the first month after discharge and monthly for the following 5 months, for the purpose of reinforcing the content of WM education and providing motivation for patients. Telephone visits also included discussions about patients’ weight monitoring skills and investigators would answer patients’ questions about WM. A follow-up questionnaire was administered at month 6 to both groups by the same researcher.
Weight Management Booklet
A booklet for patients in the intervention group was developed by our research group, including cardiac experts, nurses, and a nutritionist. The content of the booklet was in accordance with current guidelines for self-management of HF.10
- Brief Description of the Weight Management Booklet
- Definition and symptoms of HF
- Importance of weight monitoring for HF patients
- Changes in body weight reflect body fluid status.
- A sudden, unexpected weight gain of >2 kg in 3 days or >0.5 kg per day might be a sign of exacerbation.
- Sudden weight gain would be a signal to adjust diuretics.
- Conduct weight monitoring correctly
- Once daily after morning toilet; do not drink or eat
- In light clothes
- Use the same weight scale
- Place the weight scale on firm and flat ground
- Self-adjustment of diuretics
- Diuretics are important in reducing volume overlord.
- Advice on diuretics adjustment based on body weight gain
- Evaluate the effect of diuretics according to body weight
- The difference of potassium sparing diuretics and non-potassium-sparing diuretics
- Side effect of diuretics, eg, hypokalemia and hyperkalemia
- Fluid intake
- Assess fluid intake over 24 h
- Adjust fluid intake on the basis of body weight and urinary volume
- Sodium-rich foods that HF patients should avoid to eat
- Potassium-rich foods that can prevent hypokalemia
Education on Weight Management
In the 1-on-1 education session, the researcher and the patient reviewed the booklet together, with emphasis on knowledge and skills needed for WM. Patients were taught (1) how to conduct weight monitoring correctly as a daily routine and record the result in the weight diary, (2) how to identify signs of HF exacerbation according to the change in body weight, and (3) the skills for action in case of sudden weight gain (eg, patients should adjust diuretics and reduce fluid/salt intake and contact the physician if necessary). At the end of the education session, the patients were asked to express their ideas about WM to assess whether the education was effective. In the first telephone visit, the researchers would ask questions such as “How do you perform daily weight monitoring?” or “Was there any sudden weight gain since discharge? If so, what did you do?” to evaluate patients’ WM skills and the effectiveness of the education.
Adherence to Weight Monitoring
The ideal threshold to define adherence to weight monitoring is uncertain. A wide range of thresholds, from once weekly to twice daily, were used to define “good adherence” in previous studies.12 According to earlier research, different weight monitoring adherence thresholds, including 7, 5 or more, and 4 or more of 7 days per week, yielded similar odds for HF-related hospitalization or emergency department visits.12 In our research, optimal daily weight monitoring adherence was determined as 3 days or more in 1 week.
Weight Management Questionnaire
Patients’ WM ability was measured using the Weight Management Questionnaire (WMQ).18 The WMQ is a quantitative, self-report questionnaire with 3- or 4-point Likert scale response options that yields a total score that is the sum of the following 4 subscales: weight monitoring (4 items), WM-knowledge (4 items), WM-confidence (4 items), and WM-practice (5 items). The total score ranges from 0 to 42, with higher scores indicating better WM ability. Content validity of the WMQ was confirmed by an expert group, composed of 2 cardiovascular physicians, 4 clinical nurses, 2 nursing educators, and 1 nutritionist. The group determined that the items were appropriate for measuring WM ability with a content validity index of .88. The α coefficient for internal consistency was .843 for the questionnaire and ranged from .608 to .790 for the 4 subscales.
New York Heart Association Classification
Clinician-assigned NYHA classification is an established predictor of outcomes in HF and has been most commonly used system to describe the impact of HF on a patient’s daily activities. Higher (worse) NYHA class was associated with increased hospitalization rate, worse quality of life, and decreased survival rate.19 In this study, NYHA classification was assigned by the patients’ physicians or cardiovascular nurses, who were blind to the randomization, based on reported symptoms, medical history, and results from clinical tests on cardiac structure and function at enrollment and 6 months.
Heart Failure–Related Rehospitalization
Rehospitalization due to exacerbation of HF was recorded during the research period. We compared the average number of rehospitalizations between the control and intervention groups, to test the association of weight monitoring with HF-related rehospitalization after the 6-month WM intervention. We also analyzed the rehospitalization rate between those with and without optimal adherence in the intervention group.
All analyses were performed with a statistical significance level of .05 using SPSS 16.0 (SPSS, Inc, Chicago, Illinois). Data from patients who withdrew from the study or were lost to contact were not included in the analysis. Baseline characteristics were compared by independent-samples Student t test or χ2 test. We analyzed patients’ adherence to weight monitoring and changes in NYHA classification with the χ2 test. For HF-related rehospitalization, we used 2-sample t test.
Seventy-one HF patients were recruited into this study, of whom 37 were randomized to the control group and 34 were randomized to the intervention group. Three in the control group and 2 in the intervention group withdrew during the study, leaving 34 in the control group and 32 in the intervention group. Baseline characteristics were similar between the 2 groups (Table 1).
Adherence to Weight Monitoring
There was no significant difference in weight monitoring adherence between the 2 groups at enrollment. At 6 months, adherence to weight monitoring was significantly improved in the intervention group (Table 2).
Weight Management Ability
Scores on the WMQ are shown in Table 3. The WMQ scores of the entire sample at baseline were poor, and there were no differences between groups at baseline for the global scores and any of the 4 subscales. Weight management ability was significantly improved in the WM intervention group. At 6 months, the intervention group reported significantly higher WMQ scores in all of the 4 subscales compared with the control group.
Within-group comparisons revealed significant improvements in all of the 4 subscales of WMQ in the intervention group. In the control group, there was no change in any subscale score, with the exception of the WM-related practice subscale, which demonstrated a significant improvement during follow-up.
At 6 months, 6 patients (17.65%) were classified as NYHA class II; 27 (79.41%), as class III; and 1 (2.94%), as class IV in the control group. The corresponding figure in the intervention group was 14 (43.75%), 17 (53.13%), and 1 (3.13%). Table 4 shows that a significant difference was found between the 2 groups (χ2 = 5.32, P = .03), suggesting that the WM intervention was associated with improved functional status in the intervention group.
Heart Failure–Related Rehospitalization
During the 6 months of follow-up, there was a statistically significant reduction in the rate of HF-related rehospitalization in the intervention group compared with the control group. In the intervention group, optimal weight monitoring adherence was associated with fewer HF-related rehospitalizations, although not statistically significant (Table 5).
Earlier studies have demonstrated beneficial effects of self-management programs on clinical outcomes.20 These comprehensive programs are not available to most HF patients in China or other resource-scarce areas. Caldwell et al21 developed a simplified education program focusing on a single component of HF self-management and showed that education and counseling intervention on symptom recognition and management of weight could improve patients’ knowledge and self-reported self-care behaviors. In our study, our simplified WM intervention focused on not only weight monitoring but also coping skills for weight fluctuation. Because significant association was found between weight monitoring and HF-related hospitalization among HF patients with NYHA class III in our previous survey,5 we conducted the WM intervention among this group of HF patients.
In this study, an adherence rate of 81.25% for weight monitoring was found in the intervention group at 6 months, which was consistent with the previous study.22 Although regular weight monitoring has been frequently recommended to HF patients to detect deterioration and to prevent possible hospitalization, poor adherence is still common because of the lack of weight monitoring knowledge and proper skills for sudden weight gain. A survey showed that about 50% Chinese HF patients did not weigh themselves at all.23 Many rehospitalizations are potentially preventable if warning signs of decompensation are recognized and treated before the situation becomes emergent.24 In a multicenter randomized controlled trial, researchers found that telemonitoring of body weight did not improve prognosis of HF patients.25 White et al26 found that a weight monitoring diary was effective in promoting weight monitoring adherence but did not lead to more appropriate uses of physician or provider consultation. In our study, with WM education, patients with good adherence to weight monitoring tended to have lower, although not statistically significant, HF-related rehospitalization rates during the 6-month intervention. The result was consistent with our hypothesis that weight monitoring alone was not enough in preventing rehospitalization.
After the WM intervention, scores on the 4 subscales of the WMQ were significantly improved in the intervention group. In the control group, significant improvement was observed only in the WM-practice subscale when compared with their enrollment score. We hypothesized that usual education, which provides some self-care knowledge, could improve some certain behaviors. However, researchers have demonstrated that in-hospital education might not be sufficient to improve behaviors and, thereby, clinical outcomes.27 We found that the control group yielded higher rehospitalization rate because of HF and worse NYHA classification during the follow-up.
New York Heart Association classification was used as both inclusion criteria and an outcome measure in our study. New York Heart Association class has an advantage of reflecting activity information relevant to prognosis.28 Our study found significant improvement in intervention patients’ NYHA classification. A similar result was also observed in a previous study of comprehensive self-management for HF patients.29
There are some limitations that should be noted in this study. Because of the fact that this is a pilot study with a small sample size and short duration, we cannot comment on whether the improvement seen could be maintained in the long-term. Although we had asked questions about patients’ self-care skills when faced with sudden weight gain, we did not have complete records to detect patients’ WM skills. In the future, researchers should monitor patients’ weight gains and document whether patients actually acted appropriately.
A simple WM intervention that focused on knowledge and skills related to daily weighing to monitor for fluid weight gain was effective in improving patients’ adherence to weight monitoring, their weight monitoring ability, and NYHA classification. Compared with the control group, HF-related rehospitalizations were also reduced. Thus, focused interventions that provide patients with the necessary knowledge and skills to engage in a concrete self-are behavior are effective.
What’s New and Important
- Daily weight monitoring is frequently recommended as part of HF self-management to prevent exacerbations. However, our previous survey indicated that optimal weight monitoring adherence yielded higher HF-related rehospitalizations among NYHA class III HF patients.
- We developed a WM intervention that focuses on improving patients’ weight monitoring compliance and coping skills after sudden weight gain.
- The pilot study of the intervention demonstrated a positive impact on patients’ clinical outcomes.
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