|Year : 2017 | Volume
| Issue : 1 | Page : 28-33
A randomized controlled trial to assess effectiveness of a nurse-led home-based heart failure management program
Mamata Rai1, Kamlesh Kumari Sharma1, Sandeep Seth2, Pragya Pathak1
1 College of Nursing, AIIMS, New Delhi, India
2 Department of Cardiology, AIIMS, New Delhi, India
|Date of Web Publication||17-Jul-2017|
College of Nursing, AIIMS, New Delhi
Source of Support: None, Conflict of Interest: None
Introduction: The burden of cardiovascular disease is increasing in India. It is a chronic condition, and poor management can increase the risk and frequency of acute episodes resulting in poor quality of life (QOL), frequent hospital admissions, and mortality. Disease management programs can improve medication adherence and patient's QOL. Objective: The aim of this study is to assess the effectiveness of nurse-led home-based heart failure management program (HOME-N). Materials and Methods: This randomized controlled trial was conducted among fifty outpatient heart failure (HF) patients visiting a tertiary care hospital. The control group received usual routine care, whereas the experimental group received HOME-N, which included formal health teaching, a HF checklist (Hriday card), telemonitoring of vital parameters (blood pressure, heart rate, and weight) weekly through a mobile application named as “Dhadkan” and telephonic follow-up for 3 months. Kansas City Cardiomyopathy Questionnaire (KCCQ) and adherence to refills and medications scale were used to assess QOL and drug adherence, respectively, in the study patients. The outcome measures were the QOL, drug compliance, hospitalization, and mortality rate. Results: At baseline, the demographic and morbidity profile, and QOL and drug compliance scores of both groups were comparable. After intervention, the QOL domain score of KCCQ as well as drug compliance improved significantly both within the experimental group (P = 0.001, P = 0.001) and as compared to control group (P = 0.001, P = 0.004, respectively). Conclusion: The HOME-N was significantly effective in improving QOL and drug compliance in HF patients.
Keywords: Drug compliance, heart failure, hospitalization, mortality, nurse-led home-based heart failure management program, quality of life
|How to cite this article:|
Rai M, Sharma KK, Seth S, Pathak P. A randomized controlled trial to assess effectiveness of a nurse-led home-based heart failure management program. J Pract Cardiovasc Sci 2017;3:28-33
|How to cite this URL:|
Rai M, Sharma KK, Seth S, Pathak P. A randomized controlled trial to assess effectiveness of a nurse-led home-based heart failure management program. J Pract Cardiovasc Sci [serial online] 2017 [cited 2022 Jan 26];3:28-33. Available from: https://www.j-pcs.org/text.asp?2017/3/1/28/210869
| Introduction|| |
Heart failure (HF) is characterized by poor quality of life (QOL) with high hospitalization rates, and poor prognosis.
The elderly are predominantly affected by HF in western countries, but younger age groups are more affected in developing countries like India. HF can be very disabling, and QOL of patient's can be severely affected.
The prevalence of HF in India is estimated to be 1.3–4.6 million with an annual incidence of 0.5–1.8 million.
HF patients need to learn to live with the consequences of the disease, treatment and its management and seek help when symptoms occur, and improvement in their outcomes depends how much they are able to care and manage for themselves.
HF patients are suffering from many complications which could be prevented or treated. This can be achieved by making effective therapeutic or preventive regimens and encouraging patients for self-care behaviors and treatment adherence. Nurses can help HF patients and families cope with the symptoms and complications and make them follow their treatment regimens to achieve better outcomes.
Decreased QOL is one of the important adverse results of HF and is a good predictor of mortality and the need for hospitalization.
Education and support are an important way to increase self-care behavior among HF patients which results in fewer unplanned hospitalizations, improves QOL and can markedly reduce adverse clinical outcomes.,
Acute exacerbations among HF patients can be prevented with medication adherence, which is one of the most important self-care behaviors.
Daily self-care activities recommended for HF patients includes weight monitoring, medication adherence, low-salt diet, self-monitoring of symptoms, exercise, regular physician visits, etc.
Telemonitoring is another effective method where information technology is used for monitoring patients at a distance and can manage immediately if any clinical deterioration occurs.
Both mobile phone-based telemonitoring and telephonic reinforcement are effective in improving QOL in HF patients.
HF management involves various complex processes of managing drugs, devices and other interventions, putting everything together needs more than doctors and drugs. Also for effective management of HF patients, vast amount of resources are required and developing countries like India have limited resources, including the medical specialists. We, however, do have relatively more nursing workforce who can be well utilized for the home-based management of HF patients. Although HF is the most common cause of mortality and morbidity among the Indian population, there is limited work being done for nurse-led management of HF patients based on their home setting.
This study was undertaken with the aim to assess the effectiveness of nurse-led home-based heart failure management program (HOME-N).
| Materials and Methods|| |
The sample size was calculated considering a mean overall QOL summary score in HF patients in usual care as 67.5 (21.3). Anticipating twenty units improvement in overall summary score in the experimental group as compared to the usual care with a 5% level of significance and 90% power, the estimated sample size was calculated to be 22 and considering 10% of dropout rate, 25 patients were estimated to be the sample size in each group. Fifty patients (25 in each group) were enrolled who met the inclusion criteria and gave written informed consent to participate in the study from the HF clinic of a tertiary hospital in New Delhi. They were randomly assigned to either the experimental or control group through a computer-generated list of random numbers. Both the groups received usual care (follow-up with a cardiologist) while the experimental group received the program HOME-N as well. Primary outcomes were QOL and drug compliance improvement, and secondary outcomes were hospitalization and mortality rate. The study was approved by the Institute Ethics Committee for Postgraduate Research. Informed consent was obtained before enrollment.
Patients aged ≥18 years, with a diagnosis of HF (New York Heart Association [NYHA] Class I, II, and III) and may or may not be having comorbidities like (HTN, cardiomyopathies, and valvular heart disease), taking medicines for HF for at least 1 month, having an on-going assessment for revascularization, cardiac resynchronization and heart transplantation, willing to participate, could read and write Hindi or English and having their personal/landline number were included in the study.
Patients in NYHA Class IV, chronic renal failure, dementia and other psychiatric illnesses, having dyspnea other than cardiac cause (chronic obstructive pulmonary disease, asthma, chronic bronchitis, and anemia) and having illnesses that were likely to lead to hospitalization and death in near future were excluded from the study. The schematic presentation of the study design is developed in CONSORT diagram and presented in [Figure 1].
QOL referred to the patient's ability to enjoy normal life activities as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item (15 questions) self-administered questionnaire designed to quantify various domains, i.e., physical limitations, symptoms (stability, frequency, and burden), social limitations, self-efficacy, and QOL among HF patients which ranges from 0 to 100 with higher scores indicating better health status.
Drug compliance referred to the degree to which a patient correctly follows medical advice regarding drugs as measured by adherence to refills and medications scale (ARMS) which is a valid and reliable self-reported measure of medication adherence scale score ranging from 12 to 34 and lower the scores indicates better the adherence.
Permission was obtained for using the KCCQ and the ARMS questionnaires.
Hospitalization referred to the unplanned hospitalization of patients at any medical center for at least 24 h due to HF cause, and mortality was considered death due to HF cause as reported by medical documents after getting enrolled in HOME-N. Both hospitalization and mortality were assessed using self-developed morbidity/mortality assessment questionnaire.
The demographic and clinical profile of patients were collected using the structured self-developed questionnaire.
Nurse-led home-based heart failure management program
The HOME-N program is a set of components which comprises four subparts [Figure 2] basically developed to manage HF patients at their own home settings: (a) Health teaching individually given using a booklet named “HF: A guide for patient and families” which was available both in Hindi and English and included HF introduction, causes, sign/symptoms, treatment options, diet, exercise, and prevention. (b) Hriday card [Figure 3] is a checklist both in Hindi and English which includes patient's demographic profile, diagnosis, clinical status, drugs prescribed, medicine chart, blood pressure (BP) and weight monitoring log, everyday self-management plan and HF control measures. Both the copies of the booklet and Hriday card were given to patients. (c) Telemonitoring (mobile phone based) through the use of Android mobile application named “Dhadkan” [Figure 4] which transferred patient's vital parameter (BP, weight, heart rate) in the form of message in mobile phone and was made available free of cost and could be easily be downloaded from Google store. Patients were asked to send their parameters through this application once a week every Wednesday (9 a.m. to 5 p.m.). (d) The phone call was made after enrollment every Wednesday (9 a.m. to 5 p.m.) for approximately 5–10 min for 3 months of duration. During this call, patients were asked a few questions regarding his/her any sign/symptoms, activity, drug compliance, any hospitalization, and mortality events. In addition, the nurse also clarified doubts of subjects if any and reinforcement was done regarding intervention.
|Figure 2: Components of nurse-led home-based heart failure management program.|
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The nurse responses were:
- If there was a weight gain of >2 kg within a week, reinforce advise to increase diuretic dose after discussion with a cardiologist and decrease fluid intake
- If a resting heart rate was <50 beats/min or >90 beats/min, discuss with the doctor and call back with advice. Drugs to be checked to adjust doses of digoxin, beta-blockers, or ivabradine
- If the systolic BP was <90 mm of Hg or >140 mm of Hg than advise the subject to visit a cardiologist for a medication chart review or adjust the vasodilators if possible.
Experimental group were followed up till 3 months of period with weekly phone call as a part of HOME-N and control group were directly posttested after 3 months of enrollment.
The analysis was performed using STATA 14 version (STATA 14, StataCorp LLC, Texas, USA.). Descriptive statistics (mean, standard deviation, percentage, and frequency) were used to describe demographic and clinical characteristics. Inferential statistics, including Student's t- test (two-sample independent t- test), paired t- test, Chi-square test, and McNemar's test was used to compare mean scores. The level of significance was considered P < 0.05
| Results|| |
A total of sixty HF patients were screened, of whom seven did not meet the inclusion criteria and three refused to participate. There was no loss to follow-up, hence fifty patients (25 in each group) were included in the study. The mean age was 37.9 ± 15.71 in experimental and 42.4 ± 12.38 in the control group. Most of the patients were male in both the groups and were comparable in terms of demographic and clinical profile [Table 1] and also NYHA classification. After intervention, an improvement in NYHA classification in the experimental group was found as compared to the control group. However, this difference was not statistically significant [Figure 5].
|Figure 5: Comparison of New York Heart Association class among study groups. McNemar's test; *P < 0.05.|
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Quality of life
At pretest, all the KCCQ scores were similar among the study groups.
After HOME-N intervention, the scores in the experimental group improved significantly in terms of QOL, overall summary score and clinical summary score [Figure 6]. It was further seen that there was a significant improvement (P< 0.05) in posttest scores of the experimental group as compared to the control group [Table 2].
|Figure 6: Comparison of mean scores of Kansas City Cardiomyopathy Questionnaire (KCCQ) between study groups. Two sample independent t-test; *P < 0.05.|
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|Table 2: Comparison of Kansas City Cardiomyopathy Questionnaire scores between study groups (n=50)|
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At baseline, both the groups were comparable in terms of drug compliance as measured by ARMS. After the intervention, there was a significant improvement in drug compliance within the experimental group (P = 0.001) and also as compared to the control group (P = 0.004) [Table 3].
|Table 3: Comparison of adherence to refills and medication scale scores among the study groups (n=50)|
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Hospitalization and mortality
No hospitalization or mortality reported in either of the groups throughout the study period.
| Discussion|| |
The HOME-N was significantly effective in improving QOL and drug compliance in HF patients.
Quality of life
In this study, QOL improved both within the experimental group and also as compared to the control group after the intervention of HOME-N at 3 months.
Some other studies,,, findings are comparable with the present findings. These studies included six months follow-up through the use of a telephonic helpline and regular weekly telephone calls, 4 weeks multidisciplinary transition-to-care program, especially designed to provide weekly education and support to HF patients following hospitalization, supportive educational nursing care program, including education, coaching self-care, followed by 3 months telephonic interview follow-up and family-based education program comprising counseling, HF manual and DVD and telephonic support and all resulted in improved QOL in HF patients.
In contrast to the findings of this study, a nurse-based outpatient management program revealed that QOL improved from baseline to 18 months with no differences between both the intervention and control group (P = 0.3). However, this was a longer duration study that assessed QOL at 6, 12, and 18 months [Figure 6].
In the present study, the drug compliance scores improved significantly both within the experimental group (from 17.4 ± 2.32 to 15.1 ± 1.40) (P = 0.001) and also when compared with the control group (15.1 ± 1.40 vs. 16.8 ± 1.67) (P = 0.004). This finding was supported by other studies, which reported the use of an HF education program, along with hospital transition modules, and subsequent telephone education and counseling sessions and education on HF, prescribed medication and management of HF symptoms through a printed booklet.
However contrary to our findings, a nurse-led telephone or videophone contact each week for 90 days after discharge for two groups with follow-up for 18 months revealed no significant differences between the groups in medication compliance.
Hospitalization and mortality
There were no emergency or unplanned OPD visits among study subjects in the experimental group as compared to one subject had to visit emergency and two subjects had to make unplanned OPD visit once during the study period in control group. Four subjects in the experimental group had fluctuations in their vital parameters (BP, pulse) beyond the preset level during telemonitoring, but they were asymptomatic.
However, no hospitalization and mortality were reported in either of study groups. That could be because the majority of patients were stable HF patients (NYHA I and II) and follow-up period was relatively short (3 months).
Jaarsma et al. revealed hospitalization and mortality rate were comparable between one control group and two intervention groups (P > 0.05) who had additional basic or intensive support by a nurse specialize for 18 months.
However, there is some evidence that suggests significantly reduced hospitalization and mortality among experimental groups during 3 and 12 months period through nurse-led HF clinic staffed by experienced cardiac nurses among 106 HF patients. Shojaee et al. showed educating patients face to face, giving booklet and following up telephonically significantly decreased readmission within 3 months of duration. This might be because they had enrolled hospitalized HF patients who were in NYHA Class II and III.
Furthermore, subanalysis of a large systematic review and meta-analysis identified that structured telephone calls and telemonitoring which automatically transferred the physiological data reduced the relative risk of all-cause mortality and hospitalizations among HF patients.
The strength of this study lies in the fact that it was a randomized controlled trial assessing the effectiveness of HOME-N in India for the first time for the management of HF patients in a comprehensive way at their own home settings.
Some of the limitations of the study were small sample size and a single-center study which limits the generalizability of the study. There was no blinding that could lead to some bias and also study followed subjects for a relatively short period.
The findings of this study yield important information that can be used for policy making for managing HF patients in the country. Telemonitoring and telephonic support system could be developed to monitor or provide easy access to health care system to the patient at their setting. In-service educations and training for the nurses can be conducted using HOME-N components to increase their awareness about various effective methods to improve outcome in HF patients. Furthermore, emphasis should be laid on undergraduate and postgraduate nursing curriculum on the concept of developing and undertaking varieties of HF management modalities for the holistic management of HF.
Further, we recommend that a large-scale longitudinal study with larger sample size in multi-hospital setting can be conducted further to explore effectiveness in terms of other components such as reducing hospitalization and mortality.
| Conclusion|| |
It is concluded that HOME-N is a composite package which is effective in significantly improving the QOL and drug compliance in stable HF at patient's own home setting. Furthermore, this study contributes to the development of knowledge, skills, and behavioral change among HF patients in self-management at home.
The authors would like to thank KCCQ author - Dr. John Spertus and ARMS author - Dr. Sunil Kripalani for permitting permission to use the tools in the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3]