The effect of the Continuous Care Model on treatment adherence in patients with myocardial infarction: a randomised controlled trial

Abstract

Background

Adherence to treatment is one of the behaviours associated with successful outcomes following a myocardial infarction, which leads to successful treatment in the disease.

Aims

This study aimed to investigate the effect of the Continuous Care Model (CCM) on treatment adherence in patients with myocardial infarction.

Methods

This was a randomised controlled trial performed on 82 patients with myocardial infarction. Convenience sampling was used to select the participants, and then they were allocated into two groups by the stratified random method. In the intervention group, a CCM was implemented. In the intervention group, 4–6 educational sessions (1–2 h) were conducted during one month in the form of spoken questions and answers about the presented subjects. The control group received routine care. A questionnaire of demographic information and treatment adherence was completed by samples in the two groups, intervention and control, before and immediately after training and after follow-up.

Results

The results of this study showed that treatment adherence was significantly higher in the intervention group than in the control group immediately after training and after the follow-up phase (three months) (p < 0.001). Also, diet, drug and physical activity adherence were significantly higher in the intervention group than in the control group immediately after training and after follow-up (p < 0.001).

Conclusions

Implementation of CCM led to an increase in adherence to the treatment in patients with myocardial infarction. Therefore, it is suggested that this model could be used as a nursing intervention to increase treatment adherence in cardiac-rehabilitation programmes.

Introduction

Cardiovascular disease (CVD) and myocardial infarction (MI) are two of the most common causes of mortality in the United States and most countries in the world, including Iran (Muhlestein et al., 2014; Vahedian Azimi et al., 2010). According to the World Health Organization (WHO) in 2017, CVD was one of non-communicable diseases responsible for 70% of all mortalities worldwide (World Health Organization, 2017). Also, in Iran, 39% of all mortalities are due to CVD, and it is the first cause of mortality in Iran (Samavat et al., 2013). MI is the most common coronary artery disease. In the United States, one person dies because of MI every minute, (Moghadam et al., 2014, Sanchis-Gomar et al., 2016). MI patients are at risk of recurrent MI, so they should undergo long-term treatment to reduce the risk of a recurrence (Mega et al., 2012).

Treatment adherence is one of the most influential behaviours on the illness and it leads to successful treatment, reduction of adverse effects and severity of the disease (Masror Roudsari et al., 2013). Non-adherence to treatment is a significant and complex problem in all patients and is common in about 30–0% of all patients, leading to substantial financial burden and potential clinical consequences (Dong et al., 2017). Common reasons for non-adherence to treatment are treatment side effects, cost and complexity (Tamblyn et al., 2010). According to the WHO, the lack of adherence is a major global concern (Nair et al., 2011; Oliveira-Filho et al., 2012) and it is associated with a negative quality of life in chronic disease patients (Perwitasari and Urbayatun, 2016). Adherence to treatment involves a range of individual behaviours that are consistent with the recommendations of healthcare providers, such as medication adherence (Sotodeh Asl et al., 2010). Failure to follow treatment increases the possibility of complications or aggravation of the disease process, death and healthcare costs (Danielle Taddeo et al., 2008).

One way to improve treatment adherence among patients is to use educational models. It is specified that education for patients and their family can prevent or delay the complications of the disease (Rahmani-Nia et al., 2013). The Continuous Care Model (CCM) is one of the caring models designed to provide a plan for accepting and enhancing the patient’s insight and function for continuous care and control of the disease and possible complications by training in the skills needed by patients after discharge. CCM focuses on the influential and balanced role of the nurse, the patient and the patient’s family through a systematic approach and provides an effective, interactive and consistent communication between the client and the healthcare providers (Borji et al., 2016; Ghavami et al., 2006b). It has been shown in that the application of CCM improves treatment consequences of patients e.g. related to under going haemodialysis (Hashemi et al., 2015), body mass index and diabetic weight (Ghavami et al., 2006b), sleep quality and dialysis adequacy in haemodialysis patients (Hojat et al., 2015; Otaghi et al., 2016). It also improves the self-efficacy (Akbari et al., 2015) and lifestyle of patients with MI (Molazem et al., 2013). It has also been shown in several studies that this model affects schizophrenic patients (Khankeh et al., 2009) and enhances the quality of life of patients with diabetes (Ghavami et al., 2005) and heart failure (Borji et al., 2017b; Sadeghi et al., 2009).

As mentioned above, the establishment and maintenance of a dynamic and continuous care relationship between the patient and the nurse and the increasing participation of the patient are the goals of the CCM (Akbari et al., 2015; Borji et al., 2017a; Otaghi et al., 2017). On the other hand, it is necessary to design and develop a plan to increase the acceptance, insight and proper functioning of care to control the disease and its possible complications (Ghavami et al., 2006a). Therefore, the present study was carried out in one of the southeastern cities of Iran to determine the effect of CCM on treatment adherence in patients with MI.

Methods

Study design and setting

This study was a randomised controlled trial which was conducted on 82 patients with MI who were referred to the critical care unit (CCU) in Rafsanjan University of Medical Sciences, Rafsanjan.

Sample size and sampling

We used previous study results (µ1 = 5.27; S1 = 1.79 and µ2 = 6.81; S2 = 1.79) (Akbari et al., 2015) to estimate the sample size. Considering the type I error of 0.05 and the type II error of 10%, the sample size was calculated to be 26 in each group. However, to increase the power of the study we accessed 82 eligible patients with MI using convenience sampling. The inclusion criteria were lack of specific psychological and mental illness, having reading and writing skills, age less than 80 years, diagnosis of MI, lack of diseases such as unstable angina, congestive heart failure and uncontrolled blood pressure, the ability to complete a questionnaire and participate in meetings, access to the phone, the absence of a disease that impairs self-care or education. Exclusion criteria were non-attendance of more than one session or patient’s death during the study. Finally, 82 participants completed the study (41 in each group) (Figure 1).

Figure 1.

Flow diagram of the study.

Measurements

Two questionnaires were used to collect data. The first questionnaire consisted of two parts: demographic information (age, sex, occupation, marital status, education level, income and insurance) and the disease profile (referral time, the main complaint of the patient at the time of arrival and illness). The second questionnaire was on treatment adherence in cardiac patients. The questionnaire was developed by Fathollahbeigi (2013). The treatment adherence questionnaire consisted of three subscales of diet, exercise and physical activity, and medication. The total score in this subscale was 0–23. A high score would mean greater adherence. The diet subscale consists of a Likert four-option question about the number of meals daily, 10 items about the dietary habits of the patient with a five-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often and 4 = always), and 17 questions about the type of food consumed based on the frequency of food intake (0 = never, 1 = 1–2 times monthly, 2 = 1–2 times weekly, 3 = 3–4 times weekly and 4 = daily). The total score of diet adherence was 0–111. The exercise/physical activity subscale consists of 16 items: one item with a yes/no answer (score 0 and 1), two items with a Likert scale of 0–2, three items with a Likert scale of 0–3 and 10 items with a Likert scale of 0–4 (4 means the most favourable response and 0 means improper answer). The total score of physical activity adherence was 0–54. The medication adherence subscale consists of eight items: three items with a yes/no score of 0 and 1, and five items with a Likert scale of 0–4. The validity of the questionnaire was assessed using content validity, and reliability was assessed using internal consistency. The Cronbach’s alpha coefficient of three subscales of adherence to diet, physical activity and medication was 0.96, 0.94 and 0.89, respectively (Fathollahbeigi, 2013).

Intervention: CCM

After completing the written consent form, the participants were randomly allocated into intervention and control groups using stratified random method (gender and educational level were used as stratum).

For the control group, the routine care was performed. CCM, an Iranian nursing care model, was conducted for the intervention group. This model consists of four stages: orientation, sensitisation, control, and evaluation.

Stage 1

In the first phase (orientation), the sessions were held at the hospital, and the intervention group was divided into three groups of 10 and one group of 11 people based on the ability to attend classes at different hours, and they were trained for two days per week. The purpose of the first phase was to create motivation to participate in the intervention, persuade the patient, feel the need for the follow-up process, identify the patients’ problems accurately and how to interact and explain the different stages of the model. Therefore, they could become familiar with the facilities, limitations and types of expectations from each other. In this phase, each session lasted 20–25 min. Demographic information and the treatment adherence questionnaires were completed in the first session.

Stage 2

In the second phase (sensitisation), the goal of the patient–family collaboration was to implement a continuous care approach. This phase was to understand the nature of the disease, the constraints of the disease and their involvement with the problem, to address the needs, review the situation and explain the educational and skill needs of the patient, explain about the disease and complications (existing and potential), examine the basic needs and justify their necessity considering the treatment adherence and explain the problems caused by the lack of attention to the goals and programmes. The patients and their families, based on the needs of participants, attended 4–6 educational sessions (1–2 h) in the second phase. Sessions were held in the form of question and answer, lecture and presentation of educational pamphlets. At the end of this stage, the researcher’s contact number was provided to patients. This phase lasted one month. At the end of this phase, the treatment adherence questionnaire was completed by both groups.

Stage 3

In the third stage (control), new care problems of clients were investigated, and the researcher maintained mutual communication. At this stage, the behaviour of patients and how to use the training were assessed by making three contact phone calls (15, 30 and 45 days after the end of the training). The content of phone calls was based on the elementary education presented and according to the educational needs of each participant.

Stage 4

In the fourth stage (evaluation), the care and follow-up process was measured, and the control parameters were evaluated. The questionnaire was completed after the follow-up (actually three months after the start of the study) and the results of both groups were compared with each other.

Data analysis

SPSS software version 18 was used. Descriptive statistics, that is, frequency, percentage, mean, standard deviation, were used to describe the socio-demographic and clinical characteristics of the participants in both groups. Chi-square and Fisher exact tests were used to compare the qualitative variables between two groups. As the quantitative variables had a normal distribution, independent t-test and analysis of variance (ANOVA) were used to compare the quantitative variables between two groups. Repeated measurement ANOVA test was used to compare treatment adherence between and within two groups at different times. Since the sphericity assumption did not confirm, the Greenhouse-Geisser test was used to check the levels of the treatment adherence within-subjects. In addition, the mean differences in treatment adherence scores between the two groups at different times were reported.

Results

Two people were excluded from the study due to death (one person from the intervention group) and withdrawal from the study (one person from the control group). The mean age of participants in the intervention and control groups was 56.95 ± 10.26 and 59.9 ± 11.78 respectively, and there was no significant difference between the two groups regarding age (p = 0.23, t = −1.2). Most of the sample in both groups were male (75.6%), married (80%), undergraduate (48.8%) and had healthcare insurance (51.2%). There was no significant difference between the two groups regarding gender, marital status, education level, income level and type of insurance, and the two groups were similar (p > 0.05). There were significant differences between the intervention and control groups regarding occupation (p = 0.03, χ²= 8.73). There was no significant difference between the two groups regarding clinical information, except the family history of MI and the history of hospitalisation for other reasons. In the control group, 19.5% had a family history of MI, while in the intervention group 2.4% had a history of this disease (p = 0.03). In the control group 51.2% of the patients had a history of hospitalisation, while 9.8% of the intervention group had a history of hospitalisation and there was a significant difference between the two groups (p < 0.001).

The treatment adherence score after training and after follow-up was significantly increased in both groups. In the control group, there was no significant difference in treatment adherence scores after training and after follow-up. In the intervention group, the score of treatment adherence after follow-up was significantly reduced compared with after training (p = 0.01). Also, the treatment adherence scores were significantly different between the two groups after training and after follow-up. In addition, treatment adherence was higher in the intervention group than in the control group (mean difference = 9.6; standard error = 2.63; confidence interval = 4.36–14.84; p < 0.001) (Table 1) (Figure 2).

Table 1.

The treatment adherence between Continuous Care Model and routine care at different times.

	Intervention group (Continuous Care Model) (n = 41)		Control group (n = 41)
Variable Group	Mean	SD	Mean	SD	Mean difference/ standard error	Repeated measure ANOVA	p value
Treatment adherence
Before Intervention	89.98	21.47	94.8	21.69	9.6/2.63	13.31	<0.001
After training	135.46	10.11	116.54	12.22
After follow-up	131.54	11.13	116.83	11.36
Greenhouse–Geisser	168.49		47.66
p value	<0.001		<0.001

ANOVA: analysis of variance.

Figure 2.

Comparing the estimated marginal means of treatment adherence between control and Continuous Care Model (CCM) groups.

The diet, physical activity and medication adherence scores were significantly increased in both groups after training and after follow-up. However, diet and medication adherence scores had no significant difference between both groups after training and after follow-up. In the control group, the physical activity adherence score had no significant difference after training and after follow-up, while this was significantly different in the intervention group (p = 0.02). Also, the diet, physical activity and medication adherence scores were significantly different between the two groups after training and after follow-up (p < 0.001) (Table 2).

Table 2.

Comparison of treatment adherence dimensions between the two groups Continuous Care Model and routine care at different times.

	Intervention group (Continuous Care Model) (n = 41)		Control group (n = 41)
Treatment adherence dimensions Group	Mean	SD	Mean	SD	Mean difference/ standard error	Repeated measure ANOVA	p value
Diet adherence
Before Intervention	61.88	11.38	62.95	11.94	4.42/1.22	13.24	<0.001
After training	82.66	4.63	74.9	5.7
After follow-up	81.58	4.65	75	5.17
Greenhouse–Geisser	122.97		38.85
p value	<0.001		<0.001
Physical activity adherence
Before Intervention	16.07	10.65	19.54	11.49	3.87/1.57	6.06	<0.016
After training	33.44	7.01	24.1	8.12
After follow-up	30.71	7.94	24.98	8.44
Greenhouse–Geisser	71.41		7.7
p value	<0.001		0.002
Medication adherence
Before Intervention	12.02	4.05	12.32	4.33	1.31/0.48	7.59	0.007
After training	19.37	1.95	17.54	2.38
After follow-up	19.24	2.31	16.85	2.66
Greenhouse–Geisser	121.21		38.15
p value	<0.001		0.002

ANOVA: analysis of variance.

Discussion

The results suggest that the implementation of the CCM increased treatment adherence in patients with MI. Diet, physical activity and medication are the aspects of treatment adherence that have been examined in this study (Table 2). In agreement with our results, a study by Kamrani et al. reported that although both training and telephone follow-up were effective in improving the treatment adherence of patients with acute coronary syndrome, a group of patients who were instructed and followed up by telephone had a higher degree of adherence than the ones receiving the training alone. Therefore, phone follow-up is essential to complete the education process and provide better and more helpful services to patients (Kamrani et al., 2015). In a study by Sedri et al. anticoagulant medication adherence was higher in the interactive group (in addition to sending educational messages, patients had communication with their researcher) than in the control group (Sedri et al., 2014).

The study by Zolfaghari et al. also showed positive effects of one-month follow-up by cell phones and telephones on diet adherence in diabetic patients (Zolfaghari et al., 2012). Also, Shahsavari and Foroghi demonstrated an increase in adherence by the nurse’s follow-up plan for patients with type 2 diabetes during the three-month follow-up (Shahsavari and Foroghi, 2015). As a result: Interaction and collaboration with health care staff improves adherence to chronic patients

In the present study, implementation of the CCM led to increased diet adherence of patients with MI. Several studies in different populations, including patients with MI (Najafi et al., 2016), patients with heart valve replacement (Sedri et al., 2014), patients under going haemodialysis (Hashemi et al., 2015) and diabetic patients (Shahsavari and Foroghi, 2015), confirmed our results. A review of these studies demonstrates the effect of nurses’ constant encouragement and advice to patients and family members, which can increase patient autonomy and caring skills. Establishing a post-discharge care network can also solve patient care issues and improve adherence to treatment. Given the limited time of nurses and the stress of patients admitted to the cardiac care unit, face-to-face training may be difficult. Therefore, follow-up, which is not expensive, is recommended. However, it is noteworthy that the results of the Meng et al. study on cardiac patients (Meng et al., 2014) and the Wong et al. (2015) study on patients with diabetes showed that follow-up did not improve adherence. These results are not consistent with the results of the present study. This discrepancy can be attributed to the fact that diet is a particular item of culture and society, and climate issues, cultural structures, environmental conditions and many hidden and obvious issues affect it.

Our results showed the CCM increased the physical activity adherence of patients with MI. In line with the current study, the implementation of a follow-up care model increased the physical activity adherence in patients with MI (Akbari et al., 2015, 2017), heart failure (Sadeghi et al., 2009) and type 2 diabetes (Shahsavari and Foroghi, 2015). A study by Redfern et al. on the survivors of acute coronary syndrome showed that a face-to-face counselling session for 1 h and four phone calls of 10 min in three months improved physical activity for more than a year (Redfern et al., 2009).

Our results showed that the implementation of CCM led to an increase in medication adherence of patients with MI. In agreement with our results, the results of a study by Najaf et al. confirmed the improvement of adherence to medication in patients with MI (Najafi et al., 2016). The results of Shahsavari and Foroghi’s (2015) research on nurses’ telephone follow-up in type 2 diabetic patients during three months increased compliance with drug schedules, which is consistent with the results of the present study. In contrast with our results, a study by Meisinger et al. showed that patients with MI reported a decrease in a healthy behaviour, such as medication adherence, in a one-year follow-up and two years after the nurses’ follow-up (Meisinger et al., 2013). A study by Meng et al. showed that follow-up did not have any effect on adherence to medication in patients with artery disease after 12 months (Meng et al., 2014). There are many reasons why patients do not adhere to their medication which may affect the results of these studies. The patient’s transition from the hospital (discharge) to outpatient (home) is a critical period and requires care and interaction with the patient to ensure that patients continue to take their medication to achieve recovery after MI.

The limitations of this study were, first, we used only one centre in the southeast of Iran to collect the data, so generalisation should be made with caution. Second, we did not compare the CCM with other kinds of training programmes, therefore its position among different training programmes is not clear and needs more investigation. Finally, we did not evaluate the long-term effect of CCM on treatment adherence in patients with MI. Further studies are necessary to assess the long-term effect of CCM on treatment adherence among patients with chronic disease, particularly patients with MI.

Conclusion

The results of this study indicate that the implementation of CCM improves the treatment adherence in patients with MI. Considering that after discharge patients may face numerous barriers to the application and follow-up of treatment, a comprehensive support system for patients’ attending families is needed. In this regard, factors such as the interaction of patients with medical staff, the establishment of a post-discharge care network, follow-up to complete the education process, and the encouragement and continuous advice of the nurses and medical staff to the patient and family members are among the most important factors in improving the health of patients with chronic diseases such as MI. Therefore, it is recommended that CCM be used as a nursing intervention to increase treatment adherence in MI patients and in cardiac-rehabilitation programmes.

Key points for policy, practice and/or research

• Using the CCM can be helpful to increase self-care ability and proper performance in chronic disease patients, especially in patients with MI.

• Using the CCM helps nurses in accepting the patient’s treatment process.

• CCM focuses on the effective and balanced role of the nurse, client and family.

• Hospital and community governments can design and develop some programmes to increase the acceptance, insight and proper care for patients with chronic disease, and control the complications of this disease based on the CCM.

Biography

Mohammad Ali Zakeri is a researcher from Non-Communicable Diseases Research Center, Rafsanjan University of Medical Sciences. He also practices as a nurse in the intensive care unit and has a lot of experience with taking care of cardiac and emergency patients.

Zohreh Khoshnood has completed her PhD at Kerman University of Medical Sciences, School of Nursing and Midwifery. She is assistant professor in the Critical Community Health Nursing Department at the School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.

Mahlagha Dehghan has completed her PhD at Kerman University of Medical Sciences, School of Nursingand Midwifery. She is assistant professor in Critical Care Nursing Department at the School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.

Farokh Abazari has completed his PhD at Kerman University of Medical Science, School of Nursing. He was an assistant professor in the Community Health Nursing Department. He has over 30 years of experience teaching nursing students.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethics

This study was conducted based on the ethics permission (code of ethics: IR.Kmu.REC.1395.893) from the Ethics Committee of Kerman University of Medical Sciences and the controlled trial registration (Clinical Trials Code: IRCT2017083035996N1). The researcher explained the purpose and method of the study to the patients and the family of the patients and explained the confidentiality of the information, the possibility of leaving the study at any time, the safety of the research and the availability of research information for patients after the completion of the study. Patients were included in the study after obtaining written consent.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.