The participants in this randomized controlled trial included post-MI patients admitted to the coronary care unit (CCU) of Vali-Asr hospital affiliated to Birjand University of Medical Sciences (BUMS), Iran, in 2014.
3.1. Participants
With due consideration of similar studies (
20) (α = 0.05, β = 0.1, M1 = 3.35, M2 = 4.06, S1 = 0.76, S2 = 0.44), the sample size of 70 (35 participants for the intervention group and 35 for the control group) was planned to accommodate an attrition rate of up to 15%.
A convenience sampling method was used. Accordingly, a list was prepared including the patients admitted for the first MI to the coronary care unit (CCU) of Vali-Asr hospital affiliated to BUMS. This hospital is the main and referral hospital for cardiac cases in Southern Khorasan province. There are more than 297 active beds and 15 different wards in this state hospital. Patients admitted to this hospital during the past 3 - 6 months were examined. Then, patients who met the inclusion criteria were contacted. Inclusion criteria were as follows: 1) Age below 75 years, 2) A minimum literacy level of primary school, 3) Access to telephone, 4) MI for the first time with no previous history of cardiovascular surgery or percutaneous coronary intervention, 5) Lack of mobility-limiting conditions, sustained arrhythmias or a disease inhibiting self-care. Exclusion criteria consisted of individuals with an occurrence of any condition contradictory to the inclusion criteria (for example, undergoing a cardiovascular surgery during the period of the study). If the patients themselves or their close relatives were employed in healthcare organizations, they were excluded.
It is noteworthy that out of the selected 70 persons, two patients from the intervention group attended only two sessions of education, and three did not refer to the research site to complete questionnaires. In addition, five patients in the control group did not complete questionnaires at the end of the study. Therefore, data belonging to these patients were excluded, leaving 60 individuals (n = 30 in each group) for final analysis.
3.2. Measurements
Demographic data were collected through a demographic form and patient’s self-management was measured by chronic disease self-management scale (CDSMS) developed by Lorig et al. CDSMS is composed of six dimensions: general health, symptoms, physical activities, confidence in physical activities, daily activities and medical care (
21).
The general health dimension consisted of one item on a 5-point Likert scale with a score ranging from 1 - 5 (1 = excellent, 5 = poor).
The symptoms dimension included the sub-dimension of health distress and three numerical analogue scales for various feelings including fatigue, shortness of breath and pain. Health distress included four items on a 6-point Likert scale with a score range of 0 - 5 from 0 = never to 5 = always (with minimum score of zero and maximum score of 20). On the three numerical analogue scales, participants obtained a minimum score of 0 and a maximum of 10.
The physical activities dimension included six items on a 5-point Likert scale (from 0 = never to 4 = more than three times a week). The minimum score obtained by respondents in this dimension was zero, while the maximum score was 24.
The dimension of confidence in physical activities included six items concerning management of chronic conditions on a 10-point Likert scale with a score range of 1 = “I’m not sure at all” to 10 = “I’m completely sure”. The score in this dimension ranged from 0 to 60.
The daily activities dimension had four items concerning social activities limitations on a 5-point Likert scale from 0 = very little to 4 = very much (with minimum score of zero and maximum score of 16).
The medical care dimension consisted of two sub-dimensions: communication with physicians and health care utilization. Communication with physicians had three items which evaluated the patient’s interactional relationship with the physician during treatment on a 6-point Likert scale from 0 = never to 5 = always (with minimum score of zero and maximum score of 15). Health care utilization had four items which assessed the number of times a patient used health care organizations such as hospitals. Higher scores indicated greater number of health care utilization by participants.
Given the wording of the statements in the sub-dimensions, only in physical activity, confidence, and sub-dimensions of communications with physicians, a higher score indicated higher self-management ability. For the rest of the sub-dimensions of the applied scale, a lower score suggested a better self-management condition.
In the current study, the scale was first translated into Persian and then back-translated into English by two proficient translators. The scale back-translated into English was compared with the original scale in terms of content. Afterwards, the content validity of the Persian version of the scale was verified by 10 nursing and midwifery faculty members in a nursing and midwifery college in Iran.
The reliability of the CDSMS was determined by calculating Cronbach’s alpha. Satisfactory Cronbach’s alpha values were found for all CDSMS dimensions (ranging from 0.79 to 0.89).
3.3. Intervention
Upon introduction of the study and statement of the purposes, the patients provided informed consents and completed the demographics form and CDSMS in both groups. Then, the CCM was presented to the participants in the intervention group for three months, while the participants in the control group received the routine treatment.
The CCM consists of four stages: (1) orientation, (2) sensitization, (3) control and (4) evaluation (
14,
15,
17,
18).
During the orientation stage, a 30-minute session was held in which the patient, the researcher, and a family member of the patient involved in caring were familiarized with each other. Also, mutual expectations and the continuation of the care relationship were clarified. Creating motivation in clients regarding the requirements of continuous care was one of the essential aims at this stage.
At the sensitization stage, the purpose was to involve the patient and his/her family in caring for continuous care behaviors to emerge; this stage was concurrent with the orientation stage. The major activity performed for the patients included participation of the patient and his/her family member in counseling and group discussion sessions. During these sessions, the emerged problems and needs of the patients were recognized. Patients and their family members were then sensitized about the problems and were motivated to apply the solutions offered to them. To hold the sessions, patients in the intervention group were divided into three 9-member sub-groups and one 8-member sub-group. The sessions were held twice a week and started by presentation of materials by the researcher using slides and lecture and proceeded by group discussion around the presented materials, discovering the patients’ problems and needs, and giving counselling on these problems. Topics discussed in the sessions are presented in
Table 1. At the end of each session, an educational pamphlet was given to the patients, and they were asked to answer a set of questions about topics presented in the previous sessions. The content of the educational sessions and pamphlets were previously confirmed by two cardiologists. The orientation and sensitization stages were performed during the first three weeks of the CCM application.
| Stages of The CCM | Stages |
|---|
| Orientation | | | Introduction of the patient, the researcher and a family member of the patient to each other; elaboration on limitations and expectations; description of stages and benefits of involvement in the CCM |
| Sensitization | 1st week | Session 1 | Pathophysiology, symptoms and risk factors of MI |
| Session 2 | Diagnosis and complications of MI, importance of common prescribed drugs, drugs storage |
| 2nd week | Session 3 | Physical activity |
| Session 4 | Nutritional regiment, importance of regular visiting of the physician |
| 3rd week | Session 5 | Control of modifiable risk-factors such as weight, blood pressure and smoking |
| Session 6 | Stress, depression and sexual affairs |
| Control | Examination of checklists | Contact via phone 1 | 15 days after intervention |
| Contact via phone 2 | 30 days after intervention |
| Contact via phone 3 | 45 days after intervention |
| Evaluation | All stages of the model | | |
Abbreviations: CCM, continuous care model; MI, myocardial infarction.
In the control stage, the continuation of care was checked. At this stage, the counseling sessions on continuous care were assured by phone calls considering the patients’ care needs. Furthermore, checklists completed by the participants were assessed with the aim to recognize new caring problems. Generally, nine weeks were allocated to the control stage. In case the patient had a problem which was not in the scope of the researchers’ expertise, she/he was referred to a specialist of the related problem.
Finally, although the evaluation is mentioned as the fourth stage in the CCM, it was carried out all through the model stages. This stage principally aimed to evaluate the quality of process of care and judge the self-management behaviors of participants. Comparison of the completed forms by participants was a useful tool to evaluate the quality of continuous care in the study.
At the end of the 12th week, CDSMSs were completed under similar circumstances but at different times by the groups.
3.4. Ethical Considerations
The current study proposal was approved by research and ethical committees of BUMS (ethical code: 1393-04-01). The patients were verbally provided with the details of the study. In addition, a written consent was obtained from them. The patients were informed that they could withdraw from the study at any time they wished. At the end of the study period, the content of the instructional sessions presented to the intervention group were prepared as pamphlets and given to the control Group members.
3.5. Statistical Analysis
The obtained data were analyzed by SPSS version 16. Demographic characteristics of the intervention and control groups were compared using Chi-square and exact Fisher tests. The Mann-Whitney U test was applied to compare self-management sub-dimensions in the two groups before intervention. This test was also applied to compare the age means of the groups.
The Wilcoxon test was used to determine if there were any statistically significant differences between mean scores of self-management sub-dimensions before and after intervention in the intervention and control groups. Finally, including age as a covariate, an analysis of covariance (ANCOVA) was applied to compare the two groups in terms of their mean scores of self-management sub-dimensions after intervention. The significant level was set at P < 0.05.