The Effect of Telephone Consultation on the Quality of Life of Patients Receiving Interferon Therapy: A Quasi-experimental Study

Abstract

Objective: The aim of this study was to compare the effects of telephone consultation and attendance education on the quality of life of patients with hepatitis B or C receiving interferon therapy. Subjects and Methods: Through a quasi-experimental study, 80 hepatitis patients were randomly assigned to one of the two educational methods. Patients completed the Quality of Life Questionnaire once upon entering the study and also 4 and 12 weeks after the treatment. Then, the results were compared. One group received education during monthly visits at the center, and another group got counseling over the telephone for 3 months. The data were analyzed using SPSS software (IBM, Armonk, NY). Results: The results showed that the overall quality of life in both groups 4 weeks and 12 weeks after the intervention had significant differences from the pre-intervention period; however, these differences were more significant in the telephone counseling group. Conclusions: By virtue of the fact that no significant difference was found between the results of traditional education and telephone consultation and considering the high volume of patients in centers, remote distance between patients and centers, and also limited staff time, telephone advice can take the place of traditional education methods.

Introduction

Hepatitis is a chronic disease that can still be considered as a major health problem that remains widespread worldwide.¹ Hepatitis has a dire effect on health-related quality of life (QOL).² Health-related QOL is a multidimensional construct that includes the psychological, social, and functional aspects of an illness as well as its physical aspects.³ QOL in patients with chronic illness is mainly affected by a recurrent depression. Depression has a negative impact on an individual's performance and leads to the worsening of the disease symptoms, and it is associated negatively with QOL of patients.^4
–6

Treatment of hepatitis with interferon, which is effective for more than 50% of patients, has several side effects, especially in the form of hematological and psychological complications.^7,8 Although the side effects of the drug are limited to its consumption period and no long-term complications have been ever reported, it can affect the treatment process. Therapies damage patients' QOL because of side effects, including flu syndrome.⁹ Studies have indicated that the progression of liver disease and ineffective antiviral treatment increasingly damage both patients' QOL and their physical and mental health.¹⁰ Hence, patients should be carefully monitored for side effects during treatment.¹¹

Treatment-related side effects shape the bases of decision making for both physicians and patients, and they also affect the continuation or the stopping of the treatment before completion.¹² Although side effects start a few hours after interferon therapy, the patients' tolerance increases after a few weeks.⁸ These side effects sometimes lead to the stopping of treatment after a few days. Also, many patients stop their treatment because of lack of knowledge about how to use medications and also the importance of continuing treatment. Therefore, these patients need caring, long-term support and special education or rehabilitation.¹³ Effective education and appropriate monitoring of patients are crucial to empower them to observe the treatment regimen, which usually takes 24–48 weeks (depending on the level of virus and virus genotype),¹⁴ and to reduce complications during treatment as much as possible.

The point that the admitted patients should receive enough information about health issues is an undeniable fact. Also, they should engage in self-care activities and assuming greater responsibility for their own health.¹⁵

Disease should be controlled by the patient, his or her family, and the medical team. The prerequisites of disease control are consultation, self-care education, and pursuit of treatment by patients.¹⁶ The professional responsibility of healthcare staff in chronic health problems is to help patients achieve a series of self-care skills through education and consultation.¹⁷ The implementation of a counseling program with the aim of improving patients' knowledge, performance, and attitude seems necessary to support patients with self-care problems. Follow-up and continuation are necessary for the successful completion of each program.

Person-to-person or face-to-face education forms are among the most common methods in healthcare systems. These methods require more time and are difficult to implement in crowded centers. So the accomplishment process is restricted.¹⁸ In addition, hepatitis patients live in different and possibly remote cities and villages, and the possibility that they would come to the center is low. Therefore, alternative methods that could solve this problem and enjoy proper effectiveness are appropriate.¹⁹

Today, nurses are able to do a series of activities, such as patient monitoring, education, consultation, data collection, pain control, and patient's family support with tolerance, by using a phone.²⁰ Telephone consultation is seen as a good means of exchanging information, providing health education and advice, managing symptoms, providing early recognition of complications, giving reassurance, and providing quality aftercare services.²¹ Not only does using the phone to provide nursing care reduce costs and facilitate access to patients, but also it improves the relationship between patient and care providers, and it also removes the time and place barriers.²⁰ In addition, studies have shown that when nurses do follow-up telephone consultation, they feel more satisfied.²²

Although previous studies have introduced telephone consultation as one of the most effective and economical methods for follow-up of chronic diseases that can reduce the patient's distress,²³ there have been no studies on patients with chronic hepatitis treated with interferon, and at present it is not clear whether telephone consultation is also effective for these patients. Therefore, the current research was done with the aim of comparing the effects of two educational methods—(1) face-to-face education and (2) telephone consultation—on QOL and continuing treatment.

Subjects and Methods

This is a quasi-experimental study that compares the effect of telephone counseling and traditional education on QOL and continuing treatment in patients with chronic hepatitis treated with interferon.

The study population consisted of patients referred to the Hepatitis Center Hospital affiliated with the Tehran University of Medical Sciences and treated with interferon. Study participants were selected from among the patients referred to this center, and they had inclusion criteria including age between 16 to 60 years, being a candidate for interferon therapy for the first time, having no other chronic and infectious diseases, having access to a telephone, not having any speech and hearing problems or any known psychological disease, and treating hepatitis with interferon. Exclusion criteria were as follows: termination of interferon therapy by a physician, development of a physical or mental disease during the study, and lack of access to medication during the study.

The sample size was determined in each group according to the protocols of Asadi Noghabi et al.²⁴ and Zandi et al.,²⁵ and also expert statisticians assumed that the expected level of QOL has increased at a rate of about 0.3 (from 0.5 to 0.8) (p) and α=0.05, β=80%. Thus, the sample size included 40 subjects in each group equally. After full verbal explanations to patients and obtaining consent for entry to the study, patients were randomly assigned to one of the two groups.

Data collection was carried out via self-reporting through the interviewing technique (question and answer). The questionnaires were filled in during face-to-face interviews. The data collection instrument contained the demographic characteristics (12 questions) and the specific QOL in the Chronic Liver Disease Questionnaire (CLDQ). The CLDQ, developed by Younossi et al.,^26
–28 is reliable and valid both for measuring the differences between individuals at a point in time and for measuring longitudinal changes over time. It has 29 questions, and each question is answered on a scale from 0 (never) to 6 (always). The "Never" option was the highest QOL score in each question. Similarly, the "All the Time" option was the worst situation of QOL in each question. The maximum score was 174, and the minimum was 0. Higher scores indicated lower QOL. The instrument included six domains: abdominal symptoms, systemic symptoms, fatigue, activity, emotional function, and worry. The construct validity of the CLDQ was approved by a strong correlation with patients' global rating scores (r=0.84; p=0.02).²⁹

The original version of the CLDQ was translated into Farsi according to the standardized guidelines proposed by Guillemin et al.³⁰ Also, after translation, the Persian version was rendered into English again by a native English speaker (forward-and-back translation method), and then the final Persian version was tested on five patients with chronic liver diseases. The Persian CLDQ was reviewed by 10 faculty members at the Tehran University of Medical Sciences. They provided suggestions, and accordingly content validity of the questionnaire and its coverage were confirmed. The reliability of this questionnaire was shown with Cronbach's α and the test–retest method. Cronbach's α was higher than 0.91 for domains, and it was 0.93 for overall scores. The Spearman's rank correlation was also 0.89 for the CLDQ, and it was higher than 0.73 for the CLDQ domains.²⁵

The researcher reported to the selected Hepatitis Center and collected the data for 9 months, 3 days a week (Sunday, Tuesday, and Wednesday). These days were selected by getting advice from the director of The Hepatitis Consultation Center because patients treated with interferon would report in these days. This time was considered to complete the sufficient sample size. The researcher introduced himself to those patients who met the inclusion criteria and explained the aim of the study clearly and in full details. Then, those who agreed to participate in the study signed the consent form. A booklet was given to all patients. This booklet was prepared as an educational pamphlet and was validated by the researchers, clinic doctors, and some expert scholars in this field. All points in the booklet were described to the patients in the first session. Then, the patients were assigned randomly into the experimental and control groups. The telephone interventions were conducted for the experimental group within 3 months.

The researcher called up the patients for counseling, follow-up treatment, and evaluating the patients' situation. In the first month, contact with the subjects was once a week, and subsequently once every 2 weeks in the second and third months. All phone calls were made by in accordance with the individual patient's schedule between 8 a.m. to 8 p.m. The duration of each call was considered on average to be 20 min. However, if the patient had questions, this time was increased. The content of telephone conversations included the evaluation of treatment with interferon, the review of problems and complications that emerged, and the analysis of situations. Also, the patient's activity was investigated. The researcher helped the individual patient find solutions to the problems that were suggested to him. The patient's questions were answered, and, if necessary, the patient was referred to the relevant hepatitis center.

In the control group, education was provided when patients reported to the center monthly, and subsequently all their questions were answered.

The continuation of treatment was evaluated with the checklist prepared for this purpose. The questionnaires were filled in face-to-face once the patients entered the study and at 4 and 12 weeks after the intervention. When patients reported monthly to the center for liver tests, the questionnaires were filled in. Data were analyzed by SPSS software (version 11/5; IBM, Armonk, NY) and by using descriptive statistics and statistical tests including the chi-squared, Friedman, Wilcoxon, and Mann–Whitney tests.

Results

The results of the demographic data analysis showed that the subjects in the control and experimental groups did not have any statistically significant differences in age, sex, type of addiction, marital status, employment status, level of education, cigarette consumption, smoking duration, tattoo status, prison history, and history of alcohol consumption.

The results showed that the majority of samples were male (77.5%). Also, the findings showed that the QOL in the experimental and control groups was homogeneous before the study.

The study results for all patients indicated that only two persons from each group had left the study because of lack of money to pay for treatment.

The comparison of patients' QOL values among the individuals in the control group before and after the study showed that the majority of them had a good QOL (92.5%) before the interferon therapy. Four weeks after the intervention, about two-thirds (66.7%) of them had a good QOL, and 12 weeks later, 57.9% of patients had a good QOL. This group was taught monthly when coming to the center, and their questions were answered subsequently. The results of the comparison between QOL in the intervention and control groups at different stages of the study are given in Table 1.

Table 1.

Frequency Distribution of the Quality of Life of Patients Treated with Interferon

	NUMBER (%) IN GROUP
	BEFORE INTERVENTION		AFTER INTERVENTION
			4 WEEKS		12 WEEKS
QOL	INTERVENTION	CONTROL	INTERVENTION	CONTROL	INTERVENTION	CONTROL
Medium	4 (10)	3 (7.5)	7 (18.9)	13 (33.3)	16 (43.2)	16 (42.1)
Good	36 (90)	37 (92.5)	37 (81.1)	26 (66.7)	21 (56.8)	22 (57.9)
Mann–Whitney U	Z=–0.895		Z=–1.346		Z=–0.398
	p=0.371		p=0.178		p=0.69

The results of the Friedman test showed that the differences in QOL were statistically significant at different stages before and 4 weeks and 12 weeks after the intervention (p<0.001). The Wilcoxon test showed that the differences were due to the QOL score prior to the intervention until 4 weeks later (p<0.001) and between the pre-intervention score and 12 weeks later (p<0.001). However, there was no statistically significant difference in QOL between the post-intervention 4-week period and that at 12 weeks.

Also, the comparison of patients' QOL in the telephone consultation group both before and after the study showed that the majority of them had a good QOL (90%) before the interferon therapy. The QOL scores slightly decreased 4 weeks after the intervention. However, 81.1% had good scores, and after 12 weeks 56.8% of patients had a good QOL. The results of the Friedman test showed that the differences in QOL were statistically significant at different stages both before the intervention and 4 and 12 weeks after the intervention (p<0.001). The Wilcoxon test showed that the differences were due to the scores of QOL before the intervention until 4 weeks later (p<0.001), before the intervention until 12 weeks later (p<0.001), and 4 weeks after the intervention compared with 12 weeks after (p<0.004).

Discussion

This study showed that dimensions of QOL in patients with chronic hepatitis diminish over the time and that this reduction progresses with the intensification of the disease symptoms and the consequent prescription of interferon drugs. The results of the study of Younnossi et al.²⁷ showed that chronic liver disease essentially reduces the QOL. Häuser et al.³¹ showed reduction in QOL in patients with chronic hepatitis C that was not due to disease severity, but it was related to both concerns about disease and the risk of other diseases that could affect the patient at the same time. Marcellin et al.³² found that QOL worsened during treatment but returned to baseline after the end of treatment. Snow et al.³³ reported that the treated patients with hepatitis C experienced a greater decline over time than the untreated patients. Other researchers also stated that the patients with hepatitis C virus displayed decreases in QOL during therapy. It was found that the patients who reported experiencing side effects often had a reduction in physical functioning and vitality compared with those whose therapy initiation was within 3 months.⁶

The reduction of QOL in this study is also expected because of progressive nature of the disease and the interferon consumption. Nonetheless, as it was observed, the decline of QOL in the experimental group was less than in the control group. The results of the study of Hollander et al.³⁴ in Sweden showed that the QOL in patients with hepatitis C decreases overtly and that the administered treatment reduces the QOL more. The results of the study of Atiq et al.³⁵ showed that patients with liver disease had a low CLDQ score and that the five dimensions of QOL were reduced. The results of the study of Schwarzinger et al.³⁶ also showed that patients with chronic liver infection have lower QOL than other individuals. Surjadi et al.³⁷ reported that formal teaching to patients increases their awareness of hepatitis C; they found all patients had a significant improvement in their knowledge after education.

The results of the study of Asadi Noghabi et al.²⁴ also showed that there was a significant difference between the intervention and the control groups 3 and 7 months after the intervention (p<0.001). The result of research by Zandi et al.³⁸ showed that the overall mean of QOL in the experimental group had been significantly improved after caring programs in which the telephone counseling had been conducted.

The results of the current study also show that telephone counseling can be effective in the same way as attendance education on the patients' QOL, although the frequency of the interventions differed in the experimental group versus the control group, depending on the type of intervention. Rossaro et al.³⁹ found that telemedicine is an effective tool for identifying and treating patients with hepatitis C who live in rural communities because they often have little access to specialty care. Finally, more nursing care for patients with chronic diseases is needed because the population of patients with chronic diseases is increasing.

One of the important types of care-giving is patient education. Distance education in nursing can also be used because the phone is a device to which most patients have access. Therefore, telephone counseling given by nurses to this group of patients can be effective.

Considering the advantages of telephone counseling, it can be used as a suitable alternative for traditional and face-to-face education.

The results of the present study can be corroborated by the study of Baraz et al.¹⁹ They concluded that there were no significant differences in the training effectiveness of the educational methods. They recommended distance education because the traditional education is more difficult and more expensive than distance education. Therefore, distance methods are recommended as effective, low-cost, simple, and attractive for these patients.¹⁹

However, there are some studies that have shown results that are contrary to the current study and also the above-mentioned ones. For example, Saba et al.⁴⁰ concluded that the traditional method of education has a greater effect than distance education. This can be attributed to different samples being studied because pregnant women have different conditions compared with patients who suffer from chronic diseases; the former usually go to the clinic or a doctor's office for routine assessments and checkups, and as a result most of them prefer to choose a clinic that is close to their homes. Therefore, “the remoteness of distance” is not problematic for the pregnant population. However, a systematic review of the literature about telephone follow-ups showed that some studies had found that the intervention had positive results for a variety of outcomes. Overall, the studies showed clinically equivalent results between telephone follow-up and control groups.²¹

Consequently, it can be concluded that judging whether traditional education is effective and affordable or not depends on some factors that include the characteristics of the population and the target group that will be educated.

Conclusions

The results showed that equal numbers of patients left treatment in both groups, an issue that is out of the researcher's control. Patients left the treatment because of the costs, and the researcher could not provide financial support for them. Also, this problem is not related to the research intervention: telephone counseling or attendance education. Patients who left treatment did not have any insurance.

Also, the results showed that telephone follow-up and instruction alongside treatment can be effective as traditional education to achieve positive results in QOL.

Although the Mann–Whitney test showed that there were no significant differences before 4 weeks and 12 weeks after intervention between the control and the experimental groups, the overall mean QOL reduction in the experimental group was less than in the control group. Meanwhile, it is expected that interferon therapy will reduce the QOL in both groups.

In general, the findings of this study showed that the traditional and distance educational methods have similar effects on patients with chronic hepatitis who are receiving treatment with interferon. Therefore, despite the belief that traditional education is more effective and that it provides more interaction between the educator and the patients, the findings of this study showed that distance education is as effective as the traditional method.

Consequently, with regard to lack of space and time and the high costs involved in traditional education, distance education methods, such as telephone counseling, can be used.

Footnotes

Acknowledgments

This study is an M.S.N. dissertation submitted by S.M. and approved by the Tehran University of Medical Sciences. We are grateful to the Tehran Research Center for Gastroenterology and Liver Disease and all the patients who participated in our study.

Disclosure Statement

No competing financial interests exist.

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