|Year : 2018 | Volume
| Issue : 1 | Page : 17-24
Compliance of kidney transplant recipients to the recommended lifestyle measures following transplantation
Uma Rani Adhikari1, Abhijit Taraphder2, Avijit Hazra3, Tapas Das4
1 Department of Nursing Education, Govt College of Nursing, Burdwan, West Bengal, India
2 Department of Nephrology, Apollo Gleneagles Hospital, Kolkata, West Bengal, India
3 Department of Pharmacology, I.P.G.M.E.R and S.S.K.M Hospital, Kolkata, West Bengal, India
4 Department of Medicine, K.P.C Medical College, Kolkata, West Bengal, India
|Date of Web Publication||29-Mar-2018|
Dr. Uma Rani Adhikari
Government College of Nursing, Burdwan, West Bengal
Source of Support: None, Conflict of Interest: None
Introduction: Lifestyle modification has an important role to play for the success of organ transplantation. In renal transplant recipients, recommended lifestyle measures include proper diet, exercise, clinic visits, monitoring and laboratory investigations as per schedule, protection against infections, and abstinence from addictions. The objective of the present study was to assess the compliance with lifestyle recommendations following kidney transplantation and to identify the potential determinants of noncompliance. Materials and Methods: This was a longitudinal study with 153 adult individuals attending the nephrology posttransplant clinic of one tertiary care government and two private hospitals in Kolkata. Participants were followed up for 1 year at 3-month intervals. A pretested questionnaire was used to screen for noncompliance in seven lifestyle areas, and if noncompliance was identified, its extent was assessed, and individuals probed further to explore potential determinants of noncompliance. Results: 64.1% of the transplant recipients were compliant with the recommended lifestyle measures overall. Separately, compliance rates were dietary 83.66%, clinic attendance 88.23%, self-monitoring or home monitoring 89.54%, laboratory investigations completion 88.23%, infection prevention 93.46%, and abstinence from addiction 95.42%. No statistical analysis was done for exercise compliance as recommendations were judged inconsistent and inadequate. Logistic regression analysis revealed that number of comorbidities, number of adverse reactions to prescribed drugs, and perceived severity of the disease were significantly associated with noncompliance. Conclusions: Overall compliance with lifestyle recommendations was suboptimum. The noncompliance risk factors identified need to be probed further.
Keywords: Behavior, compliance, kidney transplant, lifestyle, renal allograft
|How to cite this article:|
Adhikari UR, Taraphder A, Hazra A, Das T. Compliance of kidney transplant recipients to the recommended lifestyle measures following transplantation. Indian J Transplant 2018;12:17-24
|How to cite this URL:|
Adhikari UR, Taraphder A, Hazra A, Das T. Compliance of kidney transplant recipients to the recommended lifestyle measures following transplantation. Indian J Transplant [serial online] 2018 [cited 2018 Aug 21];12:17-24. Available from: http://www.ijtonline.in/text.asp?2018/12/1/17/228926
| Introduction|| |
A favorable outcome of solid organ transplantation depends both on the skills of the transplant team and on the life-long, active cooperation of a patient., Following discharge after successful kidney transplant (KT), patients and their caregivers must know and comply with not only the medication for immunosuppression and comorbidities but also with the various lifestyle measures recommended. They must, for instance, monitor and record body weight, urine amount, blood pressure, and blood sugar periodically at recommended intervals. Such self-monitoring and record keeping is vital toward early detection of any complications. Regular visit to the transplant clinic and laboratory investigations as prescribed are also very important and allow the physician to monitor the health status of the patient and adjust medication regimens if needed. Apart from the clinic visits and self-monitoring and laboratory monitoring, proper diet, exercise, infection avoidance, and abstinence from substance abuse are essential to reduce the risk of posttransplant complications. Patients must therefore make various adjustments to their daily lifestyle to accommodate these demands following transplantation.,, The link between lifestyle adjustments and long-term successful outcome of the process of transplantation is inadequately explored but is probably vital.
Noncompliance refers to behavior that fails to coincide with medical recommendations. This not only includes irregularities in taking prescribed medicines, such as delayed or missed doses, but logically should also extend to nonadherence or inadequate adherence to recommended schedules for self-monitoring or home monitoring, laboratory investigations, clinic visits, and also inadequate attention to diet, exercise, and personal hygiene. Substance abuse will be noncompliance through acts of commission.
Unfortunately, the effect of noncompliance with recommended lifestyle behavior upon successful outcome of solid organ transplantation has received only limited attention. Since clinical trials or cohort studies will not be deemed ethical in this regard, one has to depend upon other observational studies to address this issue. Lifestyle changes adaptation may be dictated by sociocultural determinants, and hence, studies done in other parts of the world may not be equally relevant in the Indian sociocultural context. Although renal transplantation in India is being done in increasing numbers, we failed to locate any recent prospective studies from India assessing the incidence and the determinants of noncompliance with various lifestyle dimensions in posttransplantation regimens.
However, an in-depth understanding of factors associated with noncompliance with the recommended lifestyle behavior is essential before the development of any remedial strategies. Physicians as well as nurses must consider issues beyond medication facing the transplant recipient such as dietary changes, exercise regimens, monitoring by self or caregivers at home, laboratory investigations, and infection prevention.
We therefore planned a prospective observational study to assess compliance with recommended lifestyle among patients living with KT and to explore various potential determinants of noncompliance.
| Materials and Methods|| |
Based on the study criteria, adult renal transplant recipients were recruited through purposive sampling from one tertiary care government hospital and two private hospitals during the period of July 2011 to June 2013. All renal transplants performed in these hospitals were as per the Transplantation of Human Organ Act, India. Informed consent was obtained, and hospitals ethics committee approval was taken. Nonconsenting subjects and cases where both subject and primary caregiver in the family were illiterate were excluded. The first assessment was at discharge from hospital, and subsequent follow-up was at 3-month intervals for 12 months. Self-report at interview method was used to assess the incidence of noncompliance and putative factors contributing to noncompliance. To assess factors of nonadherence, the interview schedule was developed on the basis of the World Health Organization Taxonomy of Adherence, 2003. The adverse drug reaction (ADR)-related stress scale by Rosenberger et al. was utilized to assess stress from ADRs from the prescribed immunosuppressant medication. However, we also included ADRs not included in the Rosenberger scale. Stress from each of adverse effect of immunosuppressant was measured on a five-point scale: 0 - no stress, 1 - low, 2 - moderate, 3 - high, 4 - very high stress. In the context of this study, lifestyle measures related to behavior in seven areas include (a) recommended diet, (b) prescribed exercise plan, (c) scheduled clinic visits, (d) recommended monitoring (of urine output, body weight, blood pressure, and home monitoring of blood glucose) schedule, (e) recommended laboratory investigation schedule, (g) infection prevention strategies (maintenance of personal hygiene, wearing of mask, avoidance of street food), and (f) abstinence from any addictive substance (smoking, chewing tobacco, alcohol, or other agents). A screening questionnaire was applied by a researcher to check for noncompliance in any of these seven dimensions at each visit, and if a participant was identified as exhibiting potential noncompliant behavior, then he or she was probed further. The actual adherence was assessed as frequency of noncompliant behavior per month. Open-ended questions were also asked to probe reasons behind noncompliance. Each subject's primary caregiver was also interviewed to cross-check the self-reported nonadherent behavior.
The questions were first developed in English and pretested to evaluate relevance to the problem being studied and clarity. The content validity index (CVI) for questions to assess compliance was 0.97 and reliability coefficient was 1. The CVI for factors of noncompliance was 0.98 and reliability coefficient ranged from 0.847 to 0.955. After ensuring reliability, the developed English version interview schedule was translated to Bengali and then back-translated to English by independent language (Bengali and English) expert. The researcher asked questions in patient's preferred language, and she herself performed the interview of pretested questionnaire.
In general, noncompliance is regarded as the extent to which a person's behavior does not coincide with medical or health advice. In this study, the terms “noncompliance” and “nonadherence” were used interchangeably. Definition of compliance varies between studies and there is no consensus definition of acceptable compliance with lifestyle measures. In our study, it was assumed that transplant patients constitute a highly motivated group and compliance was judged in a relatively strict sense. With regard to diet or exercise, noncompliance was defined as more than three times casual deviation (from what was recommended by the transplant team) in a month over a 1-year posttransplantation period. For monitoring as well as for infection prevention behavior a similar criterion of more than three times casual deviation in any month over a 1 year period was considered. For clinic attendance, more than one time deviation from schedule in 1 year without giving prior information to the clinic regarding inability to attend was considered as noncompliance. For blood tests and other recommended laboratory investigations also, more than one time deviation in 1 year was considered noncompliance. Any use of an addictive substance was also noncompliance.
The recruitment period for this study was 2 years. Assuming that each year, 200 individuals undergo renal transplantation in West Bengal, Kolkata (through preliminary survey), we have a potential population of 400 new renal transplant recipients over a 2-year period. It was estimated that 153 subjects are needed to find out the frequency of noncompliance with recommended lifestyle behavior with 5% margin of error and 95% confidence level. This calculation assumes a 20% event (noncompliance) rate. It may be noted that the expected 20% noncompliance figure used in sample size estimation is an approximation available literature reports widely varying rates of noncompliance to different lifestyle recommendation from as low as 2.5% to as high as 39%.,,
Data have been summarized by mean and standard deviation (SD) for continuous variables and counts and percentages for categorical variables. Median and interquartile ranges (IQRs) have been provided for continuous variables with skewed distribution. Numerical variables have been compared between subgroups by Student's independent samples t-test or Mann–Whitney U-test as appropriate. Fisher's exact test or Chi-square test was employed for intergroup comparison of categorical variables. Comparisons were two-tailed and P #60; 0.05 was regarded as statistically significant. To assess the combined impact of predictor variables on overall lifestyle adherence status, all variables that returned P #60; 0.05 upon univariate analysis were entered into a binary logistic regression model. SPSS version 20 (SPSS IBM Corp, AV monk, New York, USA) software was used for statistical analysis.
| Results|| |
Of 179 transplant recipients recruited, 13 patients were lost to follow-up and another 13 patients died before completing 1-year follow-up. The baseline characteristics of the sample are depicted in [Table 1]. The majority of the subjects were relatively young; the median age being 37 years with IQR 29–48 years; around 70% being males. Majority (77.11%) were educated up to higher secondary level (12th standard) or beyond. Although majority (60.78%) had monthly family income greater than Indian Rupees 25,000/-, 9.15% were students, and 7.18% were unemployed. Around 48% had related donor transplants, and in majority instances (64.05%), the recipient's primary caregiver was the spouse. The mean (SD) waiting period for transplant was 4.12 (1.44) months and the mean dialysis duration before transplant was 10.17 (5.28) months. The great majority (95.4%) had at least some level of perceived depression. Rates of noncompliance in various dimensions overall (i.e., over the 1-year assessment period) are depicted in [Table 2]. It shows that 16.33% of patients were noncompliant with diet recommendations and the main self-reported reasons for dietary noncompliance were lack of knowledge (46.66%), lack of support person (20%) especially for patients of government hospital, unavoidable circumstances due to job (30%), and fondness for food (30%) especially for patients in private sector. Mainly patients from government sector (24.66%) were noncompliant with scheduled clinic visits, and the chief reasons cited in this regard were lack of immediate health complaints (33.33%) and lack of support persons (22.22%). About 10.45% KT subjects were noncompliant with recommended monitoring activity, mainly due to lack of knowledge and carelessness; 23.29% of patients from government sector were noncompliant with investigation schedules, mainly due to lack of support person, lack of knowledge, and financial problems. Totally, 6.53% were noncompliant with infection prevention strategies and the underlying reasons stated were lack of knowledge and feeling of isolation. From both the sectors, 7, i.e., 4.5%, transplant recipients resorted to either smoking or chewing tobacco; citing previous habit and the need to overcome depression and feel good as the reasons for nonabstinence.
|Table 1: Baseline demographic, socioeconomic and clinical profile of the study subjects (n=153)|
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|Table 2: Compliance with recommended lifestyle measures in the study subjects over a period of 1 year following kidney transplant|
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No statistical analysis was performed regarding exercise nonadherence because it was discovered that the healthcare providers did not give proper instructions about exercise during discharge and during subsequent clinic visits. From government sector, only 4 (5.47%) subjects, and from private sector, 45 (56.25%) did some exercise, mostly in the form of morning or evening walks. Even if patients enquired about exercise, no clear instructions were given and only walking was advised. However, health personnel usually instructed the transplant recipients to do regular household activities and also encouraged them for rejoining in job after 4–5 months.
[Table 3], [Table 4], [Table 5] show the results of univariate analysis. Statistically significant associations were noted with age, religion, educational status, economic status, satisfaction with support person, level of depression, overall support during depression, health information, waiting period for transplant, number of ADRs and ADR-related stress (averaged across the number of visits), overall pretransplant compliance, perceived risk of the disease, perceived severity of the disease, number of significant comorbidities, and number of posttransplant complications (also averaged across the number of visits). Dietary supervision levels were associated with dietary compliance.
|Table 3: Comparison of demographic and socioeconomic factors among renal transplant recipients complying with recommended lifestyle measures overall and their noncompliant counterparts|
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|Table 4: Comparison of psychosocial and health-care system-related factors between renal transplant recipients complying with recommended lifestyle measures overall and their noncompliant counterparts|
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|Table 5: Comparison of therapy-related factors, condition-related factors, and patient-related factors between renal transplant recipients complying with recommended lifestyle measures overall and their noncompliant counterparts|
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Although a number of potential risk factors were identified on univariate comparison, this multivariate analysis yielded only three factors – namely, the number of comorbidities, ADR numbers, and perceived severity of the disease – as having significant association with noncompliance [Table 6].
|Table 6: Summary of predictors of lifestyle compliance identified by logistic regression|
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| Discussion|| |
It is clear from the present study that a large proportion, about 65%, of the new kidney recipients was compliant with recommended lifestyle behavior. In general, the limited literature on compliance in transplant recipients indicates that patients tend to have good compliance with immunosuppressive agents and partial compliance to other lifestyle behaviors. That way, this 65% figure is not surprising. Although the overall rate of compliance behavior is encouraging, it is a matter of concern that over 1/3rd of the transplant recipients are noncompliant with one or more component of the recommended lifestyle measures. Some reasons for this are not difficult to understand such as financial constraints (particularly patient attending government hospital) and pressure of job schedule upon returning to work (particularly for patient of private hospitals). However, large components of the noncompliance can be attributed to increasingly causal attitude with passage of time, the reason for which merit psychological exploration. Another reason could be in the current scenario is the time spent in counseling in patient and the caregiver before the procedure is probably not adequate. There is crime need for dedicated pretransplant education clinic.
Rates of compliance with individual dimensions of lifestyle behavior varied. Compliance with dietary instructions was good at nearly 84%. This is better than the 67% dietary compliance figure reported by Gheith et al. for KT patients and the 34% and 56% dietary noncompliance figures, for lung- and heart-transplant recipients, respectively, reported by Dew et al. Self-control of the subjects and family cooperation in providing the recommended diet probably have contributed to this performance.
There is evidence for significant beneficial effects of regular exercise on physical fitness, walking capacity, cardiovascular parameters (e.g., blood pressure and heart rate), health-related quality of life, and some nutritional parameters in adults with chronic kidney disease (CKD). Presumably, the benefit should extend to CKD patients who eventually undergo renal transplantation. Although we intended to assess compliance to exercise instructions, in practice, we found such instructions to be both infrequent and inconsistent. There was lack of standard recommendation for exercise because of complex sample characteristics. Whatever available was mostly in the form of walking. We therefore decided not to assess exercise compliance finally. This feedback suggests that health-care providers, both doctors and nurses, themselves need sensitization and convincing of the benefits of daily exercise regimens in transplant patients. In the government sector particularly, the emphasis is on patients to resume or start paying jobs to meet the increased financial need. This possibly diverts attention from the need to exercise on a regular basis. In private sector because of diverse sociocultural and demographic background, prescribing exercise regimen for posttransplant patients was a difficult issue.
Reported rates of compliance with self and other forms of home monitoring requirement vary. While Kobus et al. documented that over 95% of renal allograft recipients regularly measured their blood pressure at home, Gheith et al. documented that compliance with daily monitoring of fluid intake, blood pressure, temperature, urinary output, and body weight was approximately at 12%, 10%, 7%, 6%, and 2% of the participants, respectively. However, the monitoring requirements were stringent (daily) in the latter study. In our sample, little over 10% of subjects were noncompliant with periodic monitoring of blood pressure, blood glucose, urinary output, and body weight and around 12% of noncompliant toward laboratory testing as per schedule. The situation was better in private sector patients presumably because of their generally better education and higher socioeconomic levels, in addition to the motivation provided by the transplant team. Patients in the private sector also maintained diaries for their self-monitoring and laboratory monitoring activity, in addition to keeping record of their medicine intake. In the government sector, it was noted that physicians were less insistent with their monitoring demands in general. In the present study, about 88% of the sample attended nephrology clinics at proper time, and this finding is comparable with Gheith et al.
Nephrologists strongly recommend avoidance of smoking, chewing tobacco, alcohol, and other forms of substance abuse before and after the transplant., Our study found that only 4.57% subjects smoked or chewed tobacco after transplantation within a 1-year period. Although this is relatively low compared to studies done by Gheith et al. and Yavuz et al., where the authors reported smoking rates of 12% and 17%, respectively, there is no room for complacency in this regard. The ideal goal is to achieve zero addiction rates in all renal allograft recipients.
Various factors that could influence adherence to recommended lifestyle behavior were explored in this study including age, educational status, economic status, satisfaction with the support person, level of depression, support during depression, availability of health information, other psychosocial aspects such as belief in god and self-esteem, waiting period for transplant, average number of ADRs and average ADR-related stress, overall pretransplant compliance, perceived severity of the disease, number of comorbidities, and number of posttransplant complications. Some of these factors presumably are the same that influence medication compliance., The impact of all these factors is yet to be adequately explored and the literature regarding this is scanty. In a study of individual and environmental correlates and predictors of early adherence and outcomes after liver transplantation, Stilley et al. reported that patterns of coping, decision-making, attitude, and social support were correlated with extent of adherence. Although ADRs and resultant stress are factors related to the mandatory immunosuppressant use in these patients, they can have considerable negative influence on lifestyle behavior  and hence were included in the study.
However, although multiple potential predictors for noncompliance were identified through univariate analysis, logistic regression analysis singled out only three among them, namely, number of comorbidities, number of ADRs, and perceived severity of the disease. It stands to logic that increased number of ADRs means patients have to face additional problems that can negatively impact on their motivation and capability toward self-care and a healthier lifestyle. Furthermore, disease if perceived as more serious leads to increased chronic stress which can reduce motivation toward healthier lifestyle behavior. On the other hand, increased number of comorbidities appears to be improving compliance with recommended lifestyle measures. Presumably, this could be due to an increased sense of responsibility on the part of the patients as also increased support from caregivers. Dew et al. studied medical compliance and its predictors in the 1st year after heart transplantation and opined that background health-related and sociodemographic characteristics show no significant influence on any area of posttransplantation compliance. However, perioperative psychosocial characteristics were strong and significant predictors of noncompliance. They have also reported that the risk of coronary artery disease and damage to the transplanted heart is increased substantially by persistent depression or anger–hostility. Hence, the impact of psychological and psychosocial variables needs to be studied further in renal transplant patients.
This study has its share of strengths and limitations. The close longitudinal follow-up is a major strength of the study. We therefore deliberately excluded subjects who were not available for the full 1-year period from analysis. Recruitment of patients from multiple centers covering both government and private hospitals implies that diverse socioeconomic backgrounds have been represented and therefore there should be better generalizability of the study findings. On the other hand, we did not assess all dimensions of lifestyle compliance such as avoiding sun exposure as a means protection against skin cancer. We also did not explore other aspects that may influence compliance with lifestyle recommendations such as social interaction with peers and sexual activity. The purposive sampling may have introduced some selection bias. However, this was the only sampling strategy feasible considering the clinical settings and the relatively long follow-up period envisaged.
| Conclusions|| |
This study finds that compliance with lifestyle recommendations after renal transplantation in the Indian sociocultural setting remains suboptimal overall, though they may be satisfactory in some dimensions such as adherence to recommended diet and abstinence from addictions. There is need for exploration of the sociodemographic and clinical backgrounds of patients before transplantation and continued exploration of these aspects along with recording of actual compliance following transplantation. Potential risk factors of noncompliance discovered through such endeavors will then need to be suitably addressed by the transplant team, other attending physicians, and nurse counselors. The outcome of intervention strategies mainly pretransplant education and posttransplant ongoing education need to be implemented to improve compliance will have to be addressed in the future studies.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]