Study area and period
The study was conducted at the St. Paul`s Hospital Millennium Medical College (SPHMMC) National Kidney Transplant Center in Addis Ababa, Ethiopia. Established in 2013, the unit is the first kidney transplant service in the country. Since 2015, it has performed around 148 transplants for chronic kidney disease (CKD) and end-stage renal disease (ESRD) patients. The center provides clinical follow-up services for more than 400 indigenous KT patients and those transplanted abroad. The study was conducted from October 12th, 2021, to January 4th, 2022.
Study design
A cross-sectional study was conducted on patients who underwent kidney transplantation at the SPHMMC renal transplant unit and abroad and who underwent clinical follow-up at the unit during the study period.
Source and study population
The study focuses on CKD and ESRD patients who have undergone kidney transplants in the SPHMMC renal transplant unit or abroad. There are 148 patients with KT service and 252 post-KT patients who received service abroad and have clinical follow-ups at the renal transplant clinic. Despite 400 post-KT patients starting clinical follow-up at the clinic, some discontinued it. The study population includes all post-KT patients who meet the inclusion criteria during the study period.
Sample size determination and sampling procedures
A purposive sampling method was used to study the small, well-defined, and unique source population. All eligible patients who had their clinical follow-up at the SPHMMC renal transplant unit during the study period were included. The study excluded patients who were lost from follow-up, deceased, or transplant rejected and were on dialysis. Data was collected during clinical follow-up appointments, which varied depending on the time of transplant and clinical condition. 270 patients were accessed and responded to, with a data collection period of two and a half months from October 12, 2021, to January 4, 2022.
Eligibility criteria
Inclusion criteria
All post-kidney transplant patients having follow-up service at SPHMMC renal transplant unit and are willing to participate in the study.
Patient recruited as they came for follow-up visit, and with that all the eligible patients will be accessed in the study period.
Exclusion criteria
The study excluded patients who are critically ill, unwilling to participate, inaccessible, under 18 years old, or with failed transplants or transplant rejections, and those on dialysis.
Study variables
Dependent variables.
Independent variables (five WHO dimensions).
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A.
Social and economic:
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Cost (treatment cost, transportation cost): occupation or income source.
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Sociodemographic variable: age, sex, educational background and marital status.
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B.
Health system related: patient to health care provider interaction, and health care provider follow up and multiple health care provider.
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C.
Condition related: these are characteristics of the disease, disease condition/severity and patient related health literacy:
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D.
Patient perceived importance of medication,: cognitive functioning, self-care motivation and social support.
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E.
Therapy related: Multiple medication, Complexity of therapy and Adverse drug reactions, and duration of therapy.
Data collection tools and procedures
Data collection tools
A structured questionnaire was used to measure medication adherence, adopting and modifying the simplified medication adherence questionnaire (SMAQ) six items. The Basel assessment of adherence to immunosuppressive medication scale (BAASIS) questionnaire was used for specific immunosuppressive medications. The questionnaire was translated into Amharic for easy comprehension by participants and trained data collectors.
Data collection procedures
The questionnaire was tested with 10 participants on October 8th, 2021, and modified after. Data collection was conducted from October 12th to January 4th, 2022. Confidentiality was maintained through anonymity and secure storage.
Data quality management
Data quality was ensured by selecting general practitioners as data collectors, training them on the procedure, and ensuring consistency. The principal investigator managed data cleaning, encoding, and analysis using Epi Info 7 software and SPSS version 26.
Data processing and analysis
The collected data was processed and cleaned until January 9, 2022.
The Simplified Medication Adherence Questionnaire (SMAQ) was used to score the prevalence of medication adherence.
The magnitude of adherence was calculated using the SMAQ scale scoring for each patient. The BAASIS questionnaire was used to measure non-adherence to immunosuppressant medications over the past four weeks.
A chi-square test was run to compare the underlying characteristics of patients based on adherence status.
Binary logistic regression analysis was used to analyze different factors for medication adherence. Bivariate analysis was used to measure the association between the dependent variable and each independent variable. Independent variables with a P < 0.25 were considered for multivariate analysis. Multicollinearity was tested with a linear regression model for the independent variables.
The goodness of model fit test was done by the Hosmer and Lemeshow tests. The multicollinearity of the independent variables was tested by a linear regression model.
The findings and conclusions were discussed, with possible interventional tools and recommendations.
Operational definitions
Immunosuppressive medication
medications that are prescribed for the purpose of preventing graft rejection in the kidney transplantation.
Adherence
the extent to which a person’s behavior in taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider.
Adherent/ complaint
if he/she responds to all of the questions with adherent answer and in terms of quantification, if the patient has responded with adherent answer in the forgetfulness, routine, adverse effect and quantifying assessment questions by using a SMAQ questionnaire score [11].
Non-adherent/non-compliant
if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months by SMAQ questionnaire score [11].
Ethical considerations and consent to participate
Ethical clearance to conduct the study and official letter was obtained from the institutional review board of SPHMMC. After explanation about the whole purpose of the study, written informed consent was obtained from study participants.
All of the study participants were informed about the purpose of the study, about their right to participate or to terminate at any time if they want and also respondents were ensured about the confidentiality of information obtained.
The authors declare that all the methods included in the study are in accordance with the declaration of Helsinki.
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- Source: https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-024-03620-z