Is simplification of immunosuppressive medication a way to promote medication adherence of kidney transplant recipients? Findings from a randomized controlled trial.
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SUBMITTER: van Zanten R
PROVIDER: S-EPMC9292224 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAmong adult kidney transplant recipients, non-adherence to immunosuppressive medications is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of kidney transplant patients experience medication non-adherence even though the problem is preventable. Existing adherence interventions have proven marginally effective for those with acute and chronic illnesses and ineffective for adult kidney transplant recipients. Our purpose is to describe the design and methods of the MAGIC (Medication Adherence Given Individual SystemCHANGE™) trialMethods/designWe report the design of a randomized controlled trial with an attention-control group to test an innovative 6-month SystemCHANGE™ intervention designed to enhance immunosuppressive medication adherence in adult non-adherent kidney transplant recipients from two transplant centers. Grounded in the Socio-Ecological Model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-led experiments to change and maintain behavior. After a 3-month screening phase of 190 eligible adult kidney transplant recipients, those who are <85 % adherent as measured by electronic monitoring, will be randomized into a 6-month SystemCHANGE™ intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention. Differences in adherence between the two groups will be assessed at baseline, 6 months (intervention phase) and 12 months (maintenance phase). Adherence mediators (social support, systems-thinking) and moderators (ethnicity, perceived health) are examined. Patient outcomes (creatinine/blood urea nitrogen, infection, acute/chronic rejection, graft loss, death) and cost effectiveness are to be examined.DiscussionBased on the large effect size of 1.4 found in our pilot study, intervention shows great promise for increasing adherence. Grounded in the socio-ecological model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. Medication adherence will be measured by electronic monitoring. Medication adherence persistence will be examined by evaluating differences between the two groups at the end of the 6-and 12- month phases. Mediators and moderators of medication adherence will be examined. Patient outcomes will be compared and a cost-effectiveness analysis will be conducted.Trial registrationClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.
| S-EPMC4947243 | biostudies-literature
Project description:We sought to evaluate the prevalence of medication understanding and non-adherence of entire drug regimens among kidney transplantation (KT) recipients and to examine associations of these exposures with clinical outcomes. Structured, in-person interviews were conducted with 99 adult KT recipients between 2011 and 2012 at two transplant centers in Chicago, IL; and Atlanta, GA. Nearly, one-quarter (24%) of participants had limited literacy as measured by the Rapid Estimate of Adult Literacy in Medicine test; patients took a mean of 10 (SD=4) medications and 32% had a medication change within the last month. On average, patients knew what 91% of their medications were for (self-report) and demonstrated proper dosing (via observed demonstration) for 83% of medications. Overall, 35% were non-adherent based on either self-report or tacrolimus level. In multivariable analyses, fewer months since transplant and limited literacy were associated with non-adherence (all P<.05). Patients with minority race, a higher number of medications, and mild cognitive impairment had significantly lower treatment knowledge scores. Non-white race and lower income were associated with higher rates of hospitalization within a year following the interview. The identification of factors that predispose KT recipients to medication misunderstanding, non-adherence, and hospitalization could help target appropriate self-care interventions.
| S-EPMC5061615 | biostudies-literature
Project description:Background:Medication non-adherence is the major risk factor for rejection episodes. The aim of this study was to determine the risk factors associated with adherence to immunosuppressive regimen and its barriers among kidney transplant (KT) recipients. Methods:A cross-sectional study was performed in two outpatient post-transplant clinics in Mashhad, northeast of Iran. All patients who attended the clinics from August to October 2017 were included. Patients's knowledge, adherence to immunosuppressive regimen, and quality of life were measured using the Kidney Transplant Understanding Tool, Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS), and SF-12V2 questionnaire, respectively. The barriers in adhering immunosuppressive regimen were investigated by Immunosuppressive Therapy Barriers Scale. Logistic regression was used to screen the significant risk factors of medication non-adherence. Results:In this study, 244 KT recipients were included with a mean age of 39.6±12.5 years. Based on the BAASIS score, 111 (45.5%) patients were adherent to immunosuppressive regimen. Female patients were more likely to be adherent (OR=0.48, p<0.01). The patients with higher level of quality of life were more likely to follow immunosuppressive medications (OR=1.078, p<0.05). The main barriers were as follows: concurrent use of many immunosuppressants, lack of knowledge about the usefulness of immunosuppressive medications, confusion in medication taking, and difficulty in remembering medication taking. Conclusion:More than half of the KT recipients were non-adherence to immunosuppressive regimen. These findings highlight the need for designing interventions in order to reduce or eliminate these barriers and consequently increase medication adherence among KT recipients.
| S-EPMC6844196 | biostudies-literature
Project description:BackgroundAmong kidney transplant recipients, gender differences in medication adherence may contribute to higher graft failure risks observed in girls and young women compared with boys and young men. Our aim was to determine whether adherence differs by gender, and whether gender differences vary by age in adolescent and young adult kidney transplant recipients.MethodsWe examined data from the 3-month run-in period (no intervention) of the randomized Teen Adherence in Kidney transplant Effectiveness of Intervention trial. Adherence was monitored using electronic pillboxes in 136 patients (11-24 y) followed in 8 transplant centers in Canada and the United States. We used ordinal logistic regression with generalized estimating equations to estimate the association between gender and each of daily taking (proportion of prescribed doses taken) and timing (proportion of prescribed doses taken on time) adherence, considering effect modification by age (11-16 y vs 17-24 y).ResultsNo difference in taking adherence was observed by gender among participants aged 11 to 16 years (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.55-1.54), whereas among participants aged 17 to 24 years, women had significantly greater odds of higher taking adherence scores (OR, 3.03; 95% CI, 1.20-7.66) than men. Results were similar for timing adherence, with no difference among participants aged 11 to 16 years (OR, 1.03; 95% CI, 0.65-1.63) but a greater odds of higher timing adherence scores in women than in men among participants aged 17 to 24 years (OR, 3.26; 95% CI, 1.43-7.45). There were no differences in adherence assessed by self-report or SD of tacrolimus trough levels.ConclusionsGender differences in adherence vary by age. Whereas younger adolescents show no adherence differences by gender, young women show much better adherence than young men.
| S-EPMC6326890 | biostudies-literature
Project description:BACKGROUND:Nonadherence to immunosuppressive therapy after renal transplantation is associated with poor graft outcomes. We aimed to evaluate whether the use of the Adhere4U mobile medication manager application could improve adherence among renal transplant recipients ?1 year posttransplantation. Adhere4U can provide medication reminders, monitor medication use, and provide information on immunosuppressants. METHODS:We conducted a prospective randomized controlled study to compare the rate of nonadherence to index immunosuppressant (tacrolimus or cyclosporine) in a group using the Adhere4U app (mobile group) and in another group receiving conventional care (control group). The primary outcome was the nonadherence rate, which was evaluated using an electronic medication event monitoring system during the 6-month intervention period. Our secondary outcome included self-reported adherence using the Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) and the visual analog scale (VAS) based on a 4-week recall on days 28, 90, and 180. Longitudinal data of repeated measures of self-rated adherence were analyzed using generalized estimating equations (GEE) to compare the between-group difference in adherence change over time. RESULTS:Between November 2013 and May 2015, 138 renal transplant recipients were randomly allocated to the control (n = 67) or the mobile group (n = 71). The overall nonadherence rate over the 6-month study period by electronic monitoring was 63.6%, with no between-group difference [mobile group, 65.0% (n = 39/60); control group, 62.1% (n = 36/58); odds ratio 1.14; 95% confidence interval 0.53-2.40; p = 0.89]. Self-rated nonadherence assessed using the BAASIS and VAS at baseline was 53.7% and 51.5%, respectively. Although the self-rated nonadherence by BAASIS of the mobile group was lower than the control group throughout the study period, there was no between-group difference in the change of nonadherence over time (?2 = 2.82, df = 3, p = 0.42 by logistic GEE). There also was no significant between-group difference in the nonadherence by VAS (?2 = 1.71, df = 3, p = 0.63 by logistic GEE) over time. The main limitation of this study was the low rate of patient engagement with the app among the mobile group. The rate of app use was 47.6% (31/65) at 28 days, 33.9% (19/56) at 90 days, and 11.5% (6/52) at 180 days. CONCLUSIONS:The Adhere4U application did not improve adherence to immunosuppressive therapy. Our evidence is limited by the high rate of attrition. Further studies on strategies to facilitate patient engagement with mobile interventions are warranted.
| S-EPMC6830819 | biostudies-literature
Project description:This study analyzed the association between medication adherence and the intrapatient variability (IPV) of tacrolimus concentrations among kidney transplant recipients through a post hoc analysis of the dataset from a recently conducted randomized controlled trial. Among 138 patients enrolled in the original trial, 92 patients with ≥ 5 months of medication event monitoring system (MEMS) use and ≥ 4 tacrolimus trough values were included in this post hoc analysis. The variability of tacrolimus trough levels was calculated using coefficient variation (CV) and mean absolute deviation. Adherence was assessed using MEMS and self-report via the Basal Assessment of Adherence to Immunosuppressive Medication Scale. There were no statistically significant differences in the CV [median 16.5% [interquartile range 11.6-25.5%] and 16.0% [11.5-23.5%], respectively, P = .602] between the nonadherent (n = 59) and adherent groups (n = 33). There was also no significant correlation between the CV and adherence detected by MEMS (taking adherence, ρ = - 0.067, P = .527; dosing adherence, ρ = - 0.098, P = .352; timing adherence, ρ = - 0.113, P = .284). Similarly, adherence measured by self-report did not significantly affect the IPV (P = .452). In this post hoc analysis, nonadherent behavior, measured through electronic monitoring or self-report, did not affect the IPV.
| S-EPMC7940492 | biostudies-literature
Project description:Adolescent transplant recipients may encounter a range of potentially traumatic events (PTEs) pre- and posttransplant, yet little is known about the relationship between posttraumatic stress symptoms (PTSS) and medication adherence in this population. In the present study, adolescent recipients and caregivers completed psychosocial questionnaires at enrollment. Outpatient tacrolimus trough level data were collected over 1 year to calculate the Medication Level Variability Index (MLVI), a measure of medication adherence. Nonadherence (MLVI ≥2) was identified in 34.8% of patients, and most (80.7%) reported ≥1 PTE exposure. Levels of PTSS indicating likely posttraumatic stress disorder (PTSD) were endorsed by 9.2% of patients and 43.7% of caregivers. PTSS and MLVI were significantly correlated in the liver subgroup (r = .30, p = .04). Hierarchical multivariable linear regression analyses revealed overall patient PTSS were significantly associated with QoL (p < .001). PTEs are common in adolescent recipients; a minority may meet criteria for PTSD. PTSS screening to identify nonadherence risk requires further investigation and addressing PTSS may improve QoL. Caregivers appear at greater risk for PTSD and may require their own supports. The study was approved by each participating center's Institutional Review Board.
| S-EPMC8897237 | biostudies-literature
Project description:Among kidney transplant recipients, non-adherence with immunosuppressive medications frequently precedes allograft loss. We sought to determine the prevalence and correlates of medication non-adherence among kidney transplant recipients.We performed a single-center, cross-sectional study of kidney transplant recipients who were at least 6 months post-transplant. We measured self-reported adherence using the Immunosuppressive Therapy Adherence Scale (ITAS, which is scored from 0 to 12, where higher scores indicate increased adherence) and barriers to adherence using the Immunosuppressive Therapy Barriers Scale (ITBS). We also used validated scales to measure perceived stress, health literacy, anxiety, depression, and interpersonal support.The 252 patients included in the study were 59.9% male, 27.0% Black, and at a median of 2.9 years post-transplant (interquartile range [IQR] 1.4-5.8). On the ITAS, 59.1% scored a perfect 12, 26.6% scored 10-11, and 14.3% scored 0-9. In univariate models, non-adherence (defined as ITAS score ?9) was significantly associated with increased scores on scales for perceived stress (OR 1.12, 95% CI 1.01-1.25) and depression (OR 1.14, 95% CI 1.02-1.28), and with more self-reported barriers to adherence on the ITBS (OR 1.15, 95% CI 1.08-1.22). After adjusting for sociodemographic factors, stress and depression were not associated with non-adherence. Higher scores on the ITBS (corresponding to more self-described barriers to adherence) were associated with lower scores on the ITAS (P < 0.001). Several individual barriers were associated with non-adherence.Among prevalent kidney transplant recipients, a minority is non-adherent. Practical barriers to adherence may serve as promising targets for future interventions.
| S-EPMC4219432 | biostudies-other
Project description:Disruption of usual routines may hinder adherence, increasing the risk of rejection. We aimed to compare weekend versus weekday medication adherence among adolescent and young adult kidney transplant recipients, hypothesizing poorer adherence on weekends. We examined data from the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT). We assessed the 3-month run-in period (no intervention) and the 12-month intervention interval, considering a potential interaction between weekend/weekday and treatment group. Adherence was monitored using electronic pillboxes in participants 11-24 years followed in eight transplant centers in Canada and the United States. We used logistic regression with generalized estimating equations to estimate the association between weekends/weekdays and each of perfect taking (100% of prescribed doses taken) and timing (100% of prescribed doses taken on time) adherence. Taking (OR = 0.72 [95% CI 0.65-0.79]) and timing (OR = 0.66 [95% CI 0.59-0.74]) adherence were poorer on weekends than weekdays in the run-in (136 participants) and the intervention interval (taking OR = 0.74 [0.67-0.81] and timing OR = 0.71 [95% CI 0.65-0.77]). There was no interaction by treatment group (64 intervention and 74 control participants). Weekends represent a disruption of regular routines, posing a threat to adherence. Patients and families should be encouraged to develop strategies to maintain adherence when routines are disrupted. TAKE-IT registration number: Clinicaltrials.gov registration: NCT01356277 (May 17, 2011).
| S-EPMC6940530 | biostudies-literature
Project description:BackgroundNonadherence to posttransplant immunosuppressive medication is associated with increased rates of rejection and graft loss, yet it is unknown to what degree ideal adherence is associated with the sequelae of overimmunosuppression. Specifically, we questioned whether excellent adherence increased the posttransplant cancer risk.MethodsBetween August 1998 and August 2006, 195 consenting kidney transplant recipients had electronic monitoring of theirimmunosuppressive medication adherence.ResultsBased on their average quantitative adherence to a single immunosuppressant drug over the first 6 months posttransplant, recipients were grouped into adherence tertiles (highest, >97.9% adherence; middle, 91-97.8%; lowest, <91%). The cumulative incidence of cancer was calculated for patients in each tertile, treating death as a competing risk. The association between adherence and cancer rate was calculated after adjusting for recipient risk factors, using a competing risk proportional hazards model. The median duration of follow-up was 10.1 years. The 10-year estimated cumulative cancer incidence was 59.4% in the most adherent, 36.1% in the middle group and 38.1% in the least adherent group (P = 0.006). Excluding nonmelanocytic skin cancers, cancer incidence remained significantly higher in the highest adherence group (P = 0.002).ConclusionsThese data provide additional support for the need to individualize immunosuppression to minimize both rejection and immunosuppressive drug-related complications including cancer.
| S-EPMC6365768 | biostudies-literature