Journal of Pediatric Psychology, Vol. 26, No. 8, 2001, pp. 455-464
© 2001 Society of Pediatric Psychology
Self-Regulation Predictors of Medication Adherence Among Ethnically Different Pediatric Patients With Renal Transplants
1 University of Florida, 2 Reed College
All correspondence should be sent to Carolyn M. Tucker, Department of Psychology, P.O. Box 112250, University of Florida, Gainesville, Florida 32611. E-mail: tucker{at}psych.ufl.edu .
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Abstract |
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Objective: To predict medication adherence among ethnically different pediatric patients with renal transplants between the ages of 6 and 20 years old, using self-regulation variables including motivation, perceived control and responsibility, and perceived support.
Methods: Twenty-six African American children and 42 Caucasian children were verbally administered the Self-Regulation of Medication Adherence Battery to assess their (1) motivation to be medication adherent, (2) perceived control of and responsibility for medication adherence, and (3) perceived support of medication adherence from their primary caregiver. Four measures were used to assess medication adherence: self-ratings, nephrologists' ratings, cyclosporine levels, and pill count/refill histories.
Results: For the African American patients, regression analyses revealed that responses to motivation and perceived control questions that focused on self-efficacy were unique predictors of medication adherence as rated by their primary nephrologist. For the Caucasian patients, one motivation question regarding how often they forget to take their medication predicted their self-reported adherence.
Conclusions: Facilitating their beliefs that they can regularly take their medications may help promote medication adherence among African American children with renal transplants, whereas for Caucasian children, providing cues and reminders to take their medications may help. We discuss implications of the results for multimodal assessment of medication adherence and for ethnic group-specific medication adherence research and interventions.
Key words: self-regulation; medication adherence; children; renal transplant; ethnicity; African American.
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Introduction |
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Medication nonadherence is a particularly challenging problem for children and adolescents who have undergone renal transplantation (Meyers, Thomson, & Wieland, 1996). These patients must take numerous medications, often in different dosages and forms, at several times throughout the day. Reported medication nonadherence rates among pediatric patients with renal transplants range from 5% to as high as 64% (Ettenger et al., 1991
; Morgenstern et
al., 1994). The potential consequences of medication nonadherence
are serious and include more frequent medical complications and
hospitalizations, higher health care costs and family stress
(Arbus, Sullivan, & Tejani,
1993; Fukunishi & Honda,
1995; Swanson, Hall, Bartos,
& Schweizer, 1992), and increased risks for allograph loss and
immunologic losses (Bittar et al.,
1992; Salvatierra et al.,
1997).
Existing research on medication adherence among children and adolescents
with renal transplants has been conducted primarily with samples of Caucasian
children. Thus, we know little about medication adherence among children with
renal transplants from other ethnic or cultural backgrounds. Yet the strongest
relative risk factor for graph survival among pediatric living donor
recipients has recently been found to be African American race
(Benfield, McDonald, Sullivan, Stablein,
& Tejani, 1999; McDonald,
Donaldson, Emmett, & Tejani, 2000). These findings and the
conclusions that medication adherence is important for successful renal
transplantation in children (Salvatierra
et al., 1997) suggest the need to examine factors in the
medication adherence of African American children with renal transplants.
In this study we used the culturally sensitive difference model research
approach (Oyemade & Rosser,
1980) to study medication adherence among children with renal
transplants. This research approach involves separately analyzing the research
data of groups that differ culturally or socio-economically in order to
identify within-group differences such as why some low-income African American
patients are medication adherent and others are not. The difference model
research approach avoids using behaviors or performance of majority Americans
(i.e., Caucasian) as the comparison standard or norm, and it avoids viewing
behaviors or performance by other ethnic groups as deficits (i.e., the deficit
model research approach) rather than as differences. Based on this approach,
this study was designed to identify, by ethnicity, behaviors, and beliefs that
predict medication adherence among African American children and Caucasian
children with renal transplants.
We used Kanfer's self-regulation model
(Kanfer & Goldstein, 1986)
as the conceptual framework for identifying potential predictors of medication
adherence among the African American children and Caucasian children in this
study. Kanfer's model as applied to health promotion suggests that regulation
of health behaviors (e.g., medication adherence) is determined by the
following self variables: (1) motivation to be healthy, (2) perceived control
over one's health, and (3) perceived support of health-promoting behaviors
from significant others. Because busy work schedules and other family
variables such as economic and marital stress sometimes limit parental
supervision of children's behaviors, self-regulation variables may be
important in understanding and promoting medication adherence among children,
particularly among African American children, given the disproportionately
high percentages of single-parent families and low-income families among
African Americans.
Consistent with Kanfer's self-regulation model and the difference model, we
hypothesized that (1) motivation to be medication adherent, perceived control
over and responsibility for medication adherence, and perceived support
received from primary caregivers for medication adherence would be significant
predictors of levels of medication adherence among both African American
children and Caucasian children with renal transplants; and (2) the strength
of these predictive relationships would vary by ethnic group. We used multiple
measures of medication adherence in this study due to the inconsistency in
medication adherence measures and medication adherence rates reported in the
research literature on medication adherence among children (Davis, Tucker,
& Fennell, 1996; Ettenger et al.,
1991; Meyers et al.,
1996; Morgenstern et al.,
1994).
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Method |
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Participants
Participants in this research were 68 pediatric patients with renal transplants (functional for at least 6 months) between the ages of 6 and 20, the age range of children who attended the clinic from which most participants in the study were recruited, and the primary caregivers of the patient participants. A further description of the patient sample is presented in Table I. Only patients with a functioning renal transplant for at least 6 months were included in the study because anecdotal clinical data as reported by the consulting pediatric nephrologist suggest that consistent adherence patterns are usually established by 6 months posttransplant (R. S. Fennell, personal communication, April 1999). Excluded from the study were patients whose medical charts revealed any one of the following diagnoses: (1) mental retardation, (2) autistic disorder or other pervasive developmental disorder, (3) a learning disability, or (4) attention-deficit hyperactivity disorder.
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Three 6-year-olds were among the research participants. These young children were included because pilot testing with three 6-year-olds and two 5-year-olds suggested that children at age 6 understood the questionnaires used in this research and because the researchers who administered these questionnaires to the 6-year-olds who actually participated in this research were confident that these children understood the questions. The pilot testing involved asking each pilot child participant some questionnaire items in two different ways to determine whether the child gave consistent responses that reflected understanding of the questions. This testing also involved repeating approximately 50% of the questions twice verbatim to estimate the reliability of the questionnaires for children ages 5 or 6.
The patient participants consisted of 26 African American patients (6 girls
and 20 boys) and 42 Caucasian patients (21 girls and 21 boys). Assuming an
effect size of.25 and 
=.0125, these sample sizes yielded power levels
of.653 and.882 for the analyses involving African American patients and
Caucasian patients, respectively. The significantly higher percentage of boys
versus girls among the African American participants is consistent with the
gender composition of the African American pediatric patients at the
nephrology clinics where African American patients were recruited. The
significant mean age differences (t[66] = 2.44, p =.017)
between the African American patients (M = 12.90) and the Caucasian
patients (M = 15.00) is likely due to the fact that African American
patients were recruited from four sites, three of which had patient
populations with a younger mean age than did the single site from where
Caucasian patients were recruited. The age difference between the groups may
also have accounted for the significant disparity for months with current
allograph (t[66] = 3.08, p =.003) between African American
(M = 33.8) and Caucasian (M = 47.2) patients.
Most of the African American primary caregivers were mothers (96%), and the
others were mother figures (stepmothers or grandmothers, 4%). Most of the
Caucasian caregivers were also mothers (86.1%), and the others were mother
figures (stepmothers or grandmothers, 6.9%) or fathers (7%). Primary
caregivers of six Caucasian patients did not participate in the research. Each
of these six patients and each patient-primary caregiver pair received $30.00
for their time and effort to participate. Over half of the participants in
both ethnic groups had low incomes, and both ethnic groups had similar income
distributions (
2 [4] = 0.597; p.10; see
Table I).
The African American patients were recruited from four Southeastern pediatric nephrology clinics known to have a concentration of African American patients higher than what is typical at such clinics. The participation rate of the African American patients and their primary caregivers across the four clinics ranged from 50% to 68%. Correct addresses were obtained in all cases where mailed forms were returned (i.e., for four African American families and two Caucasian American families). All patients and primary caregivers who returned signed informed consent forms actually participated in the research. No data were obtained regarding reasons for non-participation.
The Caucasian patients and primary caregivers were recruited from only one of the four clinics where African American patients were recruited—the one that first agreed to be a research participation site. The participation rate of the Caucasian patients and their primary caregivers at this clinic was 84%. Given this high participation rate and the relatively lower participation rate among the African American patients and their primary caregivers at this clinic, effort and money were invested in recruiting only African American patients at the other three clinics that were research participation sites.
Instruments
The 20-item Marlowe-Crowne Social Desirability Scale-Short Version (MCSDS;
Crowne & Marlowe, 1960) was
used to measure each patient's tendency to give socially desirable responses
rather than true responses. Fraboni and Cooper
(1989) reported test-retest
reliabilities for the MCSDS to be.80 to.84.
The Frazier Noncompliance Inventory (FNI;
Frazier, Davis-Ali, & Dahl,
1994) is a self-report measure of overall medication adherence.
The FNI consists of 11 items rated on a 5-point Likert scale designed to
assess how often (1 = very often to 5 = never) patients do not take their
medications for general reasons (e.g., because I am away from home). The
internal consistency of the FNI has been reported to be r =.90.
The Primary Nephrologist's Adherence Rating Form (PNARF) was used by a patient's nephrologist to rate the patient's level of overall medication adherence on a scale of 1 = very nonadherent to 5 = very adherent. No psychometric data exist for this measure.
The Pill Count/Refill History Form (PC/RHF) was used to determine and
record each patient's medication adherence based on the number of
azathioprine, cyclosporine, and prednisone pills that a patient had in his or
her possession (as reported by the primary caregiver) compared to the number
of pills of each of these medications that the patient should have,
given the number of prescribed refills of each medication the patient had
obtained. Consistent with other reported pill count adherence measurement
procedures (Lee et al., 1996),
the lower the discrepancy between the number of pills a patient has and the
number of pills she or he should have, the higher the subjective medication
adherence rating (from 1 = very nonadherent to 5 = very adherent) the patient
would be given. These ratings were given by an advanced pharmacy student
researcher and were reviewed by the primary researcher, who concurred 100%
with the ratings. No other psychometric data exist for this measure.
The Cyclosporine Level Rating Form (CLRF) was used by the researchers to record each patient's most recent cyclosporine level as indicated in her or his medical chart and each patient's rating of medication adherence based on this cyclosporine level. The consulting pediatric nephrologist for this research constructed the cyclosporine adherence rating guide that specified the cyclosporine adherence rating (from 1 = very nonadherent to 5 = very adherent) that was appropriate, given the desired range of cyclosporine levels for that point post-transplant. No psychometric data exist for this rating guide.
The Self-Regulation of Medication Adherence Battery (SRMAAB), a self-regulation theory-based assessment battery for patients, consists of (1) three medication adherence motivation (MAM) questions, (2) four perceived control of medication adherence (PCMA) questions, and (3) three perceived caregiver support of medication adherence (PCSMA) questions. These 10 questions and the rating scales used to respond to these questions are provided in Table II. No psychometric data exist for the SRMAAB.
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A demographic questionnaire (DQ) was used to obtain information about the primary caregiver's gender and family income level. Finally, a medical data sheet (MDS) was used to obtain the following from each patient's medical file: his or her current medication regimen, number of months of having the current functioning allograph, prior history of dialysis, and number and dates of renal transplants received.
Procedure
The research protocol was independently reviewed and approved by the
institutional review board of each of the participating pediatric nephrology
clinics. Physicians and staff at each of these clinics identified pediatric
patients with renal transplants who met the patient participation criteria.
The primary caregiver for each of these potential research participants
received a letter from the patient's primary nephrologist and the primary
researcher that stated the general nature of the study and what participation
in the study would involve. The letter also said that each participating
family (patient and primary caregiver) would receive $30 for their time and
effort within 4 to 6 weeks following the interview and that, to participate,
the provided informed consent forms (one for the child and one for the primary
caregiver) must be signed and returned to the primary researcher.
Upon receiving signed informed consent forms, we scheduled a data collection interview session scheduled by telephone jointly for the patient and her or his primary caregiver. The interview with each patient consisted of verbal administration of the SRMAAB, the MCSDS, and the FNI. The interview with each primary caregiver consisted of verbal administration of the DQ.
All interviews with Caucasian patients (n = 42) and half (n = 13) of the interviews with African American patients were conducted in a private room during a regular clinic visit. Because 13 (50%) of the participating African American patients were from clinics from 200 to 260 miles from the researchers, these 13 patients and their primary caregivers were interviewed separately via telephone.
Each interview, whether face-to-face or via telephone, was scheduled and conducted by one of six Caucasian college students who had been trained in all research procedures by the principal investigators, among whom was an African American clinical psychologist. This weekly training included observed practice of procedures and skills taught, occurred in three one-hour segments, and focused on (1) building rapport with and being sensitive to patients with renal transplants, (2) verbally administering the assessment questionnaires in an accurate and comfortable manner, (3) giving answers to questions from patients in an instructive manner that did not bias the research, and (4) being culturally and socioeconomically sensitive when greeting and interviewing patients.
Within 1 or 2 days before or on the day of the data collection interviews with a patient and with his or her primary caregiver, the primary caregiver was contacted via telephone to get pill count information (i.e., number of cyclosporine, prednisone, and azathriopine pills on hand) and to get the name of the pharmacy used to purchase pills for the patient. This pharmacy was then contacted by the advanced pharmacy student researcher to obtain needed pill refill history information for use in assigning the patient a subjective overall medication adherence rating on the PC/RHF.
An MDS and a CLRF were completed for each patient by a physician assistant or nurse practitioner paid by the research team or by a researcher under the supervision of the patient's primary pediatric nephrologist. A PNARF was completed by each patient's primary pediatric nephrologist.
The data for this study were obtained within a 1-year period. Data from a specific patient and his or her primary caregiver were collected within a 1-week period. Each interview with a primary caregiver lasted approximately 15 minutes, and each data collection interview with a patient lasted approximately 30 minutes. On average, the telephone data collection interviews lasted approximately 5 minutes longer than the face-to-face interviews.
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Results |
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Preliminary Analyses
Preliminary analysis of covariances (ANCOVAs) were performed on the African American patients' data to determine whether the variables clinic location and method of data collection (i.e., face-to-face or via telephone) influenced any of the four medication adherence ratings and thus should be controlled for in the main analyses. Results of these ANCOVAs were nonsignificant. Additionally, preliminary Pearson correlation analyses were performed separately by ethnic group to determine if patients' social desirability scores were significantly associated with their self-ratings on each item of the SRMAAB. These variables were not significantly correlated.
Preliminary ANCOVAs were performed separately by ethnic group to determine if age, gender, having a prior history of dialysis, or number of months of having the current functioning allograph influenced any of the four medication adherence ratings. The ANCOVAs applied to the African American patients' medication adherence data were all nonsignificant. However, the ANCOVA with the Caucasian patients' PC/RF ratings as the dependent variable proved to be significant, F(3, 24) = 3.93, p <.02. Caucasian girls were rated as significantly more (p <.01) medication adherent based on PC/RHF data (M = 4.64) than boys were rated (M = 2.62). Consequently, in the main analyses involving Caucasian patients' PC/RHF data as the criterion variable, gender was entered as a covariate.
Finally, preliminary Pearson correlation analyses were performed separately by ethnic group to determine if there were significant positive associations among the four medication adherence ratings, justifying the creation of a composite medication adherence rating. For the African American patients, a significant positive correlation was found between medication adherence ratings based on cyclosporine levels and medication adherence ratings based on the subjective judgment of each patient's primary nephrologist (n = 26, r =.61, p <.01). For the Caucasian patients, no significant correlations were found. Furthermore, for both ethnic groups, there were greatly reduced sample sizes for calculating mean cyclosporine assay ratings and pill count/refill history ratings due to missing medical chart data and pharmacy refill history data, respectively. Given the different sample sizes for calculating the adherence measures and the lack of correlation among these measures, we considered the ratings on each of the four medication adherence measures separately in the main analyses. Post-hoc t tests revealed that the Caucasian patients reported higher mean medication adherence (M = 4.37) than the African American patients (M = 3.89, t[66] = 2.19, p =.03). Other mean adherence rating differences between the groups were nonsignificant (see Table III).
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Main Analyses
Consistent with the different model research approach, we performed
multiple regression analyses separately for each ethnic group to determine the
self-regulation theory-based predictors of medication adherence for each
ethnic group. The main analyses involved first conducting four
R2 procedures to determine which self-regulation theory
variables (i.e., the items on the SRMAAB) to examine in the multiple
regression analyses as predictors of each of the four medication adherence
ratings, taking into account the small number of patients in each ethnic group
and the reduced sample size for some of these ratings. By adjusting for any
shared variance among the self-regulation theory variables, these
R2 procedures identified the best fit model (i.e., the
most uniquely influential self-regulation theory variables) for predicting
each of the four medication adherence ratings for each ethnic group. To
correct for multiple comparisons and to control experimentwise error using the
Bonferroni adjustment, we maintained the critical alpha at.0125 for all
regression analyses (.05/4, given that the data from each subject appeared in
four analyses).
Social desirability scores were included in the R2 procedures in which self-ratings of medication adherence (i.e., the FNI ratings) were the criterion variable. For the Caucasian patients only, gender was also entered in the R2 procedure that involved pill count/refill history as the criterion variable, given that, as previously noted in the preliminary analyses, gender differences were found in this variable.
For African American patients, only the multiple regression with medication adherence ratings by the primary nephrologist as the criterion variable proved to be significant using.0125 as the critical alpha (see Table IV). Based on the results of the R2 procedure prior to this multiple regression, the predictor variables entered into this regression were patients' social desirability scores and their responses to MAM question 3, PCMA questions 6 and 7, and PCSM question 9. Patients' responses to MAM question 3 (B =.69) and to PCMA questions 6 (B =.58) and 7 (B =.93) were found to be significant predictors of African American patients' medication adherence ratings as rated by their primary nephrologists. Follow-up scatter plots revealed that the following were associated with higher adherence ratings: (1) higher reported certainty by patients about when and how to take their medication, and (2) higher reported certainty by patients that they can take their medication regularly and that doing so will keep their transplanted kidney healthy. The multiple regression models for predicting cyclosporine ratings, F(4, 13) = 4.01, p <.04, R2 =.64, self-ratings, F(4, 22) = 3.81, p <.02, R2 =.46, and pill count/refill ratings, F(5, 10) = 8.19, p <.02, R2 =.89, for African American patients were not significant.
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For the Caucasian patients, only the multiple regression with self-ratings of medication adherence (FNI ratings) proved to be significant, F(5, 36) = 3.81, p <.0002, R2 =.43 (see Table IV). Based on the results of the R2 procedure that was preliminary to this multiple regression, the variables entered into this regression as predictors were social desirability ratings and responses to MAM questions 2 and 3, PCMA question 7, and PCSMA question 9. However, only Caucasian patients' responses to MAM question 2 were found to be a significant predictor of their self-ratings of medication adherence (B = -.41). A follow-up scatter plot showed that the less often Caucasian patients reported forgetting to take their medications, the higher their self-ratings of medication adherence. The multiple regression models for predicting cyclosporine ratings, F(6, 31) = 1.21, p<.33, R2 =.23, nephrologist ratings, F(5, 39) = 1.86, p <.13, R2 =.21, and pill count/ refill ratings, F(4, 22) = 4.02, p <.02, R2 =.47, were not significant.
Post-hoc t tests applied to the mean scores on each of the 10 self-regulation theory variables revealed significant differences on patient responses to three questions: MAM 2, PCMA 5, and PCMA 7 (see Table II). Inspection of the mean scores on these questions indicated that African American patients were more likely to report (1) often forgetting to take their medication (M = 2.25), (2) higher parent responsibility for taking their medication (M = 3.41), and (3) more certainty that taking their medication would promote healthy kidneys (M = 4.57) compared to Caucasian patients (M = 1.54, 2.18, and 3.13, respectively) (see Table II).
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Discussion |
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TopAbstractIntroductionMethodResultsDiscussionReferences |
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This research sought to separately identify predictors of medication adherence between two ethnic groups of pediatric patients with renal transplants—African Americans and Caucasians. The medication adherence of African American children was examined separate from that of the Caucasian children based on the culturally sensitive difference model research approach advocated by Oyemade and Rosser (1980
). The finding in this
study that the significant predictors of medication adherence differed by
ethnic group seems to provide support for using this research approach. Given
that the predictors of medication adherence examined in this research were
anchored in Kanfer's self-regulation model, the findings also suggest that
Kanfer's model may be useful in studying medication adherence of children with
renal transplants, especially those who are African American. For African
American children as compared to Caucasian children, the strength and number
of significant self-regulation theory-based predictors were greater. Specifically, for African American children, questions that tapped two self-regulation variables—motivation to be medication adherent and perceived control of medication adherence—significantly predicted medication adherence as rated by their primary nephrologist. The three questions that predicted adherence among African American children all focused on their beliefs that they could successfully take their medications and that so doing would be helpful. Thus, self-efficacy may be especially important in understanding and promoting medication adherence among African American children.
If similar future research with larger samples, complete data sets, and objective medication adherence measures reveal similar results to these findings, support will be provided for promoting medication adherence among African American pediatric patients by (1) facilitating their beliefs that they can regularly take their medications and that regularly taking their medications will help keep their kidneys healthy, and (2) teaching them strategies for reminding them to take their medications when and how these medications have been prescribed.
For the Caucasian children, only one question that tapped motivation ("How often do you forget to take your medications?") significantly predicted their self-reported medication adherence. If this finding is replicated in similar future research with larger samples and objective medication adherence measures, support will be provided for promoting medication adherence among Caucasian children by developing strategies for reminding them to take their medication.
The finding in this study of only one significant correlation among the four commonly used types of medication adherence ratings seems to suggest that using only one or two measures of medication adherence, as in most studies of medication adherence in children, may be problematic. Perhaps future medication adherence research with pediatric renal transplant patients should include the multiple measures of medication adherence used in this study to allow further examination of the relationships among these measures. Furthermore, research is needed to obtain reliability and validity data on the commonly used medication adherence measures and the SRMAAB used in this research. The lack of this data here is a limitation and requires viewing the findings in this study and conclusions drawn from these findings with much caution.
One can only speculate about the factors in the lower participation rate among African American families (.50 to.68 across the four participating clinics used to recruit African American patients) as compared to the Caucasian families (.84). A lack of trust of researchers that others have suggested to be a repercussion of the Tuskegee Syphilis Study (Corbre-Smith, 1999) cannot be ruled out as a factor. Given the similar income distributions across both ethnic groups in this research, it seems unlikely that economic-related issues (e.g., lack of transportation to the research site or not having access to a telephone) accounted for the participation rate differences between these groups.
The impact of the interviewers' race on these different participation rates or on the findings in this study is unknown. This potential confounding variable, combined with the other limitations of the study, including sample size and gender composition, further justifies viewing the findings in this research with much caution.
Multiclinic collaborative medication adherence research may be useful in increasing the number of African American pediatric renal transplant patients in studies of medication adherence. Focus groups might be helpful in uncovering the reasons for low participation rates of African American pediatric patients with renal transplants in research and in identifying what researchers can do to improve research participation rates among these patients.
If the findings in this study are supported in future similar research with larger and more gender-representative patient samples and with proven reliable and valid measures of medication adherence and of self-regulation predictors of medication adherence, self-regulation theory-based predictors of medication adherence among African American pediatric patients with renal transplants using a difference model research approach will be confirmed. The pivotal step for such research is clearly the identification of culturally sensitive participant recruitment methods that will increase the research participation rates among these patients.
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Acknowledgments |
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This research project was supported by a grant from the Cofrin Foundation. Special thanks are extended to John Dixon, the statistical consultant for this research.
Received June 21, 1999; revision received December 15, 1999; revision received April 6, 2000; revision received August 18, 2000; accepted January 8, 2001
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