dherence to IDDM Regimens: Relationship to Psychosocial Variables and Metabolic Control

LORRAINE C. SCHAFER, M.S., RUSSELL E. GLASGOW, Ph.D., KEVIN D. McCAUL, Ph.D., AND MARK DREHER, Ph.D.

Thirty-four adolescents (ages 12-14 yr) with IDDM completed a questionnaire assessing regimen adherence over the previous week and psychosocial measures potentially related to adherence. Four aspects of the IDDM regimen were studied: insulin injections, dietary patterns, glucose testing, and exercise. Psychosocial variables included (1) Social Learning Theory measures of diabetes-specific family behaviors and barriers to adherence and (2) more general measures of family interaction. Glycosylated hemoglobin levels were predicted accurately (R = 0.68) from a combination of three adherence measures. The psychosocial measures were not directly related to metabolic control, but they were associated with adherence. Degree of adherence to one aspect of the IDDM regimen was not related to adherence to other aspects of the regimen and different psychosocial variables predicted adherence to different regimen components. The diabetes-specific measures were generally more predictive of adherence than were the more global measures. Implications and limitations of this cross-sectional, correlational study were
disCUSSed. DIABETES CARE 6: 493-498, SEPTEMBER-OCTOBER 1983.

he short- and long-term complications associated with IDDM have been well documented. In brief, the disease produces detectable neuropathy and retinopathy,1 and increases the risk of developing heart and kidney disease, blindness, and infection leading to gangrene.2 Recent findings, however, suggest that such complications are not inevitable. Careful regimen management, producing good metabolic control, favors longevity3 and may even reverse the presence of short-term complications.4 Given the importance of maintaining regimen adherence and metabolic control, investigators have begun to search for factors, including psychosocial variables, that influence adherence and control. The rationale for this search is that if such factors (e.g., family discord, health beliefs) can be identified, treatments to improve adherence and control can emphasize changes in those areas. Unfortunately, to date, the results of investigations of psychosocial factors in diabetes have produced, at best, mixed results.5 Studies designed to detect personality differences between persons with "good" versus "poor" control, for example, have been almost uniformly unsuccessful.6'7 In one recent study, adolescents defined as having adequate versus inadequate blood glucose regulation did not differ in terms of anxiety, locus of control, self-concept, or any of a variety of other personality dimen-

sions.8 Similar disappointing findings have been obtained for psychosocial variables that emphasize environmental or family influences on adherence and control. 910 Taken together, the results of studies concerned with the relationship between psychosocial variables and diabetes control have been unimpressive." The guiding purpose of the present research was to improve the "fit" between psychosocial variables, regimen adherence, and metabolic control. We tested two assumptions about methods that have been used to investigate the relationships among psychosocial variables, adherence, and control. One of these assumptions, behavioral specificity, was drawn from Social Learning Theory1213 and the second from a distinction between the influence of psychosocial variables on regimen adherence as opposed to metabolic control. Social Learning Theory stresses the reciprocal interaction between individual and environmental influences on behavior. Of particular interest here is the theory's emphasis on behavioral specificity; that is, predicting a particular behavior depends on measurement of psychological and environmental influences specific to that behavior. This notion suggests that "global" psychosocial measures (e.g., a general measure of family functioning, overall self-concept) should show minimal relationships to specific diabetes regimen behaviors. It

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TABLE 1 Subject characteristics and HbA, levels Years diagnosed Barriers to adherence Fam. beh. chklist: mother-negative

Age

Sex M M M F F F F F F F M M M M M M M F F F F F F F M M M M M F F F F F

HbA,

12 12 12
12 12 12 12 12 12 12 13 13 13 13 13 13 13 13 13 13 13 13 13 13

4 11
'

9.5
12.4 12.4

2 2 4 7 8 1 2 2 9
10 10 1

9.8 8.0 7.9

12.7

16.4

5.7 7.1
11.5

9.6
10.6

8.0 9.2
14.3 12.7

2 3 4 4
9 1 1 1

9.3
14.3 12.2 14.5 11.5

14 14 14 14 14 14 14 14 14 14

3 3 4 6 7 8

4.9 8.5 8.9 13.0 11.3 12.3 9.1 12.3 11.8

18 15 41 41 38 25 48 24 26 50 27 40 27 50 38 35 54 34 63 52 36 47 33 50
18

49 25 33 37
23 61 15

12 14 13 26 13 18 21 10 24 16 12 15 7 10 15 22 24 16 15 22 21 18 14 21 14 7 16 15 14 13 8 23 15

measures of adherence. In addition, blood samples were drawn for glycosylated hemoglobin determinations of metabolic control. We compared a global measure of family functioning to a scale assessing specific family behaviors relevant to the diabetes regimen and a specific measure of barriers to adherence. In addition, we compared the success of these psychosocial measures for predicting regimen adherence versus metabolic control.

METHOD

Subjects and Setting A summer camp sponsored by the North Dakota affiliate of the American Diabetes Association was the site for collecting measures from adolescents with IDDM. The campers included 34 Caucasian adolescents (15 boys and 19 girls) from 12 to 14 yr of age who had been diagnosed as having IDDM from 1 to 11 yr. Table 1 presents more detailed information on individual subjects. Procedure Prior parental consent for participation was obtained via the mail from the parents of all campers. During their orientation to camp, subjects were met individually and given instructions on how to complete each of the questionnaires, which were administered in counterbalanced order. They were instructed to answer questionnaires on the basis of their experiences over the week prior to camp. As each subject completed the questionnaire measures, the camp nurse drew blood samples by venipuncture for HbA] analyses in vacuum blood tubes containing EDTA. Measures
Psychosocial measures: barriers to adherence and problem solv-

' A "" indicates missing data.

would be preferable to construct psychosocial measures directly related to the behaviors of interest (e.g., how does a patient's family participate in the diabetes regimen?). A second possible explanation for the minimal relationships obtained between psychosocial variables and control is that investigators often attempt to predict measures of control directly from psychosocial variables. This approach is characteristic of much research in behavioral medicine;1415 unfortunately, it confuses outcome measures with adherence behaviors. It is unlikely that psychosocial variables will impact directly on metabolic control (though stress may be an exception; see ref. 16). It is more likely that psychosocial variables such as family behavior will affect control indirectly through their influence on adherence behaviors.17 The present study served as an initial attempt to test the above assumptions. In a cross-sectional study, adolescents with IDDM completed several psychosocial measures and
494

ing. The Barriers to Adherence and Problem Solving Scale was developed to measure (1) the extent that environmental barriers interfere with compliance to the recommended selfcare regimen and (2) one's ability to solve the problems created by such barriers. The instrument was constructed using the three step Behavior Analytic Model (situational analysis, response enumeration, response evaluation) developed by Goldfried and D'Zurilla.18 First, six persons (four women, two men) who varied in age (range 14-55 yr) and duration of IDDM (range 11-21 yr since diagnosis) and two nurse educators who specialized in diabetes were assembled to assist in instrument development. Participants were asked to generate as many problem situations as possible that occur for persons with IDDM. Instructions to the participants were that they should be as specific as possible and that they should try to think of problem situations interfering with each of the following regimen components: insulin injections, glucose monitoring, exercise and diet. Redundant items were then eliminated and the remaining 36 items were rated for frequency of occurrence and the difficulty of overcoming the barrier. Items that were infrequent or not problematic were

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eliminated. * A list of the 18 remaining items was mailed to the eight people who had generated them, and they were asked to write down as many possible solutions to each problem situation as they could. Participants were instructed not to evaluate their solutions but to include both "good" and "bad" solutions. Five investigators on the project, trained in Goldfried and D'Zurilla's problem-solving techniques and knowledgeable about diabetes self-care activities, rated the solutions for effectiveness. The rating scale used had three major categories of effectiveness ranging from low (1) to high (3). A preliminary multiple-choice version of the scale was then developed. For each of the 18 items, from four to six possible solutions were included. The solutions were those on which judges were able to achieve consensus on effectiveness ratings and included at least one from each major category. This version of the scale was administered to both adolescents and adults at two chapter meetings of the American Diabetes Association in different communities. Items that were confusing to participants, or that showed no variation across subjects in frequency of occurrence or extent to which they were problematic, were discarded. The current version of the scale contains 15 items. A Barriers score is calculated by summing the frequency of occurrence of barriers across all items. Total barriers scores can range from 15 to 105. A problem solving score, which can range from 15 to 45, is calculated by summing the effectiveness ratings of all solutions selected.
Diabetes Family Behavior Checklist. The Diabetes Family

dropped. The current version of the Diabetes Family Behavior Checklist consists of 16 items with nine positive (supportive) and seven negative items and approximately equal numbers of items for each of the regimen components mentioned earlier.! A positive summary score, obtained by summing the frequency ratings over all supportive items, can vary from 9 to 45. A negative summary score, obtained by summing the frequency ratings over all negative items, can range from 7 to 35. In the present study, subjects were asked to complete the checklist for both their father's and their mother's behaviors. They were assured that their answers on this as well as all the other questionnaires would be kept confidential. Moos Family Environment Scale (FES). The FES was administered as a measure of general interaction among family members. The FES is a widely used self-report questionnaire comprised of 10 subscales that measure the social climate of the family.21-22 We were interested in and administered five subscales that past research has shown to discriminate diabetic adolescents in good control from those in poor control.23 These five scales measure cohesion, expressiveness, conflict, independence, and organization within the family.
Adherence measure: Summary of Self-Care Activities. The

Behavior Checklist was developed to assess the frequency of both supportive and nonsupportive behaviors directed toward diabetic persons by family members. This scale differs from other scales of family interaction in that the items are specific to the diabetes regimen. Drawing on the work of investigators exploring the relationship between family support and other chronic diseases,l9 a Diabetes Family Behavior Checklist was developed to assess actions of family members in the four specific regimen areas previously discussed. An initial 14-item scale was piloted in a study designed to increase adherence to the diabetic self-care regimen in three adolescents with IDDM.20 Results from this study were encouraging and the scale was then expanded to include approximately four items for each of the regimen components discussed above and four general items. In addition, the format was changed from a checklist format to a 5-point scale ranging from 1 (never) to 5 (at least once a day). The scale was then administered to adults and children with IDDM and their family members at two chapter meetings of the American Diabetes Association in two separate communities. Items that were difficult to understand or were rated as occurring an average of less than once per week were

Summary of Self-Care Activities questionnaire is a self-report measure of the frequency of completing different regimen activities over the preceding 7 days. The questions on this measure were based on a large scale project recently completed by the Rand Corporation to identify and develop psychometrically acceptable measures of compliance to diabetes regimen components considered to be most important by a panel of experts.24 Our adherence scale consists of seven questions, five of which are similar to items in the Rand study and concern diet, insulin injections, and glucose testing. We developed one item concerning exercise for this study since the Rand report did not address this regimen component, and we also constructed a measure of frequency of glucose testing.
Metabolic control measure: glycosylated hemoglobin. Blood

samples were obtained from 10 nondiabetic subjects at the same time as the camp participants for determination of stable HbAt values. All samples were refrigerated on collection and analyzed the following day. Samples were saline-incubated for 5 h according to the method of Goldstein et al.25 to remove labile components reflecting transitory blood glucose levels. HbA! values were determined according to the BioRad minicolumn method26 at ambient temperature. Bio-Rad tri-level calibrators were used to correct test values to 22C.27 All procedures were performed according to manufacturers' specifications and all samples or calibrators were done in duplicate. Results from this procedure have been found to correlate quite well with the more definitive HPLC determinants of HbA lc levels.28 tCopies of the Diabetes Family Behavior Checklist and the Barriers to Adherence scale are available on request by writing to any of the first three authors.
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* On a 7-point frequency scale, items were excluded if the mean rating was <3 (about every other day) or if on a 5-point scale of how problematic the situation was, the mean rating for the item was <3 (moderately difficult, about half the time X is performed).

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RESULTS

his section is divided into three parts. We will first present descriptive data on the measures of metabolic control, adherence, and psychosocial factors. Second, we will present a comparison of the adherence versus psychosocial variables for predicting metabolic control. Finally, data will be presented comparing the ability of the specific against the general psychosocial measures to predict regimen adherence. The average HbA, level for diabetic subjects was 10.7% (SD across subjects = 2.7%). HbA, levels for nondiabetic subjects ranged from 5.4 to 6.9%. The average standard deviation from the duplicate analyses of the same sample was 0.3%. Consistent with other reports,29 girls had higher HbA! levels than boys; Ms = 11.8 versus 9.4%; F (1,29) = 7.01, P < 0.01. The campers reported generally high levels of adherence the week prior to camp. They reported conducting an average of 3.1 glucose tests per day, exercising for at least 20 min on an average of 4.7 days per week, "usually" following their diet and performing "most" of their insulin injections on time. Fortunately, there was sufficient variability in these reports to explore possible sources of variance and relationships with other measures. There were no reliable sex differences on the adherence measures although there were nonsignificant tendencies for boys to report conducting more glucose tests (P < 0.10) and to use greater care in measuring their insulin doses (P < 0.10). On the Family Behavior Checklist, subjects reported more supportive than negative interactions with both mothers (M = 25.2 supportive versus 15.9 negative) and fathers (M = 23.6 supportive versus 14-7 negative: P < 0.001 in both cases). * Similarly, scores on the FES were high relative to national norms (which are standardized to produce mean scores of 50 on each scale) on the Cohesion scale (M = 57.7) and low relative to national norms on the Conflict scale (M = 41.8). All psychosocial measures except the problem solving subscore on the Barriers questionnaire produced sufficient variability. This measure was excluded from further analyses. There was only one sex difference on the psychosocial measures. Girls reported more negative interactions with their mother on the Family Behavior Checklist than did boys, F(l,32) = 4-70, P < 0.05 (see Table 1). Predicting metabolic control. Three of the seven adherence measures, including a measure of each regimen component except exercise, were significantly associated with HbA! levels. As indicated in Table 2, the extent to which one's diet was followed, reported care in measuring insulin doses, and number of daily glucose tests were each significantly correlated with glycosylated hemoglobin levels. Interestingly, these three measures of adherence were essentially unrelated to 'These comparisons were conducted after introducing adjustments to correct for the differential number of items on the positive and negative scales.
496

TABLE 2 Correlations between adherence reports and diabetes control Adherence measure Extent follow diet Care measuring insulin Number daily glucose tests Multiple correlation of 3 adherence measures with HbA, Correlation with HbA, -0.35* -0.44t -0.50*

0.68*

*P< 0.05. tP < 0.01. *P < 0.001. each other and to number of days exercised (rs = 0.01-0.20, all NS), suggesting that compliance to one aspect of the regimen may be independent of compliance to other regimen components. Given the relative independence of the adherence measures, it is not surprising that it was possible to predict HbA, levels well by combining the three measures in a multiple regression equation (R = 0.68, R2 corrected for shrinkage = 0.41). A multiple regression equation predicting HbA! using all seven adherence measures produced a multiple r of 0.70, which was not significantly different from the equation using the best three predictors. As expected, the psychosocial measures were not highly associated with HbA,, our index of metabolic control. Correlations between the general (FES) psychosocial measures and HbA, level ranged from 0.01 to 0.15 (NS). Correlations between the more specific social learning measures and control were slightly higher (rs = 0.06-0.28) but still nonsignificant.
Predicting adherence from psychosocial measures. Due to con-

cerns about difficulties in interpreting results from large correlation matrices, an a priori decision was made to restrict attention to the three adherence measures found to be predictive of control. As can be seen in Table 3, the psychosocial measures can be grouped into two categories. There are five "general" measures from the FES, which assesses overall family functioning. There are also five more "specific" psychosocial measures resulting from the scales developed in our laboratory. Four of these variables are subscores on the Diabetes Family Behavior Checklist and the fifth is the Barriers score from the Barriers to Adherence and Problem Solving Scale. The general measures of family interaction were not highly correlated with adherence. Only one FES scale (Conflict) was significantly associated with any of the three adherence measures. The average bivariate correlation between these five FES scales and the dependent variables was less than 0.10 and only one of the 15 correlations calculated exceeded 0.20. Results from the specific social learning measures were more encouraging. Two of the correlations calculated were significant and three others were marginally significant (P < 0.10). While the magnitude of the average correlation observed was still only modest (M = 0.18), these variables tended to be better predictors of adherence than the more general FES scales. They also produced some consistent and

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TABLE 3 Correlations between psychosocial measures and adherence measures found to be predictive of HbA, levels Adherence measures Psychosocial measure I. "General" measures FESa: Cohesion FES: Expressiveness FES: Conflict FES: Independence FES: Organization II. "Specific" measures FBCb: Mother supportive FBC: Mother negative1 FBC: Father supportive FBC: Father negative1 Barriers to adherence' Extent follow diet Care in measuring insulin Number daily glucose tests

0.03 0.20 0.04 0.00 -0.14 0.16 0.30t 0.08 0.26 0.41*

0.11 0.02 0.10 -0.05

0.10

0.00 0.03 -0.35* -0.16 -0.13

0.12 -0.350.04 0.29t 0.02

0.14 0.14 0.07 -0.01 0.29t

FES = Family Environment Scale. bFBC = Diabetes Family Behavior Checklist. c One would expect negative correlations between these measures and adherence. For the remaining measures, positive relationships would be predicted.

*P<0.05. tP < 0.10. interesting patterns of results. For example, as can be seen in Table 3, the FBC correlations involving interactions with one's mother were generally higher than those involving fathers. Also, negative interactions with one's parents seemed to be more related to adherence than did positive interactions. Another interesting result from the "specific" measures is that different social learning variables were predictive of adherence to different regimen components. The FBC measures of negative interactions with both mothers and fathers were the best predictors of number of glucose tests conducted. This finding, along with the association of the FES Conflict scale with (lack of) adherence to testing, suggests that family discord may be an important psychosocial factor influencing glucose testing. In contrast, the Barriers to Adherence scale appeared to be the best predictor of both following one's diet and care in measuring insulin doses.
DISCUSSION

everal findings related to the Social Learning Theory concept of behavioral specificity emerged. First, it was clear that reports of adherence to one area of the IDDM diabetes regimen were not highly related to reports of compliance to other regimen components. This pattern of results strongly challenges the stereotype of patients, held by many health professionals, as uniformly "good" or "poor" adherers. It also raises the possibility that different factors may influence adherence to different aspects of the regimen. Although the data are more equivocal in this regard, the pattern of correlations generally supports such a notion. Barriers to adherence were found to be more predictive of following one's diet while measures of negative family interactions were more predictive of regular glucose testing. If these findings are replicated, this information should

help health professionals to tailor treatment programs to increase adherence to certain aspects of the regimen. The data also suggest that more specific measures of psychosocial variables are better predictors of adherence than more global measures. This pattern of findings (see Table 3) is particularly interesting since in many ways the "cards were stacked" in favor of the general measures. The FES has been frequently used in diabetes research9'23 and found to be more consistently related to diabetes-relevant variables than many other (e.g., personality) measures. Second, only FES scales found to be associated with diabetes in previous research were included in the present study. Still, in many cases, the more specific social learning measures developed for this study were better predictors of adherence than this well-standardized and carefully normed measure of general family interaction. As discussed in the introduction, it is important to distinguish between the use of psychosocial measures to predict control versus their use to predict regimen adherence. As expected, the psychosocial measures employed in this study were more related to adherence than to metabolic control. It is unlikely that most social learning variables will have direct effects on metabolic control; they may, however, prove to be important influences on patient compliance (which in turn is related to level of control). There are several limitations to the present study which should be recognized. First, caution should be exercised in generalizing from our results, given the relatively small sample size. Larger scale studies with sufficient sample sizes to employ more sophisticated multivariate analysis procedures are needed to increase our understanding of psychosocial factors affecting regimen adherence. Second, this study (like most others in the area) was cross-sectional and correlational in nature. Confirmation of these findings in prospective studies and in investigations using experimental designs are necessary before developing intervention programs based on these

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results. Finally, the magnitude of the relationship between psychosocial measures and adherence was only moderate and many different analyses were conducted. Still, there were more significant findings than would be expected by chance and the results followed a relatively consistent pattern. Specific social learning measures of barriers to adherence and negative family interactions appear to be related to level of regimen adherence among adolescents with diabetes.
ACKNOWLEDGMENTS: Appreciation is expressed to the North

Dakota Affiliate of the American Diabetes Association for allowing us to collect these data at their annual summer camp for children, and especially to Fran Schindler and Drs. Al Kenien, Juan Munoz, and George Johnson. This study was supported by funds from NIH grant #28318 from the National Institute of Arthritis, Diabetes, and Digestive Diseases. From the Departments of Psychology and Food and Nutrition, North Dakota State University, Fargo, North Dakota. Address reprint requests to Lorraine Schafer, Department of Psychology, North Dakota State University, Fargo, North Dakota 58105.
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