This study is the first known RCT of a family-based group behavioral intervention to promote treatment adherence in adolescents with IBD. Adherence is a significant behavioral health issue as apparent failure of oral medication to treat disease that is actually due to nonadherence can lead to erroneous escalation in therapy, which might include biologic agents that could have long-term ramifications for young patients. Moreover, there is evidence that nonadherence is associated with greater risk of relapse11
and increased health care costs12
in adults with IBD. In the present trial, adolescents reported a significant 25% increase in mesalamine but not in 6-MP/azathioprine adherence. Evaluation of treatment effects with other measures of adherence including pill counts and electronic monitors did not reveal significant improvements. Given the known measurement variability in adherence assessment tools, including that documented in pediatric IBD4,23
, we planned a multi-method, multi-informant assessment approach in order to compensate for the limitations of each measure. However, there were some unforeseen challenges to using electronic monitor devices in our sample that may have affected the validity of that assessment tool. Fifty-six percent of the sample reported using pill boxes to organize their medications. When asked to use a pill bottle instead of the pill box for one medication (potentially further complicating an already complicated regimen), many participants reported that they did not put the medication into the bottle, but rather kept it in the pill box as usual and tried to remember to open the empty bottle each time they accessed the pill box for that medication. This resulted in the electronic monitors being used as a proxy measure. One might expect that this would result in lower electronic monitor adherence; however, based on the high electronic monitor adherence rates compared to pill counts, it appears that in our sample many patients were likely opening the bottle each time they accessed the pill box for all
medications rather than just the one being examined. This is a critical measurement issue that is not often discussed in the literature. Although we know this occurred with a substantial number of participants, we do not know the exact number as we discovered this was happening too late in data collection. These issues notwithstanding, we found significant improvement in the type of assessment most often utilized in a clinical setting (i.e., patient self-report). Nevertheless, the scope of this study and findings suggest that it should be considered pilot/preliminary data that warrant further examination in larger trials. As this study is currently in follow-up phases, we plan to evaluate any long-term changes in adherence.
Because this is an initial investigation using group-based behavioral treatment to promote adherence in this population, we sought to examine the feasibility and acceptability of the intervention. Group-based treatment is appealing because it is generally cost-effective, efficient, and allows for social networking among patients and families. In this trial, excellent feasibility was demonstrated by 99% treatment session attendance by patients in the Treatment condition. The intervention was also perceived as highly acceptable to both patients and their caregivers as evidenced by 70-100% reporting a high degree of acceptability regarding the appeal and helpfulness of the group-based format of the intervention, amount of information covered, treatment session length, number of sessions, total time commitment, convenience of treatment, use of behavioral skills taught, and perceived impact on treatment adherence.
The results of this study should be taken within the context of its methodological strengths and limitations. Our use of a RCT design reduced selection bias and spurious causality inferences. The intervention was developed using empirically supported theory driven components as well as patient and family input on session content22
. We also utilized a multi-method, multi-informant adherence assessment strategy to evaluate intervention effects, which is an uncommon approach in the adherence literature. However, the findings are limited by the small sample size used for this preliminary investigation. Second, although the sample was representative of the IBD population in general26,27
, the lack of socioeconomic and ethnic diversity limits generalizability to economically disadvantaged or minority populations. Third, the TRAQ measure of adherence was developed for this study and does not have prior psychometric data. Fourth, high baseline levels of adherence across self-report and electronic monitor assessments may have prevented increases in adherence substantial enough to detect other statistically significant differences between groups. These high baseline levels likely occurred because we did not recruit a clinical sample (i.e., patients who currently demonstrate nonadherence) for this pilot study. Finally, as previously mentioned, the high percentage of patients using pill boxes interfered with electronic monitor data, resulting in unclear findings for that measure. Use of multiple alternative measures of adherence in patients who are prescribed multiple medications and supplements helps to account for these issues and may be preferable under these circumstances.
In conclusion, the findings of the present study are encouraging but clearly indicate that further investigation is required. Future research should involve replication with a more diverse sample in terms of socioeconomic status, ethnicity, and disease severity. Alternative adherence measurement approaches should also be considered, including electronic pill boxes and/or real-time self-report (e.g., via text messaging, electronic diaries, etc.). Additionally, larger scale testing of the intervention may be necessary to fully understand its efficacy. Continued examination of adherence promotion efforts is necessary to developing self-management programs and maximizing patient health outcomes in IBD.