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Randomized Controlled Trial
. 2015 Jul:43:105-13.
doi: 10.1016/j.cct.2015.05.013. Epub 2015 May 21.

The Telehealth Enhancement of Adherence to Medication (TEAM) in pediatric IBD trial: Design and methodology

Kevin A Hommel  1 , Wendy N Gray  2 , Elizabeth Hente  3 , Katherine Loreaux  3 , Richard F Ittenbach  4 , Michele Maddux  5 , Robert Baldassano  6 , Francisco Sylvester  7 , Wallace Crandall  8 , Charles Doarn  9 , Melvin B Heyman  10 , David Keljo  11 , Lee A Denson  4
Affiliations
Randomized Controlled Trial

The Telehealth Enhancement of Adherence to Medication (TEAM) in pediatric IBD trial: Design and methodology

Kevin A Hommel et al. Contemp Clin Trials. 2015 Jul.

Abstract

Medication nonadherence is a significant health care issue requiring regular behavioral treatment. Lack of sufficient health care resources and patient/family time commitment for weekly treatment are primary barriers to receiving appropriate self-management support. We describe the methodology of the Telehealth Enhancement of Adherence to Medication (TEAM) trial for medication nonadherence in pediatric inflammatory bowel disease (IBD). For this trial, participants 11-18 years of age will be recruited from seven pediatric hospitals and will complete an initial 4-week run in to assess adherence to a daily medication. Those who take less than 90% of their prescribed medication will be randomized. A total of 194 patients with IBD will be randomized to either a telehealth behavioral treatment (TBT) arm or education only (EO) arm. All treatments will be delivered via telehealth video conferencing. The patients will be assessed at baseline, post-treatment, 3, 6, and 12 months. We anticipate that participants in the TBT arm will demonstrate a statistically significant improvement at post-treatment and 3-, 6-, and 12-month follow-up compared to participants in the EO arm for both medication adherence and secondary outcomes (i.e., disease severity, patient quality of life, and health care utilization). If efficacious, the TEAM intervention could be disseminated broadly and reduce health care access barriers so that the patients could receive much needed self-management intervention.

Keywords: Adherence; Behavioral; Inflammatory bowel disease; Pediatrics; Telehealth.

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Figures

Figure 1
Figure 1
Overview of TEAM Study design
Figure 2
Figure 2
Sample Adherence Contract following a TBT session
See this image and copyright information in PMC

References

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