Abstract
Background/Aims Participant non-adherence to study protocols can adversely affect clinical trials by reducing statistical power. Similarly non-adherence is an important issue in clinical practice. Ceasing to participate is one form of non-adherence. Subject characteristics appear to influence adherence. We evaluated relationships between subject characteristics and completion of educational sessions in IDEA, a clinical trial testing 2 modes of diabetes education in patients with sub-optimal diabetes control.
Methods IDEA eligibility criteria included Type 2 diabetes, A1c =7%, and no recent diabetes education. Subjects (n=623) were randomly allocated to one of 3 diabetes education treatment arms; individual education, group education, or a comparison group with no active intervention. Individual education consisted of three 1-hour sessions, following an AADE program. Group education was delivered in four 2-hour group sessions that emphasized patient interaction. Subjects were considered adherent if they completed all assigned sessions. At the end of the study, tracking data indicated completion rates of 72.0% (175/243) in the group education intervention and 86.1% (211/245) in the individual treatment intervention. We sought to identify demographic, psychosocial and clinical characteristics that might explain non-completion. We hypothesized that, within each arm, baseline health status (SF-12 mental composite and physical composite scores), depression (PHQ9), personality type (TIPI Big 5; extraversion, agreeability, emotional stability, conscientiousness, and openness), and Hb A1c level were associated with completion.
Results In the group education arm, subjects scoring higher on the emotional stability scale were more likely to complete (p<0.05). Generally, demographic factors were more strongly associated with completion of group education than were psychosocial or clinical factors: women and older subjects were more likely to complete than men and younger subjects (gender, p=0.008; age, p=<0.0005). Within the individual education arm, completion was predicted by higher physical health score (SF12-PCS; p=0.005), higher mental health scales (SF12-MCS, p=0.008), lower depression score (PHQ9, p=0.002), and lower Hb A1c (p<0.05). However, neither gender nor age was associated with completion.
Conclusions Factors related to study completion appear to differ between the 2 diabetes educational interventions. These results may be relevant to diabetes educational programs considering strategies to improve “no show” and lack of completion rates.
