Behavioral change stage might moderate the impact of multifaceted interventions on non-attendance from medical care among patients with type 2 diabetes: The Japan Diabetes Outcome Intervention Trial-2 Large-Scale Trial 007 (J-DOIT2-LT007)

Abstract

Aims/introduction: Non-attendance from regular medical care is a major problem in diabetes patients. This study aimed to examine the impact of a multifaceted lifestyle intervention by face-to-face approach (FFA) on non-attendance from regular medical care in comparison with that by telephone from the technical support center (TSC).

Materials and methods: This was secondary analysis from a 1-year, prospective, cluster randomized, intervention study. Patients with type 2 diabetes, who were regularly visiting primary care physicians cluster-randomized into the control or intervention (TSC or FFA according to resource availability of the district medical associations) groups, were consecutively recruited. The primary end-point was non-attendance from regular medical care. The interaction between the type of intervention (TSC vs FFA) and behavioral change stage (pre- vs post-action stage) in diet and exercise for the dropout rate was assessed.

Results: Among the 1,915 participants (mean age 56 ± 6 years; 36% women) enrolled, 828, 564 and 264 patients belonged to the control, TSC and FFA groups, respectively. We found evidence suggestive of an interaction between the intervention type and behavioral change stage in diet (P = 0.042) and exercise (P = 0.038) after adjusting for covariates. The hazard ratios (95% confidence interval) of FFA to TSC were 0.21 (0.05-0.93) and 7.69 (0.50-117.78) in the pre-action and post-action stages for diet, respectively, whereas they were 0.20 (0.05-0.92) and 4.75 (0.29-73.70) in the pre-action and post-action stages for exercise.

Conclusions: Among diabetes patients, the impact of multifaceted intervention on non-attendance from medical care might differ by the behavioral change stage.

Keywords: Behavioral change stage; Diabetes; Non-attendance.

Figure 1

Kaplan–Meier curves of the primary end‐point in patients with type 2 diabetes according to the type of intervention. The patients in the intervention group were further divided into the support by phone calls from the treatment support center (TSC) or face‐to‐face approach (FFA). Blue, green and red lines indicate control, TSC and FFA groups, respectively. (a) Overall patients. (b) Patients in the pre‐action stages (stages 1–3) of lifestyle change in eating behavior. (c) Patients in the post‐action stages (stages 4–5) of lifestyle change in eating behavior. (d) Patients in the pre‐action stages of lifestyle change in exercise behavior. (e) Patients in the post‐action stages of lifestyle change in exercise behavior.

Figure 2

Hazard ratios of lifestyle intervention (face‐to‐face approach relative to treatment support center) for the dropout rate from regular medical care by behavioral change stage in diet and exercise, and the interaction between the type of intervention and behavioral change stage (stages 1–3 vs stages 4–5) in diet and exercise. (a) Adjusted for municipal‐level district medical associations, and only interaction term between the type of intervention and behavioral change stage is included in the models. (b) Further adjusted for age, sex, glycated hemoglobin and history of non‐attendance. (c) Further adjusted for body mass index and insulin treatment in patients with available information on body mass index and insulin treatment (n = 1,562).