JMIR Publications

ABSTRACT

Background:

Adherence to core type 2 diabetes mellitus (T2DM) treatment behaviors is suboptimal and non-adherence is generally not limited to one treatment behavior. The Internet holds promise for programs that aim to improve adherence.

Objective:

We developed an eHealth program for patients with T2DM to improve their overall treatment adherence, i.e. adherence to both healthy lifestyle and medical behaviors, based on the Integrated Change Model. The objective of the current study was to examine the effectiveness of the eHealth program in a randomized controlled trial.

Methods:

Patients with T2DM were recruited by their health professional and randomized into either the intervention arm (i.e. access to the eHealth program for six months; n=243) or a waiting-list control arm (n=244). Outcome data was collected through online assessments on physical activity levels, caloric intake from unhealthy snacks and adherence to oral hypoglycemic agents and insulin therapy. Changes to separate behaviors were standardized and summed into a composite change score representing changes in overall adherence. Further standardizing these composite change scores yielded the primary outcome. Standardized change scores observed in separate behaviors acted as secondary outcomes. Mixed linear regression analyses were conducted to examine the effectiveness of the intervention on overall and separate treatment behavior adherence, accommodating for relevant covariates and patients nesting. The standardizations applied in the primary and secondary outcomes allowed for interpreting the regression coefficient of the treatment in the analyses as effect sizes.

Results:

After the six-month follow-up assessment, 111 patients in the intervention arm (47%) and 177 patients in the control arm (73%) were retained. After controlling for relevant confounders, overall treatment adherence improved significantly in the intervention arm, compared to the control arm, reflected by an overall small to medium effect size (d = .24; 95% CI .005 to .481; P = .046). In comparison to the control arm, a significant decrease was observed in caloric intake from unhealthy snacks only, when considering changes in separate treatment behaviors (d = .38; .098 to .661; P = .01).

Conclusions:

Our multi-behavior program significantly improved overall adherence to core T2DM treatment behaviors compared to the control arm. To further enhance the intervention’s impact, a wide-scale implementation of our eHealth intervention is suggested in order to be of impact in the personal, societal and economic area. Clinical Trial: The trial is registered in the Dutch Trial Register (NTR6840). The NTR is the primary registry of the Netherlands and has been recognized and accepted by the WHO and ICMJE.