The Diabetes Medication Adherence Promotion Intervention Trial

[Background]

Medication non-adherence is a major public health issue for patients with diabetes.
Approximately one third of patients with T2DM are non-compliant with their diabetes
medication. This is problematic since suboptimal medication adherence has been shown to
contribute to inferior glycemic control, increased healthcare costs, hospitalization and
premature death. The aforementioned ramifications of nonadherence to chronic medication are
a product of barriers to diabetes self-care behavior including patient-related factors
associated with glycemic control. Dr. Chandra Osborn and colleagues have identified
targetable patient factors related to patients' medication-adherence related knowledge
(e.g., information about medication purpose and dosage), motivation (e.g., awareness of
medication benefits, social support for adherence) and self-efficacy or skills (e.g.,
ability to remember dosages and obtain refills). Said factors map onto the
Information-Motivation-Behavioral skills (IMB) model, which has informed effective adherence
promotion interventions among individuals with other chronic illnesses and may have utility
in promoting medication adherence among patients with T2DM.

Intervention content will be informed by a validated theory of medication adherence.
Interventions are seldom informed by empirically established theories. This is problematic
since theory-based interventions (i.e., interventions that draw upon theories that are
relevant to the target population) have proven to be more effective than atheoretical
interventions. Few published intervention studies specifically address medication adherence
among adults with T2DM and of these limited studies, only one is grounded in theory. The
study's web-based intervention is driven from the aforementioned IMB model of adherence.
This model incorporates central components of other theoretical models and has been
validated in cross-sectional and intervention research among patients with acquired
illnesses. Furthermore, recent empirical findings indicate the IMB model's success in
predicting outcomes in our target T2DM population. Thus, it is reasonable to believe an
intervention (i.e., Diabetes MAP) that delivers IMB model-based content to a T2DM population
may successfully improve medication compliance.

Patient web portal (PWP)-delivered medication adherence promotion interventions are a
practical tool for relaying health-related information and resources. The magnitude of the
consequences associated with nonadherence to chronic medications makes web-based
interventions imperative as they aim to reduce the impact of barriers to medication-taking
practices. While there are few medication adherence promotion interventions specifically
designed for patients with T2DM, the literature suggests barriers to medication adherence
practices may be reduced with the use of interactive behavior change technologies (IBCT)
that provide patients with access to resources, web tools and health knowledge. While there
can be limitations to patient websites (e.g., poor design), the usability of the web-based
health intervention Diabetes MAP has been previously evaluated in relation to ease of
interaction and accessibility to individually-tailored components aimed at increasing
diabetes-related knowledge, motivations and skills. This study aims to leverage the use of
Diabetes MAP to help T2DM patients overcome barriers to self-care and promote medication
adherence behavior and improve diabetes outcomes.

Personality measures may moderate adherence and effectiveness of a PWP-delivered
intervention. In an attempt to broaden our understanding of self-care behavior, the study
implements an additional instrument, the Mindful Attention Awareness Scale (MAAS), to obtain
a personality measure of mindfulness. Mindfulness is a psychological construct of Buddhist
origin that draws together deliberate attention to moment-to-moment occurrences and the
cultivation of knowledge, positive emotions and ethical behavior. The MAAS is a validated
15-item scale designed to measure an individual's awareness and ability to attend to what is
occurring in the present moment. Studies indicate that the quality of mindfulness targeted
by the MAAS is related to, and predictive of, certain self-regulation and well-being
constructs. More specifically, mindfulness has been linked to increased subjective
well-being, reduced psychological symptoms and reactivity, and improved behavioral
regulation, all of which may be correlated with self-care behavior and better decision
making regarding health (i.e., diet, exercise). Therefore, study participants with high
baseline levels of self-awareness may draw even greater benefits from use of the Diabetes
MAP website and therefore display greater medication adherence and lower A1c levels than
those scoring lower on the MAAS.

[Study Objective/Aim]

The goal of this research is to evaluate a web-based medication adherence promotion
intervention that uses patient-specific information (e.g., diabetes medication, survey
responses) to deliver tailored content via the Diabetes MAP website to adults with T2DM.

The specific aim is to evaluate the ability of an existing PWP-delivered medication
adherence promotion intervention (Diabetes MAP) to improve medication adherence and glycemic
control among patient participants with T2DM. Investigators will randomly allocate patients
to a treatment (website intervention or no intervention) and subsequently test the website's
ability to increase self-reported adherence to glucose lowering agents (GLAs) and improve
diabetes health outcomes as demonstrated by lowered HbA1c levels.

[Significance]

This project evaluates the effect of the PWP-delivered medication adherence promotion
intervention, Diabetes MAP, on patient adherence to glucose lowering agents (GLAs) and
patient HbA1c. The study serves to fill the gap in the current literature by focusing on the
power of interactive and individually-tailored technology to support medication adherence
and the subsequent health benefits that arise when T2DM patients properly adhere to their
prescribed medical regimen. In addition to reducing personal costs (e.g., hospitalization,
mortality, healthcare fees), improving medication adherence among T2DM patients may benefit
society by reducing the burden said individuals' health status places on the broader
population. Ultimately, the tools and techniques utilized and the data collected from this
study will provide insight for future studies that may seek to utilize web-based
interventions to reach and impact medically afflicted individuals.

Inclusion Criteria:

- Adults 18 years and older (to be confirmed by electronic health record)

- Individuals who have received a diagnosis for type 2 diabetes mellitus (T2DM)

- Enrolled as a patient in the Vanderbilt APPC or the Eskind Diabetes Clinic

- Registered My Health at Vanderbilt user

- Individuals currently being treated with oral and/or injectable diabetes medication
(to be confirmed through electronic health record)

Exclusion Criteria:

- Non-English speakers (determined by a trained research assistant)

- Individuals with a severe hearing or visual impairment (determined subjectively by a
trained research assistant)

- Individuals with delirium or a severe cognitive impairment (determined by a lack of
orientation to person, place, and time)

- Individuals who report a caregiver administers their diabetes medications

- Individuals who report they do not have a mobile phone or computer with internet
access

- Individuals unwilling and/or unable to provide written informed consent