Leveraging Patient Portals to Improve Medication Adherence in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Glycemic control (Change in participant's HbA1c level)
研究概览
简要总结
A significant percentage of persons with diabetes fail to properly take their prescribed oral hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes patients is associated with poor health outcomes including suboptimal glycemic control, diabetes-related complications, elevated health costs and increased risk of hospitalization and mortality. Given the substantial impact of non-compliance on the health of patients, prior studies have sought to draw links between medication adherence and patient factors.
Research shows that web-based interventions that support patients' medication-related knowledge, motivation and skills effectively improve compliance.
The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered medication adherence promotion intervention on medication adherence and glycemic control among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge, motivation and skills.
This research will greatly enhance the investigators' understanding of medicine compliance and the factors that effectively improve adherence among high-risk patients with diabetes. Knowledge gained from this work may inform future internet-based patient portals that support disease management and medication adherence more broadly.
详细描述
[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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Recent A1c of 7.0 or greater
- •Individuals currently being treated with oral and/or injectable diabetes medication (to be confirmed through electronic health record)
排除标准
- •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
结局指标
主要结局
Glycemic control (Change in participant's HbA1c level)
时间窗: Change from Baseline in HbA1c level at 3 months
Change in participant's HbA1c level from study onset to study conslusion
次要结局
- Number of logins, 1 month assessment(1 month after Baseline)
- Number of logins, 3 month assessment(3 months after Baseline)
- Time spent on website, 1 month assessment(1 month after Baseline)
- Time spent on website, 3 month assessment(3 months after Baseline)
研究者
Chandra Osborn
Assistant Professor of Medicine & Biomedical Informatics, Co-Director for CHBHE
Vanderbilt University
