Evaluation of a Patient Portal Intervention for Diabetes: A Two-arm, Parallel-Design, Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 2
- 主要终点
- Change in Patient Activation at 6 Months
研究概览
简要总结
The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.
详细描述
300 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 150 will be assigned to receive access to the intervention (My Diabetes Care) embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 150 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt without the My Diabetes Care. Patients will be invited by mail (or email) to be screened for enrollment in the study. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being randomized to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month and 6-month follow-ups to assess outcomes. In addition, system usage will be collected.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •Currently being treated with at least one antihyperglycemic medication
- •Able to speak and read in English
- •Reliable access to a computer (desktop or laptop) with internet capabilities
- •Active VUMC patient web portal (known as My Health At Vanderbilt) account
排除标准
- •Residing in a long term care facility
- •Medical condition that affects my memory or ability to think.
- •Severe visual impairment
- •Currently participating in another diabetes-related research study
结局指标
主要结局
Change in Patient Activation at 6 Months
时间窗: Baseline to 6-month follow-up
The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.
Change in Patient Activation at 3 Months
时间窗: Baseline to 3-month follow-up
The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.
次要结局
- Change in Diabetes Self-Efficacy(Baseline, 3-month follow up, 6-month follow-up)
- Change in Diabetes Self-Care (Diabetes Medication Adherence)(Baseline, 3-month follow up, 6-month follow-up)
- Change in Flu Vaccination Status for 2019-20 Flu Season(Baseline, 3-month follow up)
- Change in Diabetes Knowledge(Baseline, 3-month follow up, 6-month follow-up)
- Change in Diabetes Self-Care (General Diet Adherence)(Baseline, 3-month follow up, 6-month follow-up)
- Change in Diabetes Self-Care (Exercise Adherence)(Baseline, 3-month follow up, 6-month follow-up)
- Change in Diabetes Self-Care (Specific Diet)(Baseline, 3-month follow up, 6-month follow-up)
- Change in Diabetes Distress(Baseline, 3-month follow up, 6-month follow-up)
- Change in Blood Pressure Control(Baseline to 6-month follow-up)
- System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only)(6-month follow-up)
- System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only)(6-month follow-up)
- Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)(Baseline, 3-month follow up, 6-month follow-up)
- Change in Blood Glucose Control(Baseline to 6-month follow-up)
- Satisfaction/Usability of My Health at Vanderbilt (for Control Group)(Baseline, 3-month follow up, 6-month follow-up)
- Satisfaction/Usability of My Diabetes Care (for Intervention Group)(3-month follow up, 6-month follow-up)
- System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only)(6-month follow-up)
- Change in Low Density Lipoprotein(Baseline to 6-month follow-up)
研究者
William Martinez, MD, MS
Assistant Professor of Medicine
Vanderbilt University Medical Center