Diabetes is one of the most common chronic illnesses among adults in the United States. Internet-based interventions and health promotion websites for patients with Type 2 Diabetes are typically low-cost, easily accessible, and attractive. The purpose of this study is to determine whether participants' utilization of a health \& wellness website focused on diabetes self-management increases participants' self-reported self-efficacy toward managing their Type 2 Diabetes through behavior change and self-reported medication adherence compared to standard care.
Diabetes is one of the most common chronic illnesses among adults in the United States. Merck \& Co., Inc. has produced an innovative website to engage adult patients in chronic illness self-management and medication adherence. Internet-based interventions and health promotion websites for patients are typically low-cost, easily accessible, and attractive. However, there is a growing need for improved measurement, implementation and evaluation of online health interventions to ensure patient engagement and produce more significant behavior change that can impact patients' health over the long term. The primary objective of this study is to determine whether utilization of the health and wellness website increases participants' self-reported self-efficacy toward managing their Type 2 Diabetes through behavior change and self-reported medication adherence. This study comprises a randomized controlled trial utilizing the website as the self-management support intervention. There is no interventional medical treatment, and no change in patients' medical care. In collaboration with University of Pennsylvania, potential participants will be identified and recruited from the Penn Medicine outpatient population based on specific inclusion/exclusion criteria. Participants will remain in the study for 6 months. Participants will be randomly assigned to the intervention or control condition (no exposure). Those in the intervention arm will have access to health \& wellness website for nine months post enrollment. Online surveys will be delivered during this nine month period. Primary outcomes will be baseline-to-two month and baseline-to-4 month changes in diabetes management self-efficacy scores as measured by the Diabetes Self-Efficacy Scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Educational website for patients with chronic disease (i.e., Type 2 diabetes, asthma, high blood pressure, high cholesterol). The website is a free interactive resource to help patients manage their health condition(s) each day and to help them achieve their goals. It is a multichannel health and wellness platform to help patients adhere to their treatment and care plans between office visits.
Continue with standard diabetes care without getting access to the intervention website.
Change in Diabetes Self-Efficacy Scale Score from Baseline to 4 Months
The validated Diabetes Self-Efficacy Scale (Lorig et al., 2009) assesses how confident one is in doing certain activities related to diabetes management. There are 8 items in this measure with each one pertaining to a different activity. Each item is rated on a continuous scale of 1 to 10, 1 being not at all confident and 10 being totally confident. The score for each item is the number circled and higher value score indicates greater self-efficacy.
Time frame: Baseline to 4 months
Change in Diabetes Knowledge Test Score from Baseline to 4 Months
This is a 14 item assessment, measuring general diabetes knowledge, was validated among Type 1 and Type 2 adult diabetics, Cronbach's α = 0.71. Each item is a multiple choice question, with options A-D. For scoring, the total number of questions answered correctly is calculated. The higher the score on the test, the greater knowledge one has about diabetes.
Time frame: Baseline to 4 months
Change in Self-Efficacy Scale Score for Managing Chronic Disease from Baseline to 4 Months
This measure assesses how confident one is when performing various activities related to chronic disease management. There are 6 items on this scale with each one pertaining to a different activity. Each item is rated on a continuous scale of 1 to 10, with 1 being not at all confident and 10 being totally confident. The overall score for the measure is the average value of all the items. A higher score indicates a greater self-efficacy.
Time frame: Baseline to 4 Months
Change in glycated haemoglobin (HbA1c) from Baseline to 6 Months
By measuring glycated haemoglobin (HbA1c), clinicians are able to get an overall picture of what average blood sugar levels have been over a period of weeks/months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications.
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SUPPORTIVE_CARE
Masking
NONE
Enrollment
513
Time frame: Baseline to 6 Months