NCT02757937

Reaching Better Health Study: A Website to Improve Type 2 Diabetes Self-Management

Study to Measure Merck Engage Usability and Conduct Outcomes Testing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	Health & Wellness Website	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.
OTHER	Control Arm	Continue with standard diabetes care without getting access to the intervention website.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2016-05-02
• Last updated: 2018-12-17