Status
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Patient is deceased
Patient has indicated "Do Not Solicit for Research" in medical record
Patient is less than 18 years of age
Patient is older than 75 years old
Patient uses an insulin pump or injectable insulin to treat/manage their diabetes.
Patient is non-English speaking
Patient does not have HbA1c% in chart from last 6 months
Patients' HbA1c in last 6 months is <8.0%
Patient is currently taking medications that can raise glucose levels, such as steroids
Patient has a history of cognitive disorders, mental illness, and/or cognitive impairment that may impact their ability to use an online website, including, dementia, Alzheimer's disease, Parkinson's disease, traumatic brain or head injury, and psychosis
Patient has history of Heart Failure (included Chronic Heart Disease, Chronic Heart Failure) and/or Chronic Kidney Disease, and has had other serious cardiovascular conditions (e.g, heart attack or stroke) in the last 6 months
Patient has history of endocrine gland cancers or pancreatic cancers
Patient is undergoing chemotherapy or immunotherapy treatment in last 6 months
Patient's medical record contains ICD-10 Code for Type I diabetes diagnosis.
Patient's medical record contains ICD-10 Code for pregnancy-related diabetes:
Patient is Pre-diabetic or borderline Type 2 diabetic
Patient is pregnant or lactating
Patient's electronic medical history data is not available through Penn Medicine's electronic medical record and/or is not complete in Penn Data Store
Patients who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Primary purpose
Allocation
Interventional model
Masking
513 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal