Clinical trial NCT02757937: Reaching Better Health Study: A Website to Improve Type 2 Diabetes Self-Management
Official title: Study to Measure Merck Engage Usability and Conduct Outcomes Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Medication Adherence
Self-efficacy
Behavior
Diabetes
Diabetes Mellitus
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: University of Pennsylvania
First posted: 2016-05-02
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient is a current patient in the Penn Medicine outpatient healthcare system
* Patient's Primary Care Physician (PCP) or Endocrinologist is a Penn Medicine provider
* Patient has a 12 month history of healthcare utilization in the Penn Medicine system (in-office PCP/endocrinologist visits)
* Patient has complete data (ICD-10 code for Type 2 diabetes diagnosis, date of diagnosis, name and mailing address information) in the Penn Data Warehouse
* Patient is diagnosed with Type II Diabetes as indicated by ICD-10 Codes: E11.\*\* (including any newly diagnosed)
* Patients' HbA1c was ≥8.0% in last 6 months (if more than one A1c result present in record, most recent measurement assessed)
* Patient can read and understand English well enough to complete study tasks.
* Patient has regular access to a telephone
* Patient has at least bi-weekly access to internet and email
* Patient agrees to release their medical record information to Children's Hospital of Philadelphia research team

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:

  * 024.419 (gestational diabetes)
  * 024.419 (antepartum gestational diabetes)
  * Z79.4 (type II long term insulin use)
  * 024.91x (pregnant women who are diabetic)
* 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 outcomes:
measure: Change in Diabetes Self-Efficacy Scale Score from Baseline to 4 Months
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: Change in Diabetes Knowledge Test Score from Baseline to 4 Months
timeFrame: Baseline to 4 months
measure: Change in Self-Efficacy Scale Score for Managing Chronic Disease from Baseline to 4 Months
timeFrame: Baseline to 4 Months
measure: Change in glycated haemoglobin (HbA1c) from Baseline to 6 Months
timeFrame: Baseline to 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Linda Fleisher, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: