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

NCT02757937 | Completed

• 1 other identifier: 15-011892
• Study Type: interventional
• Target: 513
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Medication Adherence; Self-efficacy; Behavior; Diabetes; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 4 months

Secondary Outcomes (3)

• Change in Diabetes Knowledge Test Score from Baseline to 4 Months

  Baseline to 4 months

• Change in Self-Efficacy Scale Score for Managing Chronic Disease from Baseline to 4 Months

  Baseline to 4 Months

• Change in glycated haemoglobin (HbA1c) from Baseline to 6 Months

  Baseline to 6 Months

Study Arms (2)

Health & Wellness Website

EXPERIMENTAL

Subjects will receive access to an interactive health \& wellness website for 6 months. The site aims to provide patients with information, tools, and resources to manage their chronic condition (e.g., Type 2 diabetes). The website will send subjects emails with tips to help them take better care of their diabetes, such as how to track diet and exercise habits and how to cook healthy meals. The study researchers will keep track of how many times subjects access the website and which parts of the site are most commonly viewed. Intervention subjects will receive questionnaires assessing engagement and satisfaction with the website. Subjects will also complete questionnaires at baseline and 2, 4, and 6 months post-baseline.

Behavioral: Health & Wellness Website

Control Arm

OTHER

Subjects in the control arm will continue with standard diabetes care without getting access to the intervention website. Subjects will also complete questionnaires at baseline and 2, 4, and 6 months post-baseline. Control subjects will be granted access to the health \& wellness website after the study is completed.

Other: Control Arm

Interventions

Health & Wellness Website BEHAVIORAL

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.

Health & Wellness Website

Control Arm OTHER

Continue with standard diabetes care without getting access to the intervention website.

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Merck Sharp & Dohme LLC: collaborator
• University of Pennsylvania: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence; Behavior; Diabetes Mellitus

Interventions

Health

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Linda Fleisher, PhD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share