Internet Diabetes Self-Management

July 25, 2011 updated by: Robert Wood Johnson Foundation

Internet Diabetes Self-Management: A Randomized Trial

Diabetes is a growing health problem causing personal suffering, comorbid conditions, premature death, and high costs to the individual, the health care system and society. Many of these problems can be prevented or delayed by controlling the disease. This in turn requires daily self-management by patients.

We will evaluate an Internet based small group Diabetes Self-Management Program. This program will be adapted from the Chronic Disease Self-Management Program Online, already developed and currently being evaluated by the investigators. Participants with type 2 diabetes will be randomized to participate in the Internet Program or serve as controls continuing with usual care. Treatment subjects will participate in a structured 6 week interactive web-based online class with 20-24 other participants and 2 trained peer moderators.

If successful, this project will result in a new and effective means of reaching the CDC objective and more importantly in improving the quality of life and health status of people with diabetes while reducing health care utilization and thus costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes is a growing health problem causing personal suffering, comorbid conditions, premature death, and high costs to the individual, the health care system and society. Many of these problems can be prevented or delayed by controlling the disease. This in turn requires daily self-management by patients.

The CDC has recognized the importance of self-management by setting a 2010 objective of having 60% of diabetics receive diabetes education. Unfortunately, many people cannot receive such education because it is not available or they do not wish to or cannot participate in small group or one on one education.

The Internet may offer a viable alternative. We will evaluate an Internet based small group Diabetes Self-Management Program. This program will be adapted from the Chronic Disease Self-Management Program Online, already developed and currently being evaluated by the investigators. Participants with type 2 diabetes will be randomized to participate in the Internet Program or serve as controls continuing with usual care. Treatment subjects will participate in a structured 6 week interactive web-based online class with 20-24 other participants and 2 trained peer moderators.

Data will be collected online at baseline, 6 months and 1 year. Outcome measures include health related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health), metabolic control (hemoglobin A1c), health care utilization (decreases in outpatient visits to physicians, increases in the percentage of participants having received an eye examination in the past year, increases in the number of times a health professional has examined participants' feet, and decreases in emergency department visits, hospitalizations, and hospital days), health behaviors (aerobic exercise, communication with physicians, diet, glucose self-monitoring, and self-examination of the feet), and self-efficacy to manage diabetes.

If successful, this project will result in a new and effective means of reaching the CDC objective and more importantly in improving the quality of life and health status of people with diabetes while reducing health care utilization and thus costs.

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Patient Education Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Live in the United States
  • Access to internet and an email account

Exclusion Criteria:

  • Under 18 years of age
  • Pregnant
  • Treatment for cancer in past 12 months
  • Have taken any Stanford self-management program previously

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Self-efficacy
Health related-quality of life
Metabolic control (HbA1c)
Heath care utilization
Behaviors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Kate Lorig, DrPH, Stanford University
  • Study Director: Diana Laurent, MPH, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 6, 2006

First Posted (Estimate)

September 7, 2006

Study Record Updates

Last Update Posted (Estimate)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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