Internet Diabetes Self-Management

Type 2 Diabetes Clinical Trial

Official title:

Internet Diabetes Self-Management: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372463
• Other study ID #: 49148
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2006
• Last updated: July 25, 2011
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2011
• Source: Robert Wood Johnson Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• 6-week Online Diabetes Self-Management Educational Program

Locations

Country	Name	City	State
United States	Stanford Patient Education Research Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related-quality of life
Primary	Metabolic control (HbA1c)
Primary	Heath care utilization
Primary	Behaviors
Primary	Self-efficacy