Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— LWD  

Official title:

Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed With Type 2 Diabetes (Evaluation Phase)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877851
• Other study ID #: 08/NIR01/97
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2022
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

NEW Brief Summary: Managing diet and physical activity are vital aspects of diabetes self-care; however, people with diabetes often find it difficult to make changes to their usual diet and physical activity patterns. There is some evidence that computer based education may help some people develop the skills they need to better manage their diabetes. The investigators have developed an external hard drive (a USB stick), focusing on knowledge, self-monitoring, goal setting and skill-development in relation to diet and physical activity for people with Type 2 diabetes. A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout the development of the computer based program. This study will examine whether this computer based program can improve knowledge, skills and self-care behaviour in people with diabetes. One hundred participants who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance to one of two groups: they will either be assigned to continue with their normal care routine consulting with their doctor as normal, or they will be assigned to use the USB stick at least once a week for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Medical diagnosis of Type 2 diabetes in the past 2 years

• Have access to a computer on a regular basis

Exclusion Criteria:

• Pregnant or lactating

• Other medical conditions where changes in diet or physical activity would be contraindicated

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Computer-based Program
The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.

Locations

Country	Name	City	State
United Kingdom	Belfast Health and Social Care Trust	Belfast	Antrim
United Kingdom	Queen's University Belfast	Belfast	Antrim

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University, Belfast

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between Group Differences in Diabetes Knowledge	ADKnowl questionnaire	12 weeks
Primary	Between Group Differences in Goal Setting		12 weeks
Secondary	Between Group Differences in Dietary Intake		12 weeks
Secondary	Between Group Differences in Physical Activity Levels		12 weeks
Secondary	Between Group Difference in Anthropometry		12 weeks
Secondary	Between Group Differences in Markers of Cardiovascular Risk		12 weeks
Secondary	Between Group Differences in Markers of Blood Glucose Control		12 weeks
Secondary	Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes		12 weeks