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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Computer-based Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Computer-based Program<br>Use of Computer-based Program for 12 weeks | Behavioral: Computer-based Program<br>* 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.<br>|
| No Intervention: 2 Control<br>Usual care and list of useful websites | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between Group Differences in Diabetes Knowledge | ADKnowl questionnaire | 12 weeks | 
| Between Group Differences in Goal Setting |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between Group Differences in Dietary Intake |  | 12 weeks | 
| Between Group Differences in Physical Activity Levels |  | 12 weeks | 
| Between Group Difference in Anthropometry |  | 12 weeks | 
| Between Group Differences in Markers of Cardiovascular Risk |  | 12 weeks | 
| Between Group Differences in Markers of Blood Glucose Control |  | 12 weeks | 
| Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Physical activity, Self management, Goal setting