Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes (LWD)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Computer-based Program
Sponsored by

About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diet, Physical activity, Self management, Goal setting
Eligibility Criteria
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
Sites / Locations
- Queen's University Belfast
- Belfast Health and Social Care Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1 Computer-based Program
2 Control
Arm Description
Use of Computer-based Program for 12 weeks
Usual care and list of useful websites
Outcomes
Primary Outcome Measures
Between Group Differences in Diabetes Knowledge
ADKnowl questionnaire
Between Group Differences in Goal Setting
Secondary Outcome Measures
Between Group Differences in Dietary Intake
Between Group Differences in Physical Activity Levels
Between Group Difference in Anthropometry
Between Group Differences in Markers of Cardiovascular Risk
Between Group Differences in Markers of Blood Glucose Control
Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes
Full Information
NCT ID
NCT00877851
First Posted
April 7, 2009
Last Updated
July 6, 2022
Sponsor
Queen's University, Belfast
1. Study Identification
Unique Protocol Identification Number
NCT00877851
Brief Title
Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes
Acronym
LWD
Official Title
Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed With Type 2 Diabetes (Evaluation Phase)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diet, Physical activity, Self management, Goal setting
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Computer-based Program
Arm Type
Experimental
Arm Description
Use of Computer-based Program for 12 weeks
Arm Title
2 Control
Arm Type
No Intervention
Arm Description
Usual care and list of useful websites
Intervention Type
Behavioral
Intervention Name(s)
Computer-based Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Between Group Differences in Diabetes Knowledge
Description
ADKnowl questionnaire
Time Frame
12 weeks
Title
Between Group Differences in Goal Setting
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Between Group Differences in Dietary Intake
Time Frame
12 weeks
Title
Between Group Differences in Physical Activity Levels
Time Frame
12 weeks
Title
Between Group Difference in Anthropometry
Time Frame
12 weeks
Title
Between Group Differences in Markers of Cardiovascular Risk
Time Frame
12 weeks
Title
Between Group Differences in Markers of Blood Glucose Control
Time Frame
12 weeks
Title
Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle McKinley, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University Belfast
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust
City
Belfast
State/Province
Antrim
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27446961
Citation
Booth AO, Lowis C, Hunter SJ, Dean M, Cardwell CR, McKinley MC. Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed with Type 2 Diabetes. J Diabetes Res. 2016;2016:3192673. doi: 10.1155/2016/3192673. Epub 2016 Jun 30.
Results Reference
derived
Learn more about this trial
Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes
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