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

July 6, 2022 updated by: Michelle McKinley, Queen's University, Belfast

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

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 Kingdom
    • Antrim
      • Belfast, Antrim, United Kingdom, BT12 6BJ
        • Queen's University Belfast
      • Belfast, Antrim, United Kingdom
        • Belfast Health and Social Care Trust

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

Description

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

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

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Queen's University, Belfast

Investigators

  • Principal Investigator: Michelle McKinley, PhD, Queen's University, Belfast

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

April 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/NIR01/97

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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