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Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes (LWD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle McKinley, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00877851
First received: April 7, 2009
Last updated: August 19, 2011
Last verified: August 2011
History of Changes

April 7, 2009
August 19, 2011
April 2009
December 2010   (final data collection date for primary outcome measure)
Between group differences in diabetes knowledge and goal setting [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Between group differences in diabetes knowledge and goal setting [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00877851 on ClinicalTrials.gov Archive Site
  • Between group differences in dietary intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • between group differences in physical activity levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • between group difference in anthropometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • between group differences in markers of cardiovascular risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Between group differences in markers of blood glucose control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Between group differences in self−efficacy and barriers to management of diabetes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Between group differences in dietary intake [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
  • between group differences in physical activity levels [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  • between group difference in anthropometry [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
  • between group differences in markers of cardiovascular risk [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
  • Between group differences in markers of blood glucose control [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
  • Between group differences in self−efficacy and barriers to management of diabetes [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes
Development and Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes (Evaluation Phase)

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 interactive CD−ROM, 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 CD−ROM. This study will examine whether this CD−ROM 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 CD−ROM at least once a week for 12 weeks.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes Mellitus, Type 2
Behavioral: CD-ROM
The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the CD−ROM and some instructions on how to navigate around the different sections of the CD−ROM. As a minimum level of use, participants will be asked to use the self−monitoring and goal setting aspects of the CD−ROM on at least a weekly basis.
  • Experimental: 1 CD-ROM
    Use of CD-ROM for 12 weeks
    Intervention: Behavioral: CD-ROM
  • No Intervention: 2 Control
    Usual care and list of useful websites
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00877851
08/NIR01/97
No
Michelle McKinley, Queen's University, Belfast
Queen's University, Belfast
Not Provided
Principal Investigator: Michelle McKinley, PhD Queen's University, Belfast
Queen's University, Belfast
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP