Trial Outcomes & Findings for Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes (NCT NCT00877851)

Results Overview

ADKnowl questionnaire

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	1 Computer-based Program Use of Computer-based Program for 12 weeks 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.	2 Control Usual care and list of useful websites
Overall Study STARTED	41	43
Overall Study COMPLETED	32	38
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Reasons for withdrawal
Measure	1 Computer-based Program Use of Computer-based Program for 12 weeks 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.	2 Control Usual care and list of useful websites
Overall Study Lost to Follow-up	5	5
Overall Study computer problem	3	0
Overall Study no longer interested in participating	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Computer-based Program n=41 Participants Use of Computer-based Program for 12 weeks 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.	2 Control n=43 Participants Usual care and list of useful websites	Total n=84 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 9.1 • n=41 Participants	60 years STANDARD_DEVIATION 10.7 • n=43 Participants	59 years STANDARD_DEVIATION 9.9 • n=84 Participants
Sex: Female, Male Female	19 Participants n=41 Participants	16 Participants n=43 Participants	35 Participants n=84 Participants
Sex: Female, Male Male	22 Participants n=41 Participants	27 Participants n=43 Participants	49 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 weeks

ADKnowl questionnaire

Outcome measures

Outcome measures
Measure	1 Computer-based Program n=32 Participants Use of Computer-based Program for 12 weeks 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.	2 Control n=38 Participants Usual care and list of useful websites
Between Group Differences in Diabetes Knowledge	67 Percent of items correct Standard Deviation 10.4	64 Percent of items correct Standard Deviation 14.2

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

1 Computer-based Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Michelle McKinley

Queen's University, Belfast

Phone: +44(0)2890632685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place