Trial Outcomes & Findings for Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program (NCT NCT00126776)

NCT ID: NCT00126776

Last Updated: 2009-08-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 743 participants
• Primary outcome timeframe: 1 yr
• Results posted on: 2009-08-25

Participant Flow

recruited by VA mailing lists July 2004-June 2006

Participant milestones

Measure	Disease Management for COPD disease management for COPD	Usual Care usual care
Overall Study STARTED	372	371
Overall Study COMPLETED	372	371
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Disease Management for COPD disease management for COPD	Usual Care usual care
Overall Study follow up complete on all patients	0	0

Baseline Characteristics

Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program

Baseline characteristics by cohort

Measure	Disease Management for COPD n=372 Participants disease management for COPD	Usual Care n=371 Participants usual care	Total n=743 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=5 Participants	103 Participants n=7 Participants	230 Participants n=5 Participants
Age, Categorical >=65 years	245 Participants n=5 Participants	268 Participants n=7 Participants	513 Participants n=5 Participants
Age Continuous	69.1 years STANDARD_DEVIATION 9.4 • n=5 Participants	70.1 years STANDARD_DEVIATION 9.7 • n=7 Participants	70.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	363 Participants n=5 Participants	365 Participants n=7 Participants	728 Participants n=5 Participants
Region of Enrollment United States	372 participants n=5 Participants	371 participants n=7 Participants	743 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 yr

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 yr

Outcome measures

Measure	Disease Management for COPD n=372 Participants disease management for COPD	Usual Care n=371 Participants usual care
Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)	0.48 events per year Interval 0.35 to 0.61	0.82 events per year Interval 0.67 to 0.97

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathryn Rice MD

Minneapolis VAMC

Phone: 612 725 2000

Email: kathryn.rice@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place