Trial Outcomes & Findings for E-Visit for COPD and Smoking Cessation (NCT NCT04155073)
NCT ID: NCT04155073
Last Updated: 2024-02-21
Results Overview
participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Baseline through Month 3
Results posted on
2024-02-21
Participant Flow
Participant milestones
| Measure |
COPD/Smoking Cessation Electronic Visit (E-visit)
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit.
smoking cessation, early COPD detection, electronic visit: electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
|
Treatment as Usual (TAU)
This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.
Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
40
|
|
Overall Study
COMPLETED
|
85
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
E-Visit for COPD and Smoking Cessation
Baseline characteristics by cohort
| Measure |
COPD/Smoking Cessation Electronic Visit (E-visit)
n=85 Participants
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit.
smoking cessation, early COPD detection, electronic visit: electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
|
Treatment as Usual (TAU)
n=40 Participants
This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.
Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.12 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
51.93 years
STANDARD_DEVIATION 8.52 • n=7 Participants
|
53.42 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 3participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Outcome measures
| Measure |
COPD/Smoking Cessation Electronic Visit (E-visit)
n=85 Participants
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit.
smoking cessation, early COPD detection, electronic visit: electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
|
Treatment as Usual (TAU)
n=40 Participants
This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.
Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking
|
|---|---|---|
|
Evidence-based Cessation Treatment Utilization
Month 1
|
44 Participants
|
10 Participants
|
|
Evidence-based Cessation Treatment Utilization
Month 3
|
51 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 3quit attempts will be assessed at each follow-up using a timeline followback for the last 6-months at baseline and since prior follow-up for each subsequent assessment
Outcome measures
| Measure |
COPD/Smoking Cessation Electronic Visit (E-visit)
n=85 Participants
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit.
smoking cessation, early COPD detection, electronic visit: electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
|
Treatment as Usual (TAU)
n=40 Participants
This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.
Treatment As Usual: Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking
|
|---|---|---|
|
Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt
Month 1
|
20 Participants
|
6 Participants
|
|
Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt
Month 3
|
24 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline through Month 3the percentage of patients who complete the initial and follow-up e-visits
Outcome measures
Outcome data not reported
Adverse Events
COPD/Smoking Cessation Electronic Visit (E-visit)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
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
Dr. Jennifer Dahne
Medical University of South Carolina
Phone: 843-876-2280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place