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The goal of this work is to develop, refine, and pilot test an electronic visit (e-visit) to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) to improve rates of COPD early detection and accurate diagnosis. The investigators will conduct a pilot RCT of the COPD/smoking cessation e-visit as compared to treatment as usual (TAU), with primary objective to provide effect size estimates for a larger RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD/smoking cessation electronic visit (e-visit) | Experimental | 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. |
|
| Treatment as Usual (TAU) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking cessation, early COPD detection, electronic visit | Behavioral | electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD) |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence-based Cessation Treatment Utilization | participants in both groups will be queried for use of a smoking cessation medication since the last assessment | Baseline through Month 3 |
| Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | quit 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 | Baseline through Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| E-visit Acceptability and Feasibility | the percentage of patients who complete the initial and follow-up e-visits | Baseline through Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36040766 | Derived | Dahne J, Player MS, Strange C, Carpenter MJ, Ford DW, King K, Miller S, Kruis R, Hawes E, Hidalgo JE, Diaz VA. Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy. J Med Internet Res. 2022 Aug 30;24(8):e38663. doi: 10.2196/38663. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence-based Cessation Treatment Utilization | participants in both groups will be queried for use of a smoking cessation medication since the last assessment | Posted | Count of Participants | Participants | Baseline through Month 3 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Dahne | Medical University of South Carolina | 843-876-2280 | dahne@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2020 | Jun 30, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2020 | Jul 21, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment As Usual | Other | 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 |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| Primary | Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | quit 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 | Posted | Count of Participants | Participants | Baseline through Month 3 |
|
|
|
| Secondary | E-visit Acceptability and Feasibility | the percentage of patients who complete the initial and follow-up e-visits | Not Posted | Baseline through Month 3 | Participants |
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |