Trial Outcomes & Findings for Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19 (NCT NCT04613739)
NCT ID: NCT04613739
Last Updated: 2022-03-09
Results Overview
Coverage status (has any insurance coverage or not)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
At follow-up (four months)
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
Insurance Navigation
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
37
|
|
Overall Study
COMPLETED
|
12
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
| Measure |
Insurance Navigation
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
|
Overall Study
potentially duplicative/fraudulent
|
1
|
3
|
Baseline Characteristics
Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19
Baseline characteristics by cohort
| Measure |
Insurance Navigation
n=19 Participants
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
n=37 Participants
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age of reference patient (years) · <=17
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age of reference patient (years) · 18-39
|
10 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Customized
Age of reference patient (years) · 40-64
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender of reference patient · Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender of reference patient · Female
|
16 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender of reference patient · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Recruitment source
Asthma and Allergy Foundation of America (AAFA)
|
7 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Recruitment source
Harvard Pilgrim
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Insurance status at baseline
Insured
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Insurance status at baseline
Uninsured
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Insurance status at baseline
Missing
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At follow-up (four months)Coverage status (has any insurance coverage or not)
Outcome measures
| Measure |
Insurance Navigation
n=12 Participants
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
n=25 Participants
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
|---|---|---|
|
Insurance Coverage
Insured
|
11 Participants
|
17 Participants
|
|
Insurance Coverage
Uninsured
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At follow-up (four months)Report of using less asthma medication than prescribed because of cost
Outcome measures
| Measure |
Insurance Navigation
n=12 Participants
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
n=25 Participants
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
|---|---|---|
|
Medication Adherence
Used less medication
|
3 Participants
|
8 Participants
|
|
Medication Adherence
Did not use less medication
|
9 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: At follow-up (four months)Report of: 1) problems paying medical bills for asthma care, or 2) having to borrow money because of the amount required to pay for asthma care
Outcome measures
| Measure |
Insurance Navigation
n=12 Participants
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
n=25 Participants
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
|---|---|---|
|
Financial Burden
financial burden
|
5 Participants
|
15 Participants
|
|
Financial Burden
no financial burden
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From baseline to follow-up (four months)Change in report of: 1) using less asthma medication than prescribed because of cost,or 2) delaying or avoiding going to the doctor for asthma because of cost
Outcome measures
| Measure |
Insurance Navigation
n=12 Participants
The intervention group will be offered access to AAFA's insurance chat bot and navigation services. Navigation will be provided through AAFA's existing online patient community platform that provides assistance with clinical, educational and financial questions and includes secure, personal messaging capabilities that will be supplemented with telephonic outreach.
insurance navigation: Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
|
Wait-list Controls
n=25 Participants
Control subjects will be offered the chat bot after completion of data collection for the intervention group (after completion of the four-month follow-up surveys)
|
|---|---|---|
|
Delayed/Forgone Care Due to Cost
Delayed/forgone asthma care due to cost
|
4 Participants
|
13 Participants
|
|
Delayed/Forgone Care Due to Cost
No delayed/forgone asthma care due to cost
|
8 Participants
|
12 Participants
|
Adverse Events
Insurance Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Controls
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. Alison Galbraith
Harvard Pilgrim Health Care Institute
Phone: 617-867-4893
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place