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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM144270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The goal of this pilot interventional study is to learn about the implementation of a home monitoring program (using remote study visits and lung function testing) in children with asthma.
The main questions to answer are:
The primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically underserved children with persistent asthma in Delaware and to determine its feasibility, acceptability, and accessibility.
Additionally, the proposed study aims to explore patient and family demographic characteristics and social factors associated with successful completion of the program and to explore the preliminary effect of the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot study arm for technology-enhanced asthma intervention | Experimental | All participants will be in the pilot arm for technology-enhanced intervention program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilot study arm for technology-enhanced asthma intervention | Behavioral | Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Retention %) | Feasibility will be evaluated by calculating retention rates at week 24. | 24 weeks |
| Acceptability | To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond "agree" or "strongly agree" to each item will be measured. | 24 weeks |
| Accessibility | The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control. | The asthma control test (ACT) will be completed at each study visit. This measure rates asthma symptoms from 5-25 with 5 being the lowest (poorest) asthma control and 25 being the highest (optimal) asthma control. | Baseline and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Health | Wilmington | Delaware | 19803 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Study Arm for Technology-enhanced Asthma Intervention | All participants will be in the pilot arm for technology-enhanced intervention program. Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
15 participants enrolled in pilot intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Study Arm for Technology-enhanced Asthma Intervention | All participants will be in the pilot arm for technology-enhanced intervention program. Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility (Retention %) | Feasibility will be evaluated by calculating retention rates at week 24. | Participants who completed the pilot through final study visit. | Posted | Count of Participants | Participants | 24 weeks |
|
6 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 | Pilot Study Arm for Technology-enhanced Asthma Intervention | All participants will be in the pilot arm for technology-enhanced intervention program. Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abigail Strang | Nemours Children's Hospital | 3026516400 | astrang@nemours.org |
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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 | Jan 11, 2023 | Mar 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2023 | Mar 16, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma
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|
| Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness. |
The Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) will be completed at each study visit. This measure rates sleepiness with scores of 0-24 with 0 being the lowest degree of daytime sleepiness and 24 being the highest (sleepiest). |
| Baseline and Week 24 |
| Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | The study-specific demographic and psychosocial assessment tool will be completed at the baseline visit. Descriptive and comparative statistics will be employed to characterize participant-specific demographic factors which may be associated with study completion at item-level. | 24 weeks |
| Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage) | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Courses of oral steroids in the prior 6 months were calculated based on participant survey results. | Baseline |
| Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits) | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Number of ER visits were calculated based on survey results | Baseline |
| Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions) | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Hospital admissions were calculated based on survey results. | Baseline |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Acceptability | To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond "agree" or "strongly agree" to each item will be measured. | Results of Satisfaction and Usability Survey for 12 participants who completed the pilot and also completed this measure. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Primary | Accessibility | The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study. | Remote visits (5 total) of 14 participants who completed pilot were analyzed for technical concerns. | Posted | Count of Units | Remote study visits | 24 weeks | Remote study visits | Remote study visits |
|
|
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| Secondary | Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control. | The asthma control test (ACT) will be completed at each study visit. This measure rates asthma symptoms from 5-25 with 5 being the lowest (poorest) asthma control and 25 being the highest (optimal) asthma control. | ACT of 14 participants who completed the pilot were analyzed. | Posted | Median | Full Range | score on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness. | The Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) will be completed at each study visit. This measure rates sleepiness with scores of 0-24 with 0 being the lowest degree of daytime sleepiness and 24 being the highest (sleepiest). | ESS-CHAD scores of all participants who completed the pilot. | Posted | Median | Full Range | score on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | The study-specific demographic and psychosocial assessment tool will be completed at the baseline visit. Descriptive and comparative statistics will be employed to characterize participant-specific demographic factors which may be associated with study completion at item-level. | Characteristics of participants who completed pilot were analyzed. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage) | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Courses of oral steroids in the prior 6 months were calculated based on participant survey results. | Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed. | Posted | Median | Full Range | Courses | Baseline |
|
|
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| Secondary | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits) | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Number of ER visits were calculated based on survey results | Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed. | Posted | Median | Full Range | ER visits | Baseline |
|
|
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| Secondary | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions) | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Hospital admissions were calculated based on survey results. | Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed. | Posted | Median | Full Range | Admissions | Baseline |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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| The introduction and training was enough. |
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| I would recommend the program to others. |
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| It helped me change my asthma habits. |
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| It helped me to understand the importance of following my asthma plan. |
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| It helped me to understand how to control my asthma. |
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| It helped me to manage my asthma in a way that I could not have done myself. |
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| It helped me to understand my asthma better. |
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| Sex: Male |
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| Sex: Female |
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| Race: White |
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| Race: Black or African-American |
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| Race: More than one race |
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