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The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.
Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.
The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma Patients | Other | Patient engagement toolkit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient engagement toolkit | Behavioral | Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Asthma Exacerbations | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline. | 12 weeks prior to baseline |
| Rate of Asthma Exacerbations | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13 | baseline to week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control | Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Njira Lugogo, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Asthma Allergy and Airway Center | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asthma Patients | Patient engagement toolkit Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asthma Patients | Patient engagement toolkit Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care |
| 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 | Rate of Asthma Exacerbations | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline. | Posted | Mean | Standard Deviation | events/12 weeks | 12 weeks prior to baseline |
|
|
13 weeks
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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 | Asthma Patients | Patient engagement toolkit Patient engagement toolkit: Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Njira Lugogo | Duke Asthma, Airway and Allergy Center | 919-613-5707 | njira.lugogo@duke.edu |
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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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|
| baseline, 13 weeks |
| Change in Asthma Symptoms | Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall. Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09 | baseline, 13 weeks |
| Change in Pulmonary Function Tests | Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline. | baseline, 13 weeks |
| Number of Emergency Department and Hospitalization Visits | Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year. | Prior Year |
| Number of Emergency Department and Hospitalization Visits | Number of emergency department and hospitalization visits will be recorded | 13 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Inter-Quartile Range | kilograms |
|
| Participants |
|
|
| Primary | Rate of Asthma Exacerbations | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13 | Posted | Mean | Standard Deviation | Events/13 weeks | baseline to week 13 |
|
|
|
| Secondary | Change in Asthma Control | Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control. | Posted | Mean | Standard Deviation | Units on a scale | baseline, 13 weeks |
|
|
|
| Secondary | Change in Asthma Symptoms | Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall. Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09 | Posted | Mean | Standard Deviation | Units on a scale | baseline, 13 weeks |
|
|
|
| Secondary | Change in Pulmonary Function Tests | Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline. | Posted | Mean | Standard Deviation | liters | baseline, 13 weeks |
|
|
|
| Secondary | Number of Emergency Department and Hospitalization Visits | Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year. | Posted | Mean | Standard Deviation | Events | Prior Year |
|
|
|
| Secondary | Number of Emergency Department and Hospitalization Visits | Number of emergency department and hospitalization visits will be recorded | Posted | Mean | Standard Deviation | Events | 13 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |