Asthma
Conditions
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALPatient 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
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a physician diagnosis of asthma for at least the previous 12 months. * Asthma that is not well controlled by NAEPP guidelines. * Ability and willingness to provide informed consent
Exclusion criteria
* Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse. * Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled. * A diagnosis of cancer with ongoing treatment. * Any terminal illness or conditions that results in a life expectancy less than one year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Asthma Exacerbations | 12 weeks prior to baseline | The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control | baseline, 13 weeks | 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. |
| Change in Asthma Symptoms | baseline, 13 weeks | 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 |
| Change in Pulmonary Function Tests | baseline, 13 weeks | 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. |
| Number of Emergency Department and Hospitalization Visits | Prior Year | Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Asthma Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 49.98 years STANDARD_DEVIATION 13.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight | 94.5 kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: 12 weeks prior to baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Rate of Asthma Exacerbations | 3.21 events/12 weeks | Standard Deviation 5.74 |
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
Time frame: baseline to week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Rate of Asthma Exacerbations | 1.25 Events/13 weeks | Standard Deviation 1.65 |
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.
Time frame: baseline, 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Change in Asthma Control | 1.67 Units on a scale | Standard Deviation 4 |
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
Time frame: baseline, 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Change in Asthma Symptoms | 0.095 Units on a scale | Standard Deviation 0.2 |
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.
Time frame: baseline, 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Change in Pulmonary Function Tests | 0.022 liters | Standard Deviation 0.3 |
Secondary
Number of Emergency Department and Hospitalization Visits
Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
Time frame: Prior Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Number of Emergency Department and Hospitalization Visits | 0.3 Events | Standard Deviation 0.61 |
Secondary
Number of Emergency Department and Hospitalization Visits
Number of emergency department and hospitalization visits will be recorded
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Patients | Number of Emergency Department and Hospitalization Visits | 0.37 Events | Standard Deviation 1.04 |