Trial Outcomes & Findings for PackHealth: Asthma Engagement Tool (NCT NCT02413684)
NCT ID: NCT02413684
Last Updated: 2018-10-09
Results Overview
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
COMPLETED
NA
53 participants
12 weeks prior to baseline
2018-10-09
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PackHealth: Asthma Engagement Tool
Baseline characteristics by cohort
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
49.98 years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
|
Weight
|
94.5 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks prior to baselineThe average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Rate of Asthma Exacerbations
|
3.21 events/12 weeks
Standard Deviation 5.74
|
PRIMARY outcome
Timeframe: baseline to week 13The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Rate of Asthma Exacerbations
|
1.25 Events/13 weeks
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: baseline, 13 weeksMeasured 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.
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Change in Asthma Control
|
1.67 Units on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: baseline, 13 weeksMeasured 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
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Change in Asthma Symptoms
|
0.095 Units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: baseline, 13 weeksMeasured 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.
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Change in Pulmonary Function Tests
|
0.022 liters
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Prior YearNumber of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Number of Emergency Department and Hospitalization Visits
|
0.3 Events
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 13 weeksNumber of emergency department and hospitalization visits will be recorded
Outcome measures
| Measure |
Asthma Patients
n=40 Participants
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
|
|---|---|
|
Number of Emergency Department and Hospitalization Visits
|
0.37 Events
Standard Deviation 1.04
|
Adverse Events
Asthma Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place