Asthma
Conditions
Keywords
pediatric asthma
Brief summary
The original and primary aim of this study is to evaluate the effects of CHESS with Nurse Case Management on asthma control (symptom-free days), and adherence factors of children aged 4-12. The investigators have expanded the scope of the specific aims. The criteria for their expanded aim is to also interview low-income African-American caregivers to gain an understanding of how they conceptualize their child's asthma, and what they consider to be barriers or facilitators to managing their child's asthma. There is no change in the investigators' original aim.
Interventions
BEHAVIORALCHESS Internet telehealth
CHESS Internet telehealth
Sponsors
National Institutes of Health (NIH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Parents of children, aged 4-12 with moderate to severe asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Changed in Adherence Score | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores | A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals. |
| Number of Symptom-free Days | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores | A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Asthma Control | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores | A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control. |
Participant flow
Recruitment details
The study extended 1,988 invitations, resulting in eligibility screening for 702 cases over the phone. A total of 305, or about 15% of the 1,988 invitations, enrolled. Some of the reasons for non-enrollment include inability of clients to reach phone, not having moderate to severe asthma, or up to 3 no shows for scheduled intake appointments.
Pre-assignment details
After initial eligibility screening, 305 parent/child dyads enrolled for study. However, four dyads dropped out after intake, but prior to randomization. Of the remaining dyads, 153 were assigned to the control group and 148 to the experimental group.
Participants by arm
| Arm | Count |
|---|---|
| CHESS + Case Mgt Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period. | 148 |
| Control Control-usual care | 153 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 26 |
Baseline characteristics
| Characteristic | Control | CHESS + Case Mgt | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 153 Participants | 148 Participants | 301 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 8.18 years STANDARD_DEVIATION 2.45 | 7.65 years STANDARD_DEVIATION 2.61 | 7.92 years STANDARD_DEVIATION 2.54 |
| Region of Enrollment United States | 153 participants | 148 participants | 301 participants |
| Sex: Female, Male Female | 66 Participants | 51 Participants | 117 Participants |
| Sex: Female, Male Male | 87 Participants | 97 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 148 | 0 / 153 |
| serious Total, serious adverse events | 0 / 148 | 0 / 153 |
Outcome results
Primary
Number of Symptom-free Days
A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.
Time frame: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores
Population: Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHESS + Case Mgt | Number of Symptom-free Days | 1.38 Days |
| Control | Number of Symptom-free Days | 1.26 Days |
Primary
Percentage Changed in Adherence Score
A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals.
Time frame: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores
Population: Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHESS + Case Mgt | Percentage Changed in Adherence Score | 2.06 Percent change |
| Control | Percentage Changed in Adherence Score | .58 Percent change |
Secondary
Improvement in Asthma Control
A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control.
Time frame: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores
Population: Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHESS + Case Mgt | Improvement in Asthma Control | -.42 Likert scale |
| Control | Improvement in Asthma Control | -.11 Likert scale |