Trial Outcomes & Findings for Internet Telehealth for Pediatric Asthma Case Management (NCT NCT00214383)
NCT ID: NCT00214383
Last Updated: 2013-01-24
Results Overview
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.
COMPLETED
NA
301 participants
Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores
2013-01-24
Participant Flow
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.
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.
Participant milestones
| Measure |
CHESS + Case Mgt
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
|
Control
Control-usual care
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
153
|
|
Overall Study
COMPLETED
|
132
|
127
|
|
Overall Study
NOT COMPLETED
|
16
|
26
|
Reasons for withdrawal
| Measure |
CHESS + Case Mgt
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
|
Control
Control-usual care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
26
|
Baseline Characteristics
Internet Telehealth for Pediatric Asthma Case Management
Baseline characteristics by cohort
| Measure |
CHESS + Case Mgt
n=148 Participants
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
|
Control
n=153 Participants
Control-usual care
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
148 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
7.65 years
STANDARD_DEVIATION 2.61 • n=5 Participants
|
8.18 years
STANDARD_DEVIATION 2.45 • n=7 Participants
|
7.92 years
STANDARD_DEVIATION 2.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=5 Participants
|
153 participants
n=7 Participants
|
301 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scoresPopulation: Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.
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.
Outcome measures
| Measure |
CHESS + Case Mgt
n=132 Participants
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
|
Control
n=127 Participants
Control-usual care
|
|---|---|---|
|
Percentage Changed in Adherence Score
|
2.06 Percent change
Interval -4.74 to 8.86
|
.58 Percent change
Interval -6.24 to 7.4
|
PRIMARY outcome
Timeframe: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scoresPopulation: Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.
A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.
Outcome measures
| Measure |
CHESS + Case Mgt
n=132 Participants
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
|
Control
n=127 Participants
Control-usual care
|
|---|---|---|
|
Number of Symptom-free Days
|
1.38 Days
Interval 1.12 to 1.71
|
1.26 Days
Interval 0.98 to 1.61
|
SECONDARY outcome
Timeframe: Baseline compared to the mean of the combined 3, 6, 9, and 12 month scoresPopulation: Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.
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.
Outcome measures
| Measure |
CHESS + Case Mgt
n=132 Participants
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
|
Control
n=127 Participants
Control-usual care
|
|---|---|---|
|
Improvement in Asthma Control
|
-.42 Likert scale
Interval -0.6 to -0.25
|
-.11 Likert scale
Interval -0.29 to 0.07
|
Adverse Events
CHESS + Case Mgt
Control
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