An interventional study of CHESS Internet telehealth in Asthma, sponsored by University of Wisconsin, Madison. Completed. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 301 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period. Support calls refer to check in calls by a nurse to the parents to see how the child is doing. CHESS services include access to a website with information on asthma management, discussion groups and a case manager. The website also include a management tool for asthma symptoms check in, and the case manager used the information entered to tailor the homepage to individual clients.
Behavioral: CHESS Internet telehealth
Control-usual care. Usual care refers to the manner in which clients generally manage their asthma.
CHESS Internet telehealth
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
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
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
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.
| Milestone | CHESS + Case Mgt | Control |
|---|---|---|
| Started | 148 | 153 |
| Completed | 132 | 127 |
| Not completed | 16 | 26 |
| Withdrew: Lost to follow-up | 16 | 26 |
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.
| Percent change | CHESS + Case Mgt | Control |
|---|---|---|
| Percentage Changed in Adherence Score | 2.06 (-4.74 to 8.86) | .58 (-6.24 to 7.40) |
A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.
| Days | CHESS + Case Mgt | Control |
|---|---|---|
| Number of Symptom-free Days | 1.38 (1.12 to 1.71) | 1.26 (.98 to 1.61) |
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.
| Likert scale | CHESS + Case Mgt | Control |
|---|---|---|
| Improvement in Asthma Control | -.42 (-.60 to -.25) | -.11 (-.29 to .07) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHESS + Case Mgt | — | 0/148 (0%) | 0/148 (0%) |
| Control | — | 0/153 (0%) | 0/153 (0%) |
| Age, Categorical(Participants) | CHESS + Case Mgt | Control | Total |
|---|---|---|---|
| <=18 years | 148 | 153 | 301 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | CHESS + Case Mgt | Control | Total |
|---|---|---|---|
| Mean | 7.65 ± 2.61 | 8.18 ± 2.45 | 7.92 ± 2.54 |
| Sex: Female, Male(Participants) | CHESS + Case Mgt | Control | Total |
|---|---|---|---|
| Female | 51 | 66 | 117 |
| Male | 97 | 87 | 184 |
| Region of Enrollment(participants) | CHESS + Case Mgt | Control | Total |
|---|---|---|---|
| United States | 148 | 153 | 301 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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