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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR007889-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHESS + Case Mgt | Experimental | 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. |
|
| Control | No Intervention | Control-usual care. Usual care refers to the manner in which clients generally manage their asthma. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHESS Internet telehealth | Behavioral | CHESS Internet telehealth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gustafson, PhD | University of Wisconsin, Madison | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16928987 | Background | Wise M, Gustafson DH, Sorkness CA, Molfenter T, Staresinic A, Meis T, Hawkins RP, Shanovich KK, Walker NP. Internet telehealth for pediatric asthma case management: integrating computerized and case manager features for tailoring a Web-based asthma education program. Health Promot Pract. 2007 Jul;8(3):282-91. doi: 10.1177/1524839906289983. Epub 2006 Aug 23. | |
| 19515862 | Result | Wise M, Pulvermacher A, Shanovich KK, Gustafson DH, Sorkness C, Bhattacharya A. Using action research to implement an integrated pediatric asthma case management and eHealth intervention for low-income families. Health Promot Pract. 2010 Nov;11(6):798-806. doi: 10.1177/1524839909334621. Epub 2009 Jun 10. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHESS + Case Mgt | Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period. |
| FG001 | Control | Control-usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CHESS + Case Mgt | Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period. |
| BG001 | Control | Control-usual care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group. | Posted | Mean | 95% Confidence Interval | Percent change | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHESS + Case Mgt | Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alice Pulvermacher | University of Wisconsin - Madison | (608) 262-8448 | alice.pulvermacher@chess.wisc.edu |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 22835804 | Result | Gustafson D, Wise M, Bhattacharya A, Pulvermacher A, Shanovich K, Phillips B, Lehman E, Chinchilli V, Hawkins R, Kim JS. The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial. J Med Internet Res. 2012 Jul 26;14(4):e101. doi: 10.2196/jmir.1964. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Control-usual care |
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|
| 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. | Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group. | Posted | Mean | 95% Confidence Interval | Days | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores |
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| 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. | Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group. | Posted | Mean | 95% Confidence Interval | Likert scale | Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores |
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| 0 |
| 148 |
| 0 |
| 148 |
| EG001 | Control | Control-usual care | 0 | 153 | 0 | 153 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |