Trial Outcomes & Findings for Problem-Solving Skills Training to Improve Care for Children With Asthma (NCT NCT00250588)
NCT ID: NCT00250588
Last Updated: 2013-06-03
Results Overview
The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, \& Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
Results posted on
2013-06-03
Participant Flow
Participants were recruited between June 11, 2004 and January 15, 2007. The final T3 follow up was completed on October 16, 2007.
Participant milestones
| Measure |
Care Coordination
The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
|
Care Coordination+Problem Solving
The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
|
Standard Care
The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
84
|
87
|
|
Overall Study
COMPLETED
|
72
|
65
|
74
|
|
Overall Study
NOT COMPLETED
|
9
|
19
|
13
|
Reasons for withdrawal
| Measure |
Care Coordination
The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
|
Care Coordination+Problem Solving
The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
|
Standard Care
The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
13
|
13
|
Baseline Characteristics
Problem-Solving Skills Training to Improve Care for Children With Asthma
Baseline characteristics by cohort
| Measure |
Care Coordination
n=81 Participants
The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
|
Care Coordination+Problem Solving
n=84 Participants
The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
|
Standard Care
n=87 Participants
The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
81 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
7.47 years
STANDARD_DEVIATION 3.13 • n=5 Participants
|
7.37 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
7.26 years
STANDARD_DEVIATION 3.02 • n=5 Participants
|
7.37 years
STANDARD_DEVIATION 3.07 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
84 participants
n=7 Participants
|
87 participants
n=5 Participants
|
252 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)Population: All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.
The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, \& Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.
Outcome measures
| Measure |
Care Coordination
n=72 Participants
The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
|
Care Coordination+Problem Solving
n=65 Participants
The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
|
Standard Care
n=74 Participants
The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
|
|---|---|---|---|
|
Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)
|
81.2 units on a scale
Standard Error 1.4
|
85.4 units on a scale
Standard Error 1.5
|
80.8 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)Population: All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3.
Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).
Outcome measures
| Measure |
Care Coordination
n=72 Participants
The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
|
Care Coordination+Problem Solving
n=65 Participants
The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
|
Standard Care
n=74 Participants
The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
|
|---|---|---|---|
|
Counts of Patients With One or More Asthma-related Emergency Department Visits.
|
10 participants
|
4 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)Population: All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.
Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.
Outcome measures
| Measure |
Care Coordination
n=72 Participants
The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
|
Care Coordination+Problem Solving
n=65 Participants
The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
|
Standard Care
n=74 Participants
The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
|
|---|---|---|---|
|
Asthma Symptoms
|
21 participants
|
9 participants
|
24 participants
|
Adverse Events
Care Coordination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Care Coordination+Problem Solving
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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