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Problem-Solving Skills Training to Improve Care for Children With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT00250588
First received: November 4, 2005
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine whether Problem-Solving Skills Training is effective in reducing barriers to health care and improving health-related quality of life for children with persistent asthma.


Condition Intervention
Asthma
Behavioral: Problem solving skills training
Behavioral: Asthma care coordination
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Barriers to Care for Vulnerable Children With Asthma

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory) [ Time Frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Counts of Patients With One or More Asthma-related Emergency Department Visits. [ Time Frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) ] [ Designated as safety issue: No ]
    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).

  • Asthma Symptoms [ Time Frame: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3) ] [ Designated as safety issue: No ]
    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.


Enrollment: 252
Study Start Date: October 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Problem solving + care coordination
Problem solving skills training and asthma care coordination
Behavioral: Problem solving skills training
See description in Results
Behavioral: Asthma care coordination
See description in Results
Other: Usual Care
Usual clinical care
Experimental: Asthma care coordination
Asthma care coordination
Behavioral: Asthma care coordination
See description in Results
Other: Usual Care
Usual clinical care
Active Comparator: Wait-list control
Usual care
Other: Usual Care
Usual clinical care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child age 2 to 12 years old, inclusive
  • Diagnosis of persistent asthma (mild, moderate, or severe) according to NHLBI criteria
  • Family speaks English or Spanish

Exclusion Criteria:

  • Family does not speak English or Spanish
  • Child has other comorbid conditions that would affect care or outcomes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250588

Locations
United States, California
Children's Hospital, San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Michael Seid, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT00250588     History of Changes
Other Study ID Numbers: R40 MC 00331
Study First Received: November 4, 2005
Results First Received: December 11, 2012
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
Asthma
Child
Problem-solving
Quality of Life
Barriers to Care

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014