To conduct a randomized controlled trial of Problem Solving (PS) compared with Attention Control (AC) to improve and sustain asthma self-management.

Condition	Intervention
Asthma Lung Diseases	Behavior: Problem Solving  Behavior: Attention Control

Further Study Details: 

DESIGN NARRATIVE: Randomized, controlled trial of Problem Solving (PS) compared with Attention Control (AC) to improve and sustain asthma self-management deliverable in a clinical setting that includes strategies to address contextual factors related to adherence. PS is based on findings from a prospective cohort study of African Americans, which identified influences of adherence in the social context. The investigators have extracted the context from their experiences with African Americans and applied it to Latinos, another group with significant asthma morbidity. In order to accomplish this, they explored such influences in focus groups of African American and Latino patients and ultimately piloted PS extensively in both patient groups. PS addresses and integrates solutions to a problem of the participants'''' choosing, tailoring problem-solving to participants'''' needs with ways to maintain or improve adherence using a simple four-step protocol. Specific aims are to test whether: 1) PS improves adherence to inhaled corticosteroids (ICS) over AC among adults with moderate or severe persistent asthma receiving care from urban clinics serving low-income minority populations, 2) PS improves asthma control over AC, and 3) PS improves asthma-related quality of life over AC. They will recruit 450 adults from five clinics and randomize these participants to PS or AC, stratifying by site and type of ICS. Because there are no electronic monitors providing date-time adherence data with the most frequently used dry powder inhalers, they have developed and tested one and will be able to obtain date-time data on all participants. The intervention will take place over three months. Participants will be followed for an additional three months. In their cohort study, attitude (the weighing of risks and benefits of ICS), trust of and satisfaction with communication with the provider were associated with adherence. They will explore whether motivation variables such as improved knowledge of ICS, attitudes about ICS benefits, and self-efficacy provided by the intervention mediate the relationship between PS and adherence. They also will explore whether personal characteristics and contextual influences (e.g. ethnic group, educational attainment, asthma severity, etc), social interactions (e.g. trust of and satisfaction with communication with the provider, social support) and generative capabilities such as innate problem-solving ability and absence of depression moderate this relationship. They will estimate the incremental cost-effectiveness of PS.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

No eligibility criteria

Please refer to this study by ClinicalTrials.gov identifier  NCT00115323

Study chairs or principal investigators

Andrea Apter,  University of Pennsylvania   

Study ID Numbers:  190
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 21, 2005
ClinicalTrials.gov Identifier:  NCT00115323
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05