This project is designed to study three adherence-promoting interventions within the Childhood Asthma Management Program (CAMP); a five year, eight center, NHLBI-sponsored clinical trial that will compare pediatric asthma therapies in children 5-12 years old.
The aims of this application are to test specialized adherence interventions and measures that optimize a clinical trial's validity, efficiency and power. Specifically, we propose to randomize all participants enrolled at three CAMP clinical centers (N=480) to one of three adherence treatment groups. All participant's medication adherence will be measured by self-report, canister weighing, and with the Nebulizer Chronolog (NC), a microprocessor-based monitor of inhaler adherence that records the date and time of each inhaler use. In the Control condition participants will receive the usual behavioral adherence interventions standard to the overall clinical trial. These participants will be informed that the NC inhaler mouthpiece measures the amount of inhaler that is used, however, they will receive no information about the precise monitoring ability of the device. In the Control conditiion, participants will receive the usual adherence intervention and will be informed of the NC's ability to record each use of the inhaler. These participants will not, however, receive any feedback of their inhaler adherence performance recorded by the NC. In the Feedback condition participants will receive the usual adherence intervention, they will be informed about the NC's measurement ability, and, in addition, these participants will receive NC feedback of their inhaler adherence at each followup visit. This study will assess the relative contribution that knowledge of monitoring without feedback, and compared to masked monitoring. We hypothesize that: 1) Feedback subjects will have significantly better adherence (as measured by the NC) than Informed participants or Control participants, and 2) Informed participants will have significantly better adherence than Control participants. Nested within the primary adherence interventions we will conduct a series of short-term secondary studies of specific behavioral strategies designed to promote adherence. Adherence outcomes will be analyzed with respect to treatment assignment, as well as CAMP measures of asthma morbidity, pulmonary function, medication side effects, physical, cognitive and psychosocial development, and quality of life. Cost effectiveness analysis will determine the relative cost per participant to reach the projected study endpoint values, with and without adherence promoting strategies.
| Krishnan, Jerry A; Bender, Bruce G; Wamboldt, Frederick S et al. (2012) Adherence to inhaled corticosteroids: an ancillary study of the Childhood Asthma Management Program clinical trial. J Allergy Clin Immunol 129:112-8 |
