Asthma Clinical Trial
To evaluate three adherence promoting interventions within the Childhood Asthma Management Program (CAMP), an eight center clinical trial that compared pediatric asthma therapies in children five to twelve years old.
BACKGROUND:
The success of any therapeutic intervention, whether preventive or curative, is ultimately
dependent on the individual's adherence to treatment. Unfortunately, the failure of a large
percentage of patients to adhere to prescribed medical regimens is a widely recognized and
well documented phenomenon. It has been estimated that as many as 50 percent of patients do
not take their prescribed medications, and of those remaining, less than two-thirds take
their medication as prescribed.
The study was part of a two grant initiative, "Evaluation of Adherence Interventions in
Clinical Trials", developed by the Behavioral Medicine Branch staff and the Clinical Trials
Branch staff and by members of the Clinical Applications and Prevention Advisory Committee
Behavioral Medicine and Prevention Working Groups. The initiative, jointly sponsored by the
NHLBI and the National Center for Nursing Research (NCNR), was released in September 1991
and awarded in September 1992.
DESIGN NARRATIVE:
All participants medication adherence was measured by self-report, canister weighing, and
with the Nebulizer Chronolog, a microprocessor-based monitor of inhaler adherence that
recorded the date and time of each inhaler use. The subjects were assigned to one of three
adherence treatment groups; a control condition, an informed condition, and a feedback
condition. Adherence outcomes were analyzed with respect to treatment assignment, as well as
CAMP measures of asthma morbidity, pulmonary function, medication side effects, psychosocial
development, and quality of life. Cost-effectiveness analyses were also conducted.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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Completed |
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Early Phase 1 | |
Recruiting |
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Phase 4 | |
Terminated |
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Phase 2 | |
Completed |
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N/A | |
Completed |
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Phase 2 | |
Completed |
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Completed |
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|
Phase 3 | |
Completed |
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|
Phase 3 | |
Completed |
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|
Phase 1 | |
Terminated |
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Phase 1 | |
Completed |
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Phase 4 | |
Recruiting |
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|
Phase 2 | |
Completed |
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Phase 2 | |
Completed |
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N/A | |
Recruiting |
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||
Withdrawn |
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N/A | |
Recruiting |
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