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Adherence in the Childhood Asthma Management Program

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ClinicalTrials.gov Identifier: NCT00005705
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date February 18, 2016
Study Start Date September 1992
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00005705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adherence in the Childhood Asthma Management Program
Official Title Not Provided
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Asthma
  • Lung Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Wamboldt FS, Bender BG, O'Connor SL, Gavin LA, Wamboldt MZ, Milgrom H, Szefler SJ, Iklé D, Rand C. Reliability of the model MC-311 MDI chronolog. J Allergy Clin Immunol. 1999 Jul;104(1):53-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date June 1996
Primary Completion Date Not Provided
Eligibility Criteria No eligibility criteria
Sex/Gender
Sexes Eligible for Study: Male
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005705
Other Study ID Numbers 4489
U01HL048999 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators National Institute of Nursing Research (NINR)
Investigators Not Provided
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date September 2002