Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005705
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Adherence in the Childhood Asthma Management Program
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 individuals 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
The success of any therapeutic intervention whether preventive or curative is ultimately dependent on the individuals 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL048999 | NIH | None | httpsreporternihgovquickSearchU01HL048999 |