Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217802
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2005-09-19
Brief Title:
The Effect of Self-regulatory Education on Women With Asthma
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:
2008-01
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:
The project evaluates an innovative educational intervention using telephone counseling based on self-regulation theory designed to address a problem heretofore overlooked in asthma self-management education the unique needs of adult female patients
Detailed Description:
BACKGROUND
More than half of the adults with asthma in the US are female Prevalence of asthma in women appears to be increasing and morbidity and mortality rates for this group are significantly higher than rates for men Recent studies point to unique features in womens management of asthma potentially attributable to gender These include for example factors associated with hormonal cycles eg menses pregnancy menopause and social roles eg household tasks exposing one to environmental triggers caregiving to children and relatives interfering with asthma management etc To date no rigorously evaluated intervention expressly designed for women with asthma has been reported in the literature
DESIGN NARRATIVE
This study is to assess the effectiveness of a gender-specific telephone counseling self-regulation intervention for women with asthma To test our hypothesis we employed a randomized controlled design utilizing an intervention group and a control group The primary outcomes are gender-related asthma management problems health care utilization days having symptoms self-regulation level management skill and quality of life We measure at three time points baseline before randomization follow-up I one year subsequent to randomization and follow-up II one year subsequent to follow-up
More than half of the adults with asthma in the US are female Prevalence of asthma in women appears to be increasing and morbidity and mortality rates for this group are significantly higher than rates for men Recent studies point to unique features in womens management of asthma potentially attributable to gender These include for example factors associated with hormonal cycles eg menses pregnancy menopause and social roles eg household tasks exposing one to environmental triggers caregiving to children and relatives interfering with asthma management etc To date no rigorously evaluated intervention expressly designed for women with asthma has been reported in the literature
DESIGN NARRATIVE
This study is to assess the effectiveness of a gender-specific telephone counseling self-regulation intervention for women with asthma To test our hypothesis we employed a randomized controlled design utilizing an intervention group and a control group The primary outcomes are gender-related asthma management problems health care utilization days having symptoms self-regulation level management skill and quality of life We measure at three time points baseline before randomization follow-up I one year subsequent to randomization and follow-up II one year subsequent to follow-up
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 |
|---|---|---|---|
| R01HL060884 | NIH | None | httpsreporternihgovquickSearchR01HL060884 |