Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414817
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2006-12-20
Brief Title:
Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Phone Calls to Promote Adherence With Inhaled Corticosteroids
Status:
COMPLETED
Status Verified Date:
2016-12
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:
Inhaled corticosteroids ICS are often prescribed as a treatment for asthma However many individuals who take these medications do not adhere to their prescribed treatment regimen The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma
Detailed Description:
Asthma is a serious chronic disease that affects lung function and impairs an individuals ability to breathe normally ICS reduce airway inflammation and are often prescribed to treat these conditions However poor medication adherence is a common problem that can lead to treatment failure hospitalization or death A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma If this study proves successful telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions
This 19-month study will enroll approximately 14000 members of the Kaiser Permanente Northwest or Hawaii health system Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care Over the 19-month period participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS If needed the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist Approximately 2000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period The questionnaires will assess quality of life respiratory health asthma control depression inhaler use beliefs and satisfaction with the intervention Electronic medical record data and questionnaires will be used to determine adherence rates
This 19-month study will enroll approximately 14000 members of the Kaiser Permanente Northwest or Hawaii health system Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care Over the 19-month period participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS If needed the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist Approximately 2000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period The questionnaires will assess quality of life respiratory health asthma control depression inhaler use beliefs and satisfaction with the intervention Electronic medical record data and questionnaires will be used to determine adherence rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL083433-01A1 | NIH | None | httpsreporternihgovquickSearchR01HL083433-01A1 |
| R01HL083433 | NIH | None | None |