Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma
Recruitment status was Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phone Calls to Promote Adherence With Inhaled Corticosteroids|
- Days supply of inhaled corticosteroids available as documented in patients' pharmacy records will measure adherence to inhaled corticosteroids [ Time Frame: Measured at 19 months ] [ Designated as safety issue: No ]
- Survey responses from a subset of our population and medical record data will be used to measure participant health status [ Time Frame: Measured at 19 months ] [ Designated as safety issue: No ]
- Medical record data will be used to measure rate of acute health care utilization for asthma [ Time Frame: Measured at 19 months ] [ Designated as safety issue: No ]
- An economic analysis will be conducted using medical record data to assess cost of acute health care utilization for asthma [ Time Frame: Measured at 19 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.
Behavioral: Telephone-Based Medication Adherence Intervention
The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.
Other Name: The BREATHE EASY Medication Reminder Program
No Intervention: 2
Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention.
Asthma is a serious, chronic disease that affects lung function and impairs an individual's 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 14,000 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 2,000 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414817
|United States, Hawaii|
|Center for Health Research/KPH|
|Honolulu, Hawaii, United States, 96817|
|United States, Oregon|
|Center for Health Research-KPNW|
|Portland, Oregon, United States|
|Principal Investigator:||William M. Vollmer, PhD||Center for Health Research/KPNW|
|Principal Investigator:||Cynthia Rand, PhD||Johns Hopkins University|
|Principal Investigator:||Joan Dubanoski, PhD||Center for Health Research/KPH|
|Principal Investigator:||Adrianne Feldstein, MD||Center for Health Research/KPNW|
|Principal Investigator:||David Smith, PhD||Center for Health Research/KPNW|