Overview

This trial is active, not recruiting.

Condition asthma
Treatment telephone-based medication adherence intervention
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Start date June 2007
End date April 2009
Trial size 14064 participants
Trial identifier NCT00414817, 443, R01 HL083433-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
telephone-based medication adherence intervention The BREATHE EASY Medication Reminder Program
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.
(No Intervention)
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.

Primary Outcomes

Measure
Days supply of inhaled corticosteroids available as documented in patients' pharmacy records will measure adherence to inhaled corticosteroids
time frame: Measured at 19 months

Secondary Outcomes

Measure
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
Medical record data will be used to measure rate of acute health care utilization for asthma
time frame: Measured at 19 months
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Received treatment for asthma in the year prior to study entry - Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry - Continuous Kaiser Permanente membership from the year prior to study entry through study entry

Additional Information

Official title Phone Calls to Promote Adherence With Inhaled Corticosteroids
Principal investigator William M. Vollmer, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).