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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00414817 |
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.
Condition | Intervention |
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Asthma |
Behavioral: Telephone-Based Medication Adherence Intervention |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phone Calls to Promote Adherence With Inhaled Corticosteroids |
Enrollment: | 14064 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Intervention Arm: Participants randomly assigned to this study arm may receive up to 5 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 12 month intervention period.
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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.
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2: 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.
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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 1-year 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 1-year period, participants in the intervention group will receive between one and five 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 Year 1. 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 |
Responsible Party: | Kaiser Permanente NW, Center for Health Research ( William M. Vollmer / Senior Investigator ) |
Study ID Numbers: | 443, R01 HL083433-01A1 |
Study First Received: | December 20, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00414817 |
Health Authority: | United States: Federal Government |
Inhaled Corticosteroids ICS Adherence |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |