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Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00414817
First received: December 20, 2006
Last updated: June 3, 2010
Last verified: April 2009
  Purpose

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
Asthma
Behavioral: Telephone-Based Medication Adherence Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14064
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)
Arms Assigned Interventions
Experimental: 1
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414817

Locations
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
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William M. Vollmer / Senior Investigator, Kaiser Permanente NW, Center for Health Research
ClinicalTrials.gov Identifier: NCT00414817     History of Changes
Other Study ID Numbers: 443, R01 HL083433-01A1
Study First Received: December 20, 2006
Last Updated: June 3, 2010
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Inhaled Corticosteroids
ICS
Adherence

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014