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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00414817
First received: December 20, 2006
Last updated: December 6, 2016
Last verified: December 2016
  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: Automated Phone-Based Refill Reminders

Study Type: Interventional
Study Design: Allocation: Randomized
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 Kaiser Permanente:

Primary Outcome Measures:
  • Modified Medication Possession Ratio [ Time Frame: Measured over 19 months ]
    We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.


Secondary Outcome Measures:
  • Juniper Asthma Quality of Life Questionnaire (Global Score) [ Time Frame: Measured at 19 months ]
    Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.

  • Rate of Acute Health Care Visits for Asthma [ Time Frame: Measured over 19 months of follow-up ]
    annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.


Enrollment: 14064
Study Start Date: June 2007
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Automated Phone-Based Refill Reminders
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: Automated Phone-Based Refill Reminders
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: Usual Care
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Willing to participate in the study

Exclusion Criteria:

  • Excluded from primary analyses if fewer than three months of follow-up
  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, 97227
Sponsors and Collaborators
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
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

Additional Information:
Publications:
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00414817     History of Changes
Other Study ID Numbers: 443
R01HL083433 ( US NIH Grant/Contract Award Number )
R01HL083433-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: December 20, 2006
Results First Received: July 23, 2015
Last Updated: December 6, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Kaiser Permanente:
Inhaled Corticosteroids
ICS
Adherence

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

ClinicalTrials.gov processed this record on June 28, 2017