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Completed

NCT Number: NCT00414817

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Research/KPH, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Phone-Based Refill Reminders

Behavioral

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 names: The BREATHE EASY Medication Reminder Program

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Phone Calls to Promote Adherence With Inhaled Corticosteroids

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2006
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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