Motivational Interviewing for Medication Adherence in Asthma

February 9, 2018 updated by: Simon Bacon, Hopital du Sacre-Coeur de Montreal

Impact of a Motivational Interviewing Intervention on Medication Adherence in Patients With Asthma

The high burden of asthma appears to be related to poor asthma control, which is associated with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and worse pulmonary function. Despite the availability of effective treatments, more than 58% of asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is considered by experts to be one of the most important behavioral factors linked to achieving optimal asthma control. However, there is a paucity of research on interventions specifically designed to improve ICS adherence among adult asthmatics. The vast majority of intervention studies to date used atheoretical interventions to target behavior change, relying mainly upon educational approaches which have been criticised for "failing to translate knowledge into action." This may be due to the fact that most education-based approaches do not specifically address or help patients overcome ambivalence about behavior change, which is necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred intervention that focuses on enhancing intrinsic motivation to change a particular behavior, and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve medication adherence) and health outcomes (reduce blood pressure, body mass index, and cholesterol levels). However, no studies to date have assessed the efficacy of using MI to improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit significantly improved ICS adherence at 6 and 12-months post-intervention, independent of baseline levels and covariates, relative to patients randomized to the usual care control condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital du Sacre-Coeur de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years and older
  • Primary diagnosis of moderate-severe persistent asthma (as per GINA)
  • Prescribed inhaled corticosteroid medication (min dose of 250 µg fluticasone equivalent per day) for at least 12 consecutive months
  • Uncontrolled asthma (≤ 19 on the Asthma Control Test)
  • Covered by a drug insurance plan (e.g., RAMQ)
  • Non-adherent to ICS medication (based on having filled less than 30% of their prescriptions over the last year)
  • Able to speak English or French.

Exclusion Criteria:

  • Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
  • Severe psychopathology (e.g., schizophrenia)
  • Apparent cognitive or language deficit
  • Are or plan to become pregnant or move outside of Quebec over the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual care
Standard medical care within 4-6 week period
Behavioral: Usual care
Standard medical care within 4-6 week period
Experimental: Motivational interviewing
Brief MI sessions within 4-6 week period
Behavioral: Motivational interviewing
Brief MI 3x30 minute sessions within 4-6 week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhaled corticosteroid adherence
Time Frame: 12 months post-intervention
measured according to the following validated equation: # of treatment days (based on the # of canisters filled at the pharmacy x the duration of each prescription) divided by the # of prescription days (# of days the patient is expected to be taking his/her medication)
12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhaled corticosteroid adherence
Time Frame: 6 months post-intervention
measured according to the following validated equation: # of treatment days (based on the # of canisters filled at the pharmacy x the duration of each prescription) divided by the # of prescription days (# of days the patient is expected to be taking his/her medication)
6 months post-intervention
Asthma Control Questionnaire (Juniper)
Time Frame: 12 months post-intervention, with preliminary data collected at 6 months
12 months post-intervention, with preliminary data collected at 6 months
Asthma Control Test
Time Frame: 12 months post-intervention, with preliminary data collected at 6 months
12 months post-intervention, with preliminary data collected at 6 months
Asthma Self-Efficacy Scale (Tobin)
Time Frame: 12 months post-intervention, with preliminary data collected at 6 months
12 months post-intervention, with preliminary data collected at 6 months
Asthma Quality of Life Questionnaire (Juniper)
Time Frame: 12 months post-intervention, with preliminary data collected at 6 months
12 months post-intervention, with preliminary data collected at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital du Sacre-Coeur de Montreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBMC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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