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Motivational Interviewing for Medication Adherence in Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Simon Bacon, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT01132430
First received: May 27, 2010
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Behavioral: Motivational interviewing
Behavioral: Usual care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Motivational Interviewing Intervention on Medication Adherence in Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Further study details as provided by Hopital du Sacre-Coeur de Montreal:

Primary Outcome Measures:
  • Inhaled corticosteroid adherence [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Inhaled corticosteroid adherence [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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)

  • Morisky Self-Rated Measure of Medication Adherence [ Time Frame: 12 months post-intervention, with preliminary data collected at 6 months ] [ Designated as safety issue: No ]
  • Asthma Control Questionnaire (Juniper) [ Time Frame: 12 months post-intervention, with preliminary data collected at 6 months ] [ Designated as safety issue: No ]
  • Asthma Control Test [ Time Frame: 12 months post-intervention, with preliminary data collected at 6 months ] [ Designated as safety issue: No ]
  • Asthma Self-Efficacy Scale (Tobin) [ Time Frame: 12 months post-intervention, with preliminary data collected at 6 months ] [ Designated as safety issue: No ]
  • Asthma Quality of Life Questionnaire (Juniper) [ Time Frame: 12 months post-intervention, with preliminary data collected at 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132430

Locations
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Investigators
Principal Investigator: Kim L Lavoie, PhD Hopital du Sacre-Coeur de Montreal
  More Information

No publications provided

Responsible Party: Simon Bacon, Co-PI, PI is Dr. Kim Lavoie, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT01132430     History of Changes
Other Study ID Numbers: MBMC001
Study First Received: May 27, 2010
Last Updated: October 16, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital du Sacre-Coeur de Montreal:
ADHERENCE
ASTHMA CONTROL
ASTHMA QUALITY OF LIFE
MOTIVATIONAL INTERVIEWING

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 May 16, 2013