Motivational Intervention for Asthma (MI-ACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Hopital du Sacre-Coeur de Montreal
Sponsor:
Collaborator:
Jewish General Hospital
Information provided by (Responsible Party):
Simon Bacon, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT01381159
First received: June 21, 2011
Last updated: October 16, 2012
Last verified: October 2012
  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: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motivational Intervention for Asthma Control Trial

Resource links provided by NLM:


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 ]
    Inhaled corticosteroid adherence 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 ]
    Inhaled corticosteroid adherence 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)

  • Modified Morisky Self-Rated Measure of Medication Adherence [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Self-reproted medication adherence measure

  • Asthma Control Questionnaire (Juniper) [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Self report measure of asthma symptoms

  • Asthma Control Test [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Self report measures of asthma symptoms

  • Asthma Self-Efficacy Scale (Tobin) [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Self report measure of asthma self-efficacy, i.e., perceived ability to deal with asthma

  • Mini Asthma Quality of Life Questionnaire (Juniper) [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Self report measure of how asthma influences quality of life


Estimated Enrollment: 182
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interviewing
Brief MI sessions within 4-6 week period
Behavioral: Motivational Interviewing
Brief MI sessions focused on medication adherence within 4-6 week period
Sham Comparator: Control
Usual care and contact time within 4-6 week period
Behavioral: Control
Standard medical care and contact time matched to the active intervention within 4-6 week period

  Show Detailed Description

  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 (≥ 1.25 on the Asthma Control Questionnaire)
  • Covered by a drug insurance plan (e.g., RAMQ)
  • Non-adherent to ICS medication (based on having filled less than 50% 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
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: NCT01381159

Contacts
Contact: Guillaume Lacoste, BSc 514-338-2222 ext 3364 g_lacoste_@hotmail.com
Contact: Chantal Daigneault, BSc 514-338-2222 ext 3364 chantal.daigneault@crhsc.rtss.qc.ca

Locations
Canada, Quebec
Hopital du Sacre-Coeur de Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Guillaume Lacoste    514-338-2222 ext 3364    g_lacoste_@hotmail.com   
Principal Investigator: Kim L Lavoie, PhD         
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Jewish General Hospital
Investigators
Principal Investigator: Kim L Lavoie, PhD Hopital du Sacre-Couer de Montreal
Study Chair: Simon L Bacon, PhD Hopital du Sacre-Coeur de Montreal
  More Information

Additional Information:
No publications provided

Responsible Party: Simon Bacon, Researcher, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT01381159     History of Changes
Other Study ID Numbers: MBMC002, MOP 111123
Study First Received: June 21, 2011
Last Updated: October 16, 2012
Health Authority: Canada: Canadian Institutes of Health Research
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 July 24, 2014