Motivational Intervention for Asthma (MI-ACT)
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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 |
- 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)
- 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 |
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| 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 |
| 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 | |
| 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 May 23, 2013